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https://zephyrnet.com/NCT03797807
2019-03-20
https://zephyrnet.com/?p=NCT03797807
NCT03797807https://www.clinicaltrials.gov/study/NCT03797807?tab=tableVandana Luthra, Dr.BHNT.Clinicaloralresearchcentre@nhs.net02078826348To compare the efficacy of a modified minimally-invasive non-surgical periodontal therapy (MINST) approach with a surgical approach (M-MIST) in determining bone and clinical attachment changes in intrabony defects
<![CDATA[
Studies
Study First Submitted Date | 2018-12-19 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-05-26 |
Start Month Year | March 20, 2019 |
Primary Completion Month Year | April 30, 2025 |
Verification Month Year | May 2023 |
Verification Date | 2023-05-31 |
Last Update Posted Date | 2023-05-26 |
Detailed Descriptions
Sequence: | 20668410 |
Description | Periodontal diseases are inflammatory conditions that affect the supporting apparatus of the teeth, including gingiva and alveolar bone. The bone loss resulting from periodontitis often is irregular and localised, giving onset to 'intrabony' or 'vertical defects' affecting one side of the tooth more than the other and more than on the neighbouring teeth. Periodontal intrabony defects have been associated with a higher risk of further progression and eventually tooth loss.
The treatment of periodontitis involves a non-specific reduction of the bacterial load below the gingival margin. This is achieved by oral hygiene instructions (OHI) and non-surgical periodontal therapy (NSPT), aimed at removing calculus and disrupting the plaque biofilm from the affected root surfaces. Intrabony defects are considered sites requiring therapy, often beyond NSPT. Decades ago, intrabony defects were treated with surgical elimination of the defect achieved by sacrificing the adjacent healthy supportive or non-supportive bone. More recently periodontal regenerative procedures have been advocated for deep intrabony defects, which are considered amenable for guided tissue regeneration. This technique results in regeneration of periodontal attachment measurable histologically and radiographically and measurable clinically. However, this is associated with potential morbidity and high costs due to the use of bone graft and barrier materials and is not always predictable. The more recent introduction of minimally-invasive surgical therapy (MIST), modified-MIST (M-MIST) and single-flap approach suggested that the use of biomaterials may not be so crucial for obtaining periodontal regeneration. Retrospective studies from the investigator's group have shown that minimally invasive non-surgical periodontal treatment of intrabony defects results in clinical improvements (measured as PPD reductions and clinical attachment level-CAL- gain) but also in bone fill of the bony defects, measurable radiographically. The extent of the radiographic resolution of the defect was positively associated with initial defect depth and use of adjunctive antibiotics, while smoking seemed to negatively influence this outcome. A non-surgical minimally-invasive treatment protocol, named MINST, has been proposed along these principles. A more recent retrospective analysis has revealed a reduction in bony defect of nearly 3 mm for cases treated with minimally-invasive non-surgical therapy. The effect of MINST may be mediated by improved blood flow and stable blood clot in the intrabony defect. However, very few studies have been published on MINST and no data are available on the comparison between MINST and MIST. This is a parallel group, single centre, examiner-blind, non-inferiority randomized controlled trial to compare the effect of a modified minimally-invasive non-surgical therapy (MINST) approach to minimally invasive surgical treatment (MIST) in the healing of periodontal intrabony defects in 66 patients with periodontitis . |
Facilities
Sequence: | 199508244 |
Status | Recruiting |
Name | Barts and The London Dental Hospital |
City | London |
Zip | E1 2AD |
Country | United Kingdom |
Facility Contacts
Sequence: | 28041986 | Sequence: | 28041987 |
Facility Id | 199508244 | Facility Id | 199508244 |
Contact Type | primary | Contact Type | backup |
Name | Rinat Ezra, PhD | Name | Simona Salomone, PhD |
BHNT.Clinicaloralresearchcentre@nhs.net | BHNT.Clinicaloralresearchcentre@nhs.net | ||
Phone | 0207 882 6348 | Phone | 0207 882 6064 |
Phone Extension | 6348 | Phone Extension | 6064 |
Conditions
Sequence: | 52032178 |
Name | Periodontitis |
Downcase Name | periodontitis |
Id Information
Sequence: | 40049393 |
Id Source | org_study_id |
Id Value | 18/LO/1956 |
Countries
Sequence: | 42447076 |
Name | United Kingdom |
Removed | False |
Design Groups
Sequence: | 55440100 | Sequence: | 55440101 | Sequence: | 55440102 | Sequence: | 55440103 |
Group Type | Experimental | Group Type | Active Comparator | Group Type | Active Comparator | Group Type | Active Comparator |
Title | MINST | Title | MIST | Title | GTI + MINST | Title | GTI + MIST |
Description | Minimally invasive non surgical treatment | Description | Minimally invasive surgical treatment | Description | Minimally invasive non surgical treatment + Geometric/Thermal Imaging (GTI subgroup) | Description | Minimally invasive surgical treatment + Geometric/Thermal Imaging (GTI subgroup) |
Interventions
Sequence: | 52344252 | Sequence: | 52344253 | Sequence: | 52344254 |
Intervention Type | Procedure | Intervention Type | Procedure | Intervention Type | Diagnostic Test |
Name | MINST | Name | MIST | Name | GTI subgroup (Geometrical/Thermal Imaging) |
Description | A non-surgical minimally invasive treatment protocol, named MINST, has been proposed for the treatment of periodontal intrabony defects, in order to minimize patient discomfort and maximize the healing potential | Description | A minimally invasive surgical treatment protocol, named MIST, has been proposed for the treatment of periodontal intrabony defects, in order to minimize patient discomfort and maximize the healing potential | Description | Geometrical/Thermal Imaging |
Design Outcomes
Sequence: | 176898043 | Sequence: | 176898044 | Sequence: | 176898045 | Sequence: | 176898046 | Sequence: | 176898047 | Sequence: | 176898048 | Sequence: | 176898049 | Sequence: | 176898050 | Sequence: | 176898051 |
Outcome Type | primary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Radiographic whole defect depth change | Measure | Probing Pocket Depth (PPD) change | Measure | Clinical Attachment Level (CAL) gain change | Measure | Markers and growth factors in gingival crevicular fluid (GCF) | Measure | Bacterial detection | Measure | Gingival inflammation and healing | Measure | Self administered OIDP (oral impact on daily performances index) | Measure | Global ratings on health and quality of life with Visual Analogue Scale (VAS) | Measure | Global ratings on health and quality of life with a question "How would you rate the quality of your life" |
Time Frame | 9 months | Time Frame | Up to 15 months | Time Frame | Up to 15 months | Time Frame | Up to 15 months | Time Frame | Up to 15 months | Time Frame | Up to 15 months | Time Frame | Up to 9 months | Time Frame | Up to 9 months | Time Frame | Up to 9 months |
Description | Radiographic whole defect depth change in millimeters at 9 months [considered a surrogate measure evaluating the entire regenerative process including bone, cementum and periodontal ligament | Description | Probing Pocket Depth (PPD) change (in mm) | Description | Clinical Attachment Level (CAL) gain change (in mm) | Description | Levels of inflammatory markers and growth factors in gingival crevicular fluid (GCF). Specifically, markers related with the healing of epithelium, connective tissue, bone and related to inflammatory/host responses will be examined. | Description | Bacterial detection associated with presence of intrabony defects | Description | Gingival inflammation and healing (as measured by geometric/thermal stereophotogrammetry imaging in the 'GTI sub-study') | Description | We will utilize the oral impact on daily performances index (OIDP) to evaluate health and treatment outcomes. The OIDP focuses on the impact that the conditions of the teeth and mouth have on the physical/functional, psychological and social well-being of the person. Particularly, it assesses the impact of oral conditions on basic daily life activities and behaviours (eating, speaking, cleaning teeth, and going out, relaxing, smiling, major work or role, emotional stability, social contact). For each performance, both the frequency and severity of oral impacts are assessed. The overall OIDP score ranges from 0 to 100, with higher scores indicating worse quality of life. | Description | The VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. | Description | The responses will be scored on a six-point scale as:
Excellent |
Browse Conditions
Sequence: | 192933827 | Sequence: | 192933828 | Sequence: | 192933829 | Sequence: | 192933830 |
Mesh Term | Periodontitis | Mesh Term | Periodontal Diseases | Mesh Term | Mouth Diseases | Mesh Term | Stomatognathic Diseases |
Downcase Mesh Term | periodontitis | Downcase Mesh Term | periodontal diseases | Downcase Mesh Term | mouth diseases | Downcase Mesh Term | stomatognathic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48189442 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Queen Mary University of London |
Overall Officials
Sequence: | 29204859 |
Role | Principal Investigator |
Name | Luigi Nibali, PhD |
Affiliation | Barts & The London School of Medicine & Dentistry, QMUL |
Central Contacts
Sequence: | 11978642 |
Contact Type | primary |
Name | Vandana Luthra, Dr. |
Phone | 02078826348 |
BHNT.Clinicaloralresearchcentre@nhs.net | |
Role | Contact |
Design Group Interventions
Sequence: | 67963528 | Sequence: | 67963529 | Sequence: | 67963530 | Sequence: | 67963531 | Sequence: | 67963532 | Sequence: | 67963533 |
Design Group Id | 55440102 | Design Group Id | 55440100 | Design Group Id | 55440103 | Design Group Id | 55440101 | Design Group Id | 55440102 | Design Group Id | 55440103 |
Intervention Id | 52344252 | Intervention Id | 52344252 | Intervention Id | 52344253 | Intervention Id | 52344253 | Intervention Id | 52344254 | Intervention Id | 52344254 |
Eligibilities
Sequence: | 30683699 |
Gender | All |
Minimum Age | 25 Years |
Maximum Age | 70 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Age 25-70 Exclusion Criteria: 1. Smoking (current or in past 5 years) including e-cigarettes/vaping 2. Medical history including diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases 3. History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures 4. Antiinflammatory or anticoagulant therapy during the month preceding the baseline exam 5. Systemic antibiotic therapy during the 3 months preceding the baseline exam 6. History of alcohol or drug abuse, 7. Self-reported pregnancy or lactation 8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that according to the investigator may increase the risk associated with trial participation, 9. Periodontal treatment to the study site within the last 12 months (excluding not-extensive subgingival debridement as judged by the examining clinician). – |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253886571 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 25 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 8 |
Designs
Sequence: | 30430426 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28796932 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 51921492 | Sequence: | 51921493 | Sequence: | 51921494 | Sequence: | 51921495 | Sequence: | 51921496 | Sequence: | 51921497 | Sequence: | 51921498 | Sequence: | 51921499 | Sequence: | 51921500 | Sequence: | 51921501 | Sequence: | 51921502 | Sequence: | 51921503 |
Pmid | 11276518 | Pmid | 2066446 | Pmid | 12787211 | Pmid | 6964676 | Pmid | 11276509 | Pmid | 16625546 | Pmid | 19186978 | Pmid | 21303402 | Pmid | 21091528 | Pmid | 21284549 | Pmid | 26257238 | Pmid | 31351492 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | derived |
Citation | Papapanou PN, Tonetti MS. Diagnosis and epidemiology of periodontal osseous lesions. Periodontol 2000. 2000 Feb;22:8-21. doi: 10.1034/j.1600-0757.2000.2220102.x. No abstract available. | Citation | Papapanou PN, Wennstrom JL. The angular bony defect as indicator of further alveolar bone loss. J Clin Periodontol. 1991 May;18(5):317-22. doi: 10.1111/j.1600-051x.1991.tb00435.x. | Citation | Heitz-Mayfield LJ, Trombelli L, Heitz F, Needleman I, Moles D. A systematic review of the effect of surgical debridement vs non-surgical debridement for the treatment of chronic periodontitis. J Clin Periodontol. 2002;29 Suppl 3:92-102; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.5.x. | Citation | Nyman S, Lindhe J, Karring T, Rylander H. New attachment following surgical treatment of human periodontal disease. J Clin Periodontol. 1982 Jul;9(4):290-6. doi: 10.1111/j.1600-051x.1982.tb02095.x. | Citation | Cortellini P, Tonetti MS. Focus on intrabony defects: guided tissue regeneration. Periodontol 2000. 2000 Feb;22:104-32. doi: 10.1034/j.1600-0757.2000.2220108.x. No abstract available. | Citation | Needleman IG, Worthington HV, Giedrys-Leeper E, Tucker RJ. Guided tissue regeneration for periodontal infra-bony defects. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD001724. doi: 10.1002/14651858.CD001724.pub2. | Citation | Trombelli L, Farina R, Franceschetti G, Calura G. Single-flap approach with buccal access in periodontal reconstructive procedures. J Periodontol. 2009 Feb;80(2):353-60. doi: 10.1902/jop.2009.080420. | Citation | Cortellini P, Tonetti MS. Clinical and radiographic outcomes of the modified minimally invasive surgical technique with and without regenerative materials: a randomized-controlled trial in intra-bony defects. J Clin Periodontol. 2011 Apr;38(4):365-73. doi: 10.1111/j.1600-051X.2011.01705.x. Epub 2011 Feb 8. | Citation | Nibali L, Pometti D, Tu YK, Donos N. Clinical and radiographic outcomes following non-surgical therapy of periodontal infrabony defects: a retrospective study. J Clin Periodontol. 2011 Jan;38(1):50-7. doi: 10.1111/j.1600-051X.2010.01648.x. Epub 2010 Nov 22. | Citation | Ribeiro FV, Casarin RC, Palma MA, Junior FH, Sallum EA, Casati MZ. Clinical and patient-centered outcomes after minimally invasive non-surgical or surgical approaches for the treatment of intrabony defects: a randomized clinical trial. J Periodontol. 2011 Sep;82(9):1256-66. doi: 10.1902/jop.2011.100680. Epub 2011 Feb 2. | Citation | Nibali L, Pometti D, Chen TT, Tu YK. Minimally invasive non-surgical approach for the treatment of periodontal intrabony defects: a retrospective analysis. J Clin Periodontol. 2015 Sep;42(9):853-859. doi: 10.1111/jcpe.12443. Epub 2015 Sep 29. | Citation | Nibali L, Koidou V, Salomone S, Hamborg T, Allaker R, Ezra R, Zou L, Tsakos G, Gkranias N, Donos N. Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial. Trials. 2019 Jul 27;20(1):461. doi: 10.1186/s13063-019-3544-8. |
]]>
https://zephyrnet.com/NCT03797794
2019-01-31
https://zephyrnet.com/?p=NCT03797794
NCT03797794https://www.clinicaltrials.gov/study/NCT03797794?tab=tableHuib Kerstjensh.a.m.kerstjens@umcg.nlNAThe effect of PESF (Pulsating Electrostatic Field) on the oxygen saturation, quality of life and the exercise capacity will be studied in a randomized, dubbel blind, placebo-controlled parallel design with 32 COPD patients GOLD III and IV with a oxygen saturation below or equal to 90%.
The patients will be treated with three 30-minute PESF- or placebo-sessions distributed over 5 days.
Directly before the first session, oxygen saturation, quality of life (CCQuestionnaire), exercise capacity (6-MWT and grip strength) and phase angle (BIA) will be measured and compared to the results directly after the third session. Oxygen saturation is also monitored during 24 hours after each session.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | January 2019 |
Primary Completion Month Year | November 1, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Facilities
Sequence: | 199965117 |
Status | Recruiting |
Name | Tjongerschans |
City | Heerenveen |
State | Friesland |
Zip | 8441 PW |
Country | Netherlands |
Facility Contacts
Sequence: | 28086663 |
Facility Id | 199965117 |
Contact Type | primary |
Name | Jaap Westbroek |
j.westbroek@tjongerschans.nl | |
Phone | 0513-685227 |
Conditions
Sequence: | 52139061 |
Name | COPD |
Downcase Name | copd |
Id Information
Sequence: | 40135104 |
Id Source | org_study_id |
Id Value | PESF and COPD |
Countries
Sequence: | 42542719 |
Name | Netherlands |
Removed | False |
Design Groups
Sequence: | 55559415 | Sequence: | 55559416 |
Group Type | Experimental | Group Type | Sham Comparator |
Title | PESF-treatment | Title | Placebo-treatment |
Description | The group undergoing the pulsating electrostatic field intervention | Description | The group undergoing the SHAM Pulsating Electrostatic Field |
Interventions
Sequence: | 52454970 | Sequence: | 52454971 |
Intervention Type | Device | Intervention Type | Device |
Name | Pulsating Electrostatic Field | Name | SHAM Pulsating Electrostatic Field |
Description | A pulsating electrostatic field is generated by the New Health 9000 (Akern). During the session the patients sits on a chair which contains the apparatus for 30 minutes. | Description | The same apparatus which produces the pulsating electrostatic field contains a 'sham-inlet'. This inlet will be used as placebo. |
Design Outcomes
Sequence: | 177264038 | Sequence: | 177264039 | Sequence: | 177264040 | Sequence: | 177264041 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Improvement of oxygen saturation | Measure | Improvement of quality of life | Measure | Improvement of exercise capacity | Measure | Improvement of phase angle |
Time Frame | 5 days | Time Frame | 5 days | Time Frame | 5 days | Time Frame | 5 days |
Description | Difference in oxygen saturation before first vs after last session | Description | Difference in CCQ score before first vs after last session | Description | Difference in 6-MWT outcome before first vs after last session | Description | Difference in oxygen saturation before first vs after last session |
Sponsors
Sequence: | 48290758 | Sequence: | 48290759 |
Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University Medical Center Groningen | Name | Tjongerschans hospital |
Central Contacts
Sequence: | 12000498 | Sequence: | 12000499 |
Contact Type | primary | Contact Type | backup |
Name | Jaap Westbroek | Name | Huib Kerstjens |
Phone | 0513-685227 | ||
j.westbroek@tjongerschans.nl | h.a.m.kerstjens@umcg.nl | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68107533 | Sequence: | 68107534 |
Design Group Id | 55559415 | Design Group Id | 55559416 |
Intervention Id | 52454970 | Intervention Id | 52454971 |
Eligibilities
Sequence: | 30747756 |
Gender | All |
Minimum Age | 40 Years |
Maximum Age | 85 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
COPD patients, post-bronchodilator FEV1/FVC <70% and FEV1 <50% predicted Exclusion Criteria: Known malignant condition with limited life expectancy |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254122066 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 40 |
Maximum Age Num | 85 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30494039 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Intervention Model Description | prospective, randomized, dubbel blind, placebo-controlled parallel study |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28860319 |
Responsible Party Type | Principal Investigator |
Name | Huib A.M. Kerstjens |
Title | Head of the department Pulmonary diseases and Tuberculosis |
Affiliation | University Medical Center Groningen |
]]>
https://zephyrnet.com/NCT03797781
2017-10-31
https://zephyrnet.com/?p=NCT03797781
NCT03797781https://www.clinicaltrials.gov/study/NCT03797781?tab=tableNANANAThe effect of different protein intakes on skeletal muscle atrophy during short term unilateral leg immobilisation.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2020-09-28 |
Start Month Year | October 31, 2017 |
Primary Completion Month Year | December 31, 2019 |
Verification Month Year | September 2020 |
Verification Date | 2020-09-30 |
Last Update Posted Date | 2020-09-28 |
Facilities
Sequence: | 200159416 |
Name | Sport and Health Science |
City | Exeter |
State | Devon |
Zip | EX1 2LU |
Country | United Kingdom |
Conditions
Sequence: | 52185496 |
Name | Muscle Atrophy |
Downcase Name | muscle atrophy |
Id Information
Sequence: | 40169077 |
Id Source | org_study_id |
Id Value | 6500619582 |
Countries
Sequence: | 42580668 |
Name | United Kingdom |
Removed | False |
Design Groups
Sequence: | 55609126 | Sequence: | 55609127 | Sequence: | 55609128 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | High protein | Title | Low protein | Title | Minimum protein |
Interventions
Sequence: | 52499438 |
Intervention Type | Other |
Name | Lower limb immobilisation (leg brace) with varying levels of protein intake |
Description | Single leg immobilisation via leg brace and crutches, the groups have different amounts of protein intake |
Design Outcomes
Sequence: | 177432050 | Sequence: | 177432051 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Muscle size | Measure | Muscle strength |
Time Frame | 3 days | Time Frame | 3 days |
Browse Conditions
Sequence: | 193540163 | Sequence: | 193540164 | Sequence: | 193540165 | Sequence: | 193540166 | Sequence: | 193540167 | Sequence: | 193540168 |
Mesh Term | Muscular Atrophy | Mesh Term | Atrophy | Mesh Term | Pathological Conditions, Anatomical | Mesh Term | Neuromuscular Manifestations | Mesh Term | Neurologic Manifestations | Mesh Term | Nervous System Diseases |
Downcase Mesh Term | muscular atrophy | Downcase Mesh Term | atrophy | Downcase Mesh Term | pathological conditions, anatomical | Downcase Mesh Term | neuromuscular manifestations | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | nervous system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332341 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Exeter |
Design Group Interventions
Sequence: | 68168188 | Sequence: | 68168189 | Sequence: | 68168190 |
Design Group Id | 55609126 | Design Group Id | 55609127 | Design Group Id | 55609128 |
Intervention Id | 52499438 | Intervention Id | 52499438 | Intervention Id | 52499438 |
Eligibilities
Sequence: | 30773581 |
Gender | Male |
Minimum Age | 18 Years |
Maximum Age | 35 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
BMI >18 and <28 no prescription medications or current illness. Exclusion Criteria: BMI <18 and >28 current prescription medication no history of leg injury. |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253952743 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 26 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 35 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30519712 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | Single |
Subject Masked | True |
Responsible Parties
Sequence: | 28886013 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52078924 |
Pmid | 32469388 |
Reference Type | derived |
Citation | Kilroe SP, Fulford J, Jackman S, Holwerda A, Gijsen A, van Loon L, Wall BT. Dietary protein intake does not modulate daily myofibrillar protein synthesis rates or loss of muscle mass and function during short-term immobilization in young men: a randomized controlled trial. Am J Clin Nutr. 2021 Mar 11;113(3):548-561. doi: 10.1093/ajcn/nqaa136. |
]]>
https://zephyrnet.com/NCT03797768
2019-12-25
https://zephyrnet.com/?p=NCT03797768
NCT03797768https://www.clinicaltrials.gov/study/NCT03797768?tab=tableNANANAChronic Obstructive Pulmonary Disease (COPD) is the fourth most important cause of death worldwide and is one of the commonest non-communicable diseases (NCDs) in Nepal. The presence of risk factors like indoor and outdoor air pollution, the high prevalence of smoking and lack of general awareness of COPD makes it a serious public health concern. However, no attempt has been made in Nepal to estimate its burden and address the disease at the community level. This community-based cluster randomized controlled study aims to fulfil that gap through mobilization of Female Community Health Workers (FCHVs) who will be trained to perform a certain set of health promotion activities aimed at prevention of the disease and its progression. Baseline and follow-up surveys will be conducted to compare the intervention and control groups. This study has the potential to generate evidence in helping address NCDs in Nepal and also other similar resource-limited countries.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2021-01-28 |
Start Month Year | December 25, 2019 |
Primary Completion Month Year | May 10, 2021 |
Verification Month Year | March 2020 |
Verification Date | 2020-03-31 |
Last Update Posted Date | 2021-01-28 |
Facilities
Sequence: | 200053304 |
Name | Aarhus University |
City | Aarhus |
Zip | 8000 |
Country | Denmark |
Conditions
Sequence: | 52156512 |
Name | Chronic Obstructive Pulmonary Disease |
Downcase Name | chronic obstructive pulmonary disease |
Id Information
Sequence: | 40148220 |
Id Source | org_study_id |
Id Value | AUTBA18 |
Countries
Sequence: | 42557739 |
Name | Denmark |
Removed | False |
Design Groups
Sequence: | 55577917 | Sequence: | 55577918 |
Group Type | Experimental | Group Type | No Intervention |
Title | Intervention | Title | Control |
Interventions
Sequence: | 52472019 |
Intervention Type | Behavioral |
Name | Behavioural-FCHV Visit |
Description | Female Community Health Volunteer will visit selected households on average 3 times a year for providing health promotion messages on improving lung health status and avoiding risk factors to COPD. |
Design Outcomes
Sequence: | 177328035 | Sequence: | 177328036 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Forced Expiratory Volume in 1 second | Measure | Proportion of risk factors of COPD between intervention and control arm |
Time Frame | 1 year | Time Frame | 1 year |
Description | Mean difference in FVE1 between intervention and control arm |
Browse Conditions
Sequence: | 193432117 | Sequence: | 193432118 | Sequence: | 193432119 | Sequence: | 193432120 | Sequence: | 193432121 | Sequence: | 193432122 | Sequence: | 193432123 |
Mesh Term | Lung Diseases | Mesh Term | Lung Diseases, Obstructive | Mesh Term | Pulmonary Disease, Chronic Obstructive | Mesh Term | Respiratory Tract Diseases | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | lung diseases | Downcase Mesh Term | lung diseases, obstructive | Downcase Mesh Term | pulmonary disease, chronic obstructive | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306094 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Aarhus |
Overall Officials
Sequence: | 29277937 |
Role | Principal Investigator |
Name | Tara Ballav Adhikari, MScPH |
Affiliation | Department of Public Health, Aarhus University, Aarhus, Denmark |
Design Group Interventions
Sequence: | 68130884 |
Design Group Id | 55577917 |
Intervention Id | 52472019 |
Eligibilities
Sequence: | 30757362 |
Gender | All |
Minimum Age | 40 Years |
Maximum Age | 90 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Capable of performing spirometry Exclusion Criteria: Younger than 40 years of age |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254228065 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 40 |
Maximum Age Num | 90 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30503587 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Links
Sequence: | 4386996 |
Url | https://doi.org/10.2147/COPD.S268110 |
Description | Prevalence of Chronic Obstructive Pulmonary Disease and its Associated Factors in Nepal: Findings from a Community-based Household Survey |
Responsible Parties
Sequence: | 28869865 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52049416 | Sequence: | 52049417 |
Pmid | 33061350 | Pmid | 34289879 |
Reference Type | background | Reference Type | derived |
Citation | Adhikari TB, Acharya P, Hogman M, Neupane D, Karki A, Drews A, Cooper BG, Sigsgaard T, Kallestrup P. Prevalence of Chronic Obstructive Pulmonary Disease and its Associated Factors in Nepal: Findings from a Community-based Household Survey. Int J Chron Obstruct Pulmon Dis. 2020 Sep 29;15:2319-2331. doi: 10.2147/COPD.S268110. eCollection 2020. | Citation | Adhikari TB, Neupane D, Karki A, Drews A, Cooper B, Hogman M, Sigsgaard T, Kallestrup P. Community-based intervention for prevention and management of chronic obstructive pulmonary disease in Nepal (COBIN-P trial): study protocol for a cluster-randomized controlled trial. Trials. 2021 Jul 21;22(1):474. doi: 10.1186/s13063-021-05447-7. |
]]>
https://zephyrnet.com/NCT03797755
2019-01-01
https://zephyrnet.com/?p=NCT03797755
NCT03797755https://www.clinicaltrials.gov/study/NCT03797755?tab=tableShing Fung Lee, MBBS (HK), FRCR (UK)leesfm@ha.org.hk852 2468 5087Many patients with incurable cancer will receive palliative oncological treatment before their death, and radiotherapy (RT) is an important element of this. The aim of palliative RT is to alleviate symptoms and improve quality of life. An accurate and practical survival prediction model for metastatic cancer patient receiving palliative RT can assist the decision making (ranging from best supportive treatment alone for expected short survival, to dose escalation for potential better disease control).
The available survival prediction models (such Survival Prediction Score using Number of Risk Factors by Chow et al and TEACHH model) have been developed in the Western world. We therefore perform a prospective observational study 1) to assess the overall survival of patients evaluated for palliative RT at a tertiary hospital in Hong Kong, and 2) to validate the prognostic score systems in our population.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | January 1, 2019 |
Primary Completion Month Year | December 31, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Facilities
Sequence: | 200244847 |
Status | Recruiting |
Name | Department of Clinical Oncology, Tuen Mun Hospital, Tuen Mun |
City | Hong Kong |
Country | Hong Kong |
Facility Contacts
Sequence: | 28128075 |
Facility Id | 200244847 |
Contact Type | primary |
Name | Shing Fung Lee, MBBS (HK), FRCR (UK) |
leesfm@ha.org.hk | |
Phone | 852 2468 5087 |
Conditions
Sequence: | 52208405 | Sequence: | 52208406 |
Name | Cancer | Name | Radiotherapy |
Downcase Name | cancer | Downcase Name | radiotherapy |
Id Information
Sequence: | 40186362 |
Id Source | org_study_id |
Id Value | NTWC_Onc_2019 |
Countries
Sequence: | 42599841 |
Name | Hong Kong |
Removed | False |
Design Groups
Sequence: | 55635012 |
Title | Palliative Cancer Patients |
Description | Stage IV cancer patients evaluated for palliative radiotherapy. |
Interventions
Sequence: | 52522369 |
Intervention Type | Radiation |
Name | palliative radiotherapy |
Description | Radiotherapy for palliating symptoms in stage IV cancer patients |
Keywords
Sequence: | 79923392 | Sequence: | 79923393 | Sequence: | 79923394 | Sequence: | 79923395 | Sequence: | 79923396 |
Name | survival | Name | cancer | Name | palliative | Name | radiotherapy | Name | prognosis |
Downcase Name | survival | Downcase Name | cancer | Downcase Name | palliative | Downcase Name | radiotherapy | Downcase Name | prognosis |
Design Outcomes
Sequence: | 177512384 | Sequence: | 177512385 | Sequence: | 177512386 | Sequence: | 177512387 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Overall Survival | Measure | Overall Survival in Each Indication of Palliative Radiotherapy | Measure | Overall Survival by Survival Prediction Model (NRF) | Measure | Overall Survival by Survival Prediction Model (TEACHH) |
Time Frame | 1 year | Time Frame | 3, 6, 9, 12 months | Time Frame | 3, 6, 9, 12 months | Time Frame | 3, 6, 9, 12 months |
Description | Overall Survival in the studied population | Description | Indications of Palliative Radiotherapy:
The indication will be as follow: spinal cord compression brain metastases tumor bleeding tumoral mass Cancer pain Superior Vena Cava Syndrome/ Airway compression |
Description | Overall Survival by Survival Prediction Score using Number of Risk Factors (NRF) | Description | Overall Survival by Survival Prediction Score using TEACHH Model |
Sponsors
Sequence: | 48354003 |
Agency Class | OTHER_GOV |
Lead Or Collaborator | lead |
Name | Tuen Mun Hospital |
Overall Officials
Sequence: | 29306143 |
Role | Principal Investigator |
Name | Shing Fung Lee, MBBS (HK), FRCR (UK) |
Affiliation | Department of Clinical Oncology, New Territory West Cluster, Hospital Authority, Hong Kong |
Central Contacts
Sequence: | 12017289 |
Contact Type | primary |
Name | Shing Fung Lee, MBBS (HK), FRCR (UK) |
Phone | 852 2468 5087 |
leesfm@ha.org.hk | |
Role | Contact |
Design Group Interventions
Sequence: | 68199602 |
Design Group Id | 55635012 |
Intervention Id | 52522369 |
Eligibilities
Sequence: | 30787045 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Stage IV cancer patients evaluated for palliative radiotherapy in Tuen Mun Hospital |
Criteria | Inclusion Criteria:
All adult patients with stage IV cancer who are referred for palliative RT in Tuen Mun Hospital, including both inpatients and outpatients. Exclusion Criteria: Patients who have received palliative RT before (i.e. not the first course palliative RT), have non-metastatic disease, are misclassified as palliative patients. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989941 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30533115 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28899409 |
Responsible Party Type | Principal Investigator |
Name | Shing Fung Lee |
Title | Resident Specialist |
Affiliation | Tuen Mun Hospital |
Study References
Sequence: | 52103396 | Sequence: | 52103397 | Sequence: | 52103398 | Sequence: | 52103399 | Sequence: | 52103400 | Sequence: | 52103401 | Sequence: | 52103402 |
Pmid | 11527298 | Pmid | 10678857 | Pmid | 20564632 | Pmid | 19018082 | Pmid | 21263086 | Pmid | 29147245 | Pmid | 24122413 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Chow E, Harth T, Hruby G, Finkelstein J, Wu J, Danjoux C. How accurate are physicians' clinical predictions of survival and the available prognostic tools in estimating survival times in terminally ill cancer patients? A systematic review. Clin Oncol (R Coll Radiol). 2001;13(3):209-18. doi: 10.1053/clon.2001.9256. | Citation | Christakis NA, Lamont EB. Extent and determinants of error in doctors' prognoses in terminally ill patients: prospective cohort study. BMJ. 2000 Feb 19;320(7233):469-72. doi: 10.1136/bmj.320.7233.469. | Citation | Gripp S, Mjartan S, Boelke E, Willers R. Palliative radiotherapy tailored to life expectancy in end-stage cancer patients: reality or myth? Cancer. 2010 Jul 1;116(13):3251-6. doi: 10.1002/cncr.25112. | Citation | Chow E, Abdolell M, Panzarella T, Harris K, Bezjak A, Warde P, Tannock I. Predictive model for survival in patients with advanced cancer. J Clin Oncol. 2008 Dec 20;26(36):5863-9. doi: 10.1200/JCO.2008.17.1363. Epub 2008 Nov 17. | Citation | Peppercorn JM, Smith TJ, Helft PR, Debono DJ, Berry SR, Wollins DS, Hayes DM, Von Roenn JH, Schnipper LE; American Society of Clinical Oncology. American society of clinical oncology statement: toward individualized care for patients with advanced cancer. J Clin Oncol. 2011 Feb 20;29(6):755-60. doi: 10.1200/JCO.2010.33.1744. Epub 2011 Jan 24. | Citation | Chow E, James JL, Hartsell W, Scarantino CW, Ivker R, Roach M III, Suh JH, Demas W, Konski A, Bruner DW. Validation of a Predictive Model for Survival in Patients With Advanced Cancer: Secondary Analysis of RTOG 9714. World J Oncol. 2011 Aug;2(4):181-190. doi: 10.4021/wjon325w. Epub 2011 Aug 24. | Citation | Krishnan MS, Epstein-Peterson Z, Chen YH, Tseng YD, Wright AA, Temel JS, Catalano P, Balboni TA. Predicting life expectancy in patients with metastatic cancer receiving palliative radiotherapy: the TEACHH model. Cancer. 2014 Jan 1;120(1):134-41. doi: 10.1002/cncr.28408. Epub 2013 Oct 2. Erratum In: Cancer. 2019 Jul 1;125(13):2325. |
Ipd Information Types
Sequence: | 3336937 |
Name | Analytic Code |
]]>
https://zephyrnet.com/NCT03797742
2018-01-01
https://zephyrnet.com/?p=NCT03797742
NCT03797742https://www.clinicaltrials.gov/study/NCT03797742?tab=tableZhangwei Chenchen.zhangwei@zs-hospital.sh.cn+86 021 64041990Heart failure (HF), a current worldwide pandemic with an unacceptable high level of morbidity and mortality, brings an enormous medical and societal burden. Chronic HF is characterized by progressive alteration of cardiac structure and function. But the molecular mechanism of these alterations is still not well-established and needs to be discussed further. HF is a highly heterogeneous disease that can be caused by a multiple of diseases. Dilated cardiomyopathy (DCM) and ischemic cardiomyopathy (ICM) are the main causes of this syndrome. Although HF is the common manifestation of DCM and ICM, the etiology and pathogenesis are different. Understanding the different pathophysiological mechanisms will contribute to the prevention and individualized therapy of heart failure. Therefore, this study aims to observation the different characteristics of the molecular biology and clinical courses in DCM and ICM patients.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-01 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | January 1, 2018 |
Primary Completion Month Year | December 1, 2022 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Facilities
Sequence: | 200108787 |
Status | Recruiting |
Name | Zhongshan Hospital |
City | Shanghai |
Country | China |
Facility Contacts
Sequence: | 28106512 |
Facility Id | 200108787 |
Contact Type | primary |
Name | Zhangwei Chen |
chen.zhangwei@zs-hospital.sh.cn | |
Phone | +8602164041990 |
Conditions
Sequence: | 52171366 |
Name | Heart Failure |
Downcase Name | heart failure |
Id Information
Sequence: | 40158706 |
Id Source | org_study_id |
Id Value | HF201801 |
Countries
Sequence: | 42569031 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55593293 | Sequence: | 55593294 | Sequence: | 55593295 |
Title | NC | Title | DCM | Title | ICM |
Description | Patients without heart failure. | Description | Dilated cardiomyopathy patients. | Description | Ischemic cardiomyopathy patients. |
Design Outcomes
Sequence: | 177379262 | Sequence: | 177379263 | Sequence: | 177379264 | Sequence: | 177379265 | Sequence: | 177379266 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | NYHA functional class | Measure | All-cause mortality | Measure | hospitalization for cardiac causes | Measure | left ventricular end-diastolic dimension(LVEDD) dilates. | Measure | left ventricular ejection fraction reduces |
Time Frame | one year after enrolled | Time Frame | one year after enrolled | Time Frame | one year after enrolled | Time Frame | one year after enrolled | Time Frame | one year after enrolled |
Description | NYHA cardiac functional class | Description | All-cause mortality during follow-up | Description | hospitalization for cardiac causes during follow-up | Description | left ventricular structure changes:left ventricular end-diastolic dimension(LVEDD) dilates. | Description | left ventricular function changes:left ventricular ejection fraction reduces |
Browse Conditions
Sequence: | 193487183 | Sequence: | 193487184 | Sequence: | 193487185 |
Mesh Term | Heart Failure | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases |
Downcase Mesh Term | heart failure | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319401 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Shanghai Zhongshan Hospital |
Central Contacts
Sequence: | 12008908 |
Contact Type | primary |
Name | Zhangwei Chen |
Phone | +86 021 64041990 |
chen.zhangwei@zs-hospital.sh.cn | |
Role | Contact |
Eligibilities
Sequence: | 30765415 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 15 Years |
Maximum Age | 80 Years |
Healthy Volunteers | No |
Population | The inpatient in the department of cardiology of Zhongshan Hospital, Fudan University will be selected. |
Criteria | Inclusion Criteria:
LVEF≤ 55% Exclusion Criteria: Known malignant tumour diseases |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 253889193 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 15 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30511581 |
Observational Model | Case-Control |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28877876 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797729
2019-05-14
https://zephyrnet.com/?p=NCT03797729
NCT03797729https://www.clinicaltrials.gov/study/NCT03797729?tab=tableHongyi Wu, MDwu.hongyi@zs-hospital.sh.cn+8602164041990Anti-platelet therapy is a key point of acute myocardial infarction (AMI) treatment. Nowadays, dual anti-platelet therapy based on aspirin and ADP-P2Y12 receptor inhibitor is the preferred treatment before primary percutaneous coronary intervention (PPCI). Restricted by pharmacokinetic and pharmacodynamic characteristics, ADP-P2Y12 receptor inhibitors cannot take effect immediately after oral administration. However, platelet glycoprotein Ⅱb / Ⅲa inhibitors take effect faster. Previous clinical trials indicated that combination of full dose of glycoprotein Ⅱb / Ⅲa inhibitor and dual anti-platelet therapy reduced AMI related ischemia events but increased bleeding events significantly. The high dose of glycoprotein Ⅱb / Ⅲa inhibitor may be the key factor contributing to the increased bleeding events. Therefore, this study aims to evaluate the effectiveness and security of triple anti-platelet therapy based on a small dose of glycoprotein Ⅱb / Ⅲa inhibitor, aspirin and ADP-P2Y12 receptor inhibitor in AMI patients receiving PPCI.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-01 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2020-01-22 |
Start Month Year | May 14, 2019 |
Primary Completion Month Year | June 2021 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2020-01-22 |
Facilities
Sequence: | 200280881 |
Status | Recruiting |
Name | Zhongshan Hospital Fudan University |
City | Shanghai |
State | Shanghai |
Zip | 200032 |
Country | China |
Facility Contacts
Sequence: | 28132928 | Sequence: | 28132929 |
Facility Id | 200280881 | Facility Id | 200280881 |
Contact Type | primary | Contact Type | backup |
Name | Zhangwei Chen, MD | Name | Danbo Lu, PhD |
chen.zhangwei@zs-hospital.sh.cn | lu.danbo@zs-hospital.sh.cn | ||
Phone | +86 21 64041990 | Phone | +86 21 64041990 |
Browse Interventions
Sequence: | 96133493 | Sequence: | 96133494 | Sequence: | 96133495 | Sequence: | 96133496 | Sequence: | 96133497 |
Mesh Term | Tirofiban | Mesh Term | Fibrinolytic Agents | Mesh Term | Fibrin Modulating Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Platelet Aggregation Inhibitors |
Downcase Mesh Term | tirofiban | Downcase Mesh Term | fibrinolytic agents | Downcase Mesh Term | fibrin modulating agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | platelet aggregation inhibitors |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52221783 |
Name | ST Elevation Myocardial Infarction |
Downcase Name | st elevation myocardial infarction |
Id Information
Sequence: | 40195804 |
Id Source | org_study_id |
Id Value | TRYIT |
Countries
Sequence: | 42609784 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55650069 | Sequence: | 55650070 |
Group Type | Placebo Comparator | Group Type | Experimental |
Title | Normal saline | Title | Tirofiban |
Interventions
Sequence: | 52535578 | Sequence: | 52535579 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Tirofiban | Name | Normal saline |
Description | Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive Tirofiban(0.05mg/ml) intravenous drip in a dosage of 4ml/hour (patients weight<50kg) or 6ml/hour (patients weight > 50kg) lasting for 24 hours. | Description | Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive normal saline intravenous drip in a dosage of 4ml/hour (patients weight<50kg) or 6ml/hour (patients weight > 50kg) lasting for 24 hours. |
Keywords
Sequence: | 79942103 | Sequence: | 79942104 | Sequence: | 79942105 |
Name | ST Elevation Myocardial Infarction | Name | Tirofiban | Name | Percutaneous Coronary Intervention |
Downcase Name | st elevation myocardial infarction | Downcase Name | tirofiban | Downcase Name | percutaneous coronary intervention |
Design Outcomes
Sequence: | 177562272 | Sequence: | 177562273 | Sequence: | 177562274 | Sequence: | 177562275 | Sequence: | 177562276 | Sequence: | 177562277 | Sequence: | 177562278 | Sequence: | 177562279 | Sequence: | 177562280 | Sequence: | 177562281 | Sequence: | 177562282 | Sequence: | 177562283 | Sequence: | 177562284 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | TFG(TIMI flow grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography). | Measure | TMP(TIMI myocardial perfusion grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography). | Measure | Remedial Tirofiban intravenous use during primary percutaneous coronary intervention procedure. | Measure | ST segment | Measure | Myocardial microcirculation perfusion estimated by cardiac magnetic (CMR). | Measure | Major adverse cardiovascular events(MACE), including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization. | Measure | Left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography. | Measure | The serum microRNA expression pattern changes after primary percutaneous coronary intervention. | Measure | All the bleeding events assessed by bleeding academic research consortium(BARC) definition for bleeding) | Measure | Major bleeding events assessed by TIMI bleeding criteria. | Measure | Severe or life-threatening and moderate bleeding events assessed by GUSTO bleeding criteria. | Measure | Major bleeding events assessed by international society on thrombosis and haemostasis(ISTH) bleeding criteria. | Measure | Adverse events and severe adverse events. |
Time Frame | Immediately after primary percutaneous coronary intervention. | Time Frame | Immediately after primary percutaneous coronary intervention. | Time Frame | During the process of primary percutaneous coronary intervention. | Time Frame | 90 minutes after primary percutaneous coronary intervention. | Time Frame | 7 days after primary percutaneous coronary intervention. | Time Frame | 30 days after primary percutaneous coronary intervention. | Time Frame | 7 and 30 days after primary percutaneous coronary intervention. | Time Frame | Pre-, 30 minutes, 3 hours and 24 hours after primary percutaneous coronary intervention. | Time Frame | 30 days after primary percutaneous coronary intervention. | Time Frame | 30 days after primary percutaneous coronary intervention. | Time Frame | 30 days after primary percutaneous coronary intervention. | Time Frame | 30 days after primary percutaneous coronary intervention. | Time Frame | 30 days after primary percutaneous coronary intervention. |
Description | TIMI flow grades: grade III. | Description | TIMI myocardial perfusion grades: grade III. | Description | Remedial Tirofiban use during primary percutaneous coronary intervention. | Description | The sum of the initial ST segment elevation drops 70% or more. | Description | Myocardial microcirculation perfusion estimated by cardiac magnetic resonance imaging. | Description | Major adverse cardiovascular events, including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization. | Description | Left ventricular ejection fraction assessed by transthoracic echocardiography. | Description | The microRNA expression pattern changes. | Description | All the bleeding events assessed by bleeding academic research consortium(BARC) definition for bleeding) | Description | Any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI); Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥ 5 g/dL; Fatal bleeding (bleeding that directly results in death within 7 d). | Description | GUSTO bleeding criteria:Severe or life-threatening :
Intracerebral hemorrhage ; Resulting in substantial hemodynamic compromise requiring treatment. Moderate: Requiring blood transfusion but not resulting in hemodynamic compromise. Mild : Bleeding that does not meet above criteria. |
Description | Fatal bleeding and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing hemoglobin drop of 20 g/L or more, and/or blood transfusion of 2 units or more | Description | Adverse events and severe adverse events. |
Browse Conditions
Sequence: | 193679412 | Sequence: | 193679413 | Sequence: | 193679414 | Sequence: | 193679415 | Sequence: | 193679416 | Sequence: | 193679417 | Sequence: | 193679418 | Sequence: | 193679419 | Sequence: | 193679420 | Sequence: | 193679421 |
Mesh Term | Myocardial Infarction | Mesh Term | ST Elevation Myocardial Infarction | Mesh Term | Infarction | Mesh Term | Ischemia | Mesh Term | Pathologic Processes | Mesh Term | Necrosis | Mesh Term | Myocardial Ischemia | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Vascular Diseases |
Downcase Mesh Term | myocardial infarction | Downcase Mesh Term | st elevation myocardial infarction | Downcase Mesh Term | infarction | Downcase Mesh Term | ischemia | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | necrosis | Downcase Mesh Term | myocardial ischemia | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | vascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366645 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Shanghai Zhongshan Hospital |
Overall Officials
Sequence: | 29313022 |
Role | Study Chair |
Name | Juying Qian, MD |
Affiliation | Fudan University |
Central Contacts
Sequence: | 12020642 | Sequence: | 12020643 |
Contact Type | primary | Contact Type | backup |
Name | Zhangwei Chen, MD | Name | Hongyi Wu, MD |
Phone | +8602164041990 | Phone | +8602164041990 |
chen.zhangwei@zs-hospital.sh.cn | wu.hongyi@zs-hospital.sh.cn | ||
Phone Extension | 612747 | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68217714 | Sequence: | 68217715 |
Design Group Id | 55650070 | Design Group Id | 55650069 |
Intervention Id | 52535578 | Intervention Id | 52535579 |
Eligibilities
Sequence: | 30794853 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 85 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Time after onset of chest pain: ≥ 30 minutes and ≤ 24 hours; Exclusion Criteria: Life expectancy ≤ 1 year; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004536 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 85 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 4 |
Number Of Other Outcomes To Measure | 7 |
Designs
Sequence: | 30540893 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26697027 |
Intervention Id | 52535579 |
Name | Sodium Chloride Injection |
Responsible Parties
Sequence: | 28907213 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797716
2019-03-01
https://zephyrnet.com/?p=NCT03797716
NCT03797716https://www.clinicaltrials.gov/study/NCT03797716?tab=tableChristopher R Evans, MBBSsitu.littlejourney@ucl.ac.uk02076799280To evaluate the clinical effectiveness of a virtual reality psychological preparation app at reducing peri-operative anxiety and its associated sequelae in children aged 3-12 years old undergoing ambulatory surgery compared to standard care.
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Studies
Study First Submitted Date | 2018-11-23 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | March 1, 2019 |
Primary Completion Month Year | September 30, 2020 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Detailed Descriptions
Sequence: | 20710007 |
Description | This is a phase III multi-centre randomised controlled trial evaluating the effectiveness of the Little Journey app: a pre-hospital psychological preparation tool designed for children undergoing ambulatory surgery.
Children presenting to the Preoperative assessment clinic before their operation will be screened for recruitment to the trial. Those meeting the inclusion criteria will be recruited to participate in the trial before randomisation into either a standard practice arm or intervention arm. Consent will be provided by parents / guardians and assent by children aged 7-12 years old. Children assigned to the intervention arm will be provided with a virtual reality google cardboard headset and access code for the Little Journey app which they can use as many times as they wish before their operation. They will also receive the standard pre-operative preparation and care as per the recruiting site. In comparison, the standard care arm will receive a google cardboard virtual reality headset with suggestions of free virtual apps to use and standard pre-operative preparation and care – as defined by each participating site. Children's anxiety will be assessed at multiple time points along the surgical journey, ranging from the preoperative assessment clinic, ward and finally in the anaesthetic room during the induction of anaesthesia. Secondary outcome measures such as parent anxiety levels, post-hospital behavioural changes, need for rescue analgesia and antiemetics in the recovery room will be recorded. Children's anxiety scores in those assigned to the intervention arm will undergo a further analysis assessing the impact of frequency and timing of Little Journey app use before surgery. |
Conditions
Sequence: | 52139051 | Sequence: | 52139052 | Sequence: | 52139053 | Sequence: | 52139054 | Sequence: | 52139055 | Sequence: | 52139056 |
Name | Anxiety Acute | Name | Anxiety Fear | Name | Peri-operative | Name | Psychological Distress | Name | Surgery | Name | Children, Only |
Downcase Name | anxiety acute | Downcase Name | anxiety fear | Downcase Name | peri-operative | Downcase Name | psychological distress | Downcase Name | surgery | Downcase Name | children, only |
Id Information
Sequence: | 40135101 |
Id Source | org_study_id |
Id Value | 18/0197 |
Design Groups
Sequence: | 55559408 | Sequence: | 55559409 |
Group Type | No Intervention | Group Type | Experimental |
Title | Standard Care arm | Title | Intervention arm |
Description | Participants will receive standard of care from the pre-assessment clinic until discharge.
A typical preparatory National Health Service pathway would include: meeting a specialist nurse in the preoperative assessment clinic; a preoperative anaesthetic and surgical consultation; interaction with health play specialists on the day of surgery; and distraction interventions such as hand-held tablets during induction of anaesthesia. Participants may have inhalation or intravenous induction depending on the primary management plan of the anaesthetist in charge. Participants in the standard care arm will also receive a virtual reality cardboard headset, which can be taken home, personalised and decorated before use with virtual reality apps available to download from the app stores. |
Description | Participants allocated to the intervention arm will receive the same peri-operative management as the standard care arm and will also receive an access code enabling them to use the Little Journey app in the weeks leading up to their operation. We suggest the Little Journey app is used in the days to weeks leading up to the child's operation depending on their age. On downloading the app, if parents/carers insert the age of the child and date of surgery into the Little Journey app they will be sent a push notifications reminding them when to use it according to their child's age. However, it can be used as frequently as the child and/or their parents or carers wish before the operation. |
Interventions
Sequence: | 52454964 |
Intervention Type | Device |
Name | Little Journey app |
Description | The Little Journey app allows children to explore 360-degree hospital environments familiarising and desensitising them to areas and staff they'll see on the day of surgery. Children can "visit" the day case ward, anaesthetic and recovery rooms where their operation will occur -all while feeling safe in their own home. As the child explores the three areas, they are introduced to animated characters of staff who explain what will happen, the equipment that will be used and how they might feel. Using head tracking technology, the child triggers the animated characters by looking at them; meaning they control the pace of learning and speed at which they progress. The preparatory tool follows a pre-set story-line reflecting what happens from admission to discharge on the day of surgery. |
Keywords
Sequence: | 79822888 |
Name | Anxiety, peri-operative, preparation, app |
Downcase Name | anxiety, peri-operative, preparation, app |
Design Outcomes
Sequence: | 177264013 | Sequence: | 177264027 | Sequence: | 177264014 | Sequence: | 177264015 | Sequence: | 177264016 | Sequence: | 177264017 | Sequence: | 177264018 | Sequence: | 177264019 | Sequence: | 177264020 | Sequence: | 177264021 | Sequence: | 177264022 | Sequence: | 177264023 | Sequence: | 177264024 | Sequence: | 177264025 | Sequence: | 177264026 | Sequence: | 177264028 | Sequence: | 177264029 | Sequence: | 177264030 | Sequence: | 177264031 | Sequence: | 177264032 | Sequence: | 177264033 | Sequence: | 177264034 | Sequence: | 177264035 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Modified Yale Pre Operative Anxiety score (shortened form) | Measure | Virtual reality headset side effects | Measure | Modified Yale Pre Operative Anxiety score (shortened form) | Measure | Parent anxiety levels | Measure | Modified Yale Pre Operative Anxiety score (shortened form) | Measure | Parent satisfaction with pre-operative information | Measure | Child compliance in the anaesthetic room | Measure | Child distress in the anaesthetic room | Measure | Parent anxiety levels | Measure | Time to induction of anaesthesia | Measure | Incidence of the need for premedication | Measure | Analgesia and anti-emetic use in the recovery room. | Measure | Time to recovery readiness | Measure | Parent satisfaction with care | Measure | Time spent in hospital | Measure | Incidence of unplanned admissions to hospital following surgery | Measure | Incidence of unplanned cancellations on the scheduled date of surgery. | Measure | Post Hospital Behavioural Questionnaire | Measure | Social cost analysis (Parents/Guardian) | Measure | Social cost analysis (Participants) | Measure | Post Hospital Behavioural Questionnaire | Measure | Social cost analysis (Parents/Guardian) | Measure | Social cost analysis (Participants) |
Time Frame | Day of surgery (Day 1): Measured during the induction of anaesthesia in the anaesthetic room | Time Frame | Day of Surgery (Day 1): Non-validated questionnaire completed immediately prior to discharge from hospital | Time Frame | Two weeks to six months before surgery: mYPAS-SF measured pre-randomisation in the Pre-Assessment clinic occurring a minimum of two-weeks before surgery, up to six-months before surgery depending on the participating research site. | Time Frame | Two-weeks to six-months before surgery: Measured pre-randomisation in the pre-assessment clinic occurring a minimum of two-weeks before surgery, up to six-months before surgery date depending on the participating research site. | Time Frame | Day of Surgery (Day 1): Measured on the ward prior to surgery | Time Frame | Day of Surgery (Day 1): Measured on the ward prior to the operation on the day of surgery. | Time Frame | Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia | Time Frame | Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia | Time Frame | Day of surgery (Day 1): Measured immediately following observation of the induction of anaesthesia. | Time Frame | Day of surgery (Day 1): Measured from entry into the anaesthetic room to entry into theatre. | Time Frame | Day of surgery (Day 1): As recorded in the anaesthetic room | Time Frame | Day of surgery (Day 1): Recorded in the recovery room following surgery | Time Frame | Day of surgery (Day 1): Measured from patients arrival in the recovery room until deemed ready for discharge. | Time Frame | Day of surgery (Day 1): Measured on the ward prior to discharge home following surgery. | Time Frame | Day of surgery (Day 1): Recorded at end of day of surgery following discharge. | Time Frame | Day of surgery (Day 1): Recorded at end of day of surgery | Time Frame | Day of surgery (Day 1): Recorded on the day of surgery | Time Frame | Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians | Time Frame | Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians | Time Frame | Day 14 post surgery: Completed at two-weeks after surgery by telephone consultation with parents/guardians | Time Frame | Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians | Time Frame | Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians | Time Frame | Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians |
Description | An independent and blinded observer completed observational scoring tool. Children are scored in four categories: Activity, vocalisations, emotional expressivity and state of apparent arousal, according to pre-determined Likert scale observations. Each category score is divided by its highest possible score, before being added together; these scores are then divided by four and multiplied by 100, giving a value between 22.92 to 100. Higher values indicate greater anxiety levels, with scores greater than 30 typically representing clinically significant anxiety. | Description | An assessment of the side effects of use of a virtual reality headset in both children and their parents assessed through a parent reported checkbox questionnaire. | Description | An independent and blinded observer completed observational scoring tool. Children are scored in four categories: Activity, vocalisations, emotional expressivity and state of apparent arousal, according to pre-determined Likert scale observations. Each category score is divided by its highest possible score, before being added together; these scores are then divided by four and multiplied by 100, giving a value between 22.92 to 100. Higher values indicate greater anxiety levels, with scores greater than 30 typically representing clinically significant anxiety. | Description | A 100mm visual analogue scale assessing the current anxiety levels of parents (VAS-PA) about their child's surgery. The VAS-PA is a rapid method of assessing self-reported anxiety levels of parents before surgery. Self reported scores range from 0-100mm with higher scores signifying greater anxiety. | Description | An independent and blinded observer completed observational scoring tool. Children are scored in four categories: Activity, vocalisations, emotional expressivity and state of apparent arousal, according to pre-determined Likert scale observations. Each category score is divided by its highest possible score, before being added together; these scores are then divided by four and multiplied by 100, giving a value between 22.92 to 100. Higher values indicate greater anxiety levels, with scores greater than 30 typically representing clinically significant anxiety. | Description | A 100mm visual analogue scale assessing parents' satisfaction with the pre-operative information. This parent-reported score ranges from 0-100mm with higher scores signifying higher levels of satisfaction. | Description | A 100mm visual analogue scale assessing the child's compliance during the induction of anaesthesia completed by the independent observer following observation of the induction of anaesthesia. This independent observer reported score ranges from 0-100mm with higher scores signifying higher levels of compliance. | Description | A 100mm visual analogue scale assessing the child's level of distress during the induction of anaesthesia completed by the independent observer following observation of the induction of anaesthesia. This independent observer reported score ranges from 0-100mm with higher scores signifying higher levels of distress during the induction. | Description | A 100mm visual analogue scale assessing the current anxiety levels of parents (VAS-PA) about their child's surgery. The VAS-PA is a rapid method of assessing self-reported anxiety levels of parents before surgery. Self reported scores range from 0-100mm with higher scores signifying greater anxiety. | Description | The time taken for the induction of anaesthesia (minutes) | Description | Number of patients given premedication prior to the induction of anaesthesia as per the prescription of the anaesthetist. | Description | As directed by the trial arm blinded clinical team based on their perceptions of child's symptoms in the recovery room. | Description | The time taken for participant to be ready for discharge back to the ward from the recovery room (minutes) as deemed by the recovery room nursing staff. | Description | A 100mm visual analogue scale assessing parents' satisfaction with the care they received on the day of surgery. This parent-reported score ranges from 0-100mm with higher scores signifying higher levels of satisfaction. | Description | The total time the participant spend in hospital from arrival on the ward to being discharged home (minutes). | Description | The number of participants requiring unplanned admission to hospital following surgery for any reason. | Description | The number of participants whose surgery is cancelled on the day of surgery for any reason. | Description | A parent-completed eleven-point questionnaire assessing changes in their child's behaviour following surgery. Consisting of eleven items, each item is scored using a five-point Likert scale ranging from "much less than before" to " much more than before". Higher scores are suggestive of increased post hospital regressive behavioural changes. | Description | The number of combined days of work missed by Parents/guardians following their child's surgery. Higher numbers are indicative of increased social costs. | Description | The number of days of school missed by children following their surgery. Higher numbers are indicative of increased social costs. | Description | A parent-completed eleven-point questionnaire assessing changes in their child's behaviour following surgery. Consisting of eleven items, each item is scored using a five-point Likert scale ranging from "much less than before" to " much more than before". Higher scores are suggestive of increased post hospital regressive behavioural changes. | Description | The number of combined days of work missed by Parents/guardians following their child's surgery. Higher numbers are indicative of increased social costs. | Description | The number of days of school missed by children following their surgery. Higher numbers are indicative of increased social costs. |
Browse Conditions
Sequence: | 193366740 | Sequence: | 193366741 |
Mesh Term | Anxiety Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | anxiety disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290753 | Sequence: | 48290754 |
Agency Class | OTHER | Agency Class | OTHER_GOV |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University College, London | Name | National Institute for Health Research, United Kingdom |
Overall Officials
Sequence: | 29268555 |
Role | Study Chair |
Name | Ramani S Moonesinghe, MBBS, MRCP, FRCA, FFICM, MD |
Affiliation | University College, London |
Central Contacts
Sequence: | 12000497 |
Contact Type | primary |
Name | Christopher R Evans, MBBS |
Phone | 02076799280 |
situ.littlejourney@ucl.ac.uk | |
Role | Contact |
Design Group Interventions
Sequence: | 68107526 |
Design Group Id | 55559409 |
Intervention Id | 52454964 |
Eligibilities
Sequence: | 30747753 |
Gender | All |
Minimum Age | 3 Years |
Maximum Age | 12 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Children aged between 3-12 years of age on the date of parental consent to participate in the trial Note: Surgery is defined as any procedure occurring in a theatre under the care of a surgeon or dentist and an anaesthetist. Exclusion Criteria: Children aged less than 3 years of age or more than 12 years' old on the date of parental consent Note: Children undergoing diagnostic procedures (e.g. MRI, Cardiac catheterisation) will not be included due to diagnostic uncertainty. |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254122019 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 3 |
Maximum Age Num | 12 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 22 |
Designs
Sequence: | 30494036 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Health Services Research |
Time Perspective | |
Masking | Double |
Caregiver Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28860316 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797703
2018-11-26
https://zephyrnet.com/?p=NCT03797703
NCT03797703https://www.clinicaltrials.gov/study/NCT03797703?tab=tableNANANAThis is a prospective study to assess the utility of Lidocaine Hydrochloride 2% gel enema (Hi-Tech Pharmacal Co., Inc.) in reducing post-procedural pain after endoscopic band ligation of internal hemorrhoids. Briefly, patients will be consented prior to entry into the study. During the endoscopic band ligation procedure, patients will be blindly placed into the treatment arm or control arm. The treatment arm will receive 15 ml enema of lidocaine gel immediately upon cessation of the procedure. In the placebo arm, oral pain medications will be provided. Researchers will assess pain following the procedure at 1 hour, 24 hours and 48 hours via telephone call. Another telephone call will be performed at 72 to 96 hours to assess any side effects of the medication.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-19 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2020-11-25 |
Start Month Year | November 26, 2018 |
Primary Completion Month Year | May 29, 2020 |
Verification Month Year | November 2020 |
Verification Date | 2020-11-30 |
Last Update Posted Date | 2020-11-25 |
Detailed Descriptions
Sequence: | 20727181 |
Description | This is a prospective single center study to evaluate side effects and efficacy of a lidocaine jelly 2% enema following endoscopic hemorrhoid band ligation. The investigators will administer a single dose of 15 mL lidocaine jelly 2%, obtained from Advocate main pharmacy, as an enema immediately post procedure. Patients will not be permitted to self-administer additional doses following discharge.
Prior to being enrolled in the study, the clinician will perform a Comprehensive Metabolic Panel and Complete Blood Count. When appropriate, a urine pregnancy test will be performed prior to enrollment. The investigators will assess for any signs or symptoms of liver disease. These assessments will occur within one month of the procedure date. If the patient has any signs of renal or hepatic impairment (creatinine greater than 2 or Childs Pugh Class 3), they will be excluded from the study. The researchers will also exclude patients with any history of arrhythmias or who are currently on anti-arrhythmic medications. Once the patient is deemed safe to proceed, the lidocaine gel enema will be placed at the cessation of the procedure by the investigator. At the time of the procedure, the clinician will assess and use their best judgement to determine if the rectal mucosa is generally intact by visual inspection. If the mucosa remains intact, the subject will be able to be included in the study. However, if the rectal mucosa is traumatized the subject will be excluded and will not participate in the randomized treatment. Following the procedure, the patient will be monitored closely with a one-on one registered nurse for 4 hours in an observation unit. Vital signs will be taken every 5 minutes, as well as continuous EKG monitoring and pulse oximetry monitoring. If any adverse side effects occur, the physician is immediately available for further management and admission to the hospital if needed. Upon completion of the 4-hour observation period, the participants will be evaluated by a registered nurse and physician prior to discharge home following the procedure. The patient will be discharged with a responsible adult who will care for the patient for 24 additional hours. The clinician will communicate with the patient and responsible adult regarding any adverse side effects. The patient will also receive a phone number to call to reach the physician or the physician's associate who will be able to verbally assist the patient immediately should any adverse events occur. For data collection, one hour following the procedure a clinician will screen for any adverse side effects and pain will be assessed using a numeric pain scale (0-10). The patient will also be contacted via telephone to assess adverse side effects and pain scale at 24 hours and 48 hours post procedure. The investigators will also call the patient at 72 to 96 hours to assess for any adverse effects. The patients will be followed up by the principal investigator for routine check-ups following the procedure. The clinician will be easily accessible via telephone and the patient will be given instructions on how to contact the clinician, if needed. Data to be collected on each subject will include: date of procedure, specific patient ID, gender, age, internal hemorrhoids grade, race (White, African American, Hispanic, Asian), BMI, comorbid conditions, pain 1 hour post procedure, pain 24 and 48 hours post procedure, requirement of narcotic pain medication, requirement of other oral analgesic medication, sedation utilized and complications or adverse side effects from the medication. Upon data collection of this trial, we will monitor for any adverse events. If there is an adverse event that is deemed by the principal investigator likely due to drug administration, we will report it to the FDA immediately through written communication and an IND Safety Report. It will be reported within at least 7 calendar days of being notified of the adverse event. |
Facilities
Sequence: | 200159414 |
Name | Advocate Christ Medical Center |
City | Oak Lawn |
State | Illinois |
Zip | 60453 |
Country | United States |
Browse Interventions
Sequence: | 96074169 | Sequence: | 96074170 | Sequence: | 96074171 | Sequence: | 96074172 | Sequence: | 96074173 | Sequence: | 96074174 | Sequence: | 96074175 | Sequence: | 96074176 | Sequence: | 96074177 | Sequence: | 96074178 | Sequence: | 96074179 | Sequence: | 96074180 |
Mesh Term | Lidocaine | Mesh Term | Anesthetics, Local | Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Anti-Arrhythmia Agents | Mesh Term | Voltage-Gated Sodium Channel Blockers | Mesh Term | Sodium Channel Blockers | Mesh Term | Membrane Transport Modulators | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | lidocaine | Downcase Mesh Term | anesthetics, local | Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | anti-arrhythmia agents | Downcase Mesh Term | voltage-gated sodium channel blockers | Downcase Mesh Term | sodium channel blockers | Downcase Mesh Term | membrane transport modulators | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52185494 |
Name | Hemorrhoids |
Downcase Name | hemorrhoids |
Id Information
Sequence: | 40169075 |
Id Source | org_study_id |
Id Value | AHC-6999-M5000223 |
Countries
Sequence: | 42580666 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55609122 | Sequence: | 55609123 |
Group Type | Experimental | Group Type | No Intervention |
Title | Treatment | Title | Control |
Description | Patients will be randomly allocated into the treatment group. The treatment group will receive a 15 mL lidocaine gel enema rectally immediately following completion of the procedure. | Description | Patients will be randomly allocated into the control group. The control group will not receive a rectal enema. |
Interventions
Sequence: | 52499435 |
Intervention Type | Drug |
Name | Lidocaine Hydrochloride 2% gel enema |
Description | Insertion of Lidocaine Hydrochloride 2% gel enema rectally immediately following the procedure. |
Design Outcomes
Sequence: | 177432042 | Sequence: | 177432043 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Change in Pain following Procedure at 1 hour, 24 hours and 48 hours | Measure | Pain Medication Needs |
Time Frame | This information will be collected at 1 hour, 24 hours and 48 hours after the procedure. | Time Frame | This will be evaluated 48 hours after the procedure. |
Description | This effect will be measured by statistical analysis comparing the treatment groups numeric pain scale ratings (0-10) with the control groups numeric pain scale ratings (0-10). | Description | This effect will be measured by asking the subject what pain medication was needed following the procedure and the amount taken. |
Browse Conditions
Sequence: | 193540144 | Sequence: | 193540145 | Sequence: | 193540146 | Sequence: | 193540147 | Sequence: | 193540148 | Sequence: | 193540149 | Sequence: | 193540150 | Sequence: | 193540151 | Sequence: | 193540152 | Sequence: | 193540153 |
Mesh Term | Hemorrhoids | Mesh Term | Pain, Procedural | Mesh Term | Rectal Diseases | Mesh Term | Intestinal Diseases | Mesh Term | Gastrointestinal Diseases | Mesh Term | Digestive System Diseases | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Pain | Mesh Term | Neurologic Manifestations |
Downcase Mesh Term | hemorrhoids | Downcase Mesh Term | pain, procedural | Downcase Mesh Term | rectal diseases | Downcase Mesh Term | intestinal diseases | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | pain | Downcase Mesh Term | neurologic manifestations |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332338 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Advocate Health Care |
Design Group Interventions
Sequence: | 68168185 |
Design Group Id | 55609122 |
Intervention Id | 52499435 |
Eligibilities
Sequence: | 30773579 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Patients older than 18 years of age Exclusion Criteria: Patients undergoing endoscopic hemorrhoids band ligation who are already on pain medications chronically due to other reasons |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952727 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 18 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30519710 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | Triple |
Subject Masked | True |
Caregiver Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28886011 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797690
2020-11-02
https://zephyrnet.com/?p=NCT03797690
NCT03797690https://www.clinicaltrials.gov/study/NCT03797690?tab=tableJohann BEAUDREUIL, PUPHjohann.beaudruil@aphp.fr+33 1 49 95 88 28The main objective is to investigate if percutaneous needle aponeurotomy is non-inferior to open surgery using aponeurectomy in treatment of flexion contracture due to Dupuytren’s disease.
Our hypothesis is that percutaneous needle aponeurotomy has suitable efficacy and safety profile for large application in the treatment of Dupuytren’s disease and that it is consequently able to drastically reduce the need of open surgery in this indication.
<![CDATA[
Studies
Study First Submitted Date | 2018-06-25 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-12-08 |
Start Month Year | November 2, 2020 |
Primary Completion Month Year | March 14, 2025 |
Verification Month Year | November 2022 |
Verification Date | 2022-11-30 |
Last Update Posted Date | 2022-12-08 |
Detailed Descriptions
Sequence: | 20663965 |
Description | Scientific justification:
Dupuytren's disease is a world-wide musculoskeletal disorder. It consists in fibrosis of the palmar aponeurosis that can induce disabling flexion contracture of the metacarpophalageal or proximal interphalangeal joints. Treatment modalities of flexion contracture include open surgery, percutaneous needle aponeurotomy and collagenase. Collagenase is not available in France. Aponeurectomy, that is also called fasciectomy, is the main open surgical technique, and open surgery is the most frequently used treatment in Dupuytren's disease. Percutaneous needle aponeurotomy is recommended as a nonsurgical treatment for Dupuytren's disease. It is a minimally invasive procedure. Its most largely accepted indication is Dupuytren's disease with metacarpophalageal joint involvement. However, percutaneous needle aponeurotomy has been successful for metacarpophalageal or proximal interphalangeal joint involvement, in nonadvanced and in advanced Dupuytren's disease. A model analysis recently demonstrated that replacing open surgery with percutaneous needle aponeurotomy could save more than 50% of the total hospitalization costs for the disease. Percutaneous needle aponeurotomy therefore appears as a unique minimally invasive approach for Dupuytren's disease. It could become a valuable alternative to open surgery. The hypothesis is that percutaneous needle aponeurotomy has suitable efficacy and safety profile for large application in the treatment of Dupuytren's disease and that it is consequently able to drastically reduce the need of open surgery in this indication. Practical procedure: Patients addressed to the consultation of the hand surgery centers for Dupuytren's disease will be prospectively selected, included, randomized, treated using percutaneous needle aponeurotomy or open surgery within six weeks after randomization, and followed at 1 week, 1, 3,12, 24 and 36 months after treatment. Assessment of efficacy will be blinded. Assessment of complications will be done by an unblinded assessor. |
Facilities
Sequence: | 199452811 | Sequence: | 199452812 | Sequence: | 199452813 | Sequence: | 199452814 |
Status | Active, not recruiting | Status | Active, not recruiting | Status | Recruiting | Status | Recruiting |
Name | Centre d'Imagerie Médicale Bachaumont Paris Centre | Name | Hopital LARIBOISIERE – Radiologie | Name | Hopital LARIBOISIERE – Rhumatologie | Name | JOUVENET – Orthopédie, chirurgie de la main et du membre supérieur |
City | Paris | City | Paris | City | Paris | City | Paris |
Zip | 75002 | Zip | 75010 | Zip | 75010 | Zip | 75016 |
Country | France | Country | France | Country | France | Country | France |
Facility Contacts
Sequence: | 28030496 | Sequence: | 28030497 |
Facility Id | 199452813 | Facility Id | 199452814 |
Contact Type | primary | Contact Type | primary |
Name | Johann BEAUDREUIL, PUPH | Name | ERIC ROULOT, PH |
johann.beaudreuil@aphp.fr | secretaire.roulot@gmail.com | ||
Phone | 01 49 95 88 28 | Phone | 01 42 15 42 33 |
Conditions
Sequence: | 52020500 |
Name | Dupuytren Disease of Finger |
Downcase Name | dupuytren disease of finger |
Id Information
Sequence: | 40040581 |
Id Source | org_study_id |
Id Value | P160903J |
Countries
Sequence: | 42437035 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55427655 | Sequence: | 55427656 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Percutaneous needle aponeurotomy | Title | Open surgery with limited aponeurectomy |
Description | It consists in cutting the fibrotic cord due to the disease and responsible for the flexion contracture, with a needle under local anesthesia. The procedure can be repeated as required during the same session. One to three sessions with at least one-week interval are usually sufficient and will be allowed. It will be performed in outpatient setting by a senior physician experienced in the procedure. End of treatment will be considered as the last session of needle aponeurotomy. | Description | It consists in excision of the fibrotic aponeurosis.It will be performed by hand surgeons under loco-regional anaesthesia during a short hospitalization (1 day stay). Post-operative cares are necessary (analgesics, splint, nursing, physiotherapy). End of surgical treatment will be considered as the removal of the stitches (two weeks after the surgical treatment). |
Interventions
Sequence: | 52333132 | Sequence: | 52333133 |
Intervention Type | Procedure | Intervention Type | Procedure |
Name | Percutaneous needle aponeurotomy | Name | Open surgery with limited aponeurectomy |
Description | It consists in cutting the fibrotic cord due to the disease and responsible for the flexion contracture, with a needle under local anesthesia. The procedure can be repeated as required during the same session. One to three sessions with at least one-week interval are usually sufficient and will be allowed. It will be performed in outpatient setting by a senior physician experienced in the procedure | Description | It consists in excision of the fibrotic aponeurosis.It will be performed by hand surgeons under loco-regional anaesthesia during a short hospitalization (1 day stay). Post-operative cares are necessary (analgesics, splint, nursing, physiotherapy) |
Keywords
Sequence: | 79626289 | Sequence: | 79626290 | Sequence: | 79626291 | Sequence: | 79626292 |
Name | Dupuytren's disease | Name | Percutaneous needle aponeurotomy | Name | Limited aponeurectomy | Name | Randomized trial |
Downcase Name | dupuytren's disease | Downcase Name | percutaneous needle aponeurotomy | Downcase Name | limited aponeurectomy | Downcase Name | randomized trial |
Design Outcomes
Sequence: | 176855118 | Sequence: | 176855119 | Sequence: | 176855120 | Sequence: | 176855121 | Sequence: | 176855122 | Sequence: | 176855123 | Sequence: | 176855124 | Sequence: | 176855125 | Sequence: | 176855126 | Sequence: | 176855127 | Sequence: | 176855128 | Sequence: | 176855129 | Sequence: | 176855130 | Sequence: | 176855131 | Sequence: | 176855132 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Metacarpophalangeal joint contracture during passive extension | Measure | Metacarpophalangeal joint contractures during passive and active extension | Measure | Main metacarpophalangeal joint contracture during passive extension, | Measure | The clinical success | Measure | The recurrence | Measure | The interphalangeal joint contractures during passive and active extension | Measure | The 70% improvement from baseline of the flexion contracture | Measure | The active range of motion of metacarpophalangeal and proximal interphalangeal treated joints | Measure | The functional limitation using Quick DASH questionnaire | Measure | The URAM scale | Measure | The patient satisfaction on a 0-100 mm visual analog scale | Measure | The number of secondary and repeated treatments | Measure | Complications and adverse events for primary treatment | Measure | Complications and adverse events for secondary treatment | Measure | The post-interventional pain and needs |
Time Frame | at 3 months after treatment | Time Frame | at 1 week, 1, 3, 12, 24 and 36 months after treatment | Time Frame | at 36 months after treament | Time Frame | at 3 months after treament | Time Frame | at 12, 24 and 36 months after treament | Time Frame | at 1 week, 1, 3,12, 24 and 36 months after treatment | Time Frame | at 1 week, 1, 3, 12, 24 and 36 months after treatment | Time Frame | at 1 week, 1, 3, 12, 24 and 36 months after treatment | Time Frame | at 1 week, 1, 3, 12, 24 and 36 months after treatment | Time Frame | at 1 week, 1, 3, 12, 24 and 36 months after treatment | Time Frame | at 1 week, 1, 3, 12, 24 and 36 months after treatment | Time Frame | at 12, 24 and 36 months after treatment | Time Frame | at the treatment time, and at 1 week, 1, 3, 12, 24 and 36 months; | Time Frame | at the treatment time, at 12, 24 and 36 months; | Time Frame | at 1 week, 1, 3, 12, 24 and 36 months |
Description | Expressed in degrees, using low energy computed tomography for blinded assessment (computed tomography imaging will be analysed by a blinded assessor not involved in the treatment). Baseline will be Metacarpophalangeal joint contracture during passive extension the day of the treatment, before any treatment | Description | Expressed in degrees using clinical goniometry, and patient wearing white opac gloves to ensure blinded assessment. | Description | Expressed in degrees, using low energy computed tomography, for blinded assessment (computed tomography imaging will be analysed by a blinded assessor not involved in the treatment). | Description | The clinical success is defined as the reduction of flexum to within 0 to 5° during passive extension, using clinical goniometry, for the main metacarpophalangeal joint); Patient will wear white opac gloves to ensure blinded assessment. | Description | The recurrence is defined as the flexum progression of 20°, during passive extension, using clinical goniometry, after clinical success. Patient will wear white opac gloves to ensure blinded assessment. | Description | Expressed in degrees, using clinical goniometry. Patient will wear white opac gloves to ensure blinded assessment. | Description | The flexion contracture of each treated joint, during passive extension will be assessed by a blinded assessor (Patient will wear white opac gloves). – Flexion contracture in degrees using goniometry reported as follows: ray Number; metacarpophalangeal angle; interphalangeal angle | Description | The active range of motion of metacarpophalangeal and proximal interphalangeal treated joints will be assessed by a blinded assessor (Patient will wear white opac gloves). | Description | The patient will fill out the auto-questionnaire. The blinded assessor will calculate the score (0 to 100, with highest value indicating highest disability). | Description | The patient will fill out the auto-questionnaire. The blinded assessor will calculate the score (0 to 45, with highest value indicating highest disability). | Description | The assessor will ask the patient the following question: "How would you rate satisfaction about the treatment you underwent in the study?" Patients will be asked to mark the level of their satisfaction on a l00-mm, nonhatched VAS scale marked at one end as "not satisfied" and at the other as "completely satisfied'' | Description | The number of secondary or repeated open surgeries and percutaneous needle aponeurotomy will be recorded by the unblinded assessor. | Description | The number and the types of complications and adverse events for primary open surgery and first line percutaneous needle aponeurotomy will be collected by an unblinded assessor. | Description | The number and the types of complications and adverse events for secondary open surgery and percutaneous needle aponeurotomy will be collected by an unblinded assessor. | Description | The post-interventional pain and needs of nursing, splinting, medication, physiotherapy,sick leave, time return to regular activities using a patient diary. These datas will be collected by the unblinded assessor. |
Browse Conditions
Sequence: | 192889470 | Sequence: | 192889471 | Sequence: | 192889472 | Sequence: | 192889473 | Sequence: | 192889474 | Sequence: | 192889475 | Sequence: | 192889476 | Sequence: | 192889477 | Sequence: | 192889478 | Sequence: | 192889479 | Sequence: | 192889480 |
Mesh Term | Dupuytren Contracture | Mesh Term | Fibroma | Mesh Term | Neoplasms, Fibrous Tissue | Mesh Term | Neoplasms, Connective Tissue | Mesh Term | Neoplasms, Connective and Soft Tissue | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Contracture | Mesh Term | Muscular Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Connective Tissue Diseases |
Downcase Mesh Term | dupuytren contracture | Downcase Mesh Term | fibroma | Downcase Mesh Term | neoplasms, fibrous tissue | Downcase Mesh Term | neoplasms, connective tissue | Downcase Mesh Term | neoplasms, connective and soft tissue | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | contracture | Downcase Mesh Term | muscular diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | connective tissue diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48178859 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Assistance Publique – Hôpitaux de Paris |
Overall Officials
Sequence: | 29198734 |
Role | Principal Investigator |
Name | Johann BEAUDREUIL, PUPH |
Affiliation | APHP |
Central Contacts
Sequence: | 11975275 |
Contact Type | primary |
Name | Johann BEAUDREUIL, PUPH |
Phone | +33 1 49 95 88 28 |
johann.beaudruil@aphp.fr | |
Role | Contact |
Design Group Interventions
Sequence: | 67948321 | Sequence: | 67948322 |
Design Group Id | 55427655 | Design Group Id | 55427656 |
Intervention Id | 52333132 | Intervention Id | 52333133 |
Eligibilities
Sequence: | 30677198 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age ≥ 18 years old Exclusion Criteria: Presence of other musculoskeletal disorders of the hand than Dupuytren's disease: known inflammatory rheumatic disease of the hand, clinical signs of inflammatory rheumatic disease of the hand, MP or PIP pain at inclusion visit. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253870611 |
Number Of Facilities | 4 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 14 |
Designs
Sequence: | 30423951 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Masking Description | The primary outcome (main metacarpophalangeal joint contracture during passive extension) will be assessed using low energy computed tomography before treatment, 3 months and 36 months after treatment for blinded assessment. Furthermore, in addition to the clinical follow-up, the patient will be followed by a blinded assessor. At each follow-up visits with the blinded assessor, patient will be asked to wear white opaque gloves to ensure the blinding for the treatment during assessment including the main outcome. Clinicians, nurses and patients will be instructed to the importance of avoiding communication about the treatment to the blinded assessor. |
Intervention Model Description | multicenter, non-inferiority PROBE (Prospective Randomized Open Blinded End-point) trial. Two groups (ratio 1:1) will be compared in this phase III pivotal study: experimental group versus control group. |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28790471 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797677
2017-03-09
https://zephyrnet.com/?p=NCT03797677
NCT03797677https://www.clinicaltrials.gov/study/NCT03797677?tab=tableNANANAThe study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000.
This pilot study evaluated subject satisfaction with the therapy and adherence to the therapy during the 90-day treatment period, and also collected clinical outcome data. Outcomes were assessed before, during and after the MN4000 treatment period.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-27 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | March 9, 2017 |
Primary Completion Month Year | November 30, 2017 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Detailed Descriptions
Sequence: | 20735940 |
Description | The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000.
This pilot study evaluated subject satisfaction with the therapy and adherence to the therapy during the 90-day treatment period, and also collected clinical outcome data. Outcomes were assessed before, during and after the MN4000 treatment period. The study did not include a control group. This pilot study was designed to provide initial information that could inform decisions for future larger-scale studies. Ten (10) patients total were enrolled from CF and NMD clinics. Eligible subjects were adult patients who were able to perform MN4000 therapy using a mouthpiece and who met all inclusion and none of the exclusion criteria. All patients received therapy with the MN4000 following the labeled instructions for the device. The MN4000 is an airway clearance and lung expansion therapy device that has been cleared to market by the FDA as The MetaNeb® System for Homecare environment, for clearance of pulmonary secretions and for treatment or prevention of pulmonary atelectasis. It is a Class II device, cleared to market on March 17, 2016 under premarket notification 510(k) K151689 as The MetaNeb® 4 System with application for homecare environment. It is commercially marketed as the MN4000. The device consists of a pneumatic compressor and an air pulse generator that delivers CHFO and CPEP to; facilitate clearance of mucous from the lungs; This "triple" mode device can provide aerosol therapy while alternating between CPEP for lung expansion and CHFO for airway clearance. Supplemental oxygen therapy may also be delivered when used with compressed oxygen. The MN4000 has three therapy modes: CHFO (Continuous High Frequency Oscillation) – delivers aerosol therapy while providing oscillating pressure pulses to the airway After assessing baseline status, therapy with the MN4000 was introduced and incorporated into the daily home respiratory care treatment regimen for all patients. Other airway clearance and/or lung expansion therapies were not to be performed during the three-month study period. The treatment regimen for other respiratory care modalities (e.g. aerosolized medications) was that which was prescribed by the patient's health care team in the routine standard care of each patient. During the three-month follow-up period, adherence to the daily prescribed therapy regimen was assessed. Subjects/caregivers were asked to provide adherence information for each day during the 90-day study period. Documentation of efficacy and safety Variables was completed by study staff at the time of occurrence, from review of the patient's medical records and from scores and rankings for questionnaires. |
Facilities
Sequence: | 200245068 |
Name | Northwestern |
City | Chicago |
State | Illinois |
Zip | 60208 |
Country | United States |
Conditions
Sequence: | 52208492 | Sequence: | 52208493 | Sequence: | 52208494 |
Name | Cystic Fibrosis | Name | Motor Neuron Disease | Name | Airway Clearance Impairment |
Downcase Name | cystic fibrosis | Downcase Name | motor neuron disease | Downcase Name | airway clearance impairment |
Id Information
Sequence: | 40186439 |
Id Source | org_study_id |
Id Value | CR-RR2016-002 |
Countries
Sequence: | 42599934 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55635115 |
Group Type | Experimental |
Title | Home based airway clearance with Metaneb |
Description | Patients with CF and MND who required regular home airway clearance therapy were enrolled to use the Metaneb device in the home setting.
The MN4000 is an airway clearance and lung expansion therapy device that has been cleared to market by the FDA as The MetaNeb® System for Homecare environment, for clearance of pulmonary secretions and for treatment or prevention of pulmonary atelectasis. It is a Class II device, cleared to market on March 17, 2016 under premarket notification 510(k) K151689 as The MetaNeb® 4 System with application for homecare environment. |
Interventions
Sequence: | 52522459 |
Intervention Type | Device |
Name | MN 4000 |
Description | Patients who required regular home airway clearance therapy were enrolled in the study and were prescribed therapy with the MN4000. Adherence to the prescribed therapy regimen and patient/caregiver satisfaction with the therapy was assessed. Pulmonary function, was assessed for each subject at baseline, after 1 month and after 3 months of home therapy. Results from the therapy period was compared to the baseline period, during which the subject received their regular airway clearance regimen. Airway Clearance Satisfaction surveys were conducted at baseline, after 1 month, and after 3 months of therapy. Results from the MN4000 therapy period were compared to the baseline period, during which the subject received their regular regimen |
Keywords
Sequence: | 79923525 | Sequence: | 79923526 | Sequence: | 79923527 | Sequence: | 79923528 |
Name | Airway Clearance | Name | Cystic Fibrosis | Name | Motor Neuron Disease | Name | Home care |
Downcase Name | airway clearance | Downcase Name | cystic fibrosis | Downcase Name | motor neuron disease | Downcase Name | home care |
Design Outcomes
Sequence: | 177512730 | Sequence: | 177512731 | Sequence: | 177512732 | Sequence: | 177512733 | Sequence: | 177512734 | Sequence: | 177512735 | Sequence: | 177512736 | Sequence: | 177512737 | Sequence: | 177512738 | Sequence: | 177512739 | Sequence: | 177512740 | Sequence: | 177512741 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Patient / Caregiver Satisfaction scores | Measure | Mean adherence to prescribed treatment regimen | Measure | ALS-Functional Rating Scale (ALS-FRS) | Measure | Cystic Fibrosis Questionnaire – Revised (CFQ-R) | Measure | Exacerbation of pulmonary disease | Measure | FEV1 | Measure | FVC | Measure | FEV1/FVC ratio | Measure | SVC | Measure | SPO2 | Measure | Maximal inspiratory pressure (MIP) | Measure | PCF |
Time Frame | 90 days | Time Frame | 90 days | Time Frame | 90 days | Time Frame | 90 days | Time Frame | 90 days | Time Frame | 90 days | Time Frame | 90 days | Time Frame | 90 days | Time Frame | 90 days | Time Frame | 90 days | Time Frame | 90 days | Time Frame | 90 days |
Description | The primary efficacy variable was patient and/or caregiver satisfaction with therapy, as evaluated using a Therapy Use Rating Scale questionnaire. The Therapy Use Rating Scale is an assessment of patient/caregiver satisfaction with the therapy and their subjective assessment of the benefit of the therapy. This was assessed by a 5 point likert scale assessing effectiveness, ease of use and likelihood to continue therapy with 5 representing positive responses and 1, negative. | Description | Evidenced by feedback on adherence to therapy. Use of the MN4000 was evaluated, collecting daily treatment usage information from study subjects and/or caregivers to determine the level of adherence to the prescribed therapy regimen. A self reporting tool has been developed for the study assessing adherence to duration of individual prescribed treatment time and overall study duration. | Description | MND patients only. MND patients only. The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) is an instrument for evaluating the functional status of patients with Amyotrophic Lateral Sclerosis. It can be used to monitor functional change in a patient over time.
It contains 10 distinct measures: Speech These 10 parameters are scored on a scale of 0-4, based on the patients' ability to perform tasks. The minimum score is 0 and maximum 40.The higher the score the more function is retained. |
Description | CF patients only. The Cystic Fibrosis Questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents and adults with cystic fibrosis (CF) > or = 14 years, consisting of 44 items on 12 generic and disease-specific scales. It offers 5 distinct 4-point Likert scales (e.g., always/often/ sometime/never). Scores for each HRQoL domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health. | Description | Hospitalization and/or antibiotics for respiratory infection or complication. Exacerbations of pulmonary disease were defined as respiratory infections that resulted in requirement for hospitalization and/or antibiotics to treat the respiratory infection or complication. Hospitalizations that are part of routine care (e.g. hospital admissions for annual "tune-up") or antibiotics that are part of the regular treatment regimen were not documented as exacerbations. Occurence of exarcerbation related hospitalization OR the necessity of a prescription for antibiotics qualify as worsening disease. | Description | FEV1: The forced expiratory volume-one second is the total volume of air a patient exhales in the first second during maximal effort. Normal range is >80%. Decreasing percentage is associated with worsening / Severe disease | Description | The functional vital capacity is the total volume of air a patient exhales for the total duration of the test during maximal effort. Normal range is >80%. Decreasing percentage is associated with worsening / Severe disease | Description | The percentage of the FVC expired in one second Results are given in both raw data (litres, litres per second) and % predicted-the test result as a percent of the "predicted values" for the patients of similar characteristics. Results over 80% are considered normal. | Description | Slow Vital Capacity displays the volume of gas measured on a complete expiration after a maximal inspiration without forced or rapid effort. Useful measurement when FVC is reduced and airway obstruction is present. educed SVC is associated with worsening respiratory disease | Description | SpO2 stands for peripheral capillary oxygen saturation, an estimate of the amount of oxygen in the blood. Low SPO2 is associated with worsening respiratory function. | Description | Maximal inspiratory pressure (MIP) is a measure of the strength of inspiratory muscles, primarily the diaphragm, and allows for the assessment of ventilatory failure, restrictive lung disease and respiratory muscle strength. Reduction in MIP is asociated with worsening neuromuscular status and poor ability to cough. | Description | The Peak Cough Flow is the maximum air flow generated during a cough. Decreasing air flow generated is associated with weakening neuromuscular status and associated poor cough impulse |
Browse Conditions
Sequence: | 193628556 | Sequence: | 193628557 | Sequence: | 193628558 | Sequence: | 193628559 | Sequence: | 193628561 | Sequence: | 193628562 | Sequence: | 193628563 | Sequence: | 193628564 | Sequence: | 193628565 | Sequence: | 193628566 | Sequence: | 193628567 | Sequence: | 193628568 | Sequence: | 193628569 | Sequence: | 193628570 | Sequence: | 193628571 | Sequence: | 193628572 | Sequence: | 193628573 | Sequence: | 193628574 | Sequence: | 193628560 |
Mesh Term | Cystic Fibrosis | Mesh Term | Motor Neuron Disease | Mesh Term | Amyotrophic Lateral Sclerosis | Mesh Term | Fibrosis | Mesh Term | Pancreatic Diseases | Mesh Term | Digestive System Diseases | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Genetic Diseases, Inborn | Mesh Term | Infant, Newborn, Diseases | Mesh Term | Neurodegenerative Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Neuromuscular Diseases | Mesh Term | Spinal Cord Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | TDP-43 Proteinopathies | Mesh Term | Proteostasis Deficiencies | Mesh Term | Metabolic Diseases | Mesh Term | Pathologic Processes |
Downcase Mesh Term | cystic fibrosis | Downcase Mesh Term | motor neuron disease | Downcase Mesh Term | amyotrophic lateral sclerosis | Downcase Mesh Term | fibrosis | Downcase Mesh Term | pancreatic diseases | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | genetic diseases, inborn | Downcase Mesh Term | infant, newborn, diseases | Downcase Mesh Term | neurodegenerative diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | neuromuscular diseases | Downcase Mesh Term | spinal cord diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | tdp-43 proteinopathies | Downcase Mesh Term | proteostasis deficiencies | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48354112 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Hill-Rom |
Overall Officials
Sequence: | 29306197 |
Role | Principal Investigator |
Name | Lisa F Wolfe, MD |
Affiliation | Northwestern University |
Design Group Interventions
Sequence: | 68199719 |
Design Group Id | 55635115 |
Intervention Id | 52522459 |
Eligibilities
Sequence: | 30787106 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Documented diagnosis of CF or MND Exclusion Criteria: Requirement for continuous mechanical ventilation |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253990028 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 8 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 11 |
Designs
Sequence: | 30533176 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Provided Documents
Sequence: | 2582508 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2016-12-05 |
Url | https://ClinicalTrials.gov/ProvidedDocs/77/NCT03797677/Prot_SAP_000.pdf |
Responsible Parties
Sequence: | 28899469 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797664
2018-12-14
https://zephyrnet.com/?p=NCT03797664
NCT03797664https://www.clinicaltrials.gov/study/NCT03797664?tab=tableNANANAThe purpose of this study is to assess the safety and tolerability of an oral solution of CDX-6114 when administered as a single dose in healthy volunteers
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2021-08-04 |
Start Month Year | December 14, 2018 |
Primary Completion Month Year | April 12, 2019 |
Verification Month Year | August 2021 |
Verification Date | 2021-08-31 |
Last Update Posted Date | 2021-08-04 |
Detailed Descriptions
Sequence: | 20721680 |
Description | This is a second Phase 1, double-blind, placebo-controlled study in approximately 24 healthy volunteers who are 18 to 55 years old. Three cohorts are planned each consisting of 8 subjects; the cohorts as planned are 7.5, 15.0 and 22.5 g of CDX-6114 (or matching placebo) in oral solution. Increasing doses of CDX-6114 will be assessed sequentially un til the final dose is evaluated or any of the stopping criteria are reached. Subjects will each receive either a single dose of CDX-6114 or matching placebo, with food, and will then be followed for a total of 22 days (3 weeks). |
Facilities
Sequence: | 200108802 |
Name | Linear Clinical Services |
City | Perth |
State | Western Australia |
Zip | 6009 |
Country | Australia |
Conditions
Sequence: | 52171369 |
Name | Healthy |
Downcase Name | healthy |
Id Information
Sequence: | 40158708 |
Id Source | org_study_id |
Id Value | CDX6114-004 |
Countries
Sequence: | 42569044 |
Name | Australia |
Removed | False |
Design Groups
Sequence: | 55593297 | Sequence: | 55593298 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Experimental: CDX-6114 | Title | Placebo Comparator: Placebo |
Description | 7.5, 15.0 and 22.5g | Description | Phosphate Buffer Diluent Solution |
Interventions
Sequence: | 52485591 | Sequence: | 52485592 |
Intervention Type | Drug | Intervention Type | Drug |
Name | CDX-6114 | Name | Placebo |
Description | CDX-6114 will be administered as a single, oral dose solution at dose levels of 7.5, 15.0 and 22.5g | Description | Phosphate Buffer Diluent oral solution |
Design Outcomes
Sequence: | 177379272 | Sequence: | 177379273 | Sequence: | 177379274 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The incidence of treatment-emergent adverse events experienced by the subjects following oral administration of CDX-6114 | Measure | Pharmacokinetics of CDX-6114 | Measure | Pharmacodynamics of CDX-6114 |
Time Frame | Up to 22 days after drug administartion | Time Frame | Up to 24 hours after drug administration | Time Frame | Up to 24 hours after drug administration |
Description | Will be measured by assessing the frequency and the nature of the AEs reported | Description | Assessed by the serum levels of CDX-6114 following oral administration of CDX-6114 | Description | Assessed by the plasma levels of phenylalanine and cinnamic acid following oral administration of CDX-6114 |
Sponsors
Sequence: | 48319403 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Codexis Inc. |
Overall Officials
Sequence: | 29285411 |
Role | Principal Investigator |
Name | Sam Salman |
Affiliation | Linear Clinical Services |
Design Group Interventions
Sequence: | 68149269 | Sequence: | 68149270 |
Design Group Id | 55593297 | Design Group Id | 55593298 |
Intervention Id | 52485591 | Intervention Id | 52485592 |
Eligibilities
Sequence: | 30765417 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 55 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Healthy male and female, non-smoking, subjects between the ages of 18 and 55 years, inclusive, at the time of screening. Male subjects and their female spouse/partner(s) who are of childbearing potential: Must agree to stay abstinent (where abstinence is the preferred and usual life-style of the subject), starting at screening and continuing throughout the clinical study period, and for 90 days after study drug administration. Or Must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continuing throughout the clinical study period, and for 90 days after study drug administration. Female subjects of childbearing potential: Must agree not to become pregnant during the clinical study period and for 30 days after study drug administration. If heterosexually active, must agree to consistently use a form of highly effective birth control, in combination with a barrier method starting at screening and continuing throughout the clinical study period, and for 30 days after study drug administration Or Must agree to stay abstinent, (where abstinence is the preferred and usual life-style of the subject), starting at screening and continuing throughout the clinical study period, and for 30 days after study drug administration. Female subjects of non-childbearing potential: Must have a confirmed clinical history of sterility Or Must be postmenopausal as defined as: amenorrhea for at least 1 year prior to screening and a laboratory confirmed serum follicle stimulating hormone (FSH) level ≥ 40mIU/mL. Subject agrees not to participate in another interventional study while participating in the present clinical study. – Exclusion Criteria: Female subject who has been pregnant within the 6 months prior to screening or breastfeeding within the 3 months prior to screening. Known allergy or adverse reaction history to any of the oral dose formulation components e.g. mannitol – |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253889233 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 3 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 55 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30511583 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Masking Description | Double-Blind |
Intervention Model Description | Dose-escalating, Randomized, Double-Blinded,. Placebo-Controlled |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28877878 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797651
2019-04-24
https://zephyrnet.com/?p=NCT03797651
NCT03797651https://www.clinicaltrials.gov/study/NCT03797651?tab=tableMyeong-Ki Hong, MD, PhDmkhong61@yuhs.ac82-2-2228-8458We hypothesized that ticagrelor monotherapy might be enough to prevent thromboembolic events without aspirin after PCI in patients with acute coronary syndrome(ACS). Moreover, ticagrelor monotherapy will reduce bleeding risk compared to DAPT with aspirin plus ticagrelor. We will also evaluate 1-year safety and efficacy of Orsiro stent for patient with acute coronary syndrome. After confirmation of enrollment, patients will be randomized to continue standard treatment (aspirin plus ticagrelor) for 1 year or to stop aspirin after discharge or less than 1 month after PCI (ticagrelor monotherapy). Randomization will be stratified according to 1) the presence of diabetes and 2) ST elevation myocardial infarction (MI). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-03-07 |
Start Month Year | April 24, 2019 |
Primary Completion Month Year | April 4, 2025 |
Verification Month Year | March 2023 |
Verification Date | 2023-03-31 |
Last Update Posted Date | 2023-03-07 |
Facilities
Sequence: | 199785018 |
Status | Recruiting |
Name | Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine |
City | Seoul |
Zip | 03722 |
Country | Korea, Republic of |
Facility Contacts
Sequence: | 28075000 |
Facility Id | 199785018 |
Contact Type | primary |
Name | Myeong-Ki Hong, MD, PhD |
mkhong61@yuhs.ac | |
Phone | 82-2-2228-8458 |
Conditions
Sequence: | 52104184 |
Name | Coronary Artery Disease, Acute Coronary Syndrome |
Downcase Name | coronary artery disease, acute coronary syndrome |
Id Information
Sequence: | 40106111 |
Id Source | org_study_id |
Id Value | 4-2018-0782 |
Countries
Sequence: | 42508632 |
Name | Korea, Republic of |
Removed | False |
Design Groups
Sequence: | 55520476 | Sequence: | 55520477 |
Group Type | Active Comparator | Group Type | Experimental |
Title | Standard DAPT | Title | Very-short DAPT within 1 month |
Description | Patient will continue standard treatment (aspirin plus ticagrelor) for 1 year. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day. | Description | Patient will stop aspirin after discharge (DAPT less than 1 months after PCI) (ticagrelor monotherapy). Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day (during hospitalization). |
Interventions
Sequence: | 52418212 | Sequence: | 52418213 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Standard DAPT | Name | Very-short DAPT less than 1 month after PCI |
Description | Patient will continue standard treatment (aspirin plus ticagrelor) for 1 year. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day. | Description | Patient will stop aspirin (ticagrelor monotherapy) after discharge or within 1 month. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day (during hospitalization). |
Design Outcomes
Sequence: | 177146235 | Sequence: | 177146236 | Sequence: | 177146237 | Sequence: | 177146238 | Sequence: | 177146239 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Net clinical benefit | Measure | Each components of net clinical benefit | Measure | Cardiovascular mortality | Measure | Major or minor bleeding | Measure | Major adverse cardiac event |
Time Frame | 1 year after procedure | Time Frame | 1 year after procedure | Time Frame | 1 year after procedure | Time Frame | 1 year after procedure | Time Frame | 1 year after procedure |
Description | A composite of all-cause death, MI, stent thrombosis, stroke, major bleeding | Description | All-cause death, MI, stent thrombosis, stroke, major bleeding | Description | Cardiovascular mortality | Description | Major or minor bleeding | Description | A composite of cardiac death, MI, stent thrombosis, ischemia-driven target-vessel revascularization |
Browse Conditions
Sequence: | 193223641 | Sequence: | 193223642 | Sequence: | 193223643 | Sequence: | 193223644 | Sequence: | 193223645 | Sequence: | 193223646 | Sequence: | 193223647 | Sequence: | 193223648 | Sequence: | 193223649 | Sequence: | 193223650 | Sequence: | 193223651 | Sequence: | 193223652 | Sequence: | 193223653 | Sequence: | 193223654 |
Mesh Term | Coronary Artery Disease | Mesh Term | Acute Coronary Syndrome | Mesh Term | Syndrome | Mesh Term | Acute Disease | Mesh Term | Disease | Mesh Term | Pathologic Processes | Mesh Term | Coronary Disease | Mesh Term | Myocardial Ischemia | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Arteriosclerosis | Mesh Term | Arterial Occlusive Diseases | Mesh Term | Vascular Diseases | Mesh Term | Disease Attributes |
Downcase Mesh Term | coronary artery disease | Downcase Mesh Term | acute coronary syndrome | Downcase Mesh Term | syndrome | Downcase Mesh Term | acute disease | Downcase Mesh Term | disease | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | coronary disease | Downcase Mesh Term | myocardial ischemia | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | arteriosclerosis | Downcase Mesh Term | arterial occlusive diseases | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | disease attributes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48257891 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Yonsei University |
Overall Officials
Sequence: | 29246925 |
Role | Principal Investigator |
Name | Myeong-Ki Hong |
Affiliation | Division of Cardiology, Severance Hospital, Yonsei University College of Medicine |
Central Contacts
Sequence: | 11994405 |
Contact Type | primary |
Name | Myeong-Ki Hong, MD, PhD |
Phone | 82-2-2228-8458 |
mkhong61@yuhs.ac | |
Role | Contact |
Design Group Interventions
Sequence: | 68059952 | Sequence: | 68059953 |
Design Group Id | 55520476 | Design Group Id | 55520477 |
Intervention Id | 52418212 | Intervention Id | 52418213 |
Eligibilities
Sequence: | 30727084 |
Gender | All |
Minimum Age | 19 Years |
Maximum Age | 80 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients ≥19 years old Exclusion Criteria: Age> 80 years |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253978812 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 19 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30473514 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28839936 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797638
2018-10-01
https://zephyrnet.com/?p=NCT03797638
NCT03797638https://www.clinicaltrials.gov/study/NCT03797638?tab=tableNANANAWriter’s cramp is a focal dystonia characterized by abnormal movements and postures during writing. Limited finger independence during writing manifests as difficulty suppressing unwanted activations of neighbouring non task-relevant fingers. Patients with Writer’s cramp also have difficulty in fine control of grip force.
The investigators have recently developed the Finger Force Manipulandum which quantifies the forces applied by each fingers in different tasks. This method is sensitive for detection and quantification of small unwanted contractions in non-active (‘stationary’) fingers. Different tasks have been developed to assess abilities such as finger individuation but also fine finger force control, finger movement regularity and speed.
The aim of this study is to assess if developed tasks allow to precisely characterize writer’s cramp condition in terms of abilities aforementioned.
To do so, performance of 20 writer’s cramp patients in the developed task will be compared with performance of 20 control participants (matched in age, sex and writing hand) in the same tasks.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2021-06-22 |
Start Month Year | October 1, 2018 |
Primary Completion Month Year | July 19, 2019 |
Verification Month Year | June 2021 |
Verification Date | 2021-06-30 |
Last Update Posted Date | 2021-06-22 |
Facilities
Sequence: | 199965116 |
Name | Fondation A de Rothschild |
City | Paris |
Zip | 75019 |
Country | France |
Conditions
Sequence: | 52139058 | Sequence: | 52139059 | Sequence: | 52139060 |
Name | Dystonic Disorder | Name | Focal Dystonia | Name | Writer's Cramp |
Downcase Name | dystonic disorder | Downcase Name | focal dystonia | Downcase Name | writer's cramp |
Id Information
Sequence: | 40135103 |
Id Source | org_study_id |
Id Value | SSA_2018_4 |
Countries
Sequence: | 42542718 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55559413 | Sequence: | 55559414 |
Group Type | Experimental | Group Type | Other |
Title | Patients with writer's cramp | Title | Control subjects |
Description | Patients with writer's cramp | Description | Control subjects, without writer's cramp, matched with case subjects with age, gender and hand writing |
Interventions
Sequence: | 52454969 |
Intervention Type | Device |
Name | Finger Force Manipuladum (FFM) |
Description | Tasks performed with the device Finger Force Manipuladum (FFM), to assess abilities such as finger individuation but also fine finger force control, finger movement regularity and speed. |
Keywords
Sequence: | 79822892 | Sequence: | 79822893 | Sequence: | 79822894 |
Name | Dystonic Disorder | Name | Focal Dystonia | Name | Writer's Cramp |
Downcase Name | dystonic disorder | Downcase Name | focal dystonia | Downcase Name | writer's cramp |
Design Outcomes
Sequence: | 177264037 |
Outcome Type | primary |
Measure | Manual dexterity by the FFM |
Time Frame | Inclusion |
Description | Compare the manual dexterity by the FFM between subjects with writer's cramp and control subject |
Browse Conditions
Sequence: | 193366748 | Sequence: | 193366749 | Sequence: | 193366750 | Sequence: | 193366751 | Sequence: | 193366752 | Sequence: | 193366753 | Sequence: | 193366742 | Sequence: | 193366743 | Sequence: | 193366744 | Sequence: | 193366745 | Sequence: | 193366746 | Sequence: | 193366747 |
Mesh Term | Nervous System Diseases | Mesh Term | Movement Disorders | Mesh Term | Central Nervous System Diseases | Mesh Term | Muscular Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Neuromuscular Manifestations | Mesh Term | Muscle Cramp | Mesh Term | Dystonia | Mesh Term | Dystonic Disorders | Mesh Term | Spasm | Mesh Term | Dyskinesias | Mesh Term | Neurologic Manifestations |
Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | movement disorders | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | muscular diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | neuromuscular manifestations | Downcase Mesh Term | muscle cramp | Downcase Mesh Term | dystonia | Downcase Mesh Term | dystonic disorders | Downcase Mesh Term | spasm | Downcase Mesh Term | dyskinesias | Downcase Mesh Term | neurologic manifestations |
Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290756 | Sequence: | 48290757 |
Agency Class | NETWORK | Agency Class | OTHER_GOV |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Fondation Ophtalmologique Adolphe de Rothschild | Name | Institut National de la Santé Et de la Recherche Médicale, France |
Overall Officials
Sequence: | 29268557 |
Role | Principal Investigator |
Name | Jean-Pierre BLETON, PhD |
Affiliation | Fondation A. de Rothschild |
Design Group Interventions
Sequence: | 68107531 | Sequence: | 68107532 |
Design Group Id | 55559414 | Design Group Id | 55559413 |
Intervention Id | 52454969 | Intervention Id | 52454969 |
Eligibilities
Sequence: | 30747755 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion criteria for patients with writer's cramp
Patient with writer's cramp and writing speed <140 letters / min Non inclusion criteria for patients with writer's cramp Patients whose writer's cramp has no impact on the handwriting and has kept a writing speed> 140 letters per minute. Inclusion criteria for control subjects •> 18 years old Without writer's cramp Non inclusion criteria for control subjects Tremor of writing Matching criteria between cases and control patients Age (± 5 years) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254122065 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 9 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30494038 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28860318 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797625
2017-05-04
https://zephyrnet.com/?p=NCT03797625
NCT03797625https://www.clinicaltrials.gov/study/NCT03797625?tab=tablechang jian hua, PDchangjianhua@163.com18017312689The aim of this study is to explore whether endostar combined with IP as treatment could improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | May 4, 2017 |
Primary Completion Month Year | December 31, 2020 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Detailed Descriptions
Sequence: | 20727186 |
Description | This study is to explore whether endostar combined with IP as treatment could improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens used as second-line treatment of advanced esophageal squamous cell carcinomas |
Facilities
Sequence: | 200159423 |
Status | Recruiting |
Name | Cancer hospital Fudan University |
City | Shanghai |
State | Shanghai |
Zip | 200032 |
Country | China |
Facility Contacts
Sequence: | 28113731 |
Facility Id | 200159423 |
Contact Type | primary |
Name | Chang jian hua, PD |
Browse Interventions
Sequence: | 96074204 | Sequence: | 96074205 | Sequence: | 96074206 | Sequence: | 96074207 | Sequence: | 96074208 | Sequence: | 96074209 | Sequence: | 96074210 | Sequence: | 96074211 | Sequence: | 96074212 | Sequence: | 96074213 | Sequence: | 96074214 | Sequence: | 96074215 | Sequence: | 96074216 |
Mesh Term | Cisplatin | Mesh Term | Irinotecan | Mesh Term | Endostar protein | Mesh Term | Antineoplastic Agents | Mesh Term | Topoisomerase I Inhibitors | Mesh Term | Topoisomerase Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Angiogenesis Inhibitors | Mesh Term | Angiogenesis Modulating Agents | Mesh Term | Growth Substances | Mesh Term | Physiological Effects of Drugs | Mesh Term | Growth Inhibitors |
Downcase Mesh Term | cisplatin | Downcase Mesh Term | irinotecan | Downcase Mesh Term | endostar protein | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | topoisomerase i inhibitors | Downcase Mesh Term | topoisomerase inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | angiogenesis inhibitors | Downcase Mesh Term | angiogenesis modulating agents | Downcase Mesh Term | growth substances | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | growth inhibitors |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52185503 |
Name | Esophageal Squamous Cell Carcinoma |
Downcase Name | esophageal squamous cell carcinoma |
Id Information
Sequence: | 40169083 |
Id Source | org_study_id |
Id Value | ENDO-SH-002 |
Countries
Sequence: | 42580674 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55609137 |
Group Type | Experimental |
Title | Endostar Combined With IP |
Description | Endostar15mg/m2 Irinotecan 60mg/m2,D1,8 DDP 60mg/m2,D1 |
Interventions
Sequence: | 52499445 | Sequence: | 52499446 | Sequence: | 52499447 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Irinotecan | Name | DDP | Name | Endostar |
Description | 60mg/m2,D1,8 | Description | 60mg/m2,D1 | Description | 15mg/d,d1-d7 civ |
Design Outcomes
Sequence: | 177432083 |
Outcome Type | primary |
Measure | Progression Free Survival |
Time Frame | from the first cycle of treatment (day one) to two month after the last cycle |
Browse Conditions
Sequence: | 193540191 | Sequence: | 193540192 | Sequence: | 193540193 | Sequence: | 193540194 | Sequence: | 193540195 | Sequence: | 193540196 | Sequence: | 193540197 | Sequence: | 193540198 | Sequence: | 193540199 | Sequence: | 193540200 | Sequence: | 193540201 | Sequence: | 193540202 | Sequence: | 193540203 | Sequence: | 193540204 | Sequence: | 193540205 |
Mesh Term | Carcinoma | Mesh Term | Carcinoma, Squamous Cell | Mesh Term | Esophageal Squamous Cell Carcinoma | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Neoplasms, Squamous Cell | Mesh Term | Esophageal Neoplasms | Mesh Term | Gastrointestinal Neoplasms | Mesh Term | Digestive System Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Head and Neck Neoplasms | Mesh Term | Digestive System Diseases | Mesh Term | Esophageal Diseases | Mesh Term | Gastrointestinal Diseases |
Downcase Mesh Term | carcinoma | Downcase Mesh Term | carcinoma, squamous cell | Downcase Mesh Term | esophageal squamous cell carcinoma | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | neoplasms, squamous cell | Downcase Mesh Term | esophageal neoplasms | Downcase Mesh Term | gastrointestinal neoplasms | Downcase Mesh Term | digestive system neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | head and neck neoplasms | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | esophageal diseases | Downcase Mesh Term | gastrointestinal diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332349 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Fudan University |
Overall Officials
Sequence: | 29292998 | Sequence: | 29292999 |
Role | Principal Investigator | Role | Principal Investigator |
Name | chang jian hua, PD | Name | wang hui jie, doctor |
Affiliation | PI | Affiliation | SUBI |
Central Contacts
Sequence: | 12012305 |
Contact Type | primary |
Name | chang jian hua, PD |
Phone | 18017312689 |
changjianhua@163.com | |
Role | Contact |
Design Group Interventions
Sequence: | 68168198 | Sequence: | 68168199 | Sequence: | 68168200 |
Design Group Id | 55609137 | Design Group Id | 55609137 | Design Group Id | 55609137 |
Intervention Id | 52499445 | Intervention Id | 52499446 | Intervention Id | 52499447 |
Eligibilities
Sequence: | 30773587 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 75 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Histologically proven primary thoracic esophageal squamous cell carcinoma According to the esophageal AJCC2009 7th to determine new stage IV esophageal cancer The subject has PD after first-line chemotherapy or radiation within a year Presence of at least one index lesion measurable by CT scan or MRI according to RECIST 1.1 Can eat more than liquid diet; No signs before esophageal perforation 18~75 years PS:0-1 Life expectancy of ≥ 3 months ANC ≥ 2×109/L,PLT ≥ 100×109/L,Hb ≥ 90g/L TB ≤ UNL; ALT/AST ≤ 2.5×UNL,AKP ≤ 5×UNL Ccr≤ UNL,Scr≥60 mL/min Normal electrocardiogram (ecg), the body had no unheal wounds Radiotherapy before within the scope of the normal dose and not affect subsequent treatment Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions Signed written informed consent Exclusion Criteria: Breast-feeding or pregnant women, no effective contraception if risk of conception exists Chronic diarrhea, enteritis, intestine obstruction which are not under control Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc. A second primary tumor (except skin basal cell carcinoma) The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms With bleeding tendency Has inherited bleeding evidence of physical or blood coagulation disorder With clear chemotherapy drug allergy Other researchers believe that patients should not participate in this testing – |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952757 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 75 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30519718 |
Allocation | Non-Randomized |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26680429 | Sequence: | 26680430 |
Intervention Id | 52499446 | Intervention Id | 52499447 |
Name | Cisplatin | Name | ENDO |
Responsible Parties
Sequence: | 28886019 |
Responsible Party Type | Principal Investigator |
Name | Chang Jian Hua |
Title | Chief Physician |
Affiliation | Fudan University |
Study References
Sequence: | 52078927 |
Pmid | 35380726 |
Reference Type | derived |
Citation | Hu Z, Sun S, Zhao X, Yu H, Wu X, Wang J, Chang J, Wang H. Rh-Endostatin Plus Irinotecan/Cisplatin as Second-Line Therapy for Advanced Esophageal Squamous Cell Carcinoma: An Open-Label, Phase II Study. Oncologist. 2022 Apr 5;27(4):253-e312. doi: 10.1093/oncolo/oyab078. |
]]>
https://zephyrnet.com/NCT03797612
2021-01-31
https://zephyrnet.com/?p=NCT03797612
NCT03797612https://www.clinicaltrials.gov/study/NCT03797612?tab=tableNANANAThis is a multi-center, Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of brivoligide injection administered intrathecally before surgery in patients with a Pain Catastrophizing Scale (PCS) score ≥16 undergoing primary unilateral total knee arthroplasty.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2020-07-13 |
Start Month Year | January 2021 |
Primary Completion Month Year | January 2022 |
Verification Month Year | July 2020 |
Verification Date | 2020-07-31 |
Last Update Posted Date | 2020-07-13 |
Detailed Descriptions
Sequence: | 20716302 |
Description | The objective of this study is to evaluate the safety and postoperative pain reducing efficacy of a single preoperative intrathecal administration of brivoligide injection in patients with a Pain Catastrophizing Scale (PCS) score ≥16 undergoing unilateral total knee arthroplasty.
Potential subjects will be prescreened for PCS scores of 16 or greater in advance; pre-qualified patients will be invited to the investigative site for informed consent and full screening within 30 days of randomization. Patients providing informed consent and meeting all study eligibility criteria will be enrolled in the study on the day of surgery (Day 1). Safety assessments will be performed through Day 28; efficacy assessments will be conducted at the follow-up visits and daily via electronic diary by subjects through Day 42. Follow up visits will occur on Days 7, 14, 21, 28, and 42. |
Facilities
Sequence: | 200053310 | Sequence: | 200053311 |
Name | Research Site | Name | Research Site |
City | Sheffield | City | Phoenix |
State | Alabama | State | Arizona |
Zip | 35660 | Zip | 85023 |
Country | United States | Country | United States |
Conditions
Sequence: | 52156519 |
Name | Pain, Postoperative |
Downcase Name | pain, postoperative |
Id Information
Sequence: | 40148226 |
Id Source | org_study_id |
Id Value | ADYX-005 |
Countries
Sequence: | 42557744 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55577923 | Sequence: | 55577924 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Brivoligide Injection 660 mg/6 mL | Title | Placebo 6 mL |
Description | Subjects randomized to the active treatment group will receive a single 660 mg/6 mL intrathecal administration of brivoligide injection as a slow bolus injection just prior to administration of spinal anesthesia, via the same needle. | Description | Subjects randomized to the placebo group will receive a single 6 mL intrathecal injection of placebo as a slow bolus injection just prior to administration of spinal anesthesia, via the same needle. |
Interventions
Sequence: | 52472024 | Sequence: | 52472025 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Brivoligide Injection 660 mg/6 mL | Name | Placebo 6 mL |
Description | Single preoperative intrathecal injection | Description | Single preoperative intrathecal injection |
Keywords
Sequence: | 79848130 | Sequence: | 79848131 | Sequence: | 79848132 |
Name | Knee replacement | Name | TKA | Name | Total Knee Arthroplasty |
Downcase Name | knee replacement | Downcase Name | tka | Downcase Name | total knee arthroplasty |
Design Outcomes
Sequence: | 177328053 | Sequence: | 177328054 | Sequence: | 177328055 | Sequence: | 177328056 | Sequence: | 177328057 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Numerical Rating Scale (NRS) Pain with Walking 15 Meters | Measure | Numerical Rating Scale (NRS) Pain at Rest | Measure | Numerical Rating Scale (NRS) Pain with 90 Degrees Passive Knee Flexion | Measure | Total Postoperative Opioid Use | Measure | Time to Numerical Rating Scale (NRS) Pain ≤ 3 for Worst Pain |
Time Frame | Day 7 to Day 28 | Time Frame | Day 7 to Day 28 | Time Frame | Day 7 to Day 28 | Time Frame | Postoperative through Day 42 | Time Frame | Postoperative through Day 42 |
Description | Least squares mean pain rating (NRS) with walking during the 15-meter walk Day 7 to Day 28 | Description | Least squares mean pain rating (NRS) at rest Day 7 to Day 28 | Description | Least squares mean pain rating (NRS) with passive knee flexion to 90 degrees from Day 7 to Day 28 | Description | Total use of postoperative opioid medications (morphine equivalents) to Day 42 | Description | Time to achieve NRS pain score ≤ 3 for worst pain |
Browse Conditions
Sequence: | 193432134 | Sequence: | 193432135 | Sequence: | 193432136 | Sequence: | 193432137 | Sequence: | 193432138 |
Mesh Term | Pain, Postoperative | Mesh Term | Postoperative Complications | Mesh Term | Pathologic Processes | Mesh Term | Pain | Mesh Term | Neurologic Manifestations |
Downcase Mesh Term | pain, postoperative | Downcase Mesh Term | postoperative complications | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | pain | Downcase Mesh Term | neurologic manifestations |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306099 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Adynxx, Inc. |
Design Group Interventions
Sequence: | 68130887 | Sequence: | 68130888 |
Design Group Id | 55577923 | Design Group Id | 55577924 |
Intervention Id | 52472024 | Intervention Id | 52472025 |
Eligibilities
Sequence: | 30757367 |
Gender | All |
Minimum Age | 40 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Score of 16 or greater on the PCS scale Exclusion Criteria: Target knee > 20 degrees valgus or varus deformity, evidence of significant bone loss or ligamentous laxity, or existing major hardware that requires removal during TKA |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254228084 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 40 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30503592 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26665922 |
Intervention Id | 52472024 |
Name | AYX1 Injection 660 mg/6 mL |
Responsible Parties
Sequence: | 28869870 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797599
2019-03-28
https://zephyrnet.com/?p=NCT03797599
NCT03797599https://www.clinicaltrials.gov/study/NCT03797599?tab=tableNANANAThis study aims to examine whether greater length of mindfulness practice results in more beneficial outcomes.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-12-11 |
Start Month Year | March 28, 2019 |
Primary Completion Month Year | December 5, 2019 |
Verification Month Year | September 2019 |
Verification Date | 2019-09-30 |
Last Update Posted Date | 2019-12-11 |
Detailed Descriptions
Sequence: | 20735944 |
Description | This study will randomise participants to one of three groups: (1) four sessions of medium length mindfulness practice (lasting 20 mins) and 5 mins of an audio book; (2) four sessions of brief mindfulness practice (lasting 5 mins) and 20 mins of an audio book; and (3) a control group who just receive 4 sessions of audio book (lasting 25 mins). In the mindfulness arms, in each session, the participants will receive the audio book prior to the mindfulness practice. Mindfulness levels, and depression, anxiety and stress will be measured by self-report at baseline, session by session, and at post-intervention. |
Facilities
Sequence: | 200245075 |
Name | Canterbury Christ Church University |
City | Tunbridge Wells |
State | Kent |
Zip | TN1 2YG |
Country | United Kingdom |
Conditions
Sequence: | 52208506 | Sequence: | 52208507 |
Name | Mindfulness | Name | Healthy Population |
Downcase Name | mindfulness | Downcase Name | healthy population |
Id Information
Sequence: | 40186444 |
Id Source | org_study_id |
Id Value | S_Strohmaier_29-11-18 |
Countries
Sequence: | 42599939 |
Name | United Kingdom |
Removed | False |
Design Groups
Sequence: | 55635122 | Sequence: | 55635123 | Sequence: | 55635124 |
Group Type | Experimental | Group Type | Active Comparator | Group Type | Placebo Comparator |
Title | 20 minutes of mindfulness practice | Title | 5 minutes of mindfulness practice | Title | Audio book control |
Description | Two sessions a week for two weeks of: 5 minutes listening to audio book excerpts followed by 20 minutes of audio guided mindfulness practice. Participants will be asked not to engage in formal mindfulness practice outside of these sessions during the study. | Description | Two sessions a week for two weeks of: 20 minutes listening to audio book excerpts followed by 5 minutes of audio guided mindfulness practice. Participants will be asked not to engage in formal mindfulness practice outside of these sessions during the study. | Description | Two sessions a week for two weeks of: 25 minutes listening to audio book excerpts (with non mindfulness practice). Participants will be asked not to engage in formal mindfulness practice during the study. |
Interventions
Sequence: | 52522466 | Sequence: | 52522467 | Sequence: | 52522468 | Sequence: | 52522469 | Sequence: | 52522470 |
Intervention Type | Behavioral | Intervention Type | Behavioral | Intervention Type | Other | Intervention Type | Other | Intervention Type | Other |
Name | 20 minutes of mindfulness practice | Name | 5 minutes of mindfulness practice | Name | 5 minute audio book | Name | 20 minute audio book | Name | 25 minute audio book |
Description | A 20 minute audio guided mindfulness of breathing practice per session, for four sessions. | Description | A 5 minute audio guided mindfulness of breathing practice per session, for four sessions. | Description | 5 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything') per session, for four sessions. | Description | 20 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything'), per session, for four sessions. | Description | 25 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything'), per session, for four sessions. |
Design Outcomes
Sequence: | 177512779 | Sequence: | 177512780 | Sequence: | 177512781 | Sequence: | 177512786 | Sequence: | 177512782 | Sequence: | 177512783 | Sequence: | 177512784 | Sequence: | 177512785 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Change from baseline at post-intervention (week 3) on the Five Factor Mindfulness Questionnaire -15 item version (FFMQ-15) | Measure | Change from baseline at post-intervention (week 3) on the Depression, Anxiety and Stress Scale – 21 item version (DASS-21). | Measure | Sessional Five Factor Mindfulness Questionnaire -15 item version (FFMQ-15) scores. | Measure | Session 4 Toronto Mindfulness Scale (TMS). | Measure | Sessional Depression, Anxiety and Stress Scale – 21 item version (DASS-21) scores | Measure | Session 1 Toronto Mindfulness Scale (TMS). | Measure | Session 2 Toronto Mindfulness Scale (TMS). | Measure | Session 3 Toronto Mindfulness Scale (TMS). |
Time Frame | Post-intervention (3 weeks after baseline). | Time Frame | Post-intervention (3 weeks after baseline). | Time Frame | Baseline, session 2 (week 1), session 3 and 4 (week 2), and post-intervention (week 3). | Time Frame | Session 4 (week 2). | Time Frame | Baseline, session 2 (week 1), session 3 and 4 (week 2), and post-intervention (week 3). | Time Frame | Session 1 (week 1). | Time Frame | Session 2 (week 1). | Time Frame | Session 3 (week 2). |
Description | The Five Factor Mindfulness Questionnaire -15 item version is a self-report measure of mindfulness, producing a total score between 15 and 75, with higher scores indicating greater levels of mindfulness. (Note that the observe subscale will be excluded from the calculation of the total score, as recommended in https://doi.org/10.1002/jclp.21865 and http://dx.doi.org/10.1037/pas0000263 producing a total score between 12 and 60). | Description | The Depression, Anxiety and Stress Scale – 21 is a self-report measure of depression, anxiety and stress, producing a total score between 0 and 63, with higher scores indicating greater symptomatology. | Description | The FFMQ-15 (described above) will be administered at the start of the first session (baseline), immediately after sessions 2 (week 1), 3 (week 2) and 4 (week 2), and at post-intervention (week 3), to examine patterns in changes in mindfulness over the course of the study. | Description | As described above. | Description | The DASS-21 (described above) will be administered at the start of the first session (baseline), immediately after sessions 2 (week 1), 3 (week 2) and 4 (week 2), and at post-intervention (week 3), to to examine patterns in changes over the course of the study. | Description | The TMS is a 13-item self-report measure of state mindfulness that produces scores for curiosity and decentering. The curiosity score ranges from 0 to 24, the decentering score from 0 to 28, and the total score from 0 to 52, with higher scores indicating greater curiosity, decentering and overall state mindfulness respectively. | Description | As described above. | Description | As described above. |
Sponsors
Sequence: | 48354119 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Canterbury Christ Church University |
Overall Officials
Sequence: | 29306205 | Sequence: | 29306206 | Sequence: | 29306207 |
Role | Study Director | Role | Study Director | Role | Principal Investigator |
Name | Fergal Jones, PhD, PsychD | Name | James Cane, PhD | Name | Sarah Strohmaier, MSc |
Affiliation | Canterbury Christ Church University | Affiliation | Canterbury Christ Church University | Affiliation | Canterbury Christ Church University |
Design Group Interventions
Sequence: | 68199727 | Sequence: | 68199728 | Sequence: | 68199729 | Sequence: | 68199730 | Sequence: | 68199731 |
Design Group Id | 55635122 | Design Group Id | 55635123 | Design Group Id | 55635122 | Design Group Id | 55635123 | Design Group Id | 55635124 |
Intervention Id | 52522466 | Intervention Id | 52522467 | Intervention Id | 52522468 | Intervention Id | 52522469 | Intervention Id | 52522470 |
Eligibilities
Sequence: | 30787110 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Members of the general public, especially university students or staff. Exclusion Criteria: Currently experiencing significant difficulties with their mental wellbeing. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253990033 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 8 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 6 |
Designs
Sequence: | 30533180 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | None (Open Label) |
Masking Description | Participants will be masked to the extent that they will not be told which group they have been allocated to nor the exact nature of the the three groups. However, they will be aware of the exercises they are asked to undertake. |
Responsible Parties
Sequence: | 28899473 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797586
2019-05-01
https://zephyrnet.com/?p=NCT03797586
NCT03797586https://www.clinicaltrials.gov/study/NCT03797586?tab=tableNANANAApproximately 70-80% of patients with advanced disease will be affected by moderate to severe pain. Opioid analgesics represented by morphine and oxycodone are the cornerstone of cancer-pain management, and recommended for use in the management of moderate to severe cancer pain according to WHO Cancer Pain Relief Guidelines. One view is that a trial of systemic opioid therapy should be administered to all cancer patients with pain of moderate or greater severity regardless of the pain mechanism. Although opioids analgesics do work well as relieving pain and improving quality of life via their action at opioid receptors in the central nervous system (CNS) and the peripheral nervous system, they also have powerful adverse effects. The overall occurrence of opioid-related adverse drug events has ranged from1.8% to 13.6%. Opioid-induced constipation (OIC), one of the most prevalent adverse events (AEs) in patients receiving opioid analgesics, defined as a change in baseline bowel habits or defecatory patterns following initiation, alteration, or increase in opioid therapy. The prevalence of OIC has been estimated to affect 41% of patients with chronic noncancer pain taking opioids and 94% of cancer patients taking opioids for pain. Unlike many other opioid-related AEs, OIC is persistent and rarely tolerated. OIC impacts pain control, patients’ quality of life and may cause patients to reduce the dose or discontinue opioid use.
Acupuncture, a traditional Chinese medicine, has been used to treat gastrointestinal disease including constipation for thousands of years. Two systematic reviews concluded that acupuncture can improve spontaneous bowel movements for functional constipation, and our recent study indicated that electroacupuncture(EA) could increase complete spontaneous bowel movements and is safe for chronic severe functional constipation. Acupuncture could improve gastrointestinal function via facilitating gastrointestinal motility. Currently, there is little detailed information available regarding the acupuncture use for OIC. The objective of this study is to assess the efficacy and safety of EA for OIC in patients with cancer.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-05 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-07-06 |
Start Month Year | May 1, 2019 |
Primary Completion Month Year | October 16, 2021 |
Verification Month Year | July 2022 |
Verification Date | 2022-07-31 |
Last Update Posted Date | 2022-07-06 |
Facilities
Sequence: | 198627730 |
Name | Guang An Men Hospital |
City | Beijing |
Zip | 100053 |
Country | China |
Conditions
Sequence: | 51788697 |
Name | Opioid-induced Constipation in Patients With Cancer |
Downcase Name | opioid-induced constipation in patients with cancer |
Id Information
Sequence: | 39854215 |
Id Source | org_study_id |
Id Value | 2018-164-KY-01 |
Countries
Sequence: | 42253048 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55208912 | Sequence: | 55208913 |
Group Type | Experimental | Group Type | Sham Comparator |
Title | Electroacupuncture group | Title | Sham electroacupuncture group |
Description | Bilateral ST25,SP14, ST37 will be used in the EA group. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal , where patients will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA. | Description | Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on. |
Interventions
Sequence: | 52111191 | Sequence: | 52111192 |
Intervention Type | Other | Intervention Type | Other |
Name | Electroacupuncture group | Name | Sham electroacupuncture group |
Description | Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA. | Description | Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on. |
Keywords
Sequence: | 79240632 |
Name | electroacupuncture;opioid-induced constipation ,cancer |
Downcase Name | electroacupuncture;opioid-induced constipation ,cancer |
Design Outcomes
Sequence: | 176147714 | Sequence: | 176147715 | Sequence: | 176147716 | Sequence: | 176147717 | Sequence: | 176147718 | Sequence: | 176147719 | Sequence: | 176147720 | Sequence: | 176147721 | Sequence: | 176147722 | Sequence: | 176147723 | Sequence: | 176147724 | Sequence: | 176147725 | Sequence: | 176147726 | Sequence: | 176147727 | Sequence: | 176147728 | Sequence: | 176147729 | Sequence: | 176147730 | Sequence: | 176147731 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | The proportion of responders | Measure | Change in the mean weekly spontaneous bowel movements (SBMs) from the baseline during weeks 1-8 and weeks 13-16. | Measure | The proportion of patients with ≥3 mean weekly spontaneous bowel movements (SBMs) during weeks 1-8 and weeks 13-16 | Measure | The proportion of patients with an increase of ≥1 mean weekly spontaneous bowel movements (SBMs) from the baseline during weeks 1-8 and weeks 13-16 | Measure | A Change in the mean weekly complete spontaneous bowel movements (CSBMs) from the baseline during weeks 1-8 and weeks 13-16. | Measure | The proportion of patients with ≥3 mean weekly spontaneous bowel movements (CSBMs) during weeks 1-8 and weeks 13-16 | Measure | The proportion of patients with an increase of ≥1 mean weekly spontaneous bowel movements (CSBMs) from the baseline during weeks 1-8 and weeks 13-16 | Measure | A change in the mean Bristol Stool Form Scale score for stool consistency of spontaneous bowel movements (SBMs) from the baseline during weeks 1-8 and weeks 13-16 | Measure | A change in the mean score for the straining of spontaneous bowel movements (SBMs) from the baseline during weeks 1-8 and weeks 13-16 | Measure | A change in the total and subscale score of the Patient Assessment of Constipation-Symptom (PAC-SYM) questionnaire from baseline at weeks 8 and 16 | Measure | A change in the total and subscale scores of the Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaires from the baseline at weeks 8 and 16 | Measure | Patients' global assessment of treatment efficacy | Measure | The proportion of patients using rescue medicine and the mean frequency of rescue medicine use per week during weeks 1-8 and weeks 9-16 | Measure | Patients'expectation of the acupuncture efficacy | Measure | The patient blinding assessment | Measure | Incidence of adverse events | Measure | The intensity of cancerous pain evaluation | Measure | The proportion of patients discontinuing the opioid, and those with a ≥30% weekly mean increase or decrease in the dose of opioid from baseline during weeks 1-8 and weeks 9-16 |
Time Frame | weeks 1-8 | Time Frame | weeks 1-8, and weeks 13-16 | Time Frame | weeks 1-8, and weeks 13-16 | Time Frame | weeks 1-8, and weeks 13-16 | Time Frame | weeks 1-8, and weeks 13-16 | Time Frame | weeks 1-8, and weeks 13-16 | Time Frame | weeks 1-8, and weeks 13-16 | Time Frame | weeks 1-8, and weeks 13-16 | Time Frame | weeks 1-8, and weeks 13-16 | Time Frame | week 8 and week 16 | Time Frame | week 8 and week 16 | Time Frame | week 8 and week 16 | Time Frame | weeks 1-8, and weeks 9-16 | Time Frame | at baseline | Time Frame | at week 8 | Time Frame | week 1 to week 16 | Time Frame | at baseline, at weeks 2, 4, 6, 8 and 16. | Time Frame | at week 8 and week 16 |
Description | A responder is defined as a patient that has at least three spontaneous bowel movements (SBMs) per week and an increase of at least one SBM a week from the baseline for at least 6 of the 8 weeks of the treatment period. | Description | An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. | Description | An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. | Description | An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. | Description | An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. A CSBM was defined as an SBM with the feeling of complete evacuation. | Description | An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. A CSBM was defined as an SBM with the feeling of complete evacuation. | Description | An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. A CSBM was defined as an SBM with the feeling of complete evacuation. | Description | For stool consistency, each patient was asked to record their stool consistency according to the Bristol Stool Form Scale, on the following seven points scale. (scored from 1 to 7 for stool types 1 to 7, respectively) | Description | For assessment of straining of SBM, each patient was asked to rate his/her score for straining using the following five-point scale: not at all difficulty (0), a little bit difficulty (1), moderately difficulty (2), quite a bit difficulty (3), extremely difficulty (4). | Description | The PAC-SYM is a 12-item evaluative questionnaire for the chronic constipation, which consists of 4-item abdominal, 3-item rectal, and 5-item stool subscales. Each item score ranges from 0 to 4 in the 2 weeks (14 days) prior to assessment. The, where 0 = symptom absent, 1 = mild,2 = moderate,3 = severe and 4 = very severe. Lower scores indicate a lower symptom burden. Each subscale score will be calculated as the mean of the completed items for that subscale. The total score will be calculated as the mean of all completed items. | Description | The PAC-QOL is a 28-item self-reported instrument for assessing the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. It is divided into four subscales: physical discomfort (items 1-4), psychosocial discomfort (items 5-12), worries/concerns (items 13-23), and satisfaction (items 24 to 28). Each of the item scores ranges from 0 (not at all) to 4 (extremely), with lower scores indicating a better quality of life. For each visit, individual subscale scores will be calculated as the mean of the completed items for that subscale. | Description | each patient was asked to rate his/her efficacy of treatment using the following 7-point self-reporting scale: markedly worse (1), moderately worse (2),slightly worse (3), no change (4), slightly improved (5), moderately improved (6), markedly improved (7). | Description | The proportion of patients using rescue medicine will be compared between groups during weeks 1-8, and weeks 9-16. The mean frequency of using rescue medicine per week during weeks 1-8 equals the total of rescue medicine consumption divided by 8. The mean frequency of using rescue medicine per week during weeks 9-16 equals the total of rescue medicine consumption divided by 8. | Description | Participants will be asked to answer the following questions before the intervention: "Do you think acupuncture will be effective in treating the disease in general?" "Do you think acupuncture will be effective in improving the OIC?" and "which acupuncture modalities do you prefer, EA or SA?" For each question, patients will choose one of the following answers: "unclear/whatever", "EA", or "SA" | Description | Five minutes after the end of any treatment in the eighth week the patients will be asked to answer the following question: "Is traditional EA the acupuncture modality that you have received?". | Description | All adverse events (AEs) t will be recorded throughout the whole trial in case report form. AEs will be categorized as treatment-related (e.g., broken needle, dizziness, fainting, localized hematoma, localized infection or abscess, or some discomforts after acupuncture) and non-treatment-related. Detailed information regarding AEs and serious adverse events (SAEs)-including the name, onset and end date, intensity, relationship with acupuncture and outcome-will be recorded. | Description | The mean cancerous pain intensity and worst cancerous pain intensity during the preceding week will be evaluated by 11 grades (from "0=no pain" to "10=worst pain (the strongest pain ever experienced)" at baseline, as well as weeks 2, 4, 6, 8 and 16. | Description | The proportion of patients discontinuing the opioid, and those with increase/decrease from baseline of ≥30% opioid usage per week will be compared between groups during weeks 1-8, and weeks 9-16 |
Browse Conditions
Sequence: | 191945859 | Sequence: | 191945860 | Sequence: | 191945861 | Sequence: | 191945862 | Sequence: | 191945863 | Sequence: | 191945864 | Sequence: | 191945865 |
Mesh Term | Constipation | Mesh Term | Opioid-Induced Constipation | Mesh Term | Signs and Symptoms, Digestive | Mesh Term | Narcotic-Related Disorders | Mesh Term | Substance-Related Disorders | Mesh Term | Chemically-Induced Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | constipation | Downcase Mesh Term | opioid-induced constipation | Downcase Mesh Term | signs and symptoms, digestive | Downcase Mesh Term | narcotic-related disorders | Downcase Mesh Term | substance-related disorders | Downcase Mesh Term | chemically-induced disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47962730 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
Overall Officials
Sequence: | 29059801 |
Role | Study Chair |
Name | Zhishun Liu |
Affiliation | China Academy of Chinese Medicine Sciences |
Design Group Interventions
Sequence: | 67687601 | Sequence: | 67687602 |
Design Group Id | 55208912 | Design Group Id | 55208913 |
Intervention Id | 52111191 | Intervention Id | 52111192 |
Eligibilities
Sequence: | 30540862 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 85 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Cancer patients who conformed to all the following conditions will be further screened for eligibility: Cancer patients must meet the Rome IV[1] diagnostic criteria for OIC: New or worsening symptoms of constipation following initiation, alteration, or increase in opioid treatment. For patients with a history of chronic functional constipation, he/she must have worsening symptoms of constipation when the opioid therapy is initiated, changed, or the dose is increased; Exclusion Criteria: Participants who fulfill any of the following criteria will be excluded: Patients diagnosed with clinically significant abnormal defecation due to structural abnormalities of the gastrointestinal tract and other tissues related to gastrointestinal tract (not including OIC): inflammatory bowel disease, rectal prolapse, gastrointestinal obstruction, peritoneal metastasis, or peritoneal tumor at the time of enrollment; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254203782 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 29 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 85 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 12 |
Number Of Other Outcomes To Measure | 5 |
Designs
Sequence: | 30289396 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Outcomes Assessor Masked | True |
Pending Results
Sequence: | 1487044 | Sequence: | 1487045 |
Event | Release | Event | Reset |
Event Date Description | August 7, 2022 | Event Date Description | July 7, 2023 |
Event Date | 2022-08-07 | Event Date | 2023-07-07 |
Responsible Parties
Sequence: | 28668356 |
Responsible Party Type | Principal Investigator |
Name | Liu Zhishun |
Title | Principal Investigator |
Affiliation | Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
Study References
Sequence: | 51684083 |
Pmid | 35492306 |
Reference Type | derived |
Citation | Wang W, Wang X, Liu Y, Sun Y, Liu X, Yan Y, Liu Z. Effects of Electroacupuncture on Opioid-Induced Constipation in Patients With Cancer: Study Protocol for a Multicenter Randomized Controlled Trial. Front Med (Lausanne). 2022 Apr 13;9:818258. doi: 10.3389/fmed.2022.818258. eCollection 2022. |
]]>
https://zephyrnet.com/NCT03797573
2014-01-20
https://zephyrnet.com/?p=NCT03797573
NCT03797573https://www.clinicaltrials.gov/study/NCT03797573?tab=tableNANANAPrevious studies showed that transcranial direct current stimulation (tDCS) transiently improves performance of motor function in stroke patients, as well as decrease muscle hypertonia. In severely brain injured patients with disorders of consciousness (DOC), a single stimulation over the left dorsolateral prefrontal cortex has shown to improve patients’ sign of consciousness. Nevertheless, other brain areas could be stimulated in order to manage other symptoms occurring in this population of patients, such as muscle hypertonia. In this study, investigators will assess the effects of bilateral fronto-central tDCS on spasticity as measured with the Modified Ashworth Scale (MAS) and on the Coma Recovery Scale-Revised (CRS-R) scores in patients with DOC in a double-blind sham-controlled experimental design.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | January 20, 2014 |
Primary Completion Month Year | June 28, 2014 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Detailed Descriptions
Sequence: | 20741271 |
Description | Following severe brain damage and coma, some patients may remain in a vegetative state (VS) or minimally conscious state (MCS). At present, there are no evidence-based guidelines regarding the treatment of patients with disorders of consciousness (DOC). A previous study showed that a single stimulation (using transcranial direct current stimulation – tDCS) of the left prefrontal cortex induces an behavioral improvement in some patients in DOC. Nevertheless, patients with DOC suffer from other invalidating dysfunctions such as spasticity (muscle hypertonia). In sroke patients, the inhibition of the motor cortex through cathodes placed over the motor region showed to reduce spasticity.
In this study, investigators aim to assess the effect of single session of transcranial direct current stimulation (tDCS) over right and left fronto-central areas (using 2 anodes and 2 cathodes), on the level of hypertonia and the level of consciousness of patients with DOC, in a double blind randomized sham controlled study. The anodes will be placed over F3 and F4, and the cathodes over C3 and C4. tDCS is a form of safe non-invasive cortical stimulation, modulating cortical excitability under the electrodes, via weak polarizing currents. It has been reported that anodal tDCS transiently improves motor functions in healthy subjects and patients with stroke or Parkinson's disease. By reducing the activity of the motor cortex (cathodes) and increasing the activity of the prefrontal cortex (anodes) we expect to observe a better motor function in patients with DOC. |
Facilities
Sequence: | 200280885 |
Name | University of Liege |
City | Liege |
Zip | 4000 |
Country | Belgium |
Conditions
Sequence: | 52221788 | Sequence: | 52221789 | Sequence: | 52221790 | Sequence: | 52221791 |
Name | Vegetative State | Name | Minimally Conscious State | Name | Spasticity, Muscle | Name | Disorder of Consciousness |
Downcase Name | vegetative state | Downcase Name | minimally conscious state | Downcase Name | spasticity, muscle | Downcase Name | disorder of consciousness |
Id Information
Sequence: | 40195808 |
Id Source | org_study_id |
Id Value | 2014/280B |
Countries
Sequence: | 42609787 |
Name | Belgium |
Removed | False |
Design Groups
Sequence: | 55650078 | Sequence: | 55650077 |
Group Type | Sham Comparator | Group Type | Active Comparator |
Title | sham tDCS | Title | active tDCS |
Description | Patients will receive sham tDCS (5 seconds of stimulation) during 20 minutes preceded and followed by a clinical assessment (Modified Ashworth Scale and Coma Recovery Scale-Revised) and neurophysiological assessment (8 channels EEG). | Description | Patients will receive tDCS (bilateral fronto-central stimulation) during 20 minutes preceded and followed by a clinical assessment (Modified Ashworth Scale and Coma Recovery Scale-Revised) and neurophysiological assessment (8 channels EEG). |
Interventions
Sequence: | 52535586 | Sequence: | 52535587 |
Intervention Type | Device | Intervention Type | Device |
Name | tDCS | Name | sham tDCS |
Description | tDCS will be applied during 20 minutes with a current of 1 mA preceded and followed by a behavioral assessments (Modified Ashworth Scale and Coma Recovery Scale Revised) and an EEG. The anodes will be placed over F3 and F4 and the cathodes over C3 and C4. | Description | Indentical to the active tDCS, except that the stimulation is terminated after 5 seconds. |
Keywords
Sequence: | 79942110 | Sequence: | 79942111 | Sequence: | 79942112 | Sequence: | 79942113 | Sequence: | 79942114 | Sequence: | 79942115 |
Name | transcranial direct current stimulation | Name | disorder of consciousness | Name | muscle hypertonia | Name | spasticity | Name | vegetative state | Name | minimally conscious state |
Downcase Name | transcranial direct current stimulation | Downcase Name | disorder of consciousness | Downcase Name | muscle hypertonia | Downcase Name | spasticity | Downcase Name | vegetative state | Downcase Name | minimally conscious state |
Design Outcomes
Sequence: | 177562303 | Sequence: | 177562304 | Sequence: | 177562305 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in MAS scores | Measure | Change in the CRS-R total score | Measure | Change in brain oscillations |
Time Frame | baseline and directly after tDCS (20 minutes) | Time Frame | Baseline and directly after the tDCS (20 minutes)] | Time Frame | Baseline and directly after the tDCS (20 minutes) |
Description | Modified Ashworth Scale (MAS) will by assessed before and after tDCS (active and sham). Comparison of treatment effect (MAS score after tDCS minus before) between active and sham tDCS. The MAS is a 5 points scale going from 0 (no spasticity) and 5 (extreme spasticity). | Description | Coma Recovery Scale Revised (CRS-R) will be performed before and after tDCS (anodal and sham). Comparison of the treatment effect (CRS-R total score score after tDCS minus before) between real and sham tDCS. The CRS-R is 23 points scale with 6 sub-scales (lower scores refer to reflexes, while higher scores refer to more complex behaviors). The total score is the sum of the scores in the 6 sub-scales. | Description | 8 channels electroencephalography (EEG) will be record before and after tDCS to record potential cortical changes induce by the stimulation. EEG power will be compared in different bandwidths (delta, theta, alpha, beta). |
Browse Conditions
Sequence: | 193679441 | Sequence: | 193679442 | Sequence: | 193679443 | Sequence: | 193679444 | Sequence: | 193679445 | Sequence: | 193679446 | Sequence: | 193679447 | Sequence: | 193679448 | Sequence: | 193679449 | Sequence: | 193679450 | Sequence: | 193679451 | Sequence: | 193679452 | Sequence: | 193679453 | Sequence: | 193679454 | Sequence: | 193679455 | Sequence: | 193679456 |
Mesh Term | Muscle Spasticity | Mesh Term | Consciousness Disorders | Mesh Term | Persistent Vegetative State | Mesh Term | Muscle Hypertonia | Mesh Term | Muscular Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Neuromuscular Manifestations | Mesh Term | Neurologic Manifestations | Mesh Term | Nervous System Diseases | Mesh Term | Neurobehavioral Manifestations | Mesh Term | Neurocognitive Disorders | Mesh Term | Mental Disorders | Mesh Term | Brain Damage, Chronic | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Unconsciousness |
Downcase Mesh Term | muscle spasticity | Downcase Mesh Term | consciousness disorders | Downcase Mesh Term | persistent vegetative state | Downcase Mesh Term | muscle hypertonia | Downcase Mesh Term | muscular diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | neuromuscular manifestations | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | neurobehavioral manifestations | Downcase Mesh Term | neurocognitive disorders | Downcase Mesh Term | mental disorders | Downcase Mesh Term | brain damage, chronic | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | unconsciousness |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366651 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Liege |
Design Group Interventions
Sequence: | 68217722 | Sequence: | 68217723 |
Design Group Id | 55650077 | Design Group Id | 55650078 |
Intervention Id | 52535586 | Intervention Id | 52535587 |
Eligibilities
Sequence: | 30794857 |
Gender | All |
Minimum Age | 16 Years |
Maximum Age | 75 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
post comatose patients Exclusion Criteria: premorbid neurology antecedent |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254004540 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 5 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 16 |
Maximum Age Num | 75 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30540897 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28907217 |
Responsible Party Type | Principal Investigator |
Name | Aurore Thibaut |
Title | Principal Investigator |
Affiliation | University of Liege |
Study References
Sequence: | 52118558 |
Pmid | 24574549 |
Reference Type | background |
Citation | Thibaut A, Bruno MA, Ledoux D, Demertzi A, Laureys S. tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study. Neurology. 2014 Apr 1;82(13):1112-8. doi: 10.1212/WNL.0000000000000260. Epub 2014 Feb 26. |
]]>
https://zephyrnet.com/NCT03797560
2019-03-22
https://zephyrnet.com/?p=NCT03797560
NCT03797560https://www.clinicaltrials.gov/study/NCT03797560?tab=tableNANANAFibromyalgia is a chronic debilitating musculoskeletal pain syndrome. Pregabalin is the only medication that has been approved to treat fibromyalgia in China. Currently, there has been a growing interest in the development of non-pharmacological therapies. Ba-Duan-Jin is an ancient Chinese exercise for health promotion yet easy to learn. Findings from our previous study showed an effectiveness and good safety of Ba-Duan-Jin in patients with fibromyalgia. This study is to evaluate the effectiveness comparison of Ba-Duan-Jin and pregabalin in managing fibromyalgia symptoms experienced by Chinese patients.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-12-06 |
Start Month Year | March 22, 2019 |
Primary Completion Month Year | October 31, 2021 |
Verification Month Year | December 2022 |
Verification Date | 2022-12-31 |
Last Update Posted Date | 2022-12-06 |
Facilities
Sequence: | 198883323 |
Name | Jiao Juan |
City | Beijing |
State | Beijing |
Zip | 100053 |
Country | China |
Browse Interventions
Sequence: | 95442541 | Sequence: | 95442554 | Sequence: | 95442549 | Sequence: | 95442542 | Sequence: | 95442543 | Sequence: | 95442544 | Sequence: | 95442545 | Sequence: | 95442546 | Sequence: | 95442547 | Sequence: | 95442548 | Sequence: | 95442550 | Sequence: | 95442551 | Sequence: | 95442552 | Sequence: | 95442553 |
Mesh Term | Pregabalin | Mesh Term | Psychotropic Drugs | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Analgesics | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Anticonvulsants | Mesh Term | Calcium Channel Blockers | Mesh Term | Membrane Transport Modulators | Mesh Term | Calcium-Regulating Hormones and Agents | Mesh Term | Anti-Anxiety Agents | Mesh Term | Tranquilizing Agents | Mesh Term | Central Nervous System Depressants |
Downcase Mesh Term | pregabalin | Downcase Mesh Term | psychotropic drugs | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | analgesics | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | anticonvulsants | Downcase Mesh Term | calcium channel blockers | Downcase Mesh Term | membrane transport modulators | Downcase Mesh Term | calcium-regulating hormones and agents | Downcase Mesh Term | anti-anxiety agents | Downcase Mesh Term | tranquilizing agents | Downcase Mesh Term | central nervous system depressants |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51867114 |
Name | Fibromyalgia |
Downcase Name | fibromyalgia |
Id Information
Sequence: | 39915355 |
Id Source | org_study_id |
Id Value | Z181100001718153 |
Countries
Sequence: | 42312531 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55293089 | Sequence: | 55293090 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Ba-Duan-Jin group | Title | Pregabalin group |
Description | Ba-Duan-Jin therapy: The participants will be guided by a research staff to do the Ba-Duan-Jin therapy for 50 minutes twice weekly for 12 weeks, in the outpatient section of the hospital.
Placebo pregabalin capsules: Pregabalin placebo treatment will be administered at bedtime once a day, starting at 150 mg for the first week, and increase to the dose of 300 mg from the second week. After one week, if 300 mg dose is tolerable, then maintain it for 10 additional weeks, if not, then go back to the 150 mg dose for 10 additional weeks. |
Description | Wellness education and muscle relaxation exercise program: This program will be held for 50 minutes twice weekly for twelve weeks, containing 10-minute wellness education, 10-minute doctor-patient discussion, and 30-minute guided muscle relaxation exercise.
Active pregabalin capsules: As same usage as the placebo pregabalin capsules. |
Interventions
Sequence: | 52186428 | Sequence: | 52186429 |
Intervention Type | Other | Intervention Type | Drug |
Name | Ba-Duan-Jin | Name | Pregabalin capsule |
Description | Ba-Duan-Jin is a common form of "self-health-care" Qigong exercise that has been practiced by Chinese people for at least eight hundred years. It consists of eight sets of simple movements. By combining meditation with slow, graceful movements, deep breathing, and relaxation, Ba-Duan-Jin practitioners believe it has the ability to move vital energy (Qi) throughout the body. Ba-Duan-Jin is also considered to be a multicomponent intervention that integrates physical, psychosocial, emotional, spiritual, and behavioral elements. While the biological mechanisms remain unclear, previous clinical trials have demonstrated that Ba-Duan-Jin can improve sleep quality, physical health, and mental health in patients with various chronic diseases | Description | Pregabalin is one of the three medications (pregabalin, duloxetine, and milnacipran) that have been approved by the Food and Drug Administration (FDA) to treat fibromyalgia in US, and the only medicine that has been approved in China. |
Keywords
Sequence: | 79373829 |
Name | Eight Brocades; Ba-Duan-Jin; Baduanjin; Qigong; Pain |
Downcase Name | eight brocades; ba-duan-jin; baduanjin; qigong; pain |
Design Outcomes
Sequence: | 176386028 | Sequence: | 176386029 | Sequence: | 176386030 | Sequence: | 176386031 | Sequence: | 176386032 | Sequence: | 176386033 | Sequence: | 176386034 | Sequence: | 176386035 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The change of the Visual Analogue Scale (VAS) for pain from baseline. | Measure | The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline. | Measure | The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline. | Measure | The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline. | Measure | The Beck II Depression Inventory (BDI) | Measure | The change of the Perceived Stress Scale (PSS) from baseline. | Measure | Global Impression of Change (PGIC) questionnaire evaluated at week 12. | Measure | The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline. |
Time Frame | up to 1 week | Time Frame | Baseline, week 4, week 8, and week 12. | Time Frame | Baseline, week 4, week 8, and week 12. | Time Frame | Baseline, week 4, week 8, and week 12. | Time Frame | Baseline, week 4, week 8, and week 12. | Time Frame | Baseline, week 4, week 8, and week 12. | Time Frame | Week 12. | Time Frame | Baseline, week 4, week 8, and week 12. |
Description | Pain VAS, range, 0 to 100 mm, where higher scores indicated the perceived pain to be more severe. | Description | A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms. | Description | The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue. | Description | Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality. | Description | The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity. | Description | The Perceived Stress Scale (PSS) is for measuring the perception of stress and current levels of experienced stress. Scores range from 0 to 56, with higher total score indicating a greater degree of symptom severity. | Description | A questionnaire determine any change in overall symptom status from the beginning of the study to its conclusion (score range, 1 [very much improved] to 7 [very much worse). | Description | The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status). |
Browse Conditions
Sequence: | 192254867 | Sequence: | 192254868 | Sequence: | 192254869 | Sequence: | 192254870 | Sequence: | 192254871 | Sequence: | 192254872 | Sequence: | 192254873 |
Mesh Term | Fibromyalgia | Mesh Term | Myofascial Pain Syndromes | Mesh Term | Muscular Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Rheumatic Diseases | Mesh Term | Neuromuscular Diseases | Mesh Term | Nervous System Diseases |
Downcase Mesh Term | fibromyalgia | Downcase Mesh Term | myofascial pain syndromes | Downcase Mesh Term | muscular diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | rheumatic diseases | Downcase Mesh Term | neuromuscular diseases | Downcase Mesh Term | nervous system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48036671 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
Design Group Interventions
Sequence: | 67784041 | Sequence: | 67784042 |
Design Group Id | 55293089 | Design Group Id | 55293090 |
Intervention Id | 52186428 | Intervention Id | 52186429 |
Eligibilities
Sequence: | 30586823 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia; Exclusion Criteria: had practiced Ba-Duan-Jin, Tai Chi, yoga or other forms of Qigong exercise within 12 months of their recruitment to the study; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253866118 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 31 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 7 |
Designs
Sequence: | 30334847 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26532048 |
Intervention Id | 52186428 |
Name | Baduanjin; Eight Brocades; Eight-Section Brocade |
Responsible Parties
Sequence: | 28713254 |
Responsible Party Type | Principal Investigator |
Name | Juan Jiao |
Title | Deputy chief physician |
Affiliation | Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
Study References
Sequence: | 51759696 |
Pmid | 34292537 |
Reference Type | derived |
Citation | Yang Y, Li YT, Sun YR, Wang J, Li Y, Zhang JH, Jiao J, Jiang Q. Therapeutic Effects of Ba-Duan-Jin versus Pregabalin for Fibromyalgia Treatment: Protocol for a Randomized Controlled Trial. Rheumatol Ther. 2021 Sep;8(3):1451-1462. doi: 10.1007/s40744-021-00341-9. Epub 2021 Jul 22. |
]]>
https://zephyrnet.com/NCT03797547
2018-06-22
https://zephyrnet.com/?p=NCT03797547
NCT03797547https://www.clinicaltrials.gov/study/NCT03797547?tab=tableNANANAThis is a multi centre, single arm, prospective observational phase 4 study in naive or pretreated patients with myopic neovascularization. The patients will be treated with intravitreal injections of Aflibercept following a real life protocol.
This sudy aims to evaluate the visual acuity during a 36 months period of time.
<![CDATA[
Studies
Study First Submitted Date | 2018-08-28 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2021-09-29 |
Start Month Year | June 22, 2018 |
Primary Completion Month Year | January 30, 2023 |
Verification Month Year | September 2021 |
Verification Date | 2021-09-30 |
Last Update Posted Date | 2021-09-29 |
Facilities
Sequence: | 200458242 |
Name | Chu de Poitiers |
City | Poitiers |
Country | France |
Browse Interventions
Sequence: | 96220658 | Sequence: | 96220659 | Sequence: | 96220660 | Sequence: | 96220661 | Sequence: | 96220662 | Sequence: | 96220663 | Sequence: | 96220664 |
Mesh Term | Aflibercept | Mesh Term | Angiogenesis Inhibitors | Mesh Term | Angiogenesis Modulating Agents | Mesh Term | Growth Substances | Mesh Term | Physiological Effects of Drugs | Mesh Term | Growth Inhibitors | Mesh Term | Antineoplastic Agents |
Downcase Mesh Term | aflibercept | Downcase Mesh Term | angiogenesis inhibitors | Downcase Mesh Term | angiogenesis modulating agents | Downcase Mesh Term | growth substances | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | growth inhibitors | Downcase Mesh Term | antineoplastic agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52277512 |
Name | Myopic Choroidal Neovascularisation |
Downcase Name | myopic choroidal neovascularisation |
Id Information
Sequence: | 40235504 |
Id Source | org_study_id |
Id Value | VIC |
Countries
Sequence: | 42653095 |
Name | France |
Removed | False |
Interventions
Sequence: | 52589568 |
Intervention Type | Other |
Name | AFLIBERCEPT |
Description | Patients will be treated following a real life protocol and according to the French recommendation |
Design Outcomes
Sequence: | 177770831 | Sequence: | 177770832 | Sequence: | 177770833 | Sequence: | 177770834 | Sequence: | 177770835 | Sequence: | 177770836 | Sequence: | 177770837 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | visual acuity measurement | Measure | visual acuity measurement in naive patient | Measure | visual acuity measurement after other treatment such as laser, pdt visudyneor other IVT treatment | Measure | pourcentage of patients who gain more than or equal of 15 letters | Measure | Anatomics parameters by oct | Measure | Anatomics parameters by color photographs | Measure | Anatomic parameters by fluoresceine angiography or angiography oct |
Time Frame | 6, 12, 24 and 36 months | Time Frame | 12, 24 and 36 months | Time Frame | 6, 12, 24 and 36 months | Time Frame | 6,12,24 and 36 months | Time Frame | 6, 12, 24 and 36 months | Time Frame | 6, 12, 24 and 36 months | Time Frame | 6, 12, 24 and 36 months |
Description | Efficacy measurement will be performed by mean change of "ETDRS" for Best Corrected Visual Acuity evaluation (ETDRS score at 4 meters) from baseline to 6, 12, 24 and 36 month after initation of treatment by aflibercept | Description | Efficacy measurement will be performed by mean change of "ETDRS" for Best corrected visual acuity evaluation from baseline to month 12, 24 and 36 after initation of treatment by aflibercept in naïve patients | Description | Efficacy measurement will be evaluated by mean change of "ETDRS" for Best corrected visual Acuity evaluation after initation of treatment by aflibercept after switch from other treatment such as laser, visudyne PDT or other IVT treatment, after 6, 12, 24 and 36 months of treatment with Eylea | Description | Efficacy measurement will be evaluated by pourcentage of patients who gain more than or equal of 15 letters at 6, 12, 24 and 36 months after initiation of treatment with aflibercept within naïve or after switch from other treatment such as laser, visudyne PDT or other IVT treatment, | Description | Evaluation of anatomic parameters will be perfomed after 6,12, and 24 and 36 months of treatment with Eylea based on OCT parameters :
On SD-OCT : Distance from CNV lesion to the fovea measured on the scan joining the fovea to the foveal edge of the mCNV Exudation assessed by presence of intraretinal cysts or subretinal fluid Central retinal thickness |
Description | On color retinal photographs:
Presence of retinal hemorrhage Presence of macular atrophy or lacquer cracks, |
Description | On fluoresceine angiography if deemed necessary by the investigator : diffusion during late phases On angiography OCT : neovascular network visualisation |
Browse Conditions
Sequence: | 193893016 | Sequence: | 193893017 | Sequence: | 193893018 | Sequence: | 193893019 | Sequence: | 193893020 | Sequence: | 193893021 | Sequence: | 193893022 | Sequence: | 193893023 | Sequence: | 193893024 |
Mesh Term | Choroidal Neovascularization | Mesh Term | Myopia | Mesh Term | Neovascularization, Pathologic | Mesh Term | Metaplasia | Mesh Term | Pathologic Processes | Mesh Term | Choroid Diseases | Mesh Term | Uveal Diseases | Mesh Term | Eye Diseases | Mesh Term | Refractive Errors |
Downcase Mesh Term | choroidal neovascularization | Downcase Mesh Term | myopia | Downcase Mesh Term | neovascularization, pathologic | Downcase Mesh Term | metaplasia | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | choroid diseases | Downcase Mesh Term | uveal diseases | Downcase Mesh Term | eye diseases | Downcase Mesh Term | refractive errors |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48418698 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Poitiers University Hospital |
Eligibilities
Sequence: | 30827067 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 99 Years |
Healthy Volunteers | No |
Population | Active mCNV among: Naïve patients. Patients with previous history of laser photocoagulation or PDT, with no history of anti-VEGF. Patients with previous history of other anti-VEGF treatments.including ranibizumab or bevacizumab, with sustaining mCNV activity, who did not receive injection since the last 3 month |
Criteria | Inclusion Criteria:
Man or woman aged 18 years and more under reliable method of contraception for woman with childbearing potenteial (hormonal or any intrauterine devices). • Patients naïve or Patients pretreated with previous history of laser photocoagulation or PDT or by other anti-VEGF treatments who did not receive injection since the last 3 month with OCT or angiography examination Exclusion Criteria: Treatment with an anti VEGF administrated by intravitreal injection within 1 months prior to baseline in the study eye. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254123813 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 99 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30572997 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28939419 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797534
2019-02-01
https://zephyrnet.com/?p=NCT03797534
NCT03797534https://www.clinicaltrials.gov/study/NCT03797534?tab=tableNANANAThe purpose of this study is to explore the individualized administration model of warfarin suitable for Chinese people, and provide a scientific reference for the use of warfarin to Chinese people.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-15 |
Start Month Year | February 1, 2019 |
Primary Completion Month Year | January 1, 2022 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-15 |
Detailed Descriptions
Sequence: | 20716306 |
Description | About 600 patients with VKORC1 and CYP2C9 gene mutations were included in the treatment of warfarin anticoagulant therapy. The main indications include valve replacement, atrial fibrillation, pulmonary embolism, etc., randomly divided into 2 groups, respectively, the control group (that is, the use of fixed-dose group), Bayesian-model group, the use of single-blind treatment method, to evaluate the number of major adverse events, TTR and INR adjustments in patients between different groups after three months of taking warfarin, and then to explore the individualized drug use model of warfarin suitable for Chinese population.
In the Bayesian group, according to the genotype of VKORC1 and CYP2C9, the stable dose was calculated by the dose prediction model of Bayesian, and the first three drugs were taken at this dose, and then adjusted to the actual stable dose according to the change of INR. Meanwhile, the control group was administered according to the traditional way, that is, the initial dose is 2.5 or 3mg/d and is gradually adjusted to a stable dose according to changes of INR. The monitoring frequency of INR is: once a day from the beginning of the drug to the time of discharge, once a week after discharge, and once a month after the stable dose is obtained. Detailed records of the number of days to reach a stable dose, the INR value and the occurrence of side effects and time are documented. The concrete steps are as follows: clinicians to judge the standard of the selection criteria; Finally,according to the outcome parameters,statistical analysis were performed with SPSS 11.5 software. A value of P < 0.05 was considered statistically significant. |
Facilities
Sequence: | 200053337 |
Status | Recruiting |
Name | the Department of Cardiovascular Surgery |
City | FuZhou |
State | Fujian |
Zip | 350001 |
Country | China |
Facility Contacts
Sequence: | 28097566 | Sequence: | 28097567 |
Facility Id | 200053337 | Facility Id | 200053337 |
Contact Type | primary | Contact Type | backup |
Name | Liang-Wan Chen, M.D Ph.D | Name | Jin-Hua Zhang, Ph.D |
343983217@qq.com | pollyzhang2006@126.com | ||
Phone | 86 13358255333 | Phone | 86 13609532263 |
Conditions
Sequence: | 52156524 |
Name | Heart Valve Prosthesis |
Downcase Name | heart valve prosthesis |
Id Information
Sequence: | 40148230 |
Id Source | org_study_id |
Id Value | CLW2018WA |
Countries
Sequence: | 42557763 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55577929 | Sequence: | 55577930 |
Group Type | No Intervention | Group Type | Experimental |
Title | Standard anticoagulant group | Title | Bayesian model group |
Interventions
Sequence: | 52472030 |
Intervention Type | Other |
Name | dose regime |
Description | The initial dose of the experimental group will be calculated by the Bayesian model. |
Keywords
Sequence: | 79848137 | Sequence: | 79848138 |
Name | warfarin | Name | gene |
Downcase Name | warfarin | Downcase Name | gene |
Design Outcomes
Sequence: | 177328074 | Sequence: | 177328075 | Sequence: | 177328072 | Sequence: | 177328076 | Sequence: | 177328073 | Sequence: | 177328068 | Sequence: | 177328069 | Sequence: | 177328070 | Sequence: | 177328071 | Sequence: | 177328077 | Sequence: | 177328078 | Sequence: | 177328079 |
Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The time required from the beginning of treatment to the stable dose; | Measure | The percentage of time below the target INR range; | Measure | Percentage of time in therapeutic range | Measure | The percentage of time above the target INR range; | Measure | The time required to reach the treatment target INR for the first time; | Measure | excessive anticoagulant time ratio | Measure | The occurrence of primary bleeding events | Measure | The occurance of secondary bleeding events | Measure | The occurrence of thrombosis events | Measure | The number of dose adjustments and the number of INR measured during the first month of treatment; | Measure | The proportion of patients in each group receiving a stable dose after follow-up; | Measure | The proportion of patients in each group having side effects after follow-up |
Time Frame | 3 months postoperatively | Time Frame | 3 months postoperatively | Time Frame | 3 months, 6 months, 12 months postoperatively | Time Frame | 3 months postoperatively | Time Frame | 3 months postoperatively | Time Frame | 3 months postoperatively | Time Frame | 3 months postoperatively | Time Frame | 3 months postoperatively | Time Frame | 3 months postoperatively | Time Frame | 3 months postoperatively | Time Frame | 3 months postoperatively | Time Frame | 3 months postoperatively |
Description | INR>3,INR>4 | Description | gastrointestinal hemorrhage, intracerebral hemorrhage,etc | Description | nasal bleeding, skin stasis,etc | Description | ischemic stroke, deep vein thrombosis,etc |
Sponsors
Sequence: | 48306103 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Fujian Medical University |
Design Group Interventions
Sequence: | 68130893 |
Design Group Id | 55577930 |
Intervention Id | 52472030 |
Eligibilities
Sequence: | 30757371 |
Gender | All |
Minimum Age | 14 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age > 14 years old; Exclusion Criteria: Severe liver dysfunction (ChildPugh ≥ 10); |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254228093 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 14 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30503596 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Caregiver Masked | True |
Responsible Parties
Sequence: | 28869874 |
Responsible Party Type | Principal Investigator |
Name | Liang-Wan Chen MD |
Title | The director of the department of cardiovascular surgery |
Affiliation | Fujian Medical University |
Study References
Sequence: | 52049419 | Sequence: | 52049420 | Sequence: | 52049421 | Sequence: | 52049422 | Sequence: | 52049423 | Sequence: | 52049424 |
Pmid | 18305455 | Pmid | 19228618 | Pmid | 25889768 | Pmid | 24251363 | Pmid | 24251361 | Pmid | 25628141 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Gage BF, Eby C, Johnson JA, Deych E, Rieder MJ, Ridker PM, Milligan PE, Grice G, Lenzini P, Rettie AE, Aquilante CL, Grosso L, Marsh S, Langaee T, Farnett LE, Voora D, Veenstra DL, Glynn RJ, Barrett A, McLeod HL. Use of pharmacogenetic and clinical factors to predict the therapeutic dose of warfarin. Clin Pharmacol Ther. 2008 Sep;84(3):326-31. doi: 10.1038/clpt.2008.10. Epub 2008 Feb 27. Erratum In: Clin Pharmacol Ther. 2008 Sep;84(3):430. | Citation | International Warfarin Pharmacogenetics Consortium; Klein TE, Altman RB, Eriksson N, Gage BF, Kimmel SE, Lee MT, Limdi NA, Page D, Roden DM, Wagner MJ, Caldwell MD, Johnson JA. Estimation of the warfarin dose with clinical and pharmacogenetic data. N Engl J Med. 2009 Feb 19;360(8):753-64. doi: 10.1056/NEJMoa0809329. Erratum In: N Engl J Med. 2009 Oct 15;361(16):1613. Dosage error in article text. | Citation | Hamberg AK, Hellman J, Dahlberg J, Jonsson EN, Wadelius M. A Bayesian decision support tool for efficient dose individualization of warfarin in adults and children. BMC Med Inform Decis Mak. 2015 Feb 7;15:7. doi: 10.1186/s12911-014-0128-0. | Citation | Pirmohamed M, Burnside G, Eriksson N, Jorgensen AL, Toh CH, Nicholson T, Kesteven P, Christersson C, Wahlstrom B, Stafberg C, Zhang JE, Leathart JB, Kohnke H, Maitland-van der Zee AH, Williamson PR, Daly AK, Avery P, Kamali F, Wadelius M; EU-PACT Group. A randomized trial of genotype-guided dosing of warfarin. N Engl J Med. 2013 Dec 12;369(24):2294-303. doi: 10.1056/NEJMoa1311386. Epub 2013 Nov 19. | Citation | Kimmel SE, French B, Kasner SE, Johnson JA, Anderson JL, Gage BF, Rosenberg YD, Eby CS, Madigan RA, McBane RB, Abdel-Rahman SZ, Stevens SM, Yale S, Mohler ER 3rd, Fang MC, Shah V, Horenstein RB, Limdi NA, Muldowney JA 3rd, Gujral J, Delafontaine P, Desnick RJ, Ortel TL, Billett HH, Pendleton RC, Geller NL, Halperin JL, Goldhaber SZ, Caldwell MD, Califf RM, Ellenberg JH; COAG Investigators. A pharmacogenetic versus a clinical algorithm for warfarin dosing. N Engl J Med. 2013 Dec 12;369(24):2283-93. doi: 10.1056/NEJMoa1310669. Epub 2013 Nov 19. | Citation | Li X, Yang J, Wang X, Xu Q, Zhang Y, Yin T. Clinical benefits of pharmacogenetic algorithm-based warfarin dosing: meta-analysis of randomized controlled trials. Thromb Res. 2015 Apr;135(4):621-9. doi: 10.1016/j.thromres.2015.01.018. Epub 2015 Jan 17. |
]]>
https://zephyrnet.com/NCT03797521
2018-12-19
https://zephyrnet.com/?p=NCT03797521
NCT03797521https://www.clinicaltrials.gov/study/NCT03797521?tab=tableNANANAThe purpose of this study is to explore the safety, tolerability and activity of SXC-2023 when dosed for 6 weeks versus placebo in adult patients with moderate to severe Trichotillomania.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2021-10-28 |
Start Month Year | December 19, 2018 |
Primary Completion Month Year | December 2, 2019 |
Verification Month Year | October 2021 |
Verification Date | 2021-10-31 |
Last Update Posted Date | 2021-10-28 |
Detailed Descriptions
Sequence: | 20787714 |
Description | This is a Phase 2, multicenter, double-blind, placebo-controlled, parallel-group study consisting of a screening period of up to 40 days, a 6 week randomized double-blind treatment period, followed by an up to 2 week safety follow-up period after the last dose of study medication.
Patients will be randomized to one of four treatment groups. Patients will participate for a total of up to 10 weeks, including screening, the 6-week treatment period and follow-up. |
Facilities
Sequence: | 200656939 | Sequence: | 200656940 | Sequence: | 200656941 | Sequence: | 200656942 | Sequence: | 200656943 | Sequence: | 200656944 | Sequence: | 200656945 | Sequence: | 200656946 | Sequence: | 200656947 | Sequence: | 200656948 | Sequence: | 200656949 | Sequence: | 200656950 | Sequence: | 200656951 |
Name | CNRI- Los Angeles | Name | Artemis Institute for Clinical Research | Name | Behavioral Clinical Research | Name | iResearch Atlanta | Name | Univ of Chicago | Name | Lake Charles Clinical Trials | Name | Massachusetts General Hospital | Name | Integrative Clinical Trials, LLC | Name | Finger Lakes Clinical Research | Name | Insight Clinical Trials, LLC | Name | IPS Research Company | Name | Carolina Clinical Trials, Inc | Name | Northwest Clinical Research Center |
City | Pico Rivera | City | Riverside | City | North Miami | City | Decatur | City | Chicago | City | Lake Charles | City | Boston | City | Brooklyn | City | Rochester | City | Shaker Heights | City | Oklahoma City | City | Charleston | City | Bellevue |
State | California | State | California | State | Florida | State | Georgia | State | Illinois | State | Louisiana | State | Massachusetts | State | New York | State | New York | State | Ohio | State | Oklahoma | State | South Carolina | State | Washington |
Zip | 90662 | Zip | 92503 | Zip | 33161 | Zip | 30030 | Zip | 60637 | Zip | 70629 | Zip | 02114 | Zip | 11229 | Zip | 14618 | Zip | 44122 | Zip | 73103 | Zip | 29407 | Zip | 98007 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States |
Conditions
Sequence: | 52340163 |
Name | Trichotillomania |
Downcase Name | trichotillomania |
Id Information
Sequence: | 40279586 |
Id Source | org_study_id |
Id Value | PRO-201 |
Countries
Sequence: | 42699712 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55781354 | Sequence: | 55781355 | Sequence: | 55781356 | Sequence: | 55781357 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Placebo Comparator |
Title | SXC-2023 50mg QD | Title | SXC-2023 200mg QD | Title | SXC-2023 800mg QD | Title | Matching Placebo QD |
Description | SXC-2023 50mg dosed once daily for 6 weeks | Description | SXC-2023 200mg dosed once daily for 6 weeks | Description | SXC-2023 800mg dosed once daily for 6 weeks | Description | Matching Placebo dosed once daily for 6 weeks |
Interventions
Sequence: | 52650881 | Sequence: | 52650882 |
Intervention Type | Drug | Intervention Type | Drug |
Name | SXC-2023 | Name | Placebo |
Description | SXC-2023 oral capsules | Description | Matching Placebo oral capsules |
Keywords
Sequence: | 80102046 | Sequence: | 80102047 | Sequence: | 80102048 |
Name | Promentis Pharmaceuticals | Name | TTM | Name | SXC-2023 |
Downcase Name | promentis pharmaceuticals | Downcase Name | ttm | Downcase Name | sxc-2023 |
Design Outcomes
Sequence: | 178002910 | Sequence: | 178002911 | Sequence: | 178002912 | Sequence: | 178002913 | Sequence: | 178002914 | Sequence: | 178002915 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Explore the incidence of treatment-emergent adverse events in adults with moderate to severe TTM | Measure | Change from baseline hairpulling frequency and severity through 6 weeks | Measure | Change from baseline hairpulling frequency and severity through 6 weeks | Measure | Change from baseline hairpulling frequency and severity through 6 weeks | Measure | Change from baseline hairpulling frequency and severity daily through 6 weeks | Measure | Preliminary psychometric evidence of the Trichotillomania Symptom Diary (TSD) will be assessed |
Time Frame | Up to 7 weeks | Time Frame | Up to 7 weeks | Time Frame | Up to 7 weeks | Time Frame | Up to 7 weeks | Time Frame | Up to 7 weeks | Time Frame | Up to 7 weeks |
Description | Safety and tolerability assessed using the frequency of subjects with serious adverse events, adverse events leading to discontinuation, and adverse events judged to be related to study medication. | Description | Improvement will be assessed using the different measurement parameters of all scales using scales such as the Massachusetts General Hospital Hairpulling scale (MGH-HPS) | Description | Improvement will be assessed using the different measurement parameters of all scales using scales such as the Clinical Global Impression of Severity and Change (CGI-S/C) | Description | Improvement will be assessed using the different measurement parameters of all scales using scales such as the Patient Global Impression of Status and Change (PGI-S/C) | Description | Improvement will be assessed using the different measurement parameters of all scales using scales such as the Trichotillomania Symptom Diary (TSD) | Description | The reliability, validity and responsiveness of the newly developed TSD assessment will be assessed at the item level. |
Browse Conditions
Sequence: | 194130239 | Sequence: | 194130240 | Sequence: | 194130241 |
Mesh Term | Trichotillomania | Mesh Term | Disruptive, Impulse Control, and Conduct Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | trichotillomania | Downcase Mesh Term | disruptive, impulse control, and conduct disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48477246 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Promentis Pharmaceuticals, Inc. |
Overall Officials
Sequence: | 29375117 |
Role | Study Director |
Name | Dean Brostowin |
Affiliation | Promentis Pharmaceuticals |
Design Group Interventions
Sequence: | 68378289 | Sequence: | 68378290 | Sequence: | 68378291 | Sequence: | 68378292 |
Design Group Id | 55781355 | Design Group Id | 55781354 | Design Group Id | 55781356 | Design Group Id | 55781357 |
Intervention Id | 52650881 | Intervention Id | 52650881 | Intervention Id | 52650881 | Intervention Id | 52650882 |
Eligibilities
Sequence: | 30863199 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 45 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria
Adult, female or male, 18-45 years of age, inclusive at screening. Diagnosis of current TTM based on Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria and confirmed using the clinician-administered MINI-TTM. In addition, subjects should: Have a history of TTM for at least one year For a female of childbearing potential: either be sexually inactive (abstinent as a life style) for 28 days prior to the first dosing and throughout the study or be using one of the following acceptable birth control options: Oral contraception for at least 3 months prior to the first dosing along with either a physical (e.g., condom, diaphragm) or a chemical (e.g., spermicide) barrier method from the time of screening and throughout the study In addition, female subjects of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method for at least 30 days following the last dose. Female of non childbearing potential: must have undergone one of the following sterilization procedures, at least 6 months prior to the first dose: hysteroscopic sterilization; Exclusion Criteria: Females who are pregnant or breastfeeding or intend to become pregnant during the study period or within 30 days of the final dose of study drug. Subjects with any of the following: Any psychiatric hospitalizations in the past year, |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253933123 |
Number Of Facilities | 13 |
Registered In Calendar Year | 2019 |
Actual Duration | 11 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 45 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30609022 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Masking Description | Double-blind, Placebo-controlled Study |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Provided Documents
Sequence: | 2592323 | Sequence: | 2592324 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2019-06-25 | Document Date | 2019-06-25 |
Url | https://ClinicalTrials.gov/ProvidedDocs/21/NCT03797521/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/21/NCT03797521/SAP_001.pdf |
Responsible Parties
Sequence: | 28975560 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52245353 |
Pmid | 34582562 |
Reference Type | derived |
Citation | Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3. |
]]>
https://zephyrnet.com/NCT03797508
2018-12-01
https://zephyrnet.com/?p=NCT03797508
NCT03797508https://www.clinicaltrials.gov/study/NCT03797508?tab=tablemohamed k abdelwahab, masterm.k.ali1987@gmail.com01000849822Threatened miscarriage occurs in about one-fifth of pregnancies with an estimated miscarriage rate of 3-16% after successful demonstration of fetal cardiac activity. Various biochemical markers have been studied previously to predict the outcome of threatened miscarriage; However, the results have been conflicting. Several studies have documented that a slow embryonic heart rate at 6.0-7.0 Weeks’ gestation is associated with a high rate of first trimester fetal demise.
our aim: To evaluate the accuracy of ultrasound findings in comparison to serum CA125 and progesterone in predicting fetal demise in cases of first trimester threatened miscarriage.
Will this pregnancy be continued after the first trimester or not?
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-02-05 |
Start Month Year | December 1, 2018 |
Primary Completion Month Year | May 31, 2019 |
Verification Month Year | February 2019 |
Verification Date | 2019-02-28 |
Last Update Posted Date | 2019-02-05 |
Detailed Descriptions
Sequence: | 20721682 |
Description | we are comparing between the accuracy of vaginal ultra sound versus serum progesterone level and serum CA 125 level in predicting of fetal demise in cases of threatened miscarriage three vaginal ultrasounds will be done ) the first one will be done at six to eight weeks of pregnancy to the patients who fulfill the criteria in this us we will make sure that the cardiac pulsations are present and measure the following:
the fetal heart rate, C) the third one will be at the end of first trimester (13 weeks) to ensure fetal viability. . embryonic bradycardia and absence of yolk sac or smaller yolk sac than expected for any given gestational age are prognostic factors of poor pregnancy outcome in the first 12 weeks of pregnancy women with small for age gestational sac are more prone to have miscarriage we will do laboratory investigation in the form of A) Serum progesterone: low maternal P levels have been useful in predicting spontaneous abortion in threatened pregnancies with a sensitivity of 80% (<10 ng /mL) so, this will be our cutoff value. B) Serum CA 125 :we will take a level of 51.5 as cut off value.this is the upper level of normal we will do them once when the patient presents to us. |
Facilities
Sequence: | 200108804 |
Status | Recruiting |
Name | Ain Shams University |
City | Cairo |
Country | Egypt |
Browse Interventions
Sequence: | 96050400 | Sequence: | 96050401 | Sequence: | 96050402 | Sequence: | 96050403 | Sequence: | 96050404 |
Mesh Term | Progesterone | Mesh Term | Progestins | Mesh Term | Hormones | Mesh Term | Hormones, Hormone Substitutes, and Hormone Antagonists | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | progesterone | Downcase Mesh Term | progestins | Downcase Mesh Term | hormones | Downcase Mesh Term | hormones, hormone substitutes, and hormone antagonists | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52171371 |
Name | Abortion Threatened |
Downcase Name | abortion threatened |
Id Information
Sequence: | 40158710 |
Id Source | org_study_id |
Id Value | us laboratory miscarriage |
Countries
Sequence: | 42569046 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55593301 |
Group Type | Other |
Title | threatened miscarriage |
Description | ultrasound ,CA125,progesterone |
Interventions
Sequence: | 52485595 |
Intervention Type | Diagnostic Test |
Name | ultrasound |
Description | To evaluate the accuracy of ultrasound findings in comparison to serum CA125and progesterone in predicting fetal demise in cases of first trimester threatened miscarriage. |
Design Outcomes
Sequence: | 177379282 |
Outcome Type | primary |
Measure | ultra sound |
Time Frame | the 12th week of gestation |
Description | presence of fetal heart rate |
Browse Conditions
Sequence: | 193487201 | Sequence: | 193487202 | Sequence: | 193487203 | Sequence: | 193487204 | Sequence: | 193487205 |
Mesh Term | Abortion, Spontaneous | Mesh Term | Abortion, Threatened | Mesh Term | Pregnancy Complications | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases |
Downcase Mesh Term | abortion, spontaneous | Downcase Mesh Term | abortion, threatened | Downcase Mesh Term | pregnancy complications | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319405 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Ain Shams University |
Overall Officials
Sequence: | 29285413 |
Role | Principal Investigator |
Name | amany a mahmoud |
Affiliation | Ain Shams University |
Central Contacts
Sequence: | 12008911 |
Contact Type | primary |
Name | mohamed k abdelwahab, master |
Phone | 01000849822 |
m.k.ali1987@gmail.com | |
Phone Extension | 002 |
Role | Contact |
Design Group Interventions
Sequence: | 68149273 |
Design Group Id | 55593301 |
Intervention Id | 52485595 |
Eligibilities
Sequence: | 30765419 |
Gender | Female |
Minimum Age | 20 Years |
Maximum Age | 35 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Singleton Pregnancy. Exclusion Criteria: Patients with recurrent miscarriage or pregnancy of unknown location (PUL). Patients had ovulation induction medications or on progesterone treatment. |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253889281 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 20 |
Maximum Age Num | 35 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30511585 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26673784 | Sequence: | 26673785 |
Intervention Id | 52485595 | Intervention Id | 52485595 |
Name | progesterone | Name | CA125 |
Responsible Parties
Sequence: | 28877880 |
Responsible Party Type | Principal Investigator |
Name | amany abdel monem mahmoud |
Title | Egypt Cairo |
Affiliation | Ain Shams University |
]]>
https://zephyrnet.com/NCT03797495
2018-12-18
https://zephyrnet.com/?p=NCT03797495
NCT03797495https://www.clinicaltrials.gov/study/NCT03797495?tab=tableCharles Nakar, MDcnakar@ihtc.org317-871-0000This is an Investigator initiated retrospective and prospective single cohort study. The study will utilize an international registry and develop a specimen biobank to provide an improved understanding of the natural history of hyposplasminogenemia, to elucidate the heterogeneity of phenotypic expression, identify markers to predict disease course, and inform improved therapeutic modalities
<![CDATA[
Studies
Study First Submitted Date | 2018-12-28 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-06-18 |
Start Month Year | December 18, 2018 |
Primary Completion Month Year | March 8, 2027 |
Verification Month Year | June 2023 |
Verification Date | 2023-06-30 |
Last Update Posted Date | 2023-06-18 |
Detailed Descriptions
Sequence: | 20845122 |
Description | The aims of this study are to:
Define PLGD natural history in a large cohort of individuals with hypoplasminogenemia and their first-degree family members. The project will be international in scope with two collaborating centers that have created and will collect the subject data and samples. In North/Central/South America, the Indiana Hemophilia & Thrombosis Center (IHTC) will serve as the primary site while University of Milan will serve as the center for all other sites. The database is housed at the University of Milan, Italy. Study population will include males and females affected with hyposplasminogenemia of any age. Both one-year retrospective and three-year prospective data will be collected on an international cohort of 100 affected individuals and their first degree family members (parents, siblings; total estimated study population ~500). Study sample analysis, except for urine analyses, will be centralized and performed in Italy; the plasminogen antibody analysis will be batched for analysis, and the urine analyses will be performed locally. A sample biorepository will be created and ultimately housed in Italy. The study will provide testing for plasminogen activity and antigen, plasminogen genetic analysis, polymorphisms in genes that impact plasminogen expression and fibrinolysis, and global hemostatic assays. In addition, stored samples will be used for further testing and analyses to potentially include whole genome sequencing to further identify plasminogen genetic mutations as needed and to investigate other genetic modifiers of disease expression. An exploratory aim includes investigating the potential relationship with streptococcal strains and altered plasminogen products. The study period will be 3 years for each enrolled subject. In-person visits will be conducted and samples for analysis will be collected at baseline and at end of study. Interval follow-up will be performed every 6 months by telephone. data will be collected at unscheduled visits that are performed for clinical need at the treating physician's discretion. |
Facilities
Sequence: | 201223995 | Sequence: | 201223996 | Sequence: | 201223997 | Sequence: | 201223998 | Sequence: | 201223999 | Sequence: | 201224000 | Sequence: | 201224001 | Sequence: | 201224002 | Sequence: | 201224003 | Sequence: | 201224004 | Sequence: | 201224005 | Sequence: | 201224006 | Sequence: | 201224007 | Sequence: | 201224008 | Sequence: | 201224009 |
Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting |
Name | Indiana Hemophila @Thrombosis Center | Name | Hemophilia Center of Western Pennsylvania | Name | Vanderbilt Children's Hematology-Oncology | Name | Cook Children's Medical Center | Name | The University of Texas Health Science Center at Houston | Name | Hospital Britanico Buenos Aires | Name | Murdoch Children's Research Institute, The Royal Children's Hospital | Name | University of Saskatchewan | Name | Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, | Name | University Hospital of Padova | Name | Faculty of Medicine, Chiang Mai University | Name | Dokuz Eylul University pediatric Pulmonology, Allergy and Clinical Immunology | Name | Istanbul Üniversitesi Onkoloji Enstitüsü | Name | Istanbul University Cerrahpsasa, Cerrahpsasa Medical Faculty Pediatric Hematology and Oncology Department | Name | Yuzuncu Yil University Faculty of Medicine Department of Ophthalmology |
City | Indianapolis | City | Pittsburgh | City | Nashville | City | Fort Worth | City | Houston | City | Buenos Aires | City | Melbourne | City | Saskatoon | City | Milano | City | Padua | City | Chiang Mai | City | Izmir | City | Istanbul | City | Istanbul | City | Van |
State | Indiana | State | Pennsylvania | State | Tennessee | State | Texas | State | Texas | State | Victoria | State | Balçova | ||||||||||||||||
Zip | 46260 | Zip | 15213 | Zip | 37232 | Zip | 76104 | Zip | 77030 | Zip | C1280 | Zip | 3052 | Zip | SK S7N 0W8 | Zip | 20122 | Zip | 35100 | Zip | 50200 | Zip | 35330 | Zip | 34093 | Zip | 34098 | Zip | 65040 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | Argentina | Country | Australia | Country | Canada | Country | Italy | Country | Italy | Country | Thailand | Country | Turkey | Country | Turkey | Country | Turkey | Country | Turkey |
Facility Contacts
Sequence: | 28273404 | Sequence: | 28273405 | Sequence: | 28273406 | Sequence: | 28273407 | Sequence: | 28273408 | Sequence: | 28273409 | Sequence: | 28273410 | Sequence: | 28273411 | Sequence: | 28273412 | Sequence: | 28273413 | Sequence: | 28273414 | Sequence: | 28273415 | Sequence: | 28273416 | Sequence: | 28273417 | Sequence: | 28273418 | Sequence: | 28273419 | Sequence: | 28273420 | Sequence: | 28273421 | Sequence: | 28273422 | Sequence: | 28273423 | Sequence: | 28273424 | Sequence: | 28273425 | Sequence: | 28273426 | Sequence: | 28273427 | Sequence: | 28273428 |
Facility Id | 201223995 | Facility Id | 201223995 | Facility Id | 201223996 | Facility Id | 201223996 | Facility Id | 201223997 | Facility Id | 201223997 | Facility Id | 201223998 | Facility Id | 201223998 | Facility Id | 201223999 | Facility Id | 201223999 | Facility Id | 201224000 | Facility Id | 201224000 | Facility Id | 201224001 | Facility Id | 201224001 | Facility Id | 201224002 | Facility Id | 201224002 | Facility Id | 201224003 | Facility Id | 201224004 | Facility Id | 201224004 | Facility Id | 201224005 | Facility Id | 201224006 | Facility Id | 201224007 | Facility Id | 201224008 | Facility Id | 201224008 | Facility Id | 201224009 |
Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | backup | Contact Type | primary |
Name | Neelam Thukral, CCRC | Name | Charles Nakar, MD | Name | Frederico Xavier, MD | Name | Debbie Vehec | Name | Delia Darst | Name | Heather McDaniel, MD, MSCI | Name | Heather Urbanek | Name | Marcela Torres, MD | Name | Katherine Addy, RN, BSN, MPH | Name | Nidra Rodriguez, MD | Name | Jhon A Avila, MD | Name | Jose M Ceresetto, MD | Name | Paul Monagle, MD | Name | Jodi Hislop, RN | Name | Sarah Tehseen, MBBS, MSc. FRCPC | Name | Rashmi Nagaraj | Name | Marzia Menegatti, PhD | Name | Maria Teresa Sartori, MD | Name | C. Dalla Porta, MD | Name | Rungrote Natesirinilkul, MD | Name | Serdar Al, MD | Name | Basak Koc, MD | Name | Ayse Gonca Kacar, MD | Name | Tulin Celkan, MD | Name | Muhammed Batur, MD |
nthukral@ihtc.org | cnakar@ihtc.org | fxavier@hmc.psu.edu | dvehec@vitalant.org | delia.h.darst@vumc.org | heather.mcdaniel@vumc.org | Heather.Urbanek@cookchildrens.org | marcela.torres@cookchildrens.org | Katherine.E.Addy@uth.tmc.edu | Nidra.I.Rodriguez@uth.tmc.edu | jaavilar@gmail.com | jceresetto@intramed.net | paul.monagle@rch.org.au | jodi.hislop@rch.org.au | Sarah.Tehseen@saskhealthauthority.ca | rashmi.nagaraj@usask.ca | marzia.menegatti@guest.unimi.it | mtsart@unipd.it | cesare.dallaporta@gmail.com | rungrote.n@cmu.ac.th | drserdaral@gmail.com | s_basakkoc@hotmail.com | goncakacar@gmail.com | tirajecelkan@yahoo.com | muhammedbatur@gmail.com | |||||||||||||||||||||||||
Phone | 317-871-0000 | Phone | 317-871-0000 | Phone | 412-209-7411 | Phone | 412-209-7564 | Phone | 615-343-7190 | Phone | 615 936 1762 | Phone | 682-885-1244 | Phone | 682 885 4007 | Phone | 713-500-8352 | Phone | 713 500 8360 | Phone | 549 114 187 9723 | Phone | 541 143 041 081 | Phone | 61 3 9936-6330 | Phone | 61 3 9936-6330 | Phone | 639 998 3972 | Phone | 306-978-8306 | Phone | +39 – 02/50320727 | Phone | 3334530450 | Phone | 39 049 821 1111 | Phone | 66 2 201 1749 | Phone | 905336510797 | Phone | 90 5326003027 | Phone | 505 259 1229 | Phone | 532 57 60723 | Phone | 904 322 150 473 |
Phone Extension | 373 | Phone Extension | 6030 |
Facility Investigators
Sequence: | 18434231 | Sequence: | 18434232 | Sequence: | 18434233 | Sequence: | 18434234 | Sequence: | 18434235 | Sequence: | 18434236 | Sequence: | 18434237 | Sequence: | 18434238 | Sequence: | 18434239 | Sequence: | 18434240 | Sequence: | 18434241 | Sequence: | 18434242 | Sequence: | 18434243 | Sequence: | 18434244 | Sequence: | 18434245 | Sequence: | 18434246 |
Facility Id | 201223995 | Facility Id | 201223995 | Facility Id | 201223997 | Facility Id | 201223998 | Facility Id | 201223999 | Facility Id | 201224000 | Facility Id | 201224000 | Facility Id | 201224001 | Facility Id | 201224002 | Facility Id | 201224003 | Facility Id | 201224004 | Facility Id | 201224005 | Facility Id | 201224006 | Facility Id | 201224007 | Facility Id | 201224008 | Facility Id | 201224009 |
Role | Principal Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator |
Name | Amy D Shapiro, MD | Name | Charles Nakar, MD | Name | Heather McDaniel, MD, MSCI | Name | Marcela Torres, MD | Name | Nidra Rodriguez, MD | Name | Jose M Ceresetto, MD | Name | Jhon A Avila, MD | Name | Paul Monagle, MD | Name | Sarah Tehseen, MBBS, MSc. FRCPC | Name | Flora Peyvandi, MD,PhD | Name | Maria Teresa Sartori, MD | Name | Rungrote Natesirinilkul, MD | Name | Serdar Al, MD | Name | Basak Koc, MD | Name | Tulin Celkan, MD | Name | Muhammed Batur, MD |
Conditions
Sequence: | 52488208 |
Name | Plasminogen Deficiency |
Downcase Name | plasminogen deficiency |
Id Information
Sequence: | 40385176 |
Id Source | org_study_id |
Id Value | HISTORY |
Countries
Sequence: | 42820903 | Sequence: | 42820904 | Sequence: | 42820905 | Sequence: | 42820906 | Sequence: | 42820907 | Sequence: | 42820908 | Sequence: | 42820909 |
Name | United States | Name | Argentina | Name | Australia | Name | Canada | Name | Italy | Name | Thailand | Name | Turkey |
Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False |
Design Outcomes
Sequence: | 178566819 | Sequence: | 178566820 | Sequence: | 178566821 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Define the natural history of plasminogen deficiency | Measure | Identify factors that contribute to or correlate with disease expression and severity | Measure | Create a specimen biobank |
Time Frame | 2 years | Time Frame | 5 years | Time Frame | 15 years |
Description | Recruit 100 subjects with hypoplasminogenemia and their first-degree family members Collect up to 1 year retrospective and 3 year prospective data on symptoms, treatment and interventions |
Description | Perform centralized plasminogen activity and antigen analyses Perform centralized genetic analysis to identify changes in the plasminogen gene Perform centralized analysis of polymorphisms that affect plasminogen activity levels and impact fibrinolysis Perform local urine analysis Collect samples to explore the interaction of altered plasminogen proteins with bacterial strains |
Description | Bank plasma, serum and DNA on consenting enrolled subjects |
Sponsors
Sequence: | 48613450 | Sequence: | 48613451 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Indiana Hemophilia &Thrombosis Center, Inc. | Name | Fondazione Angelo Bianchi Bonomi |
Overall Officials
Sequence: | 29451026 | Sequence: | 29451027 |
Role | Principal Investigator | Role | Principal Investigator |
Name | Amy D Shapiro, MD | Name | Flora Peyvandi, MD, PhD |
Affiliation | Indiana Hemophilia &Thrombosis Center, Inc. | Affiliation | Univeristy of Milan |
Central Contacts
Sequence: | 12090738 | Sequence: | 12090739 |
Contact Type | primary | Contact Type | backup |
Name | Amy D Shapiro, MD | Name | Charles Nakar, MD |
Phone | 317-871-0000 | Phone | 317-871-0000 |
ashapiro@ihtc.org | cnakar@ihtc.org | ||
Role | Contact | Role | Contact |
Eligibilities
Sequence: | 30946771 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Study population will include males and females affected with hyposplasminogenemia of any age and their first degree family members (siblings and parents). |
Criteria | Inclusion Criteria:
Signed informed consent and assent as applicable (Appendix 1) Exclusion Criteria: Previous organ transplant recipient |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254313857 |
Number Of Facilities | 15 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Number Of Primary Outcomes To Measure | 3 |
Designs
Sequence: | 30692368 |
Observational Model | Cohort |
Time Perspective | Other |
Responsible Parties
Sequence: | 29059118 |
Responsible Party Type | Principal Investigator |
Name | Amy D Shapiro, MD |
Title | Medical Director |
Affiliation | Indiana Hemophilia &Thrombosis Center, Inc. |
Study References
Sequence: | 52396186 | Sequence: | 52396187 | Sequence: | 52396188 | Sequence: | 52396189 | Sequence: | 52396190 | Sequence: | 52396191 |
Pmid | 32001536 | Pmid | 1455395 | Pmid | 17900274 | Pmid | 25208887 | Pmid | 27629020 | Pmid | 29321155 |
Reference Type | background | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result |
Citation | Shapiro AD, Menegatti M, Palla R, Boscarino M, Roberson C, Lanzi P, Bowen J, Nakar C, Janson IA, Peyvandi F. An international registry of patients with plasminogen deficiency (HISTORY). Haematologica. 2020 Mar;105(3):554-561. doi: 10.3324/haematol.2019.241158. Epub 2020 Jan 30. | Citation | Tait RC, Walker ID, Conkie JA, Islam SI, McCall F, Mitchell R, Davidson JF. Plasminogen levels in healthy volunteers–influence of age, sex, smoking and oral contraceptives. Thromb Haemost. 1992 Nov 10;68(5):506-10. | Citation | Schuster V, Hugle B, Tefs K. Plasminogen deficiency. J Thromb Haemost. 2007 Dec;5(12):2315-22. doi: 10.1111/j.1538-7836.2007.02776.x. Epub 2007 Sep 26. | Citation | Ma Q, Ozel AB, Ramdas S, McGee B, Khoriaty R, Siemieniak D, Li HD, Guan Y, Brody LC, Mills JL, Molloy AM, Ginsburg D, Li JZ, Desch KC. Genetic variants in PLG, LPA, and SIGLEC 14 as well as smoking contribute to plasma plasminogen levels. Blood. 2014 Nov 13;124(20):3155-64. doi: 10.1182/blood-2014-03-560086. Epub 2014 Sep 10. | Citation | Celkan T. Plasminogen deficiency. J Thromb Thrombolysis. 2017 Jan;43(1):132-138. doi: 10.1007/s11239-016-1416-6. | Citation | Shapiro AD, Nakar C, Parker JM, Albert GR, Moran JE, Thibaudeau K, Thukral N, Hardesty BM, Laurin P, Sandset PM. Plasminogen replacement therapy for the treatment of children and adults with congenital plasminogen deficiency. Blood. 2018 Mar 22;131(12):1301-1310. doi: 10.1182/blood-2017-09-806729. Epub 2018 Jan 10. |
]]>
https://zephyrnet.com/NCT03797482
2017-11-27
https://zephyrnet.com/?p=NCT03797482
NCT03797482https://www.clinicaltrials.gov/study/NCT03797482?tab=tableRohini A Hawaldarrwhawaldar@gmail.com09820432613To understand the effects induced by acute hypoxia that sets in during surgery in breast cancer. To study this, clinical samples (Tumor biopsies) will be obtained during the surgery after partial devascularisation (sample B) and stored for future genomic and proteonomic evaluations.
<![CDATA[
Studies
Study First Submitted Date | 2018-06-28 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-04-12 |
Start Month Year | November 27, 2017 |
Primary Completion Month Year | July 30, 2024 |
Verification Month Year | April 2023 |
Verification Date | 2023-04-30 |
Last Update Posted Date | 2023-04-12 |
Detailed Descriptions
Sequence: | 20688627 |
Description | Three tumor samples will be obtained after the patient is under anaesthesia,
Prior to starting surgery (Sample A) To understand the effects induced by acute hypoxia that sets in during surgery in breast cancer. To study this, clinical samples (Tumor biopsies) will be obtained during and stored for future genomic and proteonomic evaluations. |
Facilities
Sequence: | 199692716 |
Status | Recruiting |
Name | Tata Memorial Center |
City | Mumbai |
State | Maharashtra |
Zip | 400012 |
Country | India |
Facility Contacts
Sequence: | 28067325 | Sequence: | 28067326 |
Facility Id | 199692716 | Facility Id | 199692716 |
Contact Type | primary | Contact Type | backup |
Name | Shalaka Joshi, MS, MCh | Name | Rohini A Hawaldar, BSc |
drjoshishalaka@gmail.com | rwhawaldar@gmail.com | ||
Phone | 22241608601 | Phone | 09820432613 |
Phone Extension | 4265 |
Conditions
Sequence: | 52083075 |
Name | Breast Cancer Female |
Downcase Name | breast cancer female |
Id Information
Sequence: | 40088395 |
Id Source | org_study_id |
Id Value | Protocol 254 |
Countries
Sequence: | 42488168 |
Name | India |
Removed | False |
Design Groups
Sequence: | 55497029 |
Title | Intra-operative tumour tissue biopsies |
Description | Intra-operative tumour tissue biopsies will be collected for all patients |
Interventions
Sequence: | 52396226 |
Intervention Type | Procedure |
Name | Intra-operative Tumor Tissue Biopsy |
Description | The changing pattern of gene expression during surgery has never been studied. This could be an effect of acute hypoxia that sets in the tumour during surgery or could be a surgical response. To study these changes happening in the tumour during surgery, we are taking serial biopsies during surgery, one at the beginning, one midway during surgery and one at the end of surgery. These samples will be snap frozen and stored at -80 deg celsius in biorepository for future analysis. |
Design Outcomes
Sequence: | 177079396 | Sequence: | 177079397 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Gene expression changes | Measure | Immunohistochemistry for other markers |
Time Frame | The study aims to evaluate gene expression changes during surgical resection, which lasts for 30-90 minutes on an average. Thus, we have not planned a clinical follow-up or collection of data for the patients post sampling during surgical resection. | Time Frame | The study aims to evaluate gene expression changes during surgical resection, which lasts for 30-90 minutes on an average. Thus, we have not planned a clinical follow-up or collection of data for the patients post sampling during surgical resection. |
Description | The primary outcome measured will be gene expression changes during surgical resection. Messenger ribonucleic acid (mRNA) transcripts will be quantitated and their levels evaluated during different time-points of surgical resection, using high throughput omics technologies (Next generation sequencing, nanostring ncounter, qRT-PCR array). | Description | The secondary outcome measured will be protein expression changes during surgical resection. Protein levels will be quantitated, and their levels evaluated, during different time-points of surgical resection. Transcripts found to be de-regulated or changed at different time-points of surgical resection will be evaluated using IHC at protein level. We will also use high throughput omics technologies (SILAC, ITRAQ) for characterising these changes at protein levels. |
Browse Conditions
Sequence: | 193136462 | Sequence: | 193136463 | Sequence: | 193136464 | Sequence: | 193136465 | Sequence: | 193136466 | Sequence: | 193136467 | Sequence: | 193136468 |
Mesh Term | Breast Neoplasms | Mesh Term | Hypoxia | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Breast Diseases | Mesh Term | Skin Diseases | Mesh Term | Signs and Symptoms, Respiratory |
Downcase Mesh Term | breast neoplasms | Downcase Mesh Term | hypoxia | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | breast diseases | Downcase Mesh Term | skin diseases | Downcase Mesh Term | signs and symptoms, respiratory |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48237694 |
Agency Class | OTHER_GOV |
Lead Or Collaborator | lead |
Name | Tata Memorial Hospital |
Overall Officials
Sequence: | 29233857 |
Role | Principal Investigator |
Name | Rajendra Badwe |
Affiliation | Director, tata Memorial Centre |
Central Contacts
Sequence: | 11990529 | Sequence: | 11990530 |
Contact Type | primary | Contact Type | backup |
Name | Shalaka Joshi, MS, MCh | Name | Rohini A Hawaldar |
Phone | 9869089803 | Phone | 09820432613 |
drjoshishalaka@gmail.com | rwhawaldar@gmail.com | ||
Phone Extension | 4265 | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68032208 |
Design Group Id | 55497029 |
Intervention Id | 52396226 |
Eligibilities
Sequence: | 30714233 |
Sampling Method | Non-Probability Sample |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Women diagnosed with breast cancer at outpatient clinic |
Criteria | Inclusion Criteria:
Clinically diagnosis of breast cancer (by FNAC or Biopsy) Exclusion Criteria: Clinically diagnosis of Metastatic breast cancer |
Gender Description | Women diagnosed with breast cancer, undergoing surgery upfront |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253946115 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30460801 |
Observational Model | Other |
Time Perspective | Prospective |
Intervention Other Names
Sequence: | 26624003 |
Intervention Id | 52396226 |
Name | Breast cancer surgery |
Responsible Parties
Sequence: | 28827262 |
Responsible Party Type | Principal Investigator |
Name | Dr Rajendra A. Badwe |
Title | Director, Tata Memorial Centre and Professor, Department of Surgical Oncology |
Affiliation | Tata Memorial Centre |
Study References
Sequence: | 51979274 | Sequence: | 51979275 | Sequence: | 51979276 |
Pmid | 23222717 | Pmid | 11395851 | Pmid | 23915189 |
Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Semenza GL. Cancer-stromal cell interactions mediated by hypoxia-inducible factors promote angiogenesis, lymphangiogenesis, and metastasis. Oncogene. 2013 Aug 29;32(35):4057-63. doi: 10.1038/onc.2012.578. Epub 2012 Dec 10. | Citation | Hockel M, Vaupel P. Biological consequences of tumor hypoxia. Semin Oncol. 2001 Apr;28(2 Suppl 8):36-41. | Citation | Hoesel B, Schmid JA. The complexity of NF-kappaB signaling in inflammation and cancer. Mol Cancer. 2013 Aug 2;12:86. doi: 10.1186/1476-4598-12-86. |
]]>
https://zephyrnet.com/NCT03797469
2019-04-15
https://zephyrnet.com/?p=NCT03797469
NCT03797469https://www.clinicaltrials.gov/study/NCT03797469?tab=tableNANANAThis study seeks to test whether these over-the-counter nutritional supplements have an impact on patients’ performance during visual field testing.
<![CDATA[
Studies
Study First Submitted Date | 2018-05-28 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2021-11-11 |
Start Month Year | April 15, 2019 |
Primary Completion Month Year | December 31, 2020 |
Verification Month Year | November 2021 |
Verification Date | 2021-11-30 |
Last Update Posted Date | 2021-11-11 |
Detailed Descriptions
Sequence: | 20795555 |
Description | Glaucoma is the leading cause of irreversible blindness worldwide. The most important test to detect progression is visual field testing. Visual field testing is the reference standard to measure visual function in glaucoma. It is called called standard automated perimetry (SAP). However, this test is very subjective, often unreliable, and variable. One of the main causes of unreliable tests is the lack of attentiveness or concentration during the test. Previous studies have shown that listening to Mozart or taking vitamin B12 can improve the reliability of this test. Recent studies have suggested that over-the-counter medications such as nicotinamide (vitamin B3) and pyruvate can also improve the performance during this test. This can ultimately reduce costs due to repeated testing and increase doctor's certainty when analyzing the results of this test. |
Facilities
Sequence: | 200759979 |
Name | Columbia University Medical Center |
City | New York |
State | New York |
Zip | 10032 |
Country | United States |
Browse Interventions
Sequence: | 96349735 | Sequence: | 96349736 | Sequence: | 96349737 | Sequence: | 96349738 | Sequence: | 96349739 | Sequence: | 96349740 | Sequence: | 96349741 | Sequence: | 96349742 | Sequence: | 96349743 | Sequence: | 96349744 | Sequence: | 96349745 | Sequence: | 96349746 |
Mesh Term | Niacinamide | Mesh Term | Niacin | Mesh Term | Nicotinic Acids | Mesh Term | Vitamins | Mesh Term | Micronutrients | Mesh Term | Physiological Effects of Drugs | Mesh Term | Vitamin B Complex | Mesh Term | Hypolipidemic Agents | Mesh Term | Antimetabolites | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Lipid Regulating Agents | Mesh Term | Vasodilator Agents |
Downcase Mesh Term | niacinamide | Downcase Mesh Term | niacin | Downcase Mesh Term | nicotinic acids | Downcase Mesh Term | vitamins | Downcase Mesh Term | micronutrients | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | vitamin b complex | Downcase Mesh Term | hypolipidemic agents | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | lipid regulating agents | Downcase Mesh Term | vasodilator agents |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52360965 | Sequence: | 52360966 |
Name | Visual Field Defect, Peripheral | Name | Glaucoma, Open-Angle |
Downcase Name | visual field defect, peripheral | Downcase Name | glaucoma, open-angle |
Id Information
Sequence: | 40294466 |
Id Source | org_study_id |
Id Value | AAAR8208 |
Countries
Sequence: | 42717509 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55804119 | Sequence: | 55804120 |
Group Type | Active Comparator | Group Type | Placebo Comparator |
Title | Nicotinamide and Pyruvate (N&P) | Title | Placebo |
Description | This group will receive two separate sets of tablets containing 3 x 1000 mg of Vitamin B3 (nicotinamide) and 2 x 1500 mg of Pyruvate. | Description | This group will receive an equal number of tablets as the N&P group. |
Interventions
Sequence: | 52671754 | Sequence: | 52671755 | Sequence: | 52671756 |
Intervention Type | Dietary Supplement | Intervention Type | Dietary Supplement | Intervention Type | Dietary Supplement |
Name | Vitamin B3 | Name | Pyruvate | Name | Placebo |
Description | 3 tablets of 1000 mg each will be administered orally. | Description | 2 tablets of 1500 mg each will be administered orally. | Description | Tablets will look identical to the supplements and the number of tablets will equal the amount of supplements provided. |
Keywords
Sequence: | 80129277 | Sequence: | 80129278 | Sequence: | 80129279 | Sequence: | 80129280 | Sequence: | 80129281 | Sequence: | 80129282 |
Name | Perimetry | Name | Vitamins | Name | Glaucoma | Name | Supplements | Name | Vitamin B3 | Name | Nicotinamide |
Downcase Name | perimetry | Downcase Name | vitamins | Downcase Name | glaucoma | Downcase Name | supplements | Downcase Name | vitamin b3 | Downcase Name | nicotinamide |
Design Outcomes
Sequence: | 178080272 | Sequence: | 178080273 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Change in 24-2 visual field test | Measure | Change in Montreal Cognitive Assessment (MoCA) scores |
Time Frame | Up to 20 weeks | Time Frame | Up to 20 weeks |
Description | Changes in 24-2 visual field results based upon point-wise and global metrics before and after intervention, and between treatment and placebo groups will be compared. | Description | Montreal Cognitive Assessment (MoCA) score before and after intervention and correlate these changes with those seen on visual field tests will be compared. The Montreal Cognitive Assessment (MoCA) is a brief 30-question test that assesses different types of cognitive abilities. Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal. |
Browse Conditions
Sequence: | 194208995 | Sequence: | 194208996 | Sequence: | 194208997 | Sequence: | 194208998 |
Mesh Term | Glaucoma | Mesh Term | Glaucoma, Open-Angle | Mesh Term | Ocular Hypertension | Mesh Term | Eye Diseases |
Downcase Mesh Term | glaucoma | Downcase Mesh Term | glaucoma, open-angle | Downcase Mesh Term | ocular hypertension | Downcase Mesh Term | eye diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48495865 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Columbia University |
Overall Officials
Sequence: | 29385559 |
Role | Principal Investigator |
Name | Jeffrey M Liebmann, MD |
Affiliation | Columbia University |
Design Group Interventions
Sequence: | 68407797 | Sequence: | 68407798 | Sequence: | 68407799 |
Design Group Id | 55804119 | Design Group Id | 55804119 | Design Group Id | 55804120 |
Intervention Id | 52671754 | Intervention Id | 52671755 | Intervention Id | 52671756 |
Eligibilities
Sequence: | 30874786 |
Gender | All |
Minimum Age | 40 Years |
Maximum Age | 80 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Confirmed diagnosis of primary open-angle glaucoma; Exclusion Criteria: Significant cataract or media opacity; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254022798 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 20 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 40 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30620578 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Triple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Intervention Other Names
Sequence: | 26769282 | Sequence: | 26769283 |
Intervention Id | 52671754 | Intervention Id | 52671755 |
Name | B-3 Nicotinamide | Name | Calcium Pyruvate |
Responsible Parties
Sequence: | 28987109 |
Responsible Party Type | Principal Investigator |
Name | Jeffrey Liebmann |
Title | Professor of Ophthalmology |
Affiliation | Columbia University |
Study References
Sequence: | 52264794 | Sequence: | 52264795 | Sequence: | 52264796 | Sequence: | 52264797 | Sequence: | 52264798 | Sequence: | 52264799 | Sequence: | 52264800 |
Pmid | 29497468 | Pmid | 29295624 | Pmid | 28858158 | Pmid | 28538117 | Pmid | 28487632 | Pmid | 28209901 | Pmid | 34792559 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | derived |
Citation | Williams PA, Harder JM, Cardozo BH, Foxworth NE, John SWM. Nicotinamide treatment robustly protects from inherited mouse glaucoma. Commun Integr Biol. 2018 Jan 19;11(1):e1356956. doi: 10.1080/19420889.2017.1356956. eCollection 2018. | Citation | Zhang M, Ying W. NAD+ Deficiency Is a Common Central Pathological Factor of a Number of Diseases and Aging: Mechanisms and Therapeutic Implications. Antioxid Redox Signal. 2019 Feb 20;30(6):890-905. doi: 10.1089/ars.2017.7445. Epub 2018 Feb 7. | Citation | Williams PA, Harder JM, John SWM. Glaucoma as a Metabolic Optic Neuropathy: Making the Case for Nicotinamide Treatment in Glaucoma. J Glaucoma. 2017 Dec;26(12):1161-1168. doi: 10.1097/IJG.0000000000000767. | Citation | Liebmann JM, Cioffi GA. Nicking Glaucoma with Nicotinamide? N Engl J Med. 2017 May 25;376(21):2079-2081. doi: 10.1056/NEJMcibr1702486. No abstract available. | Citation | Williams PA, Harder JM, Foxworth NE, Cardozo BH, Cochran KE, John SWM. Nicotinamide and WLDS Act Together to Prevent Neurodegeneration in Glaucoma. Front Neurosci. 2017 Apr 25;11:232. doi: 10.3389/fnins.2017.00232. eCollection 2017. | Citation | Williams PA, Harder JM, Foxworth NE, Cochran KE, Philip VM, Porciatti V, Smithies O, John SW. Vitamin B3 modulates mitochondrial vulnerability and prevents glaucoma in aged mice. Science. 2017 Feb 17;355(6326):756-760. doi: 10.1126/science.aal0092. | Citation | De Moraes CG, John SWM, Williams PA, Blumberg DM, Cioffi GA, Liebmann JM. Nicotinamide and Pyruvate for Neuroenhancement in Open-Angle Glaucoma: A Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2022 Jan 1;140(1):11-18. doi: 10.1001/jamaophthalmol.2021.4576. |
]]>
https://zephyrnet.com/NCT03797456
2019-04-01
https://zephyrnet.com/?p=NCT03797456
NCT03797456https://www.clinicaltrials.gov/study/NCT03797456?tab=tableNANANAThe phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.
Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with R/R MZL will be evaluated in approximately 110 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-10-12 |
Start Month Year | April 1, 2019 |
Primary Completion Month Year | December 31, 2023 |
Verification Month Year | October 2022 |
Verification Date | 2022-10-31 |
Last Update Posted Date | 2022-10-12 |
Facilities
Sequence: | 198936606 |
Name | Beijing Cancer Hospital |
City | Beijing |
State | Beijing |
Zip | 102206 |
Country | China |
Conditions
Sequence: | 51879506 |
Name | MZL |
Downcase Name | mzl |
Id Information
Sequence: | 39927542 |
Id Source | org_study_id |
Id Value | ICP-CL-00104 |
Countries
Sequence: | 42321502 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55299439 |
Group Type | Experimental |
Title | ICP-022 |
Interventions
Sequence: | 52197663 |
Intervention Type | Drug |
Name | ICP-022 |
Description | ICP-022 (tablets, 50 mg) is given orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression. |
Design Outcomes
Sequence: | 176408966 | Sequence: | 176408967 | Sequence: | 176408968 | Sequence: | 176408969 | Sequence: | 176408970 | Sequence: | 176408971 | Sequence: | 176408972 | Sequence: | 176408973 | Sequence: | 176408974 | Sequence: | 176408975 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Overall Response Rate (ORR) | Measure | Occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria in Part I | Measure | Progressioin free survival (PFS) | Measure | Duration of Response (DR) | Measure | Overall survival (OS) | Measure | Area under the concentration time curve up to the time "t" (AUC(0-t)) | Measure | Maximum plasma drug concentrations (Cmax) | Measure | Time of maximum plasma drug concentrations (Tmax) | Measure | Apparent half-life for designated elimination phases (t½) | Measure | Area under the concentration time curve up to the last data point above LOQ (AUC(last)) |
Time Frame | Up to 3 years | Time Frame | Up to 3 years | Time Frame | Up to 3 years | Time Frame | Up to 3 years | Time Frame | Up to 3 years | Time Frame | up to 4 weeks | Time Frame | up to 4 weeks | Time Frame | up to 4 weeks | Time Frame | up to 4 weeks | Time Frame | up to 4 weeks |
Description | The efficacy measured by overall response rate (ORR) in Part II according to the 2014 International Working Group NHL | Description | The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria in Part I | Description | Progression free survival (PFS) is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment. | Description | Duration of response as defined as the period from the first response (at least PR) to treatment until evidence of disease progression, relapse or death of any cause. Patients alive without progression and relapse will be censored at the latest tumor assessment date or the stopping date. | Description | Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date. | Description | Area under the concentration time curve up to the time "t" (AUC(0-t)) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin. | Description | Individual plasma concentrations of ICP-022 will be measured and Cmax will be calculated with noncompartmental analysis using WinNonlin. | Description | Time of maximum plasma drug concentrations (Tmax) of ICP-022 will be recorded. | Description | Apparent half-life for designated elimination phases (t½) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin. | Description | Area under the concentration time curve up to the last data point above LOQ (AUC(last)) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin. |
Browse Conditions
Sequence: | 192307384 | Sequence: | 192307383 | Sequence: | 192307385 | Sequence: | 192307386 | Sequence: | 192307387 | Sequence: | 192307388 | Sequence: | 192307389 | Sequence: | 192307390 | Sequence: | 192307391 | Sequence: | 192307392 |
Mesh Term | Lymphoma | Mesh Term | Lymphoma, B-Cell, Marginal Zone | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Lymphoproliferative Disorders | Mesh Term | Lymphatic Diseases | Mesh Term | Immunoproliferative Disorders | Mesh Term | Immune System Diseases | Mesh Term | Lymphoma, B-Cell | Mesh Term | Lymphoma, Non-Hodgkin |
Downcase Mesh Term | lymphoma | Downcase Mesh Term | lymphoma, b-cell, marginal zone | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lymphoproliferative disorders | Downcase Mesh Term | lymphatic diseases | Downcase Mesh Term | immunoproliferative disorders | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | lymphoma, b-cell | Downcase Mesh Term | lymphoma, non-hodgkin |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48046371 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Beijing InnoCare Pharma Tech Co., Ltd. |
Overall Officials
Sequence: | 29113941 |
Role | Principal Investigator |
Name | Jun Zhu, PhD |
Affiliation | Peking University Cancer Hospital & Institute |
Design Group Interventions
Sequence: | 67793235 |
Design Group Id | 55299439 |
Intervention Id | 52197663 |
Eligibilities
Sequence: | 30593151 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 75 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Men and women between 18 and 75 years old Subjects meet the following laboratory parameters: Absolute neutrophil count (ANC) ≥ 1.5×109/L Platelet count ≥ 75×109/L, independent of growth factor support within 7 days of the first dose with study drug, Hemoglobin ≥ 75 g/L; ANC ≥ 1.0×109/L, Platelet count ≥ 50×109/L, Hemoglobin ≥ 50 g/L; if bone marrow involvement Exclusion Criteria: History of other active malignancies within 5 years of study entry, unless cured without evidence of relapse or metastasis Current clinically significant cardiovascular disease including: Any class 3 or 4 cardiac disease such as arrhythmia, congestive heart failure or myocardial infarction defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) < 50% |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253882634 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 75 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 9 |
Designs
Sequence: | 30340809 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28717440 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797443
2019-01-01
https://zephyrnet.com/?p=NCT03797443
NCT03797443https://www.clinicaltrials.gov/study/NCT03797443?tab=tableNANANAThe purpose of this study is to see if a combination of paclitaxel protein bound (also known as nab-paclitaxel), gemcitabine, and cisplatin when given with high dose Ascorbic Acid will be safe and effective in individuals with untreated metastatic pancreatic cancer.
Vitamin C is a nutrient found in food and dietary supplements. It protects cells and also plays a key role in making collagen (which provides strength and structure to skin, bones, tissues and tendons). High-dose vitamin C may be given by intravenous (IV) infusion (through a vein into the bloodstream) or orally (taken by mouth). When taken by intravenous infusion, vitamin C can reach much higher levels in the blood than when the same amount is taken by mouth. Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-05 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-05-31 |
Start Month Year | January 1, 2019 |
Primary Completion Month Year | January 2022 |
Verification Month Year | May 2019 |
Verification Date | 2019-05-31 |
Last Update Posted Date | 2019-05-31 |
Facilities
Sequence: | 200245306 | Sequence: | 200245307 | Sequence: | 200245308 |
Name | Piedmont Cancer Institute | Name | Piedmont Cancer Institute | Name | Piedmont Cancer Institute |
City | Atlanta | City | Fayetteville | City | Newnan |
State | Georgia | State | Georgia | State | Georgia |
Zip | 30318 | Zip | 30214 | Zip | 30265 |
Country | United States | Country | United States | Country | United States |
Browse Interventions
Sequence: | 96113860 | Sequence: | 96113861 | Sequence: | 96113862 | Sequence: | 96113863 | Sequence: | 96113864 | Sequence: | 96113865 | Sequence: | 96113866 | Sequence: | 96113867 | Sequence: | 96113868 | Sequence: | 96113869 | Sequence: | 96113870 | Sequence: | 96113871 | Sequence: | 96113872 | Sequence: | 96113873 | Sequence: | 96113874 | Sequence: | 96113875 |
Mesh Term | Ascorbic Acid | Mesh Term | Paclitaxel | Mesh Term | Gemcitabine | Mesh Term | Antineoplastic Agents, Phytogenic | Mesh Term | Antineoplastic Agents | Mesh Term | Tubulin Modulators | Mesh Term | Antimitotic Agents | Mesh Term | Mitosis Modulators | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Vitamins | Mesh Term | Micronutrients | Mesh Term | Physiological Effects of Drugs | Mesh Term | Antimetabolites, Antineoplastic | Mesh Term | Antimetabolites | Mesh Term | Antioxidants | Mesh Term | Protective Agents |
Downcase Mesh Term | ascorbic acid | Downcase Mesh Term | paclitaxel | Downcase Mesh Term | gemcitabine | Downcase Mesh Term | antineoplastic agents, phytogenic | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | tubulin modulators | Downcase Mesh Term | antimitotic agents | Downcase Mesh Term | mitosis modulators | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | vitamins | Downcase Mesh Term | micronutrients | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | antimetabolites, antineoplastic | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | antioxidants | Downcase Mesh Term | protective agents |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52208628 |
Name | Metastatic Pancreatic Cancer |
Downcase Name | metastatic pancreatic cancer |
Id Information
Sequence: | 40186532 |
Id Source | org_study_id |
Id Value | PAN-VITC |
Countries
Sequence: | 42600024 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55635252 |
Group Type | Experimental |
Title | AA NABPLAGEM |
Description | Ascorbic Acid Paclitaxel protein-bound cisplatin gemcitabine |
Interventions
Sequence: | 52522570 | Sequence: | 52522567 | Sequence: | 52522568 | Sequence: | 52522569 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Gemcitabine | Name | Ascorbic Acid | Name | nab paclitaxel | Name | Cisplatin |
Description | 30 minute IV infusion on days 1 and 8 repeated every 21 days | Description | Four escalating dose levels are planned in order to determine the MTD for Phase II
The dose level for Phase II patients will be determined following completion of the Phase 1b study based on response from 3-6 patients receiving the designated dose level of ascorbic acid. |
Description | 30 minute IV infusions on days 1 and 8 repeated every 21 days, followed by Cisplatin | Description | 60minute IV infusion on days 1 and 8 repeated every 21 days followed by Gemcitabine |
Keywords
Sequence: | 79923720 | Sequence: | 79923721 | Sequence: | 79923722 | Sequence: | 79923723 | Sequence: | 79923724 | Sequence: | 79923725 | Sequence: | 79923726 | Sequence: | 79923727 |
Name | Metastatic Pancreatic Cancer | Name | Cancer | Name | Pancreatic | Name | Vitamin C | Name | Ascorbic Acid | Name | Paclitaxel Protein Bound | Name | Cisplatin | Name | Gemcitabine |
Downcase Name | metastatic pancreatic cancer | Downcase Name | cancer | Downcase Name | pancreatic | Downcase Name | vitamin c | Downcase Name | ascorbic acid | Downcase Name | paclitaxel protein bound | Downcase Name | cisplatin | Downcase Name | gemcitabine |
Design Outcomes
Sequence: | 177513231 | Sequence: | 177513232 | Sequence: | 177513233 | Sequence: | 177513234 | Sequence: | 177513235 | Sequence: | 177513236 | Sequence: | 177513237 | Sequence: | 177513238 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Maximum Tolerated Dose | Measure | Disease control rate (CR+PR+SD x18 weeks) | Measure | Incidence of Treatment | Measure | Percent of patients who normalize their CA19-9 | Measure | Overall survival (OS) | Measure | Progression free | Measure | Changes in patient's self-reported quality of life | Measure | Changes in patient's self-reported pain levels |
Time Frame | approx 63 days | Time Frame | approx 63 days | Time Frame | 63 days | Time Frame | 63 days | Time Frame | 12 weeks | Time Frame | approximately 12 weeks from last study treatment ] | Time Frame | 63 days | Time Frame | 63 days |
Description | To determine the maximum tolerated dose (MTD) of high dose ascorbic acid (AA) with triple therapy of nanoparticle paclitaxel protein bound+ cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer | Description | To determine the preliminary efficacy (Disease control rate of CR+ PR+SD X 18 weeks) of the combination of high dose ascorbic acid (AA) at MTD with triple therapy of nanoparticle albumin- bound paclitaxel + cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer. | Description | Lab testing will be completed to evaluate standard of care labs for subject safety | Description | Lab testing will be completed to evaluate normalization of CA19-19 | Description | Telephone followup will be conducted every 12 weeks from the last dose of treatment to determine survival status | Description | Telephone followup will be conducted every 12 weeks from the last dose of treatment to determine status of disease progression | Description | Changes in patient's self-reported quality of life will be determined by administering the MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI) to assess the severity of multiple gastrointestinal cancer-related syymptoms and the impact of these symptoms of daily functiong. | Description | Changes in patient's self-reported pain levels will be determined by administering the Brief Pain Inventory (BPI) to assess the severity of pain and the impact of pain on daily functions. |
Browse Conditions
Sequence: | 193629117 | Sequence: | 193629118 | Sequence: | 193629119 | Sequence: | 193629120 | Sequence: | 193629121 | Sequence: | 193629122 | Sequence: | 193629123 | Sequence: | 193629124 |
Mesh Term | Pancreatic Neoplasms | Mesh Term | Digestive System Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Endocrine Gland Neoplasms | Mesh Term | Digestive System Diseases | Mesh Term | Pancreatic Diseases | Mesh Term | Endocrine System Diseases |
Downcase Mesh Term | pancreatic neoplasms | Downcase Mesh Term | digestive system neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | endocrine gland neoplasms | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | pancreatic diseases | Downcase Mesh Term | endocrine system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48354228 | Sequence: | 48354229 | Sequence: | 48354230 | Sequence: | 48354231 | Sequence: | 48354232 | Sequence: | 48354233 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Piedmont Cancer Institute | Name | Cancer Research UK | Name | Stand Up To Cancer | Name | Lustgarten Foundation | Name | Destroy Pancreatic Cancer | Name | Translational Genomics Research Institute |
Design Group Interventions
Sequence: | 68199868 | Sequence: | 68199869 | Sequence: | 68199870 | Sequence: | 68199871 |
Design Group Id | 55635252 | Design Group Id | 55635252 | Design Group Id | 55635252 | Design Group Id | 55635252 |
Intervention Id | 52522567 | Intervention Id | 52522568 | Intervention Id | 52522569 | Intervention Id | 52522570 |
Eligibilities
Sequence: | 30787181 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Be willing and able to provide written informed consent/assent for the trial. Exclusion Criteria: Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the adjuvant setting with gemcitabine and/or 5-FU or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253990154 |
Number Of Facilities | 3 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30533251 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Ascorbic Acid Paclitaxel Protein Bound Cisplatin Gemcitabine |
Intervention Other Names
Sequence: | 26692239 |
Intervention Id | 52522567 |
Name | Vitamin C |
Responsible Parties
Sequence: | 28899543 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797430
2019-01-02
https://zephyrnet.com/?p=NCT03797430
NCT03797430https://www.clinicaltrials.gov/study/NCT03797430?tab=tableNANANAthe aim of this study is to determine normal values for SEBT in young national or international handball women players for determining specific level for SEBT to predict risk of injury
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2020-07-17 |
Start Month Year | January 2, 2019 |
Primary Completion Month Year | January 2, 2020 |
Verification Month Year | July 2020 |
Verification Date | 2020-07-31 |
Last Update Posted Date | 2020-07-17 |
Conditions
Sequence: | 52256584 |
Name | Handball Players |
Downcase Name | handball players |
Id Information
Sequence: | 40220816 |
Id Source | org_study_id |
Id Value | SEBTHAND ( 29BRC18.0254) |
Keywords
Sequence: | 79989877 | Sequence: | 79989878 | Sequence: | 79989879 | Sequence: | 79989880 |
Name | hand ball | Name | evaluation | Name | risk of injury | Name | women |
Downcase Name | hand ball | Downcase Name | evaluation | Downcase Name | risk of injury | Downcase Name | women |
Design Outcomes
Sequence: | 177692173 |
Outcome Type | primary |
Measure | determination of normal values for SEBT |
Time Frame | one day |
Description | star excursion balance test : it is a functionnal test for predicting the risk of injury |
Sponsors
Sequence: | 48399114 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University Hospital, Brest |
Overall Officials
Sequence: | 29331573 |
Role | Principal Investigator |
Name | Marc BEAUMONT, PhD |
Affiliation | CHU Brest |
Eligibilities
Sequence: | 30815001 |
Sampling Method | Probability Sample |
Gender | Female |
Minimum Age | 14 Years |
Maximum Age | 18 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | national or international hanball women players, aged from 14 to 18 years old |
Criteria | Inclusion Criteria:
women Exclusion Criteria: no french language |
Gender Description | handball women players |
Gender Based | True |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254076027 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 14 |
Maximum Age Num | 18 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30560964 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28927368 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797417
2018-09-18
https://zephyrnet.com/?p=NCT03797417
NCT03797417https://www.clinicaltrials.gov/study/NCT03797417?tab=tableQingrong Ninitina.tn@gmail.com15109230226Vitiligo is a chronic depigmenting autoimmune-associated skin disease and a growing psychological health concern because of its low quality of life. Genetics, immunology and environment triggers contribute to the pathophysiology of vitiligo. Identify and decrease the risk factors of vitiligo is very crucial for vitiligo treatment and prevention. Emerging evidence has linked gut microbiome to human autoimmune diseases. Here the investigators will analyze 10,913 metagenomes in stool samples from 100 adult vitiligo patients and gut microbiome associated metabolites in patients serum.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-05 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | September 18, 2018 |
Primary Completion Month Year | June 1, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Detailed Descriptions
Sequence: | 20741283 |
Description | Vitiligo, an autoimmune disease of the skin, is a commonly acquired chronic depigmenting disorder characterized by loss of epidermal melanocytes and progressive depigmentation clinically, affecting from 0.5% to 1% of the world population and about 1% in China Vitiligo can be a psychologically crushing associated with low quality of life, especially in colored skinned individuals. The pathoetiology of vitiligo is multifactorial and has genetic, immunological, and environmental components. Several environment-associated mechanisms have been implicated to explain melanocyte disappearance, including ultraviolet (UV) radiation exposure, repeated mechanical or thermal stress, and exposure to chemicals (especially phenols or catechols), but epidemiologic data remain limited.
Broader gut dysbioses have been identified as potential causes or contributing factors to human autoimmune diseases; however, human studies have not yet identified microbial compositional or functional triggers that are predictive of skin autoimmunity or vitiligo. Metabolites from intestinal microbiota are key determinants of host-microbe mutualism and, consequently, the health or disease of the intestinal tract. However, whether such host-microbe crosstalk influences inflammation in peripheral tissues, such as the skin, is poorly understood. The investigators will perform a metagenome association study and serum metabolomics profiling in a cohort of vitiligo Chinese individuals. |
Facilities
Sequence: | 200280928 |
Status | Recruiting |
Name | Xijing Hospital |
City | Xi'an |
State | Shaanxi |
Zip | 710032 |
Country | China |
Facility Contacts
Sequence: | 28132946 | Sequence: | 28132947 |
Facility Id | 200280928 | Facility Id | 200280928 |
Contact Type | primary | Contact Type | backup |
Name | Xijing Hospital | Name | Qingrong Ni |
nitina.tn@gmail.com | |||
Phone | 15109230226 | ||
Phone Extension | +86 |
Conditions
Sequence: | 52221812 |
Name | Gut Microbiome |
Downcase Name | gut microbiome |
Id Information
Sequence: | 40195826 |
Id Source | org_study_id |
Id Value | XJPF-LCY-V201812 |
Countries
Sequence: | 42609803 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55650105 | Sequence: | 55650106 |
Title | Disease | Title | Healthy Control |
Description | patients with vitiligo | Description | healthy control |
Keywords
Sequence: | 79942133 | Sequence: | 79942134 | Sequence: | 79942135 |
Name | Gut Microbiome | Name | Vitiligo | Name | Metabolic Pathways |
Downcase Name | gut microbiome | Downcase Name | vitiligo | Downcase Name | metabolic pathways |
Design Outcomes
Sequence: | 177562358 | Sequence: | 177562359 | Sequence: | 177562360 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Gut microbiota sequencing results by analyzing metagenomes of 16s rRNA gene or microbial genes | Measure | Gut microbiota associated metabolic pathways by using metabolomics profiling of serum samples study | Measure | Vitiligo associated activity measurements like VASI assays, serum markers detection |
Time Frame | 2018.10.1–2019.3.1 | Time Frame | 2018.12.1–2019.3.1 | Time Frame | 2019.1–2019.3.1 |
Description | Fecal samples are obtained from all recruited subjects for metagenomic sequencing. The individuals have not received any antibiotic treatment for at least one month before sample collection. In the seven days before sample collection, subjects did not take any food containing probiotics such as yogurt. Each sample was either frozen immediately at -80 °C or briefly stored in personal -20 °C freezers before transport to the laboratory within 24 h. After extracting DNA from fecal samoles, gut microbiota sequencing results by using Shotgun Strategy or Meta 16s high-throughput sequencing. | Description | All serum samples will be thawed on ice and a quality control (QC) sample, made by mixing and blending equal volumes (10 μl) of each serum sample, is used to estimate a mean profile representing all the analytes encountered during analysis. The acquired MS data pretreatments included peak selection and grouping, retention time correction, second peak grouping, and isotopes and adducts annotation, will be performed as previously described56. LC-MS raw data files will be converted into mzXML format and then analyzed by the XCMS and CAMERA toolbox with R statistical language. | Description | VASI assays will be used to evaluate patients disease condition. VASI Scoring Criteria VASI=Σall body sites (hand units) × depigmentation. Serum markers like CXCL10, IL-2, and sCD25 will be detected by ELISA kits. |
Browse Conditions
Sequence: | 193679546 | Sequence: | 193679547 | Sequence: | 193679548 | Sequence: | 193679549 |
Mesh Term | Vitiligo | Mesh Term | Hypopigmentation | Mesh Term | Pigmentation Disorders | Mesh Term | Skin Diseases |
Downcase Mesh Term | vitiligo | Downcase Mesh Term | hypopigmentation | Downcase Mesh Term | pigmentation disorders | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366675 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Xijing Hospital |
Overall Officials
Sequence: | 29313037 |
Role | Principal Investigator |
Name | Chunying Li |
Affiliation | Study Principal Investigator |
Central Contacts
Sequence: | 12020650 |
Contact Type | primary |
Name | Qingrong Ni |
Phone | 15109230226 |
nitina.tn@gmail.com | |
Phone Extension | +86 |
Role | Contact |
Eligibilities
Sequence: | 30794871 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 3 Years |
Maximum Age | 65 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | We recruit patients who have clinically advanced vitiligo, and barely have other diseases which may disturb our study results. |
Criteria | Inclusion Criteria:
Subjects who volunteered and signed Informed Consent Form; Exclusion Criteria: Patients who had taken systemic or local treatment with vitiligo in the last month; |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254004559 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 3 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Designs
Sequence: | 30540911 |
Observational Model | Case-Control |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28907231 |
Responsible Party Type | Principal Investigator |
Name | Li Chunying-1 |
Title | Vice Chief |
Affiliation | Xijing Hospital |
]]>
https://zephyrnet.com/NCT03797404
2019-04-24
https://zephyrnet.com/?p=NCT03797404
NCT03797404https://www.clinicaltrials.gov/study/NCT03797404?tab=tableNANANAChronic airway changes, such as smooth muscle hypertrophy/hyperplasia, reticular basement membrane (RBM) thickening, goblet cells hyperplasia characterize severe asthma. Chronic inflammation, and especially eosinophilia and T2 cytokines are involved in these structural changes. The aim of this prospective observational study is to assess airway changes, assessed by bronchial biopsies before treatment, then after 6 months and 12 months, induced by mepolizumab in 40 severe asthma patients who will receive the treatment as part of their standard care. Changes in RBM thickening, in airway smooth muscle (ASM) area, in the number of PGP9 sections will be assessed on bronchial biopsies after 6 months and 12 months of mepolizumab treatment. Bronchoalveolar lavage (BAL) levels of inflammatory and remodeling mediators and of extra-cellular matrix (ECM) components will be measured after 6 months and 12 months of mepolizumab treatment. Relationship between clinical response to mepolizumab and remodeling changes after 6 months and 12 months will be assessed.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-06 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-01-20 |
Start Month Year | April 24, 2019 |
Primary Completion Month Year | June 21, 2022 |
Verification Month Year | January 2023 |
Verification Date | 2023-01-31 |
Last Update Posted Date | 2023-01-20 |
Detailed Descriptions
Sequence: | 20722444 |
Description | Scientific Rationale & Hypothesis:
Chronic airway changes, such as smooth muscle hypertrophy/hyperplasia, reticular basement membrane thickening, goblet cells hyperplasia characterize severe asthma. Chronic inflammation, and especially eosinophilia and T2 cytokines are involved in these structural changes. Increased ASM layer has been associated with eosinophilia for example, but not RBM thickening, suggesting that differential patterns of remodeling can be observed according to inflammatory patterns. Omalizumab, an anti IgE therapy, can reduce some features of airway remodeling, especially RBM and some parameters related to ASM. No data are available on potential changes in airway remodeling induced by mepolizumab. The aim of the study is to assess airway changes, assessed by bronchial biopsies, induced by mepolizumab in severe asthma patients who will receive the treatment as part of their standard care. All asthma patients refered to the asthma clinic are proposed to participate to the COBRA cohort (French national asthma cohort). Serum and DNA are collected at inclusion and every 6 months. Fiberoptic bronchoscopy (FOB) is routinely performed as part of the standard care for difficult-to-severe asthma in our centre for many years, to assess differential diagnosis and inflammatory pattern since Fractional exhaled nitric oxide (FeNO) is not routinely performed in France. BAL and 4 to 6 bronchial biopsies are performed. Study Population: Severe asthma patients, refered to Severe Asthma Centre in Bichat and Bicetre Hospitals, receiving mepolizumab according to French recommendations (eos >300mm3 in the previous year, >2 exacerbations, despite optimal step 4-5 therapy, including daily use of steroids). Study Design & Methods: General study design Prospective, observational study in one Severe Asthma Centre : Bichat Hospital (Prof C.Taillé). 40 patients will be prospectively included during a 32 months period. This study aims to assess : Changes in RBM thickening, in ASM area after 6 months and 12 months of mepolizumab treatment The following will perform at inclusion, 6 months and 12 months after initiating mepolizumab: clinical evaluation (age, BMI, atopic status, chronic rhinosinusitis, daily doses of steroids, exacerbations…) Blood test for eosinophil count and serum conservation. Study groups/arms Group 1 (prospective) : patients initiating a mepolizumab treatment. Group 2 (retrospective): to assess airway changes that can "spontaneously" occur during a 12 month-period, a retrospective "historical group" of patients included in the previous ASMATHERM study who had 2 sets of biopsies and BAL within a 6 to 12 month-interval, without exposure to mepolizumab and without change in their treatment during this interval, will be studied as a control group . Clinical data are available at inclusion and after 12 months. Biopsies are fixed in formaldehyde and processed to paraffin wax for immunohistochemical (IHC) and morphometric studies. One biopsy will be stored at -80°C for further RNAseq analyses. RBM thickening (morphometry), ASM area and the rate of ASM-proliferating cells (PCNA immuno-staining) will be measured. PGP9 staining can assess the number of nerves in the bronchial wall. The number of inflammatory cells (eosinophils, neutrophils, mast cells, T-lymphocytes evaluated respectively by MBP, elastase, tryptase, CD4 expression) and vascular sections will also be enumerated after IHC. Eosinophils localization in the airway will be described. Cytospin preparations from BAL cell pellets will be used to assess the proportion of eosinophils and neutrophils. In parallel, the levels of different pro-inflammatory and remodeling mediators will be measured in BAL aliquots concentrated x 10, by specific Elisa and Luminex assays. • Trial plan V0: screening visit V1: inclusion visit clinical evaluation V2: 6-month visit Clinical response assessment by GETE and ACT, clinical evaluation V3: 12-month visit clinical response assessment by GETE and ACT, clinical evaluation |
Facilities
Sequence: | 200113249 |
Name | Bichat hospital |
City | Paris |
Zip | 75018 |
Country | France |
Conditions
Sequence: | 52173480 |
Name | Asthma |
Downcase Name | asthma |
Id Information
Sequence: | 40160073 | Sequence: | 40160074 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | P180501J | Id Value | 2018-002591-40 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42570357 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55595508 | Sequence: | 55595509 |
Title | Mepolizumab | Title | Patients w/o mepolizumab (retrospective) |
Description | Patients receiving mepolizumab | Description | Retrospective control group of patients not exposed to mepolizumab, included in the COBRA cohort and the ASMATHERM protocol, who had 2 sets of biopsies and BAL within a 6 to 12 month-interval, without change in their treatment. Clinical data for this patients are available at inclusion and after 12 months. |
Keywords
Sequence: | 79871470 | Sequence: | 79871471 | Sequence: | 79871472 | Sequence: | 79871473 |
Name | Eosinophil | Name | Bronchial biopsies | Name | Mepolizumab | Name | Severe |
Downcase Name | eosinophil | Downcase Name | bronchial biopsies | Downcase Name | mepolizumab | Downcase Name | severe |
Design Outcomes
Sequence: | 177387163 | Sequence: | 177387164 | Sequence: | 177387162 | Sequence: | 177387135 | Sequence: | 177387136 | Sequence: | 177387137 | Sequence: | 177387138 | Sequence: | 177387139 | Sequence: | 177387140 | Sequence: | 177387141 | Sequence: | 177387142 | Sequence: | 177387143 | Sequence: | 177387144 | Sequence: | 177387145 | Sequence: | 177387146 | Sequence: | 177387147 | Sequence: | 177387148 | Sequence: | 177387149 | Sequence: | 177387150 | Sequence: | 177387151 | Sequence: | 177387152 | Sequence: | 177387153 | Sequence: | 177387154 | Sequence: | 177387155 | Sequence: | 177387156 | Sequence: | 177387157 | Sequence: | 177387158 | Sequence: | 177387159 | Sequence: | 177387160 | Sequence: | 177387161 | Sequence: | 177387165 | Sequence: | 177387166 | Sequence: | 177387167 |
Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Total lung capacity (TLC) | Measure | Residual volume (RV) | Measure | Total lung capacity (TLC) | Measure | Changes in reticular basement membrane (RBM) thickening | Measure | Changes in airway smooth muscle (ASM) area | Measure | Number of proliferating muscle cells | Measure | Number of nerve endings | Measure | Number of vascular sections | Measure | Number of infiltrating inflammatory cells in the biopsies | Measure | Number of inflammatory cells in the BAL | Measure | Proportion of eosinophils expressing MBP/IL3R | Measure | Interferon-gamma concentration | Measure | IL-13 concentration | Measure | Periostin concentration | Measure | IL-17A concentration | Measure | IL-22 concentration | Measure | IL-33 concentration | Measure | Thymic Stromal Lymphopoietin (TSLP) concentration | Measure | Fibronectin concentration | Measure | Tenascin concentration | Measure | Fibulin-1 concentration | Measure | Monocyte chemoattractant protein-1 (CCL/MCP-1) concentration | Measure | EGF concentration | Measure | bFGF concentration | Measure | PDGF-BB concentration | Measure | Total score at Asthma Control Test | Measure | Global evaluation of mepolizumab benefit | Measure | Forced expiratory volume (FEV1) | Measure | Forced expiratory volume (FEV1) | Measure | Forced expiratory volume/Vital capacity (FEV1/VC) | Measure | Residual volume (RV) | Measure | Proportion of patients with pre-bronchodilator FEV1 greater than 80% | Measure | Proportion of patients with an increase from baseline in pre-bronchodilator FEV1 greater than 20% |
Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 0, 6 and 12 months | Time Frame | 6 and 12 months | Time Frame | 6 and 12 months |
Description | Measured during lung function test, pre/post salbutamol, expressed in % of predicted value. | Description | Measured during lung function test, pre/post salbutamol, expressed in ml. | Description | Measured during lung function test, pre/post salbutamol, expressed in ml. | Description | The absolute variation in RBM thickening (µm, morphometry measurement on bronchial biopsies) over 12 months is defined as the difference between month twelve and baseline (V1).
The absolute variation in RBM thickening over 6 months is defined as the difference between month six and baseline (V1). |
Description | Measured in morphometry in µm2 and expressed as a percentage of smooth muscle surface area relative to the biopsy surface.
The absolute variation in ASM area over 12 months is defined as the difference between month twelve and baseline (V1). The absolute variation in ASM area over 6 months is defined as the difference between month six and baseline (V1). |
Description | Evaluated by anti proliferating cell nuclear antigen (PCNA) antibodies, expressed as the number of positive cells per muscle surface. | Description | Evaluated by PGP9 and expressed as number of positive cells per biopsy surface in mm2 | Description | Measured with an anti-CD31 antibody, expressed in number of sections per mm2. | Description | Number of infiltrating inflammatory cells (infiltrating neutrophils, lymphocytes and eosinophils) expressed as number of positive cells per biopsy surface in mm2 | Description | Number of inflammatory cells (neutrophils, lymphocytes and eosinophils) expressed as % of total cells in the BAL | Description | Measured on bronchial biopsies, expressed as number of cells per biopsy surface in mm2 | Description | Interferon-gamma (Th1 cytokine) will be measured in BAL and serum | Description | IL-13 (Th2 cytokine) will be measured in BAL and serum | Description | Periostin (Th2 cytokine) will be measured in BAL and serum | Description | IL-17A (Th17 cytokine) will be measured in BAL and serum | Description | IL-22 (Th17 cytokine) will be measured in BAL and serum | Description | IL-33 (innate immune cytokines) will be measured in BAL and serum | Description | TSLP (innate immune cytokines) will be measured in BAL and serum | Description | Fibronectin (soluble hallmarks of ECM remodeling) will be measured in BAL and serum | Description | Tenascin (soluble hallmarks of ECM remodeling) will be measured in BAL and serum | Description | Fibulin-1 (soluble hallmarks of ECM remodeling) will be measured in BAL and serum | Description | Will be measured in BAL and serum | Description | Will be measured in BAL and serum | Description | Will be measured in BAL and serum | Description | Will be measured in BAL and serum | Description | Measured using the Asthma Control Test (ACT) scale (range: 5 to 25). ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control.
5 items, with 4-week recall (on symptoms and daily functioning) The total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma. |
Description | Benefit of mepolizumab will be evaluated by patient and by physician according to the physician's Global Evaluation of Treatment Effectiveness (GETE).
Patients will be considered as "responders" if classified as "excellent response" or "good response" by their physician. |
Description | Measured during lung function test, pre/post salbutamol, expressed in ml. | Description | Measured during lung function test, pre/post salbutamol, expressed in % of predicted value. | Description | Measured during lung function test, pre/post salbutamol, expressed in % | Description | Measured during lung function test, pre/post salbutamol, expressed in % of predicted value. | Description | In order to assess functional response to treatment | Description | In order to assess functional response to treatment |
Browse Conditions
Sequence: | 193495134 | Sequence: | 193495135 | Sequence: | 193495136 | Sequence: | 193495137 | Sequence: | 193495138 | Sequence: | 193495139 | Sequence: | 193495140 | Sequence: | 193495141 | Sequence: | 193495142 | Sequence: | 193495143 | Sequence: | 193495144 |
Mesh Term | Asthma | Mesh Term | Airway Remodeling | Mesh Term | Bronchial Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Lung Diseases, Obstructive | Mesh Term | Lung Diseases | Mesh Term | Respiratory Hypersensitivity | Mesh Term | Hypersensitivity, Immediate | Mesh Term | Hypersensitivity | Mesh Term | Immune System Diseases | Mesh Term | Pathological Conditions, Anatomical |
Downcase Mesh Term | asthma | Downcase Mesh Term | airway remodeling | Downcase Mesh Term | bronchial diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | lung diseases, obstructive | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory hypersensitivity | Downcase Mesh Term | hypersensitivity, immediate | Downcase Mesh Term | hypersensitivity | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | pathological conditions, anatomical |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48321189 | Sequence: | 48321190 | Sequence: | 48321191 |
Agency Class | OTHER | Agency Class | INDUSTRY | Agency Class | OTHER_GOV |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Assistance Publique – Hôpitaux de Paris | Name | GlaxoSmithKline | Name | Institut National de la Santé Et de la Recherche Médicale, France |
Overall Officials
Sequence: | 29286432 |
Role | Principal Investigator |
Name | Camille TAILLE, MD, PhD |
Affiliation | Assistance Publique – Hôpitaux de Paris |
Eligibilities
Sequence: | 30766568 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Patients with severe uncontrolled eosinophil asthma with an indication for mepolizumab according to French recommandations (eos >300mm3 in the previous year, >2 exacerbations, despite optimal step 4-5 therapy, including daily use of steroids). |
Criteria | Inclusion criteria:
adult >18 years, Exclusion criteria : pregnancy, |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253917990 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 38 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 8 |
Number Of Secondary Outcomes To Measure | 25 |
Designs
Sequence: | 30512730 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28879029 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797391
2018-12-13
https://zephyrnet.com/?p=NCT03797391
NCT03797391https://www.clinicaltrials.gov/study/NCT03797391?tab=tableXuemei Xiexmxie@epimab.com+86-21-61043299First-in-human, Phase I/II, Multicenter, Open-Label Study of EMB-01 in Patients with Advanced/Metastatic Solid Tumors
<![CDATA[
Studies
Study First Submitted Date | 2018-12-26 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-05-31 |
Start Month Year | December 13, 2018 |
Primary Completion Month Year | March 14, 2025 |
Verification Month Year | May 2023 |
Verification Date | 2023-05-31 |
Last Update Posted Date | 2023-05-31 |
Detailed Descriptions
Sequence: | 20661413 |
Description | This is a first-in-human (FIH), open-label, Phase I/II study of EMB-01, a bispecific Epidermal growth factor receptor (EGFR) and c-Mesenchymal-Epithelial Transition (cMet) antibody, in patients with advanced solid tumors who have progressed on available standard therapies or for which no standard therapy exists. The study consists of two parts: Phase I (dose escalation) and Phase II (cohort expansion). The study is planning to recruit tentatively 33-66 subjects with advanced/metastatic solid tumors in phase I and approximately 42-120 subjects with EGFR mutant and/or cMET aberrated NSCLC who have progressed on or are intolerant to standard treatment(s) (including platinum-based therapy) will be enrolled at the RP2D(s) in phase II part of the study. In phase II, patients will be assigned to five groups according to their molecular status at baseline. The trial will consist of molecular pre-screening period (Phase II only), clinical screening period (-28 to -1 days), treatment cycles (each cycle is 28 days, maximum up to 2 years), and safety follow-up period (30 days after the last dose). |
Facilities
Sequence: | 199431224 | Sequence: | 199431225 | Sequence: | 199431226 | Sequence: | 199431227 | Sequence: | 199431228 |
Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting |
Name | Dana-Farber Cancer Institute | Name | Barbara Ann Karmanos Cancer Institute | Name | Gabrail Cancer Center Research | Name | Guangdong General Hospital | Name | Shanghai Chest Hosptial |
City | Boston | City | Detroit | City | Canton | City | Guangzhou | City | Shanghai |
State | Massachusetts | State | Michigan | State | Ohio | State | Guang Dong | State | Shanghai |
Zip | 02215 | Zip | 48201 | Zip | 44718 | Zip | 510080 | Zip | 200030 |
Country | United States | Country | United States | Country | United States | Country | China | Country | China |
Conditions
Sequence: | 52014308 | Sequence: | 52014309 | Sequence: | 52014310 |
Name | Neoplasms | Name | Neoplasm Metastasis | Name | Non-Small-Cell Lung Cancer |
Downcase Name | neoplasms | Downcase Name | neoplasm metastasis | Downcase Name | non-small-cell lung cancer |
Id Information
Sequence: | 40035738 |
Id Source | org_study_id |
Id Value | EMB01X101 |
Countries
Sequence: | 42431802 | Sequence: | 42431803 |
Name | United States | Name | China |
Removed | False | Removed | False |
Design Groups
Sequence: | 55420456 |
Group Type | Experimental |
Title | Dose Escalation-Part 1, Expansion-Part 2 |
Description | In part 1, escalating dose cohort, patients will receive intravenous infusions of EMB-01 weekly (QW). The duration of each treatment cycle is 28 days (4 weeks). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) is reached or all planned doses are administered.
In part 2, participants will receive intravenous infusion of EMB-01 at the recommended Phase II dose (RP2D) regimen(s) once weekly. The duration of each treatment cycle is 28 days (4 weeks). |
Interventions
Sequence: | 52326680 |
Intervention Type | Drug |
Name | EMB-01 |
Description | In part 1, patients will receive intravenous infusions of EMB01 weekly (QW). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) is reached or all planned doses are administered.
In part 2, participants will receive intravenous infusion of EMB-01 at RP2D The duration of each treatment cycle in both part 1 and part 2 is 28 days (4 weeks). Participants may continue to receive study drug until discontinuation criteria are met. |
Keywords
Sequence: | 79616780 | Sequence: | 79616781 | Sequence: | 79616782 | Sequence: | 79616783 | Sequence: | 79616784 | Sequence: | 79616785 |
Name | Human Bispecific antibody, | Name | Epidermal Growth Factor Receptor (EGFR), | Name | c-Mesenchymal-Epithelial Transition (cMet), | Name | Neoplasms, Neoplasm Metastasis, | Name | Non-Small-Cell Lung Cancer (NSCLC), First-in-human, | Name | EMB-01, Tyrosine Kinase Inhibitor (TKI) Resistant |
Downcase Name | human bispecific antibody, | Downcase Name | epidermal growth factor receptor (egfr), | Downcase Name | c-mesenchymal-epithelial transition (cmet), | Downcase Name | neoplasms, neoplasm metastasis, | Downcase Name | non-small-cell lung cancer (nsclc), first-in-human, | Downcase Name | emb-01, tyrosine kinase inhibitor (tki) resistant |
Design Outcomes
Sequence: | 176831541 | Sequence: | 176831542 | Sequence: | 176831543 | Sequence: | 176831544 | Sequence: | 176831545 | Sequence: | 176831546 | Sequence: | 176831547 | Sequence: | 176831548 | Sequence: | 176831549 | Sequence: | 176831550 | Sequence: | 176831551 | Sequence: | 176831552 | Sequence: | 176831553 | Sequence: | 176831554 | Sequence: | 176831555 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other |
Measure | Maximum tolerated dose (MTD) (phase 1 only) | Measure | Adverse Events (AEs), and Serious Adverse Events (SAEs) | Measure | Overall Response Rate (ORR) (phase 2 only) | Measure | Maximum Serum Concentration (Cmax) | Measure | Area Under the Plasma Concentration-Time Curve (AUC) | Measure | Trough Serum Concentration (Ctrough) | Measure | Elimination half-life (t1/2) | Measure | Clearance (CL) | Measure | Volume of distribution at steady state (Vss) | Measure | Accumulation Ratio (AR) | Measure | Dose Proportionality | Measure | Anti-Drug Antibodies (ADA) | Measure | Duration Of Response (DOR) | Measure | Progression-Free Survival (PFS) | Measure | Pharmacodynamic (Soluble EGFR and cMET concentration) |
Time Frame | cycle 1 (1cycle = 28 days) | Time Frame | Screening up to follow-up (30 days after the last dose) | Time Frame | From the date fo dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months | Time Frame | Through treatment discontinuation: an average of 6 months | Time Frame | Through treatment discontinuation: an average of 6 months | Time Frame | Through treatment discontinuation: an average of 6 months | Time Frame | Through treatment discontinuation: an average of 6 months | Time Frame | Through treatment discontinuation: an average of 6 months | Time Frame | Through treatment discontinuation: an average of 6 months | Time Frame | hrough treatment discontinuation: an average of 6 months | Time Frame | Through treatment discontinuation: an average of 6 months | Time Frame | Through study completion, an average of 7 months | Time Frame | From the date fo dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months | Time Frame | Through treatment discontinuation: an average of 6 months | Time Frame | Through treatment discontinuation: an average of 6 months |
Description | Maximum tolerated dose | Description | Adverse Events, and Serious Adverse Events | Description | Overall Response Rate | Description | Maximum Serum Concentration | Description | Area Under the Plasma Concentration-Time Curve | Description | Trough Serum Concentration | Description | Elimination half-life | Description | Clearance | Description | volume of distribution at steady state | Description | Accumulation Ratio | Description | Dose Proportionality | Description | Anti-Drug Antibodies | Description | Duration Of Response | Description | Progression-free survival | Description | Pharmacodynamic (Soluble EGFR and cMET concentration) |
Browse Conditions
Sequence: | 192864810 | Sequence: | 192864811 | Sequence: | 192864812 | Sequence: | 192864813 | Sequence: | 192864814 | Sequence: | 192864815 | Sequence: | 192864816 | Sequence: | 192864817 | Sequence: | 192864818 | Sequence: | 192864819 | Sequence: | 192864820 | Sequence: | 192864821 | Sequence: | 192864822 |
Mesh Term | Neoplasms | Mesh Term | Carcinoma, Non-Small-Cell Lung | Mesh Term | Neoplasm Metastasis | Mesh Term | Lung Neoplasms | Mesh Term | Respiratory Tract Neoplasms | Mesh Term | Thoracic Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Carcinoma, Bronchogenic | Mesh Term | Bronchial Neoplasms | Mesh Term | Neoplastic Processes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | neoplasms | Downcase Mesh Term | carcinoma, non-small-cell lung | Downcase Mesh Term | neoplasm metastasis | Downcase Mesh Term | lung neoplasms | Downcase Mesh Term | respiratory tract neoplasms | Downcase Mesh Term | thoracic neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | carcinoma, bronchogenic | Downcase Mesh Term | bronchial neoplasms | Downcase Mesh Term | neoplastic processes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48172882 | Sequence: | 48172883 |
Agency Class | INDUSTRY | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Shanghai EpimAb Biotherapeutics Co., Ltd. | Name | Covance |
Central Contacts
Sequence: | 11973960 | Sequence: | 11973961 |
Contact Type | primary | Contact Type | backup |
Name | Xiaodong Sun, MD | Name | Xuemei Xie |
Phone | +86-21-61043299 | Phone | +86-21-61043299 |
xdsun@epimab.com | xmxie@epimab.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 67938917 |
Design Group Id | 55420456 |
Intervention Id | 52326680 |
Eligibilities
Sequence: | 30673422 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Molecular Pre-screening Inclusion criteria (Phase II only) The patient must sign the molecular pre-screening Inform Consent to allow for the molecular pre-screening process. All patients must have documented evidence of EGFR and/or cMet aberrations. Screening Inclusion Criteria Able to understand and willing to sign the Informed Consent Form (ICF). Histologically/cytologically confirmed advanced/metastatic solid tumors with measurable disease [Response Evaluation Criteria in Solid Tumors (RECIST) v1.1]: Phase I: advanced/metastatic solid tumors including but not limited to NSCLC, colorectal cancer, gastric cancer and liver cancer refractory to standard therapy or for which no standard therapy is available or accessible. Phase II: Advanced/metastatic NSCLC Patients have confirmed EGFR mutant and/or cMET aberration, and have progressed after standard treatment (including platinum-based therapy) or are intolerant to standard treatment. Additionally, patients with T790M mutation have received FDA/Health Authority approved therapies (if accessible) for this indication (i.e., osimertinib) and have progressed or became intolerant. A patient who has refused all currently available therapy is allowed to enroll, but must be documented in the source record. Must have adequate organ function. Regarding prior anti-tumor therapy: Must have stopped treatment at least 4 weeks or within 5 half-lives. Exclusion Criteria: Molecular Pre-screening Exclusion Criteria (Phase II only) Subject who meets any of the follow criteria can't be proceeded to clinical screening: Patients who are unwilling to sign the molecular pre-screening ICF. Screening Exclusion Criteria Life expectancy < 3 months. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253859444 |
Number Of Facilities | 5 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 11 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30420189 |
Allocation | N/A |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Dose escalation followed by Protocol at 100mg, 200mg, 350mg, 500mg, 700mg, 900mg, 1200mg, 1600mg, 2100mg, 2700mg and 3000mg . |
Intervention Other Names
Sequence: | 26586999 |
Intervention Id | 52326680 |
Name | FIT-013a |
Responsible Parties
Sequence: | 28786708 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797378
2019-08-09
https://zephyrnet.com/?p=NCT03797378
NCT03797378https://www.clinicaltrials.gov/study/NCT03797378?tab=tableNANANAThe purpose of this study is to test the effects of an innovative exercise program referred to as movement-2-music (M2M) on health and fitness outcomes in adults with physical/mobility disabilities. One hundred and eight participants with physical/mobility disabilities will be recruited and randomly enrolled into one of two groups: a) M2M or b) waitlist control. The primary aim of this study is to determine the effects of a 12-week M2M program on health and fitness in participants with physical/mobility disabilities who are in one of three functional mobility groups: 1) Group I – only able to exercise while sitting, 2) Group II – able to exercise sitting and standing with/without support, and 3) Group III – able to exercise one side of the body more than the other side. The second aim is to compare the observed effects of the program in this study to a previous M2M study that groups participants based on disability type. The third aim of this study is to test whether adherence (defined as attendance to the 12-week program) affects the effects of M2M in participants with physical/mobility disabilities. The potential influences of different functional mobility and disabilities of participants on how the program affects participants’ health and fitness outcomes will also be tested.
**In response to COVID-19, the 12-week M2M intervention and all assessments have been modified from being delivered in-person at Lakeshore Foundation to being delivered remotely in real-time through videoconferencing technology.**
<![CDATA[
Studies
Study First Submitted Date | 2018-11-13 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-05-31 |
Start Month Year | August 9, 2019 |
Primary Completion Month Year | May 25, 2023 |
Verification Month Year | May 2023 |
Verification Date | 2023-05-31 |
Last Update Posted Date | 2023-05-31 |
Detailed Descriptions
Sequence: | 20668028 |
Description | The proposed intervention efficacy trial examines a remotely-delivered, rhythmic-based movement-2-music (eM2M) intervention with 108 adults with physical/mobility disabilities who are randomized into one of two groups: a) eM2M or b) waitlist control. The primary aim is to determine the effects of a 12-week eM2M intervention on physical and psychosocial health outcomes in participants with physical/mobility disabilities who are classified into three functional mobility groups: 1) Group I – only able to exercise while sitting, 2) Group II – able to exercise sitting and standing with/without support, and 3) Group III – able to exercise one side of the body more than the other side. The secondary aim is to compare effect sizes of the physical health outcomes including cardiorespiratory fitness, muscle strength and lower extremity function obtained in the current study to a previous M2M trial that grouped participants based on disability type. The tertiary aim of this study is to explore whether adherence (defined in terms of attendance to the 12-week intervention) moderates effects of eM2M in participants with physical/mobility disabilities. The heterogeneity of treatment effect across the physical health outcomes will also be examined using functional mobility and disability groups as moderators.
Participants will complete a set of assessments at baseline and after the 12-week intervention period remotely through videoconferencing technology. They will also be asked to complete the questionnaire portion of the assessments every 6 months and the entire set of assessments every year for up to 5 years. The assessments include cardiorespiratory fitness measured using a heart rate recovery test, grip strength measured using hand-held dynamometer, lower extremity function measured using the Short Physical Performance Battery and the Timed Up and Go test as well as questionnaires that assess health-related quality of life (NIH PROMIS 10 Global Health Items, NIH PROMIS Ability to Participate in Social Roles and Activities), physical activity (Godin Leisure Time Exercise Questionnaire), exercise self-efficacy (Exercise Self-efficacy Scale), exercise goal-setting (Exercise Goal-setting Scale), outcome expectation for exercise (Multidimensional Outcomes Expectations for Exercise Scale), social support (Social Provision Scale) and barriers in physical activity (Barriers in Physical Activity Questionnaire). In addition, at the end of the 12-week intervention, participants will be interviewed about their study experience and perceived impact of eM2M on their fitness and health. |
Facilities
Sequence: | 199504795 |
Name | UAB Research Collaborative |
City | Birmingham |
State | Alabama |
Zip | 35209 |
Country | United States |
Conditions
Sequence: | 52031128 | Sequence: | 52031129 | Sequence: | 52031130 | Sequence: | 52031131 | Sequence: | 52031132 | Sequence: | 52031133 | Sequence: | 52031134 |
Name | Spinal Cord Injuries | Name | Traumatic Brain Injury | Name | Spina Bifida | Name | Cerebral Palsy | Name | Stroke | Name | Parkinson Disease | Name | Multiple Sclerosis |
Downcase Name | spinal cord injuries | Downcase Name | traumatic brain injury | Downcase Name | spina bifida | Downcase Name | cerebral palsy | Downcase Name | stroke | Downcase Name | parkinson disease | Downcase Name | multiple sclerosis |
Id Information
Sequence: | 40048716 |
Id Source | org_study_id |
Id Value | IRB-300002645 |
Countries
Sequence: | 42446383 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55439073 | Sequence: | 55439074 |
Group Type | Experimental | Group Type | No Intervention |
Title | eM2M | Title | Waitlist Control |
Description | Participants in the eM2M arm will participate in an intervention that involves three 60-minute M2M sessions per week for 12 weeks. All sessions are delivered remotely in real-time through videoconferencing technology. At the beginning and end of each session, vital signs (heart rate, blood pressure and peripheral capillary oxygen saturation) are obtained from participants. Participants rate perceived exertion, pain, and fatigue level on a log. Participants set weekly exercise goals and expectations at first session of each week. Participants also record daily activities using a provided log. | Description | Participants in the waitlist control arm are instructed to maintain their usual activities during the 12-week intervention period and are asked to record their activities on a provided log. |
Interventions
Sequence: | 52343361 |
Intervention Type | Other |
Name | eM2M |
Description | The eM2M intervention involves three 60-minute sessions per week for 12 weeks. All sessions are delivered remotely in real-time through videoconferencing technology. The intervention uses combinations of movement patterns that target range of motion, muscle strength, cardiorespiratory fitness, balance, and breathing. Each session consists of movement routines choreographed to music, and every routine can be adapted to participants' functional ability. |
Design Outcomes
Sequence: | 176894286 | Sequence: | 176894287 | Sequence: | 176894288 | Sequence: | 176894289 | Sequence: | 176894290 | Sequence: | 176894291 | Sequence: | 176894292 | Sequence: | 176894293 | Sequence: | 176894294 | Sequence: | 176894295 | Sequence: | 176894296 | Sequence: | 176894297 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Change from baseline cardiorespiratory fitness at 3 months | Measure | Change from baseline muscle strength at 3 months | Measure | Change from baseline lower extremity function at 3 months | Measure | Change from baseline lower extremity function at 3 months | Measure | Change from baseline health-related quality of life at 3 months | Measure | Change from baseline social participation at 3 months | Measure | Change from baseline physical activity at 3 months | Measure | Change from baseline barriers in physical activity at 3 months | Measure | Change from baseline exercise self-efficacy at 3 months | Measure | Change from baseline exercise goal-setting at 3 months | Measure | Change from baseline outcome expectations for exercise at 3 months | Measure | Change from baseline social support at 3 months |
Time Frame | Baseline and post 12-week intervention | Time Frame | Baseline and post 12-week intervention | Time Frame | Baseline and post 12-week intervention | Time Frame | Baseline and post 12-week intervention | Time Frame | Baseline and post 12-week intervention | Time Frame | Baseline and post 12-week intervention | Time Frame | Baseline and post 12-week intervention | Time Frame | Baseline and post 12-week intervention | Time Frame | Baseline and post 12-week intervention | Time Frame | Baseline and post 12-week intervention | Time Frame | Baseline and post 12-week intervention | Time Frame | Baseline and post 12-week intervention |
Description | The cardiorespiratory fitness is measured using a heart rate recovery test | Description | Muscle strength is measured with grip strength using a hand-held dynamometer. | Description | Lower extremity function is assessed using the Short Physical Performance Battery (SPPB) | Description | Lower extremity function will be assessed using the Timed Up and Go (TUG) test. | Description | Health-related quality of life is measured using the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Items. The instrument is a 10-item measure with the response scores ranging from 1 (very severe) to 5 (none). Two summary scores, a global physical health score and a global mental health score, can be calculated from this scale, with each score ranging from 4 to 20. Higher scores indicate better health. The total raw score is translated into a T-score for each participant for analysis. | Description | Social participation is measured using the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities. The instrument is a 8-item measure with the response scores ranging from 1 (always) to 5 (never). The lowest possible total raw score is 8 and the highest possible score is 40. Higher scores indicate better ability to participate in social roles and activities. The total raw score is translated into a T-score for each participant for analysis. | Description | Physical activity is measured using the Godin Leisure Time Exercise Questionnaire. The questionnaire contains two questions. The first question asks participants to report weekly frequencies of activities they perform at different intensities. A total weekly leisure activity is a sum of activity scores calculated by multiplying the weekly frequencies of strenuous, moderate, and light activities by 9, 5, and 3, respectively. The second question asks participants the frequency of weekly leisure-time activities performed that are long enough to work up a sweat. | Description | Barriers in physical activity will be assessed using the Barriers in Physical Activity Questionnaire. The instrument contains 43 items. Each item is responded with either no (1) or yes (2). If response is yes, a follow-up response that ranges from 1 (very small) to 5 (very large) is selected. There are 8 domains, which include personal health, attitudes/beliefs towards physical activity, friends, family, fitness center built environment, policy/programs/staff, community built environment, and safety. Each domain score is calculated by summing the item responses with its respective item weight. Higher domain scores indicate greater perceived barriers to physical activity. | Description | Exercise self-efficacy will be assessed using the Exercise Self-Efficacy Scale. The scale contains 8 items, with response options of each item ranging from 0% (not at all confident) to 100% (highly confident). All items are summed and a mean score is calculated. Higher scores indicate higher levels of self-efficacy. | Description | Exercise goal-setting will be measured using the Exercise Goal-Setting Scale. The instrument contains 10 items with response options ranging from 1 (does not describe) to 5 (describes completely). A mean score is calculated. A higher mean score indicate better goal-setting and self-monitoring for exercise. | Description | Outcome expectations for exercise will be assessed using the Multidimensional Outcome Expectations for Exercise Scale. The instrument contains 15 items, with the response options ranging from 1 (strongly disagree) to 5 (strongly agree). Three domains of outcome expectations for exercise are assessed, which include physical outcome expectations (6 items), social outcome expectations (4 items), and self-evaluative outcome expectations (5 items). Each dimension is scored by summing the item responses. Higher scores indicate higher levels of outcome expectations for exercise. | Description | Social support will be assessed using the Social Provision Scale. The instrument contains 24 items, with the response options ranging from 1 (strongly disagree) to 4 (strongly agree). A total score is calculated by summing scores from all items. A higher score indicates a greater degree of perceived support. |
Browse Conditions
Sequence: | 192930142 | Sequence: | 192930135 | Sequence: | 192930136 | Sequence: | 192930137 | Sequence: | 192930138 | Sequence: | 192930139 | Sequence: | 192930140 | Sequence: | 192930141 | Sequence: | 192930143 | Sequence: | 192930144 | Sequence: | 192930145 | Sequence: | 192930146 | Sequence: | 192930147 | Sequence: | 192930148 | Sequence: | 192930149 | Sequence: | 192930150 | Sequence: | 192930151 | Sequence: | 192930152 | Sequence: | 192930153 | Sequence: | 192930154 | Sequence: | 192930155 | Sequence: | 192930156 | Sequence: | 192930157 | Sequence: | 192930158 | Sequence: | 192930159 | Sequence: | 192930160 | Sequence: | 192930161 | Sequence: | 192930162 |
Mesh Term | Wounds and Injuries | Mesh Term | Parkinson Disease | Mesh Term | Multiple Sclerosis | Mesh Term | Brain Injuries | Mesh Term | Spinal Cord Injuries | Mesh Term | Cerebral Palsy | Mesh Term | Brain Injuries, Traumatic | Mesh Term | Spinal Dysraphism | Mesh Term | Parkinsonian Disorders | Mesh Term | Basal Ganglia Diseases | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Movement Disorders | Mesh Term | Synucleinopathies | Mesh Term | Neurodegenerative Diseases | Mesh Term | Demyelinating Autoimmune Diseases, CNS | Mesh Term | Autoimmune Diseases of the Nervous System | Mesh Term | Demyelinating Diseases | Mesh Term | Autoimmune Diseases | Mesh Term | Immune System Diseases | Mesh Term | Craniocerebral Trauma | Mesh Term | Trauma, Nervous System | Mesh Term | Spinal Cord Diseases | Mesh Term | Brain Damage, Chronic | Mesh Term | Neural Tube Defects | Mesh Term | Nervous System Malformations | Mesh Term | Congenital Abnormalities |
Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | parkinson disease | Downcase Mesh Term | multiple sclerosis | Downcase Mesh Term | brain injuries | Downcase Mesh Term | spinal cord injuries | Downcase Mesh Term | cerebral palsy | Downcase Mesh Term | brain injuries, traumatic | Downcase Mesh Term | spinal dysraphism | Downcase Mesh Term | parkinsonian disorders | Downcase Mesh Term | basal ganglia diseases | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | movement disorders | Downcase Mesh Term | synucleinopathies | Downcase Mesh Term | neurodegenerative diseases | Downcase Mesh Term | demyelinating autoimmune diseases, cns | Downcase Mesh Term | autoimmune diseases of the nervous system | Downcase Mesh Term | demyelinating diseases | Downcase Mesh Term | autoimmune diseases | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | craniocerebral trauma | Downcase Mesh Term | trauma, nervous system | Downcase Mesh Term | spinal cord diseases | Downcase Mesh Term | brain damage, chronic | Downcase Mesh Term | neural tube defects | Downcase Mesh Term | nervous system malformations | Downcase Mesh Term | congenital abnormalities |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48188563 | Sequence: | 48188564 | Sequence: | 48188565 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | University of Alabama at Birmingham | Name | Lakeshore Foundation | Name | YMCA of Greater Birmingham |
Design Group Interventions
Sequence: | 67962284 |
Design Group Id | 55439073 |
Intervention Id | 52343361 |
Eligibilities
Sequence: | 30683168 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Primary diagnosis of head injury, stroke, multiple sclerosis, spinal cord injury, spina bifida, Parkinson disease, cerebral palsy by a physician Exclusion Criteria: Participate in an exercise intervention or a similar intervention in the last 6 months |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253885473 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 46 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 5 |
Number Of Other Outcomes To Measure | 5 |
Designs
Sequence: | 30429896 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28796401 |
Responsible Party Type | Principal Investigator |
Name | James Rimmer |
Title | Lakeshore Foundation Endowed Chair in Health Promotion and Rehabilitation Sciences |
Affiliation | University of Alabama at Birmingham |
Study References
Sequence: | 51920421 |
Pmid | 34743701 |
Reference Type | derived |
Citation | Young HJ, Lai B, Mehta T, Thirumalai M, Wilroy J, Yates A, Kane B, Rimmer JH. The movement-to-music (M2M) study: study protocol for a randomized controlled efficacy trial examining a rhythmic teleexercise intervention for people with physical disabilities. Trials. 2021 Nov 7;22(1):779. doi: 10.1186/s13063-021-05751-2. |
Ipd Information Types
Sequence: | 3325526 | Sequence: | 3325527 |
Name | Study Protocol | Name | Statistical Analysis Plan (SAP) |
]]>
https://zephyrnet.com/NCT03797365
2019-01-10
https://zephyrnet.com/?p=NCT03797365
NCT03797365https://www.clinicaltrials.gov/study/NCT03797365?tab=tablePierre-André MAL, residentmalpierreandre@gmail.com+33659363500This trial is a pathophysiological study evaluating the impact of a cognitive therapy on the perineal neuromuscular mechanisms in women patients with urinary incontinence.
Some research works have been realized on the impact of a cognitive load test (CLT) on the neuromuscular continence urinary mechanisms. It had been demonstrated that a CLT induced an increase in the latency of voluntary perineal contraction. It had also been demonstrated that a CLT had an influence on the involuntary perineal contraction pre-activation. Most recently, the impact of a cognitive therapy on the perineal neuromuscular mechanisms on healthy participants had been evaluated. It demonstrated that a cognitive therapy inhibited the impact of the CLT on the perineal neuromuscular mechanisms.
The present project is about the evaluation of the interest of a cognitive therapy on the neuromuscular mechanisms in case of attentional test in a urinary incontinent women population. It could conduce to new therapeutic leads for the management of urinary incontinence.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | January 10, 2019 |
Primary Completion Month Year | July 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20735962 |
Description | Objectives and results expected
Cognition seems to have an effect on the physiological mechanisms of urinary continence. Urinary continence is, among others, the effect of a good coordination between detrusor's contraction and pelvic floor muscles' contraction. A cognitive disturbance involves coordination's disturbance. It has already been demonstrated that a double task rehabilitation (between cognition and perineal muscles) could annihilate the effects induced by a cognitive disturbance on the physiological neuromuscular mechanisms of the urinary incontinence. The objective of this study is to evaluate the benefit of a double task cognitive rehabilitation for the patients with urinary incontinence (UI). Current knowledge situation Pelvic floor muscles have a major incidence for the physiological urinary continence. Even if the external anal sphincter (EAS)'s muscles are not directly involved in urinary incontinence, many studies have shown they had a synergistic contraction with levator ani muscles during the voluntary and involuntary perineal contraction . Because they are easily reachable for an electromyographic (EMG) recording, many authors have registered these muscles in order to investigate the physiologic urinary continence. Amarenco et al. had shown that pelvic floor muscles' intensity of contraction in response to a cough fit was proportional to the cough intensity in an healthy volunteers population. This correlation was beyond bladder's filling. For the patients with UI, Deffieux et al. shown a loss of correlation between cough intensity and perineal contraction. Deffieux et al. also analyzed the temporal sequence of muscle activation for the EAS during a cough fit. A perineal pre contraction in an healthy volunteers population was observed. EAS's muscles EMG activation began 210 ms (median) before external intercostal (EIC) muscles. This EAS's muscles anticipation of contraction was not found in the group of patients with UI. The observation that fewer patients were activating their AES's muscles, more the modulation of EAS's muscles contraction was distorted when coughing was made. Thubert et al. observed that the perineal contraction's latency was multiplied by 4 in case of cognitive load test (CLT) in an healthy volunteers population. CLT leads to an EAS's muscles pre activation in case of coughing effort, was also observed. A lowing of 29% of AES's muscles pre activation has been demonstrated. These results suggest that cognition is involved in urinary continence's physiological mechanisms. So it seamed to be interesting to study the impact of a double task rehabilitation (cognitive and muscular) on the urinary continence's neuromuscular mechanisms in case of diversion of attention. It was a randomized trial including two groups of healthy volunteers: one group had double task rehabilitation during 15 days, the other had no rehabilitation. After 15 days rehabilitation, in the rehabilitation's group, the attention deficit's correction restored the resistive abilities of UI in case of attention hijacking. According to the last AFU's (Association Française d'Urologie – Urology French Association) and CNGOF's (Collège national des gynécologues et obstétriciens français – French Gynecologists and Obstetricians National College) recommendations, the first intention treatment of urinary incontinence is pelvi-perineal rehabilitation. Pelvi-perineal rehabilitation conducted by a therapist is multimodal with different facets: a cognitive part (education, pelvic floor realization), a behavioral part of bladder training (modification of micturition habits), a muscle building part (voluntary contractions against resistance with and without biofeedback and electrosimulation), and also a postural work part (balance and pelvis position). Perineal rehabilitation technics' heterogeneity and the lack of description of these technics let the professionals adapt their rehabilitation's protocols. The objective of this study is to compare the results of two rehabilitation's technics in urinary incontinent patients. Methodology, study population, previous studies and feasibility Study population: The population is made of voluntary incontinent women. Inclusion criteria are the followings: Major women with stress urinary incontinence or mixed urinary incontinence or urge urinary incontinence, in need to benefit from perineal rehabilitation or cognitive-behavioral rehabilitation, women able to read, understand, accept and sign the consent. Exclusion criteria are the following: pregnant women, refusal to participate, dementia and cognitive troubles (Mini Mental State score: MMS <30). Participants will be subjects to a medical statement (antecedents, age, weight, size, UDI6 (Urogenital Distress Inventory) questioner, Contilife and Wexner scores). The absence of a mental deficit will be verifies by Mini Mental Status questioner (MMS). Ethical considerations: A "CPP" (comité de protection des personnes – persons' protection comity) have been requested and obtained for this study (N° cpp17-065a/2016-A01651-50). An information letter will be delivered to the volunteers, who will be included only after the acceptation and signature of the written consent. Volunteers' randomization: Participants will be randomized in two groups (1/1) with data processing software at the first visit at the therapist practicing the perineal rehabilitation. The first group will receive "Classical" perineal rehabilitation for duration of height weeks. The second group will receive perineal rehabilitation associated with a double task cognitive therapy for a duration of height weeks. Participants will be evaluated during the consultation. Initial evaluation of volunteers: initial evaluation will consist of an interrogation able to check the participants' antecedents and characteristics, urinary incontinence symptoms (quality life score (Contilife) and severity score (International Consultation on Incontinence Questionnaire Short Form: ICIQ-SF), Urinary Handicap Measurement (MHU – Mesure du Handicap Urinaire) and also clinical examination (Pelvic Organ Prolaps Quantification: POP-Q, Ulmsten Test, levator Testing among Oxford, ureteral mobility). In a second time, the EMG analysis will be realized. It consists in the analysis of the CLT impact on the voluntary and unvoluntary perineal contraction. The CLT used is Paced Auditory Serial addition Test (PASAT). Test arrangements are the followings: The volunteer will listen to an audiotape on witch is recorded a 61 random numbers set inconstant from 1 to 9 (for example "1, 9, 4, 5…"). The volunteer patient will have to add each pair of number in order to add the number with the previous and speak verbally the response. To test the willingly perineal contraction, the volunteer will be in a sitting position with her arms on the armrests. The practitioner will position the two electrodes with self-adhesive surface from either side of the volunteer's anus regarding to the EAS muscle. These electrodes are usually used in a setting of classical evaluation with biofeedback or electro simulation. An order will be given to the volunteer in order to contract perineal muscles when she feels a stimulus on the left wrist (an electric reflex hammer regarding to the median nerve on the inside of the left wrist). The volunteer women will have to repeat the experience in two conditions: with and without the CLT. Different settings measurement will be realized: time limit for the perineal contraction reaction (RT), that is latency between stimulus and begins of AES's EMG activity increase. The other settings will be the RT max (latency between stimulus and maximum AES's EMG activity), maximum AES's EMG activity and air under the curve for the AES's EMG activity. Volunteer's perineal contraction (following coughing instruction) will also be evaluated with and without CLT. The coughing instruction will be ordered by an impulse (Reflex hammer) on the inside of the left wrist. Two more self-adhesive detection electrodes will be glued regarding the external intercostal muscles (7th right space). Principal data analyzed will be: latency between stimulus and perineal muscles (RT1) and latency between intercostal muscles and perineal muscles (RT3). The data set will be collected using a Biopac ®, Acknowledge ®. Classical perineal rehabilitation protocol Participants will benefit from two-phases perineal rehabilitation: first phase pelvic floor muscles (PFM)'s analytic rehabilitation, then a functional rehabilitation. First phase will include the PFM's awareness and voluntary contraction learning with manual, biofeedback technics and functional electro stimulation (FES). Then, therapist will propose PFM's reinforcement under the PERFECT method (Pressure, Endurance, rapid Contraction, time measurement between each contraction sequence). These exercises will call out the manual rehabilitation technics (voluntary contraction learning, pelvic anatomy), biofeedback and electro stimulation. Electro stimulation and biofeedback will necessit the use of an electrode that serves to the electromyographic measurement with and without cognitive load test. Each classical rehabilitation session will take 30 minutes with 20 minutes of active working, twice per week. About the self-training, there will be no consensus for optimal homemade exercises, neither on the number, nor on the duration. The different authors describe very different types of protocols. The self-training program will be set up as soon as the participant will be able to realize, under therapist's manual control, a voluntary analytic contraction without synergy or command reversion. Exercises' number and characteristic will be given according to the PERFECT Scheme. For the second phase, the participant will hold a micturition calendar. With the noticed elements, a behavior analyze will be summarized in order to update the favoring situations and inappropriate situations. The objective will be the learning of perineal locking and reinstatement of anticipative postural activity for stress urinary incontinence. The strategy put in place will be organized in unlearning of deleterious perineal habits and learning new behavior program. The functional training program will be made of activation of PFM's voluntary contractions during different stains of every day life; the main goal being the perineal locking set up (PFM's voluntary contraction associated with a good abdominal and perineal synergy), this locking must be systematic before and during efforts like carrying loads, trimming, coughing. During the second phase, the physiotherapist will twice weekly perform evaluations. These evaluations are similar to those in the first phase. Cognitive associated rehabilitation protocol: Added to the classic perineal muscular rehabilitation, the cognitive associated rehabilitation group randomized participants will have to execute twice a day the rehabilitation protocol. Each cognitive rehabilitation session will take three minutes. Participants will have to synergistically execute attentional tests (N-Back Test) and execute a perineal contraction during the contraction instructions. (10 randomized auditory stimuli in three minutes). The attentional tests' difficulty will be gradually increased each 15 days. N-Back Test modalities are the followings: the participant will visualize a series of random numbers. First difficulty step will be to click the dedicated button when the volunteer will see the indicated letter. The second difficulty step will be to click the dedicated button when she will see two consecutives times the same letter. The third difficulty step will be to click the dedicated button when she will see two times the same letter separated by one different letter, and so on… The data will be saved on the digital application. Methodology: Participants will consult twice per week their therapist. An intermediary clinical and EMG recording will be done in the fourth week to evaluate the evolution of symptoms and EMG's criteria, with the same arrangements as those of the first evaluation. Participants' final evaluation: During the last visit in the eighth week, participants will be evaluated with same arrangements as those of the first evaluation. Judgment criteria: About the involuntary perineal contraction study, the principal judgment criteria will be the latency between intercostal muscles contraction and perineal muscles contraction (RT3). Secondary judgment criteria will be: latency between stimulus and perineal muscles contraction (RT1) for the voluntary perineal contraction study, MHU score obtained (Mesure du Handicap Urinaire – urinary handicap score), ICIQ (International Consultation on Incontinence Questionnaire), Contilife. Statistic analysis: Descriptive data will be expressed in the form of median and interquartile gap. The Wilcoxon Test will be used to compare quantitative values before and after rehabilitation, and Student Test to compare quantitative values between "classical perineal rehabilitation" group and "perineal rehabilitation + cognitive therapy" group. According to the literature, middle RT3 is -60ms, expected difference after rehabilitation is 16,66ms and known standard deviation is 18,7ms. For an alpha risk 5% and power 80%, it is necessary to include 20 participants by group, whether total of 40 participants. |
Conditions
Sequence: | 52208565 | Sequence: | 52208566 |
Name | Urinary Incontinence, Stress | Name | Urinary Incontinence, Urge |
Downcase Name | urinary incontinence, stress | Downcase Name | urinary incontinence, urge |
Id Information
Sequence: | 40186480 |
Id Source | org_study_id |
Id Value | cpp17-065a/2016-A01651-50 |
Design Groups
Sequence: | 55635177 | Sequence: | 55635178 |
Group Type | Active Comparator | Group Type | Experimental |
Title | Classical rehabilitation | Title | Classical and cognitive associated rehabilitation |
Description | Twenty women will benefit from two-phases perineal rehabilitation: first phase pelvic floor muscles (PFM)'s analytic rehabilitation, then a functional rehabilitation. | Description | Twenty women will receive, added to the classic perineal rehabilitation, the cognitive rehabilitation and will have to execute twice a day the rehabilitation protocol. |
Interventions
Sequence: | 52522510 | Sequence: | 52522511 |
Intervention Type | Other | Intervention Type | Behavioral |
Name | Classical rehabilitation | Name | Cognitive associated rehabilitation |
Description | Participants will benefit from two-phases perineal rehabilitation:
First phase will include the PFM's awareness and voluntary contraction learning with manual, biofeedback technics and functional electro stimulation. These exercises will call out the manual rehabilitation technics, biofeedback and electro stimulation. Each classical rehabilitation session will take 30 minutes with 20 minutes of active working, twice per week. About the self-training, there will be no consensus for optimal homemade exercises. For the second phase, a behavior analyze will be summarized in order to update the favoring and inappropriate situations. The strategy put in place will be organized in unlearning of deleterious perineal habits and learning new behavior program. The main goal will be the perineal locking set up, which must be systematic before and during efforts. During this phase, the physiotherapist will twice weekly perform evaluations (similar to those in the first phase) |
Description | The cognitive associated rehabilitation group randomized participants will have to execute twice a day the rehabilitation protocol. Each cognitive rehabilitation session will take three minutes. Participants will have to synergistically execute attentional tests (N-Back Test) and execute a perineal contraction during the contraction instructions. (10 randomized auditory stimuli in three minutes). The attentional tests' difficulty will be gradually increased each 15 days. N-Back Test modalities are the followings: the participant will visualize a series of random numbers. First difficulty step will be to click the dedicated button when the volunteer will see the indicated letter. The second difficulty step will be to click the dedicated button when she will see two consecutives times the same letter. The third difficulty step will be to click the dedicated button when she will see two times the same letter separated by one different letter, and so on… |
Design Outcomes
Sequence: | 177512962 | Sequence: | 177512963 | Sequence: | 177512964 | Sequence: | 177512965 | Sequence: | 177512966 | Sequence: | 177512967 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | RT3 – EMG Latency between intercostal muscles contraction and perineal muscles contraction | Measure | RT3 – EMG Latency between intercostal muscles contraction and perineal muscles | Measure | RT1 – EMG Latency between stimulus and perineal muscles contraction | Measure | Urinary Handicap Measurement (Mesure du Handicap Urinaire – MHU) | Measure | International Consultation on Incontinence Questionnaire (ICIQ-SF) | Measure | Questionnaire for assessment of quality of life related to women urinary incontinence (Contilife) |
Time Frame | Final evaluation at the eighth week follow up | Time Frame | Intermediary evaluation at the fourth week follow up | Time Frame | Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up | Time Frame | Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up | Time Frame | Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up | Time Frame | Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up |
Description | EMG Latency between intercostal muscles contraction and perineal muscles contraction | Description | EMG Latency between intercostal muscles contraction and perineal muscles contraction | Description | EMG Latency between stimulus and perineal muscles contraction | Description | Urinary Handicap Measurement is a quantitative measurement of different urinary symptoms, with 7 different questions, each response is associated to a value from 0 to 4, and with a final score from 0 (lowest score, no symptoms of urinary incontinence) to 28 (Higher score, maximum urinary incontinence symptoms). | Description | The ICIQ SF is a subjective measurement of severity of urinary loss and quality of life for those with urinary incontinence. It has 4 main items (of 6 total) ask for rating of symptoms in the past 4 weeks. The actual score takes sum score of items 3+4+5 (items 1 and 2 are demographic). The final item (6) is self diagnostic item that is unscored.
Final score is from 0 (lowest score, no symptoms of urinary incontinence), to 21 (Higher score, maximum urinary incontinence symptoms). |
Description | Auto survey of 28 questions for the quality of life related to the women with urinary incontinence. There are 6 main subjects related to quality of life, and each question has a score from 0 or 1 to 5. The final score is Final score is from 23 (lowest score, no impact of urinary incontinence on quality of life), to 140 (Higher score, maximum impact of urinary incontinence on quality of life). |
Browse Conditions
Sequence: | 193628870 | Sequence: | 193628871 | Sequence: | 193628872 | Sequence: | 193628873 | Sequence: | 193628874 | Sequence: | 193628875 | Sequence: | 193628876 | Sequence: | 193628877 | Sequence: | 193628878 | Sequence: | 193628879 | Sequence: | 193628880 | Sequence: | 193628881 | Sequence: | 193628882 | Sequence: | 193628883 | Sequence: | 193628884 |
Mesh Term | Urinary Incontinence | Mesh Term | Enuresis | Mesh Term | Urinary Incontinence, Stress | Mesh Term | Urinary Incontinence, Urge | Mesh Term | Urination Disorders | Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Male Urogenital Diseases | Mesh Term | Lower Urinary Tract Symptoms | Mesh Term | Urological Manifestations | Mesh Term | Behavioral Symptoms | Mesh Term | Elimination Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | urinary incontinence | Downcase Mesh Term | enuresis | Downcase Mesh Term | urinary incontinence, stress | Downcase Mesh Term | urinary incontinence, urge | Downcase Mesh Term | urination disorders | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | male urogenital diseases | Downcase Mesh Term | lower urinary tract symptoms | Downcase Mesh Term | urological manifestations | Downcase Mesh Term | behavioral symptoms | Downcase Mesh Term | elimination disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48354170 | Sequence: | 48354171 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Pierre and Marie Curie University | Name | APHP |
Overall Officials
Sequence: | 29306234 | Sequence: | 29306235 |
Role | Principal Investigator | Role | Study Chair |
Name | Thibault THUBERT, MD | Name | Pierre-André MAL, resident |
Affiliation | CHU Hotel Dieu Nantes | Affiliation | CHU Hopital Tenon APHP |
Central Contacts
Sequence: | 12017337 | Sequence: | 12017338 |
Contact Type | primary | Contact Type | backup |
Name | Thibault THUBERT, MD | Name | Pierre-André MAL, resident |
Phone | +33647697800 | Phone | +33659363500 |
Thibault.thubert@chu-nantes.fr | malpierreandre@gmail.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68199784 | Sequence: | 68199785 |
Design Group Id | 55635177 | Design Group Id | 55635178 |
Intervention Id | 52522510 | Intervention Id | 52522511 |
Eligibilities
Sequence: | 30787141 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 80 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Major women with stress urinary incontinence or mixed urinary incontinence or urge urinary incontinence, in need to benefit from perineal rehabilitation or cognitive-behavioral rehabilitation Exclusion Criteria: Pregnant women, |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253990097 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30533211 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | This study is a controlled randomized single blind multicentric study on a sample of 40 women stress or mixed urinary incontinent. Participants will be randomized in two groups with a 1/1 ratio with data processing software at the first visit at the therapist practicing the perineal rehabilitation. The first group will receive "Classical" perineal rehabilitation for duration of height weeks. The second group will receive perineal rehabilitation associated to a double task cognitive therapy for duration of height weeks. Participants will be evaluated during the consultation. |
Responsible Parties
Sequence: | 28899503 |
Responsible Party Type | Principal Investigator |
Name | Thubert Thibault |
Title | Principal Investigator, Medical Doctor of Gynecology |
Affiliation | Pierre and Marie Curie University |
Study References
Sequence: | 52103548 | Sequence: | 52103549 | Sequence: | 52103550 | Sequence: | 52103551 | Sequence: | 52103552 | Sequence: | 52103553 | Sequence: | 52103554 | Sequence: | 52103555 | Sequence: | 52103556 | Sequence: | 52103557 | Sequence: | 52103558 | Sequence: | 52103559 | Sequence: | 52103560 |
Pmid | 11494188 | Pmid | 15592060 | Pmid | 17934686 | Pmid | 20236751 | Pmid | 22999088 | Pmid | 19214996 | Pmid | 10813117 | Pmid | 2265941 | Pmid | 26451967 | Pmid | 24519688 | Pmid | 27794195 | Pmid | 17905093 | Pmid | 17803192 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result |
Citation | Sapsford RR, Hodges PW. Contraction of the pelvic floor muscles during abdominal maneuvers. Arch Phys Med Rehabil. 2001 Aug;82(8):1081-8. doi: 10.1053/apmr.2001.24297. | Citation | Amarenco G, Ismael SS, Lagauche D, Raibaut P, Rene-Corail P, Wolff N, Thoumie P, Haab F. Cough anal reflex: strict relationship between intravesical pressure and pelvic floor muscle electromyographic activity during cough. Urodynamic and electrophysiological study. J Urol. 2005 Jan;173(1):149-52. doi: 10.1097/01.ju.0000147305.00443.df. | Citation | Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. External intercostal muscles and external anal sphincter electromyographic activity during coughing. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Apr;19(4):521-4. doi: 10.1007/s00192-007-0473-y. Epub 2007 Oct 13. | Citation | Fritel X, Fauconnier A, Bader G, Cosson M, Debodinance P, Deffieux X, Denys P, Dompeyre P, Faltin D, Fatton B, Haab F, Hermieux JF, Kerdraon J, Mares P, Mellier G, Michel-Laaengh N, Nadeau C, Robain G, de Tayrac R, Jacquetin B; French College of Gynaecologists and Obstetricians. Diagnosis and management of adult female stress urinary incontinence: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians. Eur J Obstet Gynecol Reprod Biol. 2010 Jul;151(1):14-9. doi: 10.1016/j.ejogrb.2010.02.041. Epub 2010 Mar 16. | Citation | Hermieu JF, Denys P, Fritel X. [Critical review of guidelines for female urinary incontinence diagnosis and treatment]. Prog Urol. 2012 Oct;22(11):636-43. doi: 10.1016/j.purol.2012.08.004. Epub 2012 Sep 10. French. | Citation | Klovning A, Avery K, Sandvik H, Hunskaar S. Comparison of two questionnaires for assessing the severity of urinary incontinence: The ICIQ-UI SF versus the incontinence severity index. Neurourol Urodyn. 2009;28(5):411-5. doi: 10.1002/nau.20674. | Citation | Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236. | Citation | Horton AM Jr, Alana S. Validation of the Mini-Mental State Examination. Int J Neurosci. 1990 Aug;53(2-4):209-12. doi: 10.3109/00207459008986604. | Citation | Thubert T, Villot A, Billecocq S, Auclair L, Amarenco G, Deffieux X. Influence of a distraction task on the involuntary reflex contraction of the pelvic floor muscles following cough. Neurourol Urodyn. 2017 Jan;36(1):160-165. doi: 10.1002/nau.22903. Epub 2015 Oct 9. | Citation | Thubert T, Deffieux X, Jousse M, Guinet-Lacoste A, Ismael SS, Amarenco G. Influence of a distraction task on pelvic floor muscle contraction. Neurourol Urodyn. 2015 Feb;34(2):139-43. doi: 10.1002/nau.22524. Epub 2014 Feb 12. | Citation | Villot A, Deffieux X, Billecocq S, Auclair L, Amarenco G, Thubert T. Influence of cognitive rehabilitation on pelvic floor muscle contraction: A randomized controlled trial. Neurourol Urodyn. 2017 Aug;36(6):1636-1644. doi: 10.1002/nau.23169. Epub 2016 Oct 29. | Citation | Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Pelvic floor muscle activity during coughing: altered pattern in women with stress urinary incontinence. Urology. 2007 Sep;70(3):443-7; discussion 447-8. doi: 10.1016/j.urology.2007.03.084. | Citation | Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Abnormal pelvic response to cough in women with stress urinary incontinence. Neurourol Urodyn. 2008;27(4):291-6. doi: 10.1002/nau.20506. |
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https://zephyrnet.com/NCT03797352
2019-01-31
https://zephyrnet.com/?p=NCT03797352
NCT03797352https://www.clinicaltrials.gov/study/NCT03797352?tab=tableAssociate Professor Reshma Merchant, MDreshmaa@nuhs.edu.sg67795555Certain clinical syndromes eg frailty, sarcopenia, dementia, depression, cognitive impairment, vision impairment, falls in older adults carry an increased risk for poor health outcomes and if identified early, can be prevented, delayed or reversible. There is evidence to suggest that exercise and dietary intervention can help delay or prevent sarcopenia, frailty and dementia. Through early screening and detection of frailty and cognitive impairment, the investigators will be able to identify participants at risk of future physical or mental decline in primary care setting and ambulatory care clinics. Those prefrail, frail but ambulant with / without cognitive impairment will be randomised to dual task exercise with/without cognitive stimulation therapy and health education. The main hypothesis is that the combination of multicomponent group exercise activities and dual task exercise is effective in reversing frailty and improving cognition.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-01 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | January 2019 |
Primary Completion Month Year | May 2021 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Detailed Descriptions
Sequence: | 20721684 |
Description | Major challenges in the Singapore healthcare landscape include a rapidly aging population, due to rising life expectancy at birth combined with declining total fertility, and an epidemiological transition in the main source of disease burden from communicable and infectious conditions to non-communicable, chronic conditions. While acute care will always remain a crucial component of healthcare delivery systems, the increased healthcare burden centered on chronic diseases and the concomitant aging population is putting increased strain on healthcare resources. Frailty is reversible and progression to dementia can be delayed. From most recent study, prevalence of pre-frailty is 37% and mild cognitive impairment about 15-20%. WHO's definition of healthy ageing is maintaining functional ability. Cognicise, a dual task exercise has shown to delay decline in cognition and there are many studies which shows aerobic exercise improves endurance. Patients seen in Geriatric, Medicine Clinic or polyclinics who are prefrail, frail but ambulant with / without cognitive impairment will be randomised to dual task exercise with/without cognitive stimulation therapy and health education. In addition, high protein diet has been shown to improve muscle protein synthesis. Therefore, the aims of the study are to assess: a) Assess the effectiveness of dual task exercise with/without cognitive stimulation therapy b) Effect of health education alone for delaying the progression to dementia and mobility decline c) Assess impact of exercise on inflammatory and bone health biomarkers eg IL, TNF, Osteocalcin, sclerostin and C telopeptide in a subgroup of older adults randomly selected. |
Conditions
Sequence: | 52171373 |
Name | Frail Elderly Syndrome |
Downcase Name | frail elderly syndrome |
Id Information
Sequence: | 40158712 |
Id Source | org_study_id |
Id Value | 2108/11 |
Design Groups
Sequence: | 55593303 | Sequence: | 55593304 |
Group Type | No Intervention | Group Type | Experimental |
Title | Control | Title | Intervention |
Description | Receive healthy ageing advice every 3 months for the duration of 12 months | Description | To participate in supervised Multicomponent exercise (combined exercise and cognitive activity) up to three times a week for 6 months and receive healthy ageing advice |
Interventions
Sequence: | 52485597 |
Intervention Type | Other |
Name | Multicomponent exercise |
Description | To identify frailty and other potential health issues, and determine if Multicomponent exercise helps at-risk elderly to have better health outcomes. |
Keywords
Sequence: | 79868738 | Sequence: | 79868739 | Sequence: | 79868740 | Sequence: | 79868741 |
Name | Bone Health | Name | Cognitive Decline | Name | Health Education | Name | Mobility Decline |
Downcase Name | bone health | Downcase Name | cognitive decline | Downcase Name | health education | Downcase Name | mobility decline |
Design Outcomes
Sequence: | 177379284 | Sequence: | 177379285 | Sequence: | 177379286 | Sequence: | 177379287 | Sequence: | 177379288 | Sequence: | 177379289 | Sequence: | 177379290 | Sequence: | 177379291 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Changes in frailty status | Measure | Functional improvement | Measure | Upper extremity strength | Measure | Reduction of prevalence of depression | Measure | reduction in social isolation | Measure | Improved quality of life | Measure | Improved cognition | Measure | Improved cognition |
Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year |
Description | Changes in frailty status by 5-item FRAIL scale Scale range from 0 to 5, the higher the value, the more frail (3 or greater = frailty; 1 or 2 = prefrail) | Description | Changes in short physical performance battery (SPPB) summary score 3 subscales (range from 0 to 4 for balance, gait speed and chair stand) summed to give total score range from 0 to 12. The higher the value, the better the performance of lower extremity. | Description | Changes in handgrip strength test performance (kg) | Description | Changes in Geriatric Depression Scale (GDS) Scale range from 0 to 15, the higher the score, the greater the likelihood of depression. A score > 5 points is suggestive of depression, a score ≥ 10 points is almost always indicative of depression | Description | Changes in Lubben Social Network Scale (LSNS-6). Scale range from 0 to 30, the lower the value, the more likelihood of social isolation, A score of 12 and lower delineates "at-risk" for social isolation | Description | Changes in EuroQoL-5D (EQ5D) score 5 subscales (1 to 5): Mobility, self-care, usual activities, pain/discomfort, anxiety/depressed Each subscale assessed individually. | Description | Changes in Montreal Cognitive Assessment (MoCA), the scoring range from 0 to 30, the lower the scoring, the more likelihood of cognitive impairment. A score of 26 and higher is generally considered normal. | Description | Changes in Mini Mental State Examination (MMSE) score 5 subscales: Orientation (0 to 10), Registration (0 to 3), Attention and Calculation (0 to 5), Recall (0 to 3), Language and Praxis (0 to 9). Total scale range from 0 to 30, the higher the value, the less cognitive impairment. A score of 23 or lower is indicative of cognitive impairment. |
Sponsors
Sequence: | 48319407 | Sequence: | 48319408 |
Agency Class | OTHER | Agency Class | OTHER_GOV |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | National University Hospital, Singapore | Name | National Medical Research Council (NMRC), Singapore |
Overall Officials
Sequence: | 29285416 |
Role | Principal Investigator |
Name | Associate Professor Reshma Merchant, MD |
Affiliation | National University Hospital, Singapore |
Central Contacts
Sequence: | 12008912 |
Contact Type | primary |
Name | Associate Professor Reshma Merchant, MD |
Phone | 67795555 |
reshmaa@nuhs.edu.sg | |
Role | Contact |
Design Group Interventions
Sequence: | 68149275 |
Design Group Id | 55593304 |
Intervention Id | 52485597 |
Eligibilities
Sequence: | 30765421 |
Gender | All |
Minimum Age | 65 Years |
Maximum Age | 120 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Pre frail or frail but ambulant (Frail scale score of at least 1) Exclusion Criteria: Unable to give consent personally |
Adult | False |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253889357 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 65 |
Maximum Age Num | 120 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30511587 |
Allocation | Randomized |
Intervention Model | Factorial Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Investigator Masked | True |
Responsible Parties
Sequence: | 28877882 |
Responsible Party Type | Principal Investigator |
Name | Medicine |
Title | Head & Senior Consultant, Division of Geriatric Medicine |
Affiliation | National University Hospital, Singapore |
]]>
https://zephyrnet.com/NCT03797339
2017-07-01
https://zephyrnet.com/?p=NCT03797339
NCT03797339https://www.clinicaltrials.gov/study/NCT03797339?tab=tableJuer Liu, masterliujesysu@163.com13430267895This study aimed to explore underlying mechanisms of individual differences in drugs for coronary heart disease treatment and its association with adverse consequences. It will enroll approximately 4000 coronal heart disease patients aged between 18 and 80 years in mainland China and follow-up for at least 1 years. Questionnaires, anthropometric measures, laboratory tests, and biomaterials will be collected . The principal clinical outcomes of the study consist of ischemia attack , cardiac death, renal injury,and myotoxic activity.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-05 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-02-12 |
Start Month Year | July 1, 2017 |
Primary Completion Month Year | December 31, 2019 |
Verification Month Year | February 2019 |
Verification Date | 2019-02-28 |
Last Update Posted Date | 2019-02-12 |
Detailed Descriptions
Sequence: | 20741285 |
Description | The study is a multicenter prospective cohort study, aimed to explore underlying mechanisms of individual differences in drugs for coronary heart disease treatment and its association with adverse consequences.The genomic genotype, DNA methylation and metabolome of 1000 patients with coronary heart disease were determined using illumina high-density genotyping chip, high-throughput sequencing and high-resolution mass spectrometry. Blood exposures of statins and metoprolol and its metabolites was determined by UPLC-MS/MS.
The biological network using cross-omics analysis was reconstructed to identify potential causative key genes, bacteria, and endogenous metabolite targets that cause differences in individual responses. A machine identification algorithm selecting clinical factors and multi-omics targets was used to establish a predictive mathematical model. A multi-center clinical cohort of 3000 coronal heart disease patients was used to verify the effects of various levels of omic targets on drug blood exposures, efficacy and toxic side effects. A comprehensive model based on multi-target combination of individualized drugs was constructed, and the predictive effect was clinically analyzed. |
Facilities
Sequence: | 200280929 | Sequence: | 200280930 | Sequence: | 200280931 | Sequence: | 200280932 | Sequence: | 200280933 |
Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting |
Name | Guangdong General Hospital | Name | The First Affiliated Hospital of Sun Yat-sen University | Name | XiangYa Hospital Central South University | Name | Renji Hospital Affiliated to Shanghai Jiaotong University | Name | West China Hospital, Sichuan University |
City | Guangzhou | City | Guangzhou | City | Changsha | City | Shanghai | City | Chengdu |
State | Guangdong | State | Guangdong | State | Hunan | State | Shanghai | State | Sichuan |
Zip | 510080 | Zip | 510080 | Zip | 410008 | Zip | 200233 | Zip | 610041 |
Country | China | Country | China | Country | China | Country | China | Country | China |
Facility Contacts
Sequence: | 28132948 | Sequence: | 28132949 | Sequence: | 28132950 | Sequence: | 28132951 | Sequence: | 28132952 |
Facility Id | 200280929 | Facility Id | 200280930 | Facility Id | 200280931 | Facility Id | 200280932 | Facility Id | 200280933 |
Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary |
Name | Shilong Zhong, Ph.D | Name | Chen Liu, MD, PhD | Name | Qilin Ma, MD | Name | Linghong Shen, MD, PhD | Name | Liang Ouyang, PhD |
zhongsl@hotmail.com | chenliu81@hotmail.com | mqilin2004@163.com | drshenlinghong@126.com | ouyangliang@scu.edu.cn | |||||
Phone | 8618620819696 | Phone | 8615013270269 | Phone | 86731-84327203 | Phone | 8613916495713 | Phone | 8613880674611 |
Conditions
Sequence: | 52221814 |
Name | Coronary Heart Disease |
Downcase Name | coronary heart disease |
Id Information
Sequence: | 40195828 |
Id Source | org_study_id |
Id Value | 2017YFC0909301 |
Countries
Sequence: | 42609804 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55650109 | Sequence: | 55650110 |
Title | Discovery cohort | Title | Validation corhort |
Description | 1000 cases of coronary heart disease follow-up cohort was used for multi-omics target discovery.During the follow-up period, the information about the occurrence and risk factors of adverse cardiovascular events will be collected. | Description | 3000 coronary heart disease follow-up cohorts was used for validating the results from the discovery corhort. During the follow-up period, the occurrence and risk factors of adverse cardiovascular events.Predictive mathematical models based on multi-omics combination will be constructed finally. |
Interventions
Sequence: | 52535611 | Sequence: | 52535612 | Sequence: | 52535613 | Sequence: | 52535614 |
Intervention Type | Other | Intervention Type | Other | Intervention Type | Other | Intervention Type | Other |
Name | risk factors of adverse cardiovascular events | Name | multi-omics target discovery | Name | validation | Name | Predictive mathematical models |
Description | During the follow-up period,general information(age, sex, BMI, blood pressure, the history of drink and smoke, medical history, etc).Blood biochemistry parameters(Lipid, hsCRP levels, etc)and other laboratory examination parameters will be collected | Description | Genome-wide genotype , DNA methylation and metabolomes were determined using illumina high-density genotyping chips, high-throughput sequencing, and high-resolution mass spectrometry respectly. Blood exposure of statins and metoprolol and its metabolites was determined by UPLC-MS/MS. | Description | The genome-wide genotype of patients with coronary heart disease was detected using the illumina chip. The methylation level of the functional region was detected by the target region enrichment methylation sequencing method. Intestinal flora differences were detected using 16SrDNA high-throughput sequencing. | Description | Machine learning algorithms such as multiple linear regression or Bayesian classification are used to optimize clinical factors and multi-group targets to establish predictive mathematical models. |
Keywords
Sequence: | 79942136 | Sequence: | 79942137 | Sequence: | 79942138 | Sequence: | 79942139 | Sequence: | 79942140 | Sequence: | 79942141 |
Name | epigenome | Name | metabolome | Name | microbiome | Name | genome | Name | multi-omics targets | Name | individual drug use |
Downcase Name | epigenome | Downcase Name | metabolome | Downcase Name | microbiome | Downcase Name | genome | Downcase Name | multi-omics targets | Downcase Name | individual drug use |
Design Outcomes
Sequence: | 177562364 | Sequence: | 177562365 | Sequence: | 177562366 | Sequence: | 177562367 | Sequence: | 177562368 | Sequence: | 177562369 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other |
Measure | Death | Measure | MACE | Measure | Bleeding | Measure | Statin-induced myopathy (SIM) | Measure | CI-AKI | Measure | SYNTAX score |
Time Frame | from date of baseline examination until the date of first documented death,up to 48 months | Time Frame | from date of baseline examination until the date of first documented cardiovascular events,up to 48 months | Time Frame | from date of baseline examination until the date of first documented bleeding,up to 48 months | Time Frame | from date of baseline examination until the date of first documented SIM,up to 48 months | Time Frame | more than 6 h within 48 h after Coronary Angiography | Time Frame | more than 6 h within 48 h after Coronary Angiography |
Description | All-cause death | Description | MACE was defined as the occurrence of cardiac death, nonfatal myocardial infarctions, coronary revascularisation and cerebral infraction. | Description | Bleeding was the six-month incidence of combined alarming, internal, and nuisance bleeding events defined according to Serebruany et al15. Alarming bleeding included bleeding requiring a transfusion, intracranial bleeding, and life-threatening bleeding. Internal bleeding included haematoma, epistaxis, blood loss from the mouth, vagina, melaena, eye bleed, haematuria, and haematemesis. Nuisance bleeding included easy bruising, bleeding from small cuts, petechiae, and ecchymosis. | Description | The definition of SIM from statin treatment was based on the patients' subjective sense of muscular pain as well as CK elevations. These muscular side effects included myalgia (muscle pain/ache without serum CK elevations), other muscle-related symptoms such as weakness, cramps, spasms, soreness and twitching, CK elevations without physical symptoms, myositis or other muscle symptoms with CK elevations, and rhabdomyolysis. | Description | CI-AKI was diagnosed if a patient had an absolute increase in serum creatinine (sCr) concentration ≥ 0.3 mg/dl (26.4 μmol/L) from baseline or a relative increase ≥ 50 % in sCr concentration for more than 6 h within 48 h after surgery | Description | It is mainly used for the treatment of left main coronary artery lesions and/or three-vessel lesions.Patients with a score of ≥33 are recommended for CABG. Patients with a score between 23 and 32 can choose either PCI or CABG. Patients with a score of ≤22 are recommended for PCI and CABG. |
Browse Conditions
Sequence: | 193679558 | Sequence: | 193679559 | Sequence: | 193679560 | Sequence: | 193679561 | Sequence: | 193679562 | Sequence: | 193679563 | Sequence: | 193679564 | Sequence: | 193679565 |
Mesh Term | Heart Diseases | Mesh Term | Coronary Disease | Mesh Term | Coronary Artery Disease | Mesh Term | Myocardial Ischemia | Mesh Term | Cardiovascular Diseases | Mesh Term | Vascular Diseases | Mesh Term | Arteriosclerosis | Mesh Term | Arterial Occlusive Diseases |
Downcase Mesh Term | heart diseases | Downcase Mesh Term | coronary disease | Downcase Mesh Term | coronary artery disease | Downcase Mesh Term | myocardial ischemia | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | arteriosclerosis | Downcase Mesh Term | arterial occlusive diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366677 | Sequence: | 48366678 | Sequence: | 48366679 | Sequence: | 48366680 | Sequence: | 48366681 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Guangdong Provincial People's Hospital | Name | RenJi Hospital | Name | West China Hospital | Name | Xiangya Hospital of Central South University | Name | First Affiliated Hospital, Sun Yat-Sen University |
Overall Officials
Sequence: | 29313039 |
Role | Principal Investigator |
Name | Shilong Zhong, Ph.D |
Affiliation | Guangdong Provincial People's Hospital |
Central Contacts
Sequence: | 12020651 | Sequence: | 12020652 |
Contact Type | primary | Contact Type | backup |
Name | Shilong Zhong, Ph.D | Name | Juer Liu, master |
Phone | 862083827812 | Phone | 13430267895 |
zhongsl@hotmail.com | liujesysu@163.com | ||
Phone Extension | 51157 | Phone Extension | 51157 |
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68217754 | Sequence: | 68217755 | Sequence: | 68217756 | Sequence: | 68217757 | Sequence: | 68217758 |
Design Group Id | 55650109 | Design Group Id | 55650110 | Design Group Id | 55650109 | Design Group Id | 55650110 | Design Group Id | 55650110 |
Intervention Id | 52535611 | Intervention Id | 52535611 | Intervention Id | 52535612 | Intervention Id | 52535613 | Intervention Id | 52535614 |
Eligibilities
Sequence: | 30794873 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 80 Years |
Healthy Volunteers | No |
Population | Chinese Han patients with coronary artery disease who have ingested metoprolol and statins were prospectively recruited from Guangdong General Hospital, Shanghai Jiao Tong University, Central South University, Sun Yat-sen University and Sichuan University. |
Criteria | Inclusion Criteria:
age: 18-80 years Exclusion Criteria: renal insufficiency (defined as serum creatinine concentration > 2 times the upper limit of normal [230 μmol/L], renal transplantation or dialysis) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004561 |
Number Of Facilities | 5 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30540913 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28907233 |
Responsible Party Type | Principal Investigator |
Name | ShiLong Zhong |
Title | Professor |
Affiliation | Guangdong Provincial People's Hospital |
]]>
https://zephyrnet.com/NCT03797326
2019-02-12
https://zephyrnet.com/?p=NCT03797326
NCT03797326https://www.clinicaltrials.gov/study/NCT03797326?tab=tableNANANAThe purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-08-22 |
Start Month Year | February 12, 2019 |
Primary Completion Month Year | December 22, 2023 |
Verification Month Year | August 2022 |
Verification Date | 2022-08-31 |
Last Update Posted Date | 2022-08-22 |
Facilities
Sequence: | 201025693 | Sequence: | 201025694 | Sequence: | 201025695 | Sequence: | 201025696 | Sequence: | 201025697 | Sequence: | 201025698 | Sequence: | 201025699 | Sequence: | 201025700 | Sequence: | 201025701 | Sequence: | 201025702 | Sequence: | 201025703 | Sequence: | 201025704 | Sequence: | 201025705 | Sequence: | 201025706 | Sequence: | 201025707 | Sequence: | 201025708 | Sequence: | 201025709 | Sequence: | 201025710 | Sequence: | 201025711 | Sequence: | 201025712 | Sequence: | 201025713 | Sequence: | 201025714 | Sequence: | 201025715 | Sequence: | 201025716 | Sequence: | 201025717 | Sequence: | 201025718 | Sequence: | 201025719 | Sequence: | 201025720 | Sequence: | 201025721 | Sequence: | 201025722 | Sequence: | 201025723 | Sequence: | 201025724 | Sequence: | 201025725 | Sequence: | 201025726 | Sequence: | 201025727 | Sequence: | 201025728 | Sequence: | 201025729 | Sequence: | 201025730 | Sequence: | 201025731 | Sequence: | 201025732 | Sequence: | 201025733 | Sequence: | 201025734 | Sequence: | 201025735 | Sequence: | 201025736 | Sequence: | 201025737 | Sequence: | 201025738 | Sequence: | 201025739 | Sequence: | 201025740 | Sequence: | 201025741 | Sequence: | 201025742 | Sequence: | 201025743 | Sequence: | 201025744 | Sequence: | 201025745 | Sequence: | 201025746 | Sequence: | 201025747 | Sequence: | 201025748 | Sequence: | 201025749 | Sequence: | 201025750 | Sequence: | 201025751 | Sequence: | 201025752 | Sequence: | 201025753 | Sequence: | 201025754 | Sequence: | 201025755 | Sequence: | 201025756 | Sequence: | 201025757 | Sequence: | 201025758 | Sequence: | 201025759 | Sequence: | 201025760 | Sequence: | 201025761 | Sequence: | 201025762 | Sequence: | 201025763 | Sequence: | 201025764 | Sequence: | 201025765 | Sequence: | 201025766 | Sequence: | 201025767 | Sequence: | 201025768 | Sequence: | 201025769 | Sequence: | 201025770 | Sequence: | 201025771 | Sequence: | 201025772 | Sequence: | 201025773 | Sequence: | 201025774 | Sequence: | 201025775 | Sequence: | 201025776 | Sequence: | 201025777 | Sequence: | 201025778 | Sequence: | 201025779 | Sequence: | 201025780 |
Name | City of Hope ( Site 0002) | Name | Cedars Sinai Medical Center ( Site 0003) | Name | University of California Davis Comprehensive Cancer Center ( Site 0005) | Name | University of Colorado, Anschutz Cancer Pavilion ( Site 0007) | Name | University of Florida-Health Cancer Center-Orlando ( Site 0015) | Name | Rutgers Cancer Institute of New Jersey ( Site 0009) | Name | Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0023) | Name | Sanford Fargo Medical Center ( Site 0059) | Name | Lehigh Valley Hospital- Cedar Crest ( Site 0047) | Name | Sanford Cancer Center ( Site 0058) | Name | West Cancer Center – East Campus ( Site 0018) | Name | Mary Crowley Cancer Research Centers – Medical City Hospital ( Site 0049) | Name | Swedish Medical Center ( Site 0021) | Name | University of Wisconsin Carbone Cancer Center ( Site 0017) | Name | Fundacion Favaloro para la Docencia e Investigacion Medica ( Site 2106) | Name | Hospital Aleman ( Site 2100) | Name | Hospital Britanico de Buenos Aires ( Site 2109) | Name | Instituto de Oncologia de Rosario ( Site 2105) | Name | CEMIC ( Site 2104) | Name | IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2101) | Name | Royal Brisbane and Women s Hospital ( Site 0901) | Name | Alfred Health ( Site 0902) | Name | Sir Charles Gairdner Hospital ( Site 0903) | Name | BC Cancer – Abbotsford ( Site 0200) | Name | CancerCare Manitoba ( Site 0201) | Name | Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0208) | Name | Sunnybrook Research Institute ( Site 0207) | Name | Princess Margaret Cancer Centre ( Site 0202) | Name | Centre Hospitalier de l Universite de Montreal – CHUM ( Site 0210) | Name | CHU de Quebec Universite de Laval ( Site 0206) | Name | Centro Investigación del Cáncer James Lind ( Site 1203) | Name | Fundacion Arturo Lopez Perez ( Site 1201) | Name | Pontificia Universidad Catolica de Chile ( Site 1202) | Name | Hospital Clinico Universidad de Chile ( Site 1200) | Name | Fundacion Colombiana de Cancerologia Clinica Vida ( Site 1105) | Name | Instituto Nacional de Cancerologia E.S.E ( Site 1102) | Name | Oncologos del Occidente S.A. ( Site 1106) | Name | Fundacion Valle del Lili ( Site 1101) | Name | Centre Antoine Lacassagne ( Site 0404) | Name | Centre Leon Berard ( Site 0405) | Name | Institut Claudius Regaud IUCT Oncopole ( Site 0403) | Name | Centre Oscar Lambret ( Site 0401) | Name | Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0402) | Name | Institut Gustave Roussy ( Site 0400) | Name | Robert Bosch GmbH ( Site 0307) | Name | Universitaetsklinikum Regensburg ( Site 0304) | Name | Universitaetsklinikum Frankfurt ( Site 0306) | Name | HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0301) | Name | SRH Wald-Klinikum Gera GmbH ( Site 0309) | Name | Universitaetsklinikum Jena ( Site 0302) | Name | Soroka Medical Center ( Site 0601) | Name | Rambam Medical Center ( Site 0602) | Name | Hadassah Ein Kerem Medical Center ( Site 0604) | Name | Chaim Sheba Medical Center ( Site 0600) | Name | Sourasky Medical Center ( Site 0603) | Name | Istituto Clinico Humanitas Research Hospital ( Site 1402) | Name | Policlinico Le Scotte – A.O. Senese ( Site 1401) | Name | Istituto Nazionale Tumori Fondazione Pascale ( Site 1400) | Name | Fondazione Policlinico Universitario A. Gemelli ( Site 1403) | Name | Asan Medical Center ( Site 1002) | Name | Seoul National University Hospital ( Site 1000) | Name | Severance Hospital Yonsei University Health System ( Site 1001) | Name | Arkhangelsk Clinical Oncological Dispensary ( Site 1600) | Name | Russian Oncological Research Center n.a. N.N. Blokhin ( Site 1604) | Name | Leningrad Regional Oncology Center ( Site 1609) | Name | Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1610) | Name | City Clinical Oncology Center ( Site 1608) | Name | Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1603) | Name | Hospital Clinic i Provincial ( Site 0703) | Name | Hospital Universitario Gregorio Maranon ( Site 0701) | Name | Clinica Universitaria de Navarra ( Site 0704) | Name | Hospital Ramon y Cajal ( Site 0702) | Name | Inselspital Universitaetsspital Bern ( Site 1705) | Name | Kantonsspital Graubuenden ( Site 1704) | Name | Kantonsspital St. Gallen ( Site 1702) | Name | Ospedale Regionale di Bellinzona e Valli ( Site 1703) | Name | Hopitaux Universitaires de Geneve HUG ( Site 1701) | Name | Universitaetsspital Zurich ( Site 1700) | Name | National Cheng Kung University Hospital ( Site 3003) | Name | National Taiwan University Hospital ( Site 3000) | Name | Chulalongkorn University ( Site 5001) | Name | Ramathibodi Hospital. ( Site 5002) | Name | Siriraj Hospital ( Site 5003) | Name | Cambridge University Hospitals NHS Trust ( Site 0803) | Name | Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 0804) | Name | Guy's Hospital ( Site 0806) | Name | Royal Marsden Hospital (Sutton) ( Site 0800) | Name | Christie NHS Foundation Trust ( Site 0805) |
City | Duarte | City | Los Angeles | City | Sacramento | City | Aurora | City | Orlando | City | New Brunswick | City | New York | City | Fargo | City | Allentown | City | Sioux Falls | City | Germantown | City | Dallas | City | Seattle | City | Madison | City | Ciudad Autonoma de Buenos Aires | City | Buenos Aires | City | Ciudad de Buenos Aires | City | Rosario | City | Buenos Aires | City | Caba | City | Herston | City | Melbourne | City | Nedlands | City | Abbotsford | City | Winnipeg | City | Hamilton | City | Toronto | City | Toronto | City | Montreal | City | Quebec | City | Temuco | City | Santiago | City | Santiago | City | Santiago | City | Medellin | City | Bogota | City | Pereira | City | Cali | City | Nice | City | Lyon | City | Toulouse | City | Lille | City | Saint-Herblain | City | Villejuif | City | Stuttgart | City | Regensburg | City | Frankfurt am Main | City | Wiesbaden | City | Gera | City | Jena | City | Beer Sheva | City | Haifa | City | Jerusalem | City | Ramat Gan | City | Tel Aviv | City | Rozzano | City | Siena | City | Napoli | City | Roma | City | Songpagu | City | Seoul | City | Seoul | City | Arkhangelsk | City | Moscow | City | Saint-Petersburg | City | Saint-Petersburg | City | Saint-Petersburg | City | Kazan | City | Barcelona | City | Madrid | City | Madrid | City | Madrid | City | Bern | City | Chur | City | St. Gallen | City | Bellinzona | City | Geneve | City | Zurich | City | Tainan | City | Taipei | City | Bangkok | City | Bangkok | City | Bangkok | City | Cambridge | City | Leicester | City | London | City | London | City | Manchester |
State | California | State | California | State | California | State | Colorado | State | Florida | State | New Jersey | State | New York | State | North Dakota | State | Pennsylvania | State | South Dakota | State | Tennessee | State | Texas | State | Washington | State | Wisconsin | State | Buenos Aires | State | Caba | State | Caba | State | Santa Fe | State | Queensland | State | Victoria | State | Western Australia | State | British Columbia | State | Manitoba | State | Ontario | State | Ontario | State | Ontario | State | Quebec | State | Araucania | State | Region M. De Santiago | State | Region M. De Santiago | State | Region M. De Santiago | State | Antioquia | State | Distrito Capital De Bogota | State | Risaralda | State | Valle Del Cauca | State | Alpes-Maritimes | State | Auvergne | State | Haute-Garonne | State | Nord | State | Val-de-Marne | State | Val-de-Marne | State | Baden-Wurttemberg | State | Bayern | State | Hessen | State | Hessen | State | Thuringen | State | Thuringen | State | Milano | State | Toscana | State | Seoul | State | Arkhangel Skaya Oblast | State | Moskva | State | Sankt-Peterburg | State | Sankt-Peterburg | State | Sankt-Peterburg | State | Tatarstan, Respublika | State | Berne | State | Grisons | State | Sankt Gallen | State | Ticino | State | Krung Thep Maha Nakhon | State | Krung Thep Maha Nakhon | State | Krung Thep Maha Nakhon | State | Cambridgeshire | State | Leicestershire | State | London, City Of | State | Surrey | ||||||||||||||||||||||||||||||||||||||||||
Zip | 91010 | Zip | 90048 | Zip | 95817 | Zip | 80045 | Zip | 32806 | Zip | 08901 | Zip | 10016 | Zip | 58102 | Zip | 18103 | Zip | 57104 | Zip | 38138 | Zip | 75230 | Zip | 98104 | Zip | 53792-0001 | Zip | C1078AAI | Zip | 1118 | Zip | C1280AEB | Zip | S2000KZE | Zip | C1431FWO | Zip | C1012AAR | Zip | 4029 | Zip | 3004 | Zip | 6009 | Zip | V2S 0C2 | Zip | R3E 0V9 | Zip | L8V 4X2 | Zip | M4N 3M5 | Zip | M5G 2M9 | Zip | H2X 3E4 | Zip | G1R 2J6 | Zip | 4780000 | Zip | 7500921 | Zip | 8330024 | Zip | 8380456 | Zip | 050030 | Zip | 110321 | Zip | 660001 | Zip | 760032 | Zip | 06189 | Zip | 69373 | Zip | 31059 | Zip | 59000 | Zip | 44805 | Zip | 94800 | Zip | 70376 | Zip | 93053 | Zip | 60528 | Zip | 65199 | Zip | 07548 | Zip | 07740 | Zip | 8457108 | Zip | 3109601 | Zip | 9112001 | Zip | 5262000 | Zip | 6423906 | Zip | 53100 | Zip | 80131 | Zip | 00168 | Zip | 05505 | Zip | 03080 | Zip | 03722 | Zip | 163045 | Zip | 115478 | Zip | 188663 | Zip | 197758 | Zip | 198255 | Zip | 420029 | Zip | 08036 | Zip | 28009 | Zip | 28027 | Zip | 28034 | Zip | 3010 | Zip | 7000 | Zip | 9007 | Zip | 6500 | Zip | 1211 | Zip | 8091 | Zip | 704 | Zip | 10002 | Zip | 10330 | Zip | 10400 | Zip | 10700 | Zip | CB2 0QQ | Zip | LE1 5WW | Zip | SE1 9RT | Zip | SM3 5PT | Zip | M20 4BX | ||
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | Argentina | Country | Argentina | Country | Argentina | Country | Argentina | Country | Argentina | Country | Argentina | Country | Australia | Country | Australia | Country | Australia | Country | Canada | Country | Canada | Country | Canada | Country | Canada | Country | Canada | Country | Canada | Country | Canada | Country | Chile | Country | Chile | Country | Chile | Country | Chile | Country | Colombia | Country | Colombia | Country | Colombia | Country | Colombia | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Israel | Country | Israel | Country | Israel | Country | Israel | Country | Israel | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Switzerland | Country | Switzerland | Country | Switzerland | Country | Switzerland | Country | Switzerland | Country | Switzerland | Country | Taiwan | Country | Taiwan | Country | Thailand | Country | Thailand | Country | Thailand | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom |
Browse Interventions
Sequence: | 96458967 | Sequence: | 96458968 | Sequence: | 96458969 | Sequence: | 96458970 | Sequence: | 96458971 | Sequence: | 96458972 | Sequence: | 96458973 | Sequence: | 96458974 |
Mesh Term | Pembrolizumab | Mesh Term | Lenvatinib | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Antineoplastic Agents | Mesh Term | Immune Checkpoint Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Protein Kinase Inhibitors | Mesh Term | Enzyme Inhibitors |
Downcase Mesh Term | pembrolizumab | Downcase Mesh Term | lenvatinib | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | immune checkpoint inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | protein kinase inhibitors | Downcase Mesh Term | enzyme inhibitors |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52429204 | Sequence: | 52429205 | Sequence: | 52429206 | Sequence: | 52429207 | Sequence: | 52429208 | Sequence: | 52429209 | Sequence: | 52429210 | Sequence: | 52429211 |
Name | Advanced Solid Tumors | Name | Triple Negative Breast Cancer | Name | Ovarian Cancer | Name | Gastric Cancer | Name | Colorectal Cancer | Name | Glioblastoma | Name | Biliary Tract Cancers | Name | Pancreatic Cancer |
Downcase Name | advanced solid tumors | Downcase Name | triple negative breast cancer | Downcase Name | ovarian cancer | Downcase Name | gastric cancer | Downcase Name | colorectal cancer | Downcase Name | glioblastoma | Downcase Name | biliary tract cancers | Downcase Name | pancreatic cancer |
Id Information
Sequence: | 40342086 | Sequence: | 40342087 | Sequence: | 40342088 | Sequence: | 40342089 | Sequence: | 40342090 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | 7902-005 | Id Value | MK-7902-005 | Id Value | E7080-G000-224 | Id Value | LEAP-005 | Id Value | 2018-003747-37 |
Id Type | Other Identifier | Id Type | Other Identifier | Id Type | Other Identifier | Id Type | EudraCT Number | ||
Id Type Description | Merck Protocol Number | Id Type Description | Eisai Protocol Number | Id Type Description | Merck | ||||
Countries
Sequence: | 42773650 | Sequence: | 42773651 | Sequence: | 42773652 | Sequence: | 42773653 | Sequence: | 42773654 | Sequence: | 42773655 | Sequence: | 42773656 | Sequence: | 42773657 | Sequence: | 42773658 | Sequence: | 42773659 | Sequence: | 42773660 | Sequence: | 42773661 | Sequence: | 42773662 | Sequence: | 42773663 | Sequence: | 42773664 | Sequence: | 42773665 | Sequence: | 42773666 |
Name | United States | Name | Argentina | Name | Australia | Name | Canada | Name | Chile | Name | Colombia | Name | France | Name | Germany | Name | Israel | Name | Italy | Name | Korea, Republic of | Name | Russian Federation | Name | Spain | Name | Switzerland | Name | Taiwan | Name | Thailand | Name | United Kingdom |
Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False |
Design Groups
Sequence: | 55879552 | Sequence: | 55879553 |
Group Type | Experimental | Group Type | Experimental |
Title | Pembrolizumab + Lenvatinib (Arm 1) | Title | Lenvatinib Monotherapy (Arm 2) |
Description | Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) plus lenvatinib 20 mg via oral capsule once a day (QD). Pembrolizumab will be administered for up to 35 cycles (up to 2 years). Lenvatinib will be administered until progressive disease or unacceptable toxicity (up to at least 2 years). | Description | Participants receive lenvatinib 24 mg via oral capsule QD, to be administered until progressive disease or unacceptable toxicity (up to at least 2 years). |
Interventions
Sequence: | 52738566 | Sequence: | 52738567 |
Intervention Type | Biological | Intervention Type | Drug |
Name | Pembrolizumab | Name | Lenvatinib |
Description | Administered as an IV infusion on Day 1 Q3W. | Description | Administered orally once a day during each 21-day cycle. |
Keywords
Sequence: | 80217521 | Sequence: | 80217522 | Sequence: | 80217523 | Sequence: | 80217524 | Sequence: | 80217525 | Sequence: | 80217526 | Sequence: | 80217527 | Sequence: | 80217528 |
Name | programmed cell death 1 (PD-1, PD1) | Name | programmed cell death ligand 1 (PD-L1, PDL1) | Name | programmed cell death ligand 2 (PD-L2, PDL2) | Name | tyrosine kinase inhibitor (TKI) | Name | multiple TKI | Name | Vascular Endothelial Growth Factor Receptor (VEFG) | Name | Fibroblast Growth Factor (FGF) | Name | Platelet-Derived Growth Factor (PDGF) |
Downcase Name | programmed cell death 1 (pd-1, pd1) | Downcase Name | programmed cell death ligand 1 (pd-l1, pdl1) | Downcase Name | programmed cell death ligand 2 (pd-l2, pdl2) | Downcase Name | tyrosine kinase inhibitor (tki) | Downcase Name | multiple tki | Downcase Name | vascular endothelial growth factor receptor (vefg) | Downcase Name | fibroblast growth factor (fgf) | Downcase Name | platelet-derived growth factor (pdgf) |
Design Outcomes
Sequence: | 178349302 | Sequence: | 178349303 | Sequence: | 178349304 | Sequence: | 178349305 | Sequence: | 178349306 | Sequence: | 178349307 | Sequence: | 178349308 | Sequence: | 178349309 | Sequence: | 178349310 | Sequence: | 178349311 | Sequence: | 178349312 | Sequence: | 178349313 | Sequence: | 178349314 | Sequence: | 178349315 | Sequence: | 178349316 | Sequence: | 178349317 | Sequence: | 178349318 | Sequence: | 178349319 | Sequence: | 178349320 | Sequence: | 178349321 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria for Glioblastoma (GBM) by Investigator Assessment in Initial Cohorts | Measure | ORR per RECIST 1.1 or RANO (GBM) by Blinded Independent Central Review (BICR) in Expanded Cohorts (Combined with Initial Cohorts) | Measure | Percentage of Participants Receiving Pembrolizumab Plus Lenvatinib who Experience an Adverse Event (AE) | Measure | Percentage of Participants Receiving Pembrolizumab Plus Lenvatinib who Discontinue Study Treatment Due to an AE | Measure | Percentage of Participants Receiving Lenvatinib Monotherapy who Experience an AE | Measure | Percentage of Participants Receiving Lenvatinib Monotherapy who Discontinue Study Treatment Due to an Adverse Event (AE) | Measure | Disease Control Rate (DCR) per RECIST 1.1 by Investigator Assessment in Initial Cohorts | Measure | Duration of Response (DOR) per RECIST 1.1 or RANO (GBM) by Investigator Assessment in Initial Cohorts | Measure | Progression Free Survival (PFS) per RECIST 1.1 or RANO (GBM) by Investigator Assessment in Initial Cohorts | Measure | Overall Survival (OS) in Initial Cohorts | Measure | DCR per RECIST 1.1 by BICR in Expanded Cohorts (Combined with Initial Cohorts) | Measure | DOR per RECIST 1.1 or RANO (GBM) by BICR in Expanded Cohorts (Combined with Initial Cohorts) | Measure | PFS per RECIST 1.1 or RANO (GBM) by BICR in Expanded Cohorts (Combined with Initial Cohorts) | Measure | OS in Expanded Cohorts (Combined with Initial Cohorts) | Measure | ORR per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm | Measure | DCR per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm | Measure | DOR per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm | Measure | PFS per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm | Measure | OS in Lenvatinib Monotherapy Arm | Measure | Plasma Concentration of Lenvatinib |
Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Up to approximately 72 months | Time Frame | Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose and 2-12 hours post-dose; Cycle 2 Day 1: pre-dose, 0.5-4 hours, and 6-10 hours post-dose (up to approximately 23 days). Each cycle is 21 days. |
Description | ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1, which is modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. For participants with GBM, response will be assessed by the investigator based on RANO criteria (CR: disappearance of all target lesions, PR: sum of products of diameters [SPD] decreased by ≥ 50% from baseline value). For participants in the pancreatic cancer cohort, response will be assessed by blinded independent central review (BICR). | Description | ORR is defined as the percentage of participants who have a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) as assessed by BICR per RECIST 1.1, which is modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. For participants with GBM, response will be assessed based on RANO criteria (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value). | Description | An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants receiving pembrolizumab plus lenvatinib who experience at least one AE will be reported. | Description | An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants receiving pembrolizumab plus lenvatinib who discontinue study treatment due to an AE will be reported. | Description | An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants receiving lenvatinib monotherapy who experience at least one AE will be reported. | Description | An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants receiving lenvatinib monotherapy who discontinue study treatment due to an AE will be reported. | Description | DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per RECIST 1.1. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DCR will be assessed by the investigator for all initial cohorts except for the pancreatic cancer cohort, will be assessed by BICR. | Description | DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response until earliest date of disease progression or death from any cause, whichever comes first. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DOR will be assessed by the investigator for all initial cohorts except for the pancreatic cancer cohort, will be assessed by BICR. | Description | PFS is defined as the time from date of study treatment to the first documented disease progression based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ (or RANO for GBM participants), or death due to any cause, whichever occurs first. PFS will be assessed by the investigator for all initial cohorts except for the pancreatic cancer cohort, will be assessed by BICR. | Description | OS is defined as the time from the date of study treatment to the date of death due to any cause. | Description | DCR is defined as the percentage of participants who have a best overall response of CR, PR, or (SD) per RECIST 1.1. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and will be assessed by BICR for this outcome measure. | Description | DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response until earliest date of disease progression or death from any cause, whichever comes first. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and will be assessed by BICR for this outcome measure. | Description | PFS is defined as the time from date of study treatment to the first documented disease progression based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ (or RANO for GBM participants), or death due to any cause, whichever occurs first, as assessed by BICR. | Description | OS is defined as the time from the date of study treatment to the date of death due to any cause. | Description | ORR is defined as the percentage of participants who have a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) as assessed by BICR per RECIST 1.1, which is modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. | Description | DCR is defined as the percentage of participants who have a best overall response of CR, PR, or SD per RECIST 1.1. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and will be assessed by BICR for this outcome measure. | Description | DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response until earliest date of disease progression or death from any cause, whichever comes first. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and will be assessed by BICR for this outcome measure. | Description | PFS is defined as the time from date of study treatment to the first documented disease progression based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ (or RANO for GBM participants), or death due to any cause, whichever occurs first, as assessed by BICR. | Description | OS is defined as the time from the date of study treatment to the date of death due to any cause. | Description | Blood samples will be obtained on Day 1 and Day 15 of Cycle 1 (21-day cycle) and Day 1 of Cycle 2 (21-day cycle) for pharmacokinetic (PK) analysis to determine the plasma concentration of lenvatinib. |
Browse Conditions
Sequence: | 194467972 | Sequence: | 194467973 | Sequence: | 194467974 | Sequence: | 194467975 | Sequence: | 194467976 | Sequence: | 194467977 | Sequence: | 194467978 | Sequence: | 194467979 | Sequence: | 194467980 | Sequence: | 194467981 | Sequence: | 194467982 | Sequence: | 194467983 | Sequence: | 194467984 | Sequence: | 194467985 | Sequence: | 194467986 | Sequence: | 194467987 | Sequence: | 194467988 | Sequence: | 194467989 | Sequence: | 194467990 |
Mesh Term | Glioblastoma | Mesh Term | Triple Negative Breast Neoplasms | Mesh Term | Biliary Tract Neoplasms | Mesh Term | Neoplasms | Mesh Term | Digestive System Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Digestive System Diseases | Mesh Term | Astrocytoma | Mesh Term | Glioma | Mesh Term | Neoplasms, Neuroepithelial | Mesh Term | Neuroectodermal Tumors | Mesh Term | Neoplasms, Germ Cell and Embryonal | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms, Nerve Tissue | Mesh Term | Breast Neoplasms | Mesh Term | Breast Diseases | Mesh Term | Skin Diseases | Mesh Term | Biliary Tract Diseases |
Downcase Mesh Term | glioblastoma | Downcase Mesh Term | triple negative breast neoplasms | Downcase Mesh Term | biliary tract neoplasms | Downcase Mesh Term | neoplasms | Downcase Mesh Term | digestive system neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | astrocytoma | Downcase Mesh Term | glioma | Downcase Mesh Term | neoplasms, neuroepithelial | Downcase Mesh Term | neuroectodermal tumors | Downcase Mesh Term | neoplasms, germ cell and embryonal | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms, nerve tissue | Downcase Mesh Term | breast neoplasms | Downcase Mesh Term | breast diseases | Downcase Mesh Term | skin diseases | Downcase Mesh Term | biliary tract diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48558185 | Sequence: | 48558186 |
Agency Class | INDUSTRY | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Merck Sharp & Dohme LLC | Name | Eisai Inc. |
Overall Officials
Sequence: | 29419486 |
Role | Study Director |
Name | Medical Director |
Affiliation | Merck Sharp & Dohme LLC |
Design Group Interventions
Sequence: | 68501784 | Sequence: | 68501785 | Sequence: | 68501786 |
Design Group Id | 55879552 | Design Group Id | 55879553 | Design Group Id | 55879552 |
Intervention Id | 52738566 | Intervention Id | 52738567 | Intervention Id | 52738567 |
Eligibilities
Sequence: | 30913351 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Has a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the following cohorts: TNBC, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, GBM, BTC (intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater), Pancreatic Cancer For Triple Negative Breast Cancer Participants: Has received one or 2 prior lines of therapy For Ovarian Cancer Participants: – Has primary ovarian cancer and has received 3 prior lines of therapy. For Gastric Cancer Participants: – Has received 2 prior lines of therapy. Note: Gastric cancer will include participants with both gastric and gastroesophageal junction (GEJ) adenocarcinoma. Participants with squamous cell carcinoma histology are not eligible For Colorectal Cancer Participants: – Has received 2 prior lines of therapy For GBM Participants: Has failed initial systemic therapy for newly diagnosed GBM For Biliary Tract Cancer Participants: Has received 1 prior line of therapy For Pancreatic Cancer Participants: Has pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma that is metastatic at enrollment Exclusion Criteria: Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib For GBM Participants: Has carcinomatous meningitis |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254176392 |
Number Of Facilities | 88 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 6 |
Number Of Secondary Outcomes To Measure | 14 |
Designs
Sequence: | 30659046 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26800394 | Sequence: | 26800395 | Sequence: | 26800396 | Sequence: | 26800397 | Sequence: | 26800398 |
Intervention Id | 52738566 | Intervention Id | 52738566 | Intervention Id | 52738567 | Intervention Id | 52738567 | Intervention Id | 52738567 |
Name | MK-3475 | Name | Keytruda® | Name | MK-7902 | Name | E7080 | Name | LENVIMA™ |
Links
Sequence: | 4407745 |
Url | http://merckoncologyclinicaltrials.com |
Description | Merck Oncology Clinical Trial Information |
Responsible Parties
Sequence: | 29025720 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797313
2019-01-22
https://zephyrnet.com/?p=NCT03797313
NCT03797313https://www.clinicaltrials.gov/study/NCT03797313?tab=tableNANANAThis is an observational cohort study of the association between patient expectations for functional recovery and quality of life among acute respiratory failure survivors 6 months after hospital discharge.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2021-12-15 |
Start Month Year | January 22, 2019 |
Primary Completion Month Year | December 1, 2021 |
Verification Month Year | February 2021 |
Verification Date | 2021-02-28 |
Last Update Posted Date | 2021-12-15 |
Detailed Descriptions
Sequence: | 20774584 |
Description | This study will enroll adults who are diagnosed with acute respiratory failure during an ICU admission and discharged from the ICU alive. All participants will receive usual clinical care. Participant expectations for functional recovery will be assessed before hospital discharge via a standardized questionnaire containing a visual analogue scale and questions about expected ability and importance of being able to perform activities of daily living and instrumental activities of daily living in 6 months. At 6 months, participants will be re-contacted by phone. Study staff will administer questionnaires to assess whether patient expectations have been met. Quality of life will be assessed using the WHOQOL-BREF and the EQ-5D-VAS. |
Facilities
Sequence: | 200548214 | Sequence: | 200548215 | Sequence: | 200548216 | Sequence: | 200548217 |
Name | Johns Hopkins University | Name | Beth Israel Deaconess Medical Center | Name | Vanderbilt University | Name | Intermountain Medical Center |
City | Baltimore | City | Boston | City | Nashville | City | Murray |
State | Maryland | State | Massachusetts | State | Tennessee | State | Utah |
Zip | 21287 | Zip | 02215 | Zip | 37235 | Zip | 84107 |
Country | United States | Country | United States | Country | United States | Country | United States |
Conditions
Sequence: | 52306590 | Sequence: | 52306591 |
Name | Acute Respiratory Failure | Name | Post Intensive Care Syndrome |
Downcase Name | acute respiratory failure | Downcase Name | post intensive care syndrome |
Id Information
Sequence: | 40255942 | Sequence: | 40255943 | Sequence: | 40255944 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | IRB00197235 | Id Value | 00181895 | Id Value | K01HL141637-01 |
Id Type | Other Identifier | Id Type | U.S. NIH Grant/Contract | ||
Id Type Description | Other | ||||
Id Link | https://reporter.nih.gov/quickSearch/K01HL141637-01 |
Countries
Sequence: | 42674764 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55744516 | Sequence: | 55744517 |
Title | Patient's expectations met at Hospital discharge | Title | Patient's with unmet expectations at Hospital Discharge |
Description | ARF survivors whose expectations for recovery at hospital discharge are fully met 6 months later. | Description | ARF survivors whose expectations for recovery at hospital discharge are not fully met 6 months later. |
Design Outcomes
Sequence: | 177878415 | Sequence: | 177878416 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Quality of life measured using the World Health Organization Quality of Life-BREF instrument (WHOQOL-BREF) after hospital discharge | Measure | Patient expectation error measure using EQ-5D VAS |
Time Frame | 6 months after hospital discharge | Time Frame | 6 months after hospital discharge |
Description | WHOQOL-BREF is a measure of overall quality of life that evaluates satisfaction with important aspects of life rather than of health. The instrument contains 26 items across 4 domains, and requires approximately 5 minutes to administer over the phone. The 26 items in the WHOQOL-BREF are scored in four domains: physical, psychological, social relations, and environment, with between 3 and 8 items in each domain and two "benchmark" items addressing overall QoL. Transforming the raw scores results in a domain score between 0 – 100, enabling comparisons between domains with different numbers of items. Higher scores indicate greater participant satisfaction with their quality of life and lower scores indicate worse satisfaction with quality of life. | Description | A secondary analysis will estimate patient expectation error, defined as the difference between the health-related quality of life score expected at hospital discharge and the actual health related quality of life score assessed using the EQ-5D VAS 6 months after hospital discharge. The EQ-5D VAS ranges from 0 to 100 with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. |
Browse Conditions
Sequence: | 194004048 | Sequence: | 194004049 | Sequence: | 194004050 | Sequence: | 194004051 | Sequence: | 194004052 |
Mesh Term | Respiratory Insufficiency | Mesh Term | Respiratory Distress Syndrome | Mesh Term | Respiration Disorders | Mesh Term | Respiratory Tract Diseases | Mesh Term | Lung Diseases |
Downcase Mesh Term | respiratory insufficiency | Downcase Mesh Term | respiratory distress syndrome | Downcase Mesh Term | respiration disorders | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | lung diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48446356 | Sequence: | 48446357 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Johns Hopkins University | Name | National Heart, Lung, and Blood Institute (NHLBI) |
Overall Officials
Sequence: | 29358082 |
Role | Principal Investigator |
Name | Alison Turnbull |
Affiliation | Johns Hopkins University |
Eligibilities
Sequence: | 30844061 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | survivors of acute respiratory failure (ARF) who are expected to be discharged home alive. |
Criteria | Inclusion Criteria:
Age ≥ 18 years High flow nasal cannula with FIO2 ≥ 0.5 and flow rate ≥ 30 LPM for ≥ 24 consecutive hours* *Occasional rest periods of ≤ 1 hour each are not deducted from the calculation of consecutive hours. Expected by the clinical team to be discharged home alive Exclusion Criteria: Patient in ICU < 24 hours |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254193084 |
Number Of Facilities | 4 |
Registered In Calendar Year | 2019 |
Actual Duration | 34 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30589932 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28956380 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52208856 | Sequence: | 52208857 | Sequence: | 52208858 | Sequence: | 52208859 | Sequence: | 52208860 | Sequence: | 52208861 | Sequence: | 52208862 | Sequence: | 52208863 | Sequence: | 52208864 | Sequence: | 52208865 | Sequence: | 52208866 | Sequence: | 52208867 | Sequence: | 52208868 | Sequence: | 52208869 | Sequence: | 52208870 | Sequence: | 52208871 | Sequence: | 52208872 | Sequence: | 52208873 | Sequence: | 52208874 | Sequence: | 52208875 | Sequence: | 52208876 | Sequence: | 52208877 | Sequence: | 52208878 | Sequence: | 52208879 | Sequence: | 52208880 | Sequence: | 52208881 | Sequence: | 52208882 | Sequence: | 52208883 | Sequence: | 52208884 |
Pmid | 16236739 | Pmid | 19865004 | Pmid | 20224063 | Pmid | 18263687 | Pmid | 19011152 | Pmid | 21946660 | Pmid | 28463657 | Pmid | 28448162 | Pmid | 21965016 | Pmid | 24160906 | Pmid | 19770733 | Pmid | 27632675 | Pmid | 27294981 | Pmid | 7655809 | Pmid | 20088892 | Pmid | 21629159 | Pmid | 23575998 | Pmid | 27622598 | Pmid | 24787107 | Pmid | 30160803 | Pmid | 5420677 | Pmid | 5349366 | Pmid | 14754765 | Pmid | 12964174 | Pmid | 26821587 | Pmid | 15085902 | Pmid | 2280326 | Pmid | 28395702 | Pmid | 25531451 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Rubenfeld GD, Caldwell E, Peabody E, Weaver J, Martin DP, Neff M, Stern EJ, Hudson LD. Incidence and outcomes of acute lung injury. N Engl J Med. 2005 Oct 20;353(16):1685-93. doi: 10.1056/NEJMoa050333. | Citation | Cox CE, Docherty SL, Brandon DH, Whaley C, Attix DK, Clay AS, Dore DV, Hough CL, White DB, Tulsky JA. Surviving critical illness: acute respiratory distress syndrome as experienced by patients and their caregivers. Crit Care Med. 2009 Oct;37(10):2702-8. doi: 10.1097/CCM.0b013e3181b6f64a. | Citation | Spragg RG, Bernard GR, Checkley W, Curtis JR, Gajic O, Guyatt G, Hall J, Israel E, Jain M, Needham DM, Randolph AG, Rubenfeld GD, Schoenfeld D, Thompson BT, Ware LB, Young D, Harabin AL. Beyond mortality: future clinical research in acute lung injury. Am J Respir Crit Care Med. 2010 May 15;181(10):1121-7. doi: 10.1164/rccm.201001-0024WS. Epub 2010 Mar 11. | Citation | Zambon M, Vincent JL. Mortality rates for patients with acute lung injury/ARDS have decreased over time. Chest. 2008 May;133(5):1120-7. doi: 10.1378/chest.07-2134. Epub 2008 Feb 8. | Citation | Phua J, Badia JR, Adhikari NK, Friedrich JO, Fowler RA, Singh JM, Scales DC, Stather DR, Li A, Jones A, Gattas DJ, Hallett D, Tomlinson G, Stewart TE, Ferguson ND. Has mortality from acute respiratory distress syndrome decreased over time?: A systematic review. Am J Respir Crit Care Med. 2009 Feb 1;179(3):220-7. doi: 10.1164/rccm.200805-722OC. Epub 2008 Nov 14. | Citation | Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75. | Citation | Hopkins RO, Suchyta MR, Kamdar BB, Darowski E, Jackson JC, Needham DM. Instrumental Activities of Daily Living after Critical Illness: A Systematic Review. Ann Am Thorac Soc. 2017 Aug;14(8):1332-1343. doi: 10.1513/AnnalsATS.201701-059SR. | Citation | Kamdar BB, Huang M, Dinglas VD, Colantuoni E, von Wachter TM, Hopkins RO, Needham DM; National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome Network. Joblessness and Lost Earnings after Acute Respiratory Distress Syndrome in a 1-Year National Multicenter Study. Am J Respir Crit Care Med. 2017 Oct 15;196(8):1012-1020. doi: 10.1164/rccm.201611-2327OC. | Citation | Lieu TA, Au D, Krishnan JA, Moss M, Selker H, Harabin A, Taggart V, Connors A; Comparative Effectiveness Research in Lung Diseases Workshop Panel. Comparative effectiveness research in lung diseases and sleep disorders: recommendations from the National Heart, Lung, and Blood Institute workshop. Am J Respir Crit Care Med. 2011 Oct 1;184(7):848-56. doi: 10.1164/rccm.201104-0634WS. | Citation | Carson SS, Goss CH, Patel SR, Anzueto A, Au DH, Elborn S, Gerald JK, Gerald LB, Kahn JM, Malhotra A, Mularski RA, Riekert KA, Rubenfeld GD, Weaver TE, Krishnan JA; American Thoracic Society Comparative Effectiveness Research Working Group. An official American Thoracic Society research statement: comparative effectiveness research in pulmonary, critical care, and sleep medicine. Am J Respir Crit Care Med. 2013 Nov 15;188(10):1253-61. doi: 10.1164/rccm.201310-1790ST. | Citation | Cox CE, Martinu T, Sathy SJ, Clay AS, Chia J, Gray AL, Olsen MK, Govert JA, Carson SS, Tulsky JA. Expectations and outcomes of prolonged mechanical ventilation. Crit Care Med. 2009 Nov;37(11):2888-94; quiz 2904. doi: 10.1097/CCM.0b013e3181ab86ed. | Citation | Lamas DJ, Owens RL, Nace RN, Massaro AF, Pertsch NJ, Gass J, Bernacki RE, Block SD. Opening the Door: The Experience of Chronic Critical Illness in a Long-Term Acute Care Hospital. Crit Care Med. 2017 Apr;45(4):e357-e362. doi: 10.1097/CCM.0000000000002094. | Citation | Turnbull AE, Davis WE, Needham DM, White DB, Eakin MN. Intensivist-reported Facilitators and Barriers to Discussing Post-Discharge Outcomes with Intensive Care Unit Surrogates. A Qualitative Study. Ann Am Thorac Soc. 2016 Sep;13(9):1546-52. doi: 10.1513/AnnalsATS.201603-212OC. | Citation | Thompson AG, Sunol R. Expectations as determinants of patient satisfaction: concepts, theory and evidence. Int J Qual Health Care. 1995 Jun;7(2):127-41. doi: 10.1093/intqhc/7.2.127. | Citation | Gonzalez Saenz de Tejada M, Escobar A, Herrera C, Garcia L, Aizpuru F, Sarasqueta C. Patient expectations and health-related quality of life outcomes following total joint replacement. Value Health. 2010 Jun-Jul;13(4):447-54. doi: 10.1111/j.1524-4733.2009.00685.x. Epub 2010 Jan 15. | Citation | Soroceanu A, Ching A, Abdu W, McGuire K. Relationship between preoperative expectations, satisfaction, and functional outcomes in patients undergoing lumbar and cervical spine surgery: a multicenter study. Spine (Phila Pa 1976). 2012 Jan 15;37(2):E103-8. doi: 10.1097/BRS.0b013e3182245c1f. | Citation | Hamilton DF, Lane JV, Gaston P, Patton JT, Macdonald D, Simpson AH, Howie CR. What determines patient satisfaction with surgery? A prospective cohort study of 4709 patients following total joint replacement. BMJ Open. 2013 Apr 9;3(4):e002525. doi: 10.1136/bmjopen-2012-002525. Print 2013. | Citation | Pihl K, Roos EM, Nissen N, JoRgensen U, Schjerning J, Thorlund JB. Over-optimistic patient expectations of recovery and leisure activities after arthroscopic meniscus surgery. Acta Orthop. 2016 Dec;87(6):615-621. doi: 10.1080/17453674.2016.1228411. Epub 2016 Sep 13. | Citation | Waljee J, McGlinn EP, Sears ED, Chung KC. Patient expectations and patient-reported outcomes in surgery: a systematic review. Surgery. 2014 May;155(5):799-808. doi: 10.1016/j.surg.2013.12.015. Epub 2013 Dec 16. | Citation | Aversa M, Chowdhury NA, Tomlinson G, Singer LG. Preoperative expectations for health-related quality of life after lung transplant. Clin Transplant. 2018 Oct;32(10):e13394. doi: 10.1111/ctr.13394. Epub 2018 Sep 25. | Citation | Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30. doi: 10.1093/geront/10.1_part_1.20. No abstract available. | Citation | Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available. | Citation | Charney DS. Psychobiological mechanisms of resilience and vulnerability: implications for successful adaptation to extreme stress. Am J Psychiatry. 2004 Feb;161(2):195-216. doi: 10.1176/appi.ajp.161.2.195. | Citation | Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113. | Citation | Cosco TD, Kaushal A, Richards M, Kuh D, Stafford M. Resilience measurement in later life: a systematic review and psychometric analysis. Health Qual Life Outcomes. 2016 Jan 28;14:16. doi: 10.1186/s12955-016-0418-6. | Citation | Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00. | Citation | Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095. | Citation | Shumaker SC, Frazier SK, Moser DK, Chung ML. Psychometric Properties of the Multidimensional Scale of Perceived Social Support in Patients With Heart Failure. J Nurs Meas. 2017 Apr 1;25(1):90-102. doi: 10.1891/1061-3749.25.1.90. | Citation | Hoffmann TC, Del Mar C. Patients' expectations of the benefits and harms of treatments, screening, and tests: a systematic review. JAMA Intern Med. 2015 Feb;175(2):274-86. doi: 10.1001/jamainternmed.2014.6016. |
]]>
https://zephyrnet.com/NCT03797300
2018-12-12
https://zephyrnet.com/?p=NCT03797300
NCT03797300https://www.clinicaltrials.gov/study/NCT03797300?tab=tableNANANAAssessment of Spry Health’s Loop oximetry accuracy in profound hypoxia Assessment of Spry Health’s Respiratory rate accuracy in normal conditions and profound hypoxia
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | December 12, 2018 |
Primary Completion Month Year | December 14, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Facilities
Sequence: | 200053339 |
Name | UCSF Hypoxia Lab |
City | San Francisco |
State | California |
Zip | 94143 |
Country | United States |
Conditions
Sequence: | 52156526 | Sequence: | 52156527 | Sequence: | 52156528 |
Name | Hypoxia | Name | Hypercapnia | Name | Hypocapnia |
Downcase Name | hypoxia | Downcase Name | hypercapnia | Downcase Name | hypocapnia |
Id Information
Sequence: | 40148232 |
Id Source | org_study_id |
Id Value | SpryUCSF2 |
Countries
Sequence: | 42557765 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55577932 |
Group Type | Experimental |
Title | Primary |
Interventions
Sequence: | 52472032 |
Intervention Type | Device |
Name | Spry Loop Band |
Description | Loop band measures pulse oximetry and respiration rate |
Design Outcomes
Sequence: | 177328082 | Sequence: | 177328083 |
Outcome Type | primary | Outcome Type | primary |
Measure | Accuracy of SpO2 measurement | Measure | Accuracy of Respiratory Rate measurement |
Time Frame | duration of subject monitoring, usually up to one hour | Time Frame | duration of subject monitoring, usually up to one hour |
Description | Pulse oximetry measurement accuracy vs. gold standard | Description | Respiratory rate measurement accuracy vs. gold standard |
Browse Conditions
Sequence: | 193432165 | Sequence: | 193432166 | Sequence: | 193432167 | Sequence: | 193432168 |
Mesh Term | Hypoxia | Mesh Term | Hypercapnia | Mesh Term | Hypocapnia | Mesh Term | Signs and Symptoms, Respiratory |
Downcase Mesh Term | hypoxia | Downcase Mesh Term | hypercapnia | Downcase Mesh Term | hypocapnia | Downcase Mesh Term | signs and symptoms, respiratory |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306107 | Sequence: | 48306108 |
Agency Class | INDUSTRY | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Spry Health | Name | University of California, San Francisco |
Design Group Interventions
Sequence: | 68130895 |
Design Group Id | 55577932 |
Intervention Id | 52472032 |
Eligibilities
Sequence: | 30757373 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Healthy adult willing to participate Exclusion Criteria: Wrist size outside the indicated use |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254228117 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 0 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Designs
Sequence: | 30503598 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28869876 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797287
2020-02-01
https://zephyrnet.com/?p=NCT03797287
NCT03797287https://www.clinicaltrials.gov/study/NCT03797287?tab=tableNANANAThis study will compare arthroscopic transosseous versus anchored rotator cuff repairs in terms of clinical outcomes, rotator cuff integrity, and cost-effectiveness. With the collection of patient-reported outcomes the health of patients undergoing each rotator cuff repair technique will be assessed. The aims of this study will be achieved through a clinical randomized controlled trial and a cost-effectiveness analysis.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-05-30 |
Start Month Year | February 1, 2020 |
Primary Completion Month Year | December 2025 |
Verification Month Year | May 2019 |
Verification Date | 2019-05-31 |
Last Update Posted Date | 2019-05-30 |
Detailed Descriptions
Sequence: | 20735953 |
Description | Study Design: After the decision to proceed with arthroscopic rotator cuff repair, patients will be asked to participate in this prospective randomized clinical trial.
Study Procedures: Before Surgery: The Informed Consent process will be completed prior to any data collection. Consent will be completed after explanation of each treatment group and the data to be collected. Baseline and demographic data will be collected prior to surgery: Randomization: Subjects will be randomized prior to surgery into one of the two rotator cuff repair technique groups using REDCap software. Randomization will be stratified by gender. Patient Visits: Patients will complete their questionnaires and testing before surgery then within 2 weeks, 3 months, 6 months, 1 year, and 2 years After the first week of surgery, patients will be given a pain diary to record all narcotic pain medications they consume during the 1st week post-op. An ultrasound will be done during their 6 month, 1 year, and 2 year follow up. |
Facilities
Sequence: | 200245101 |
Name | Johns Hopkins |
City | Columbia |
State | Maryland |
Zip | 21044 |
Country | United States |
Conditions
Sequence: | 52208532 | Sequence: | 52208533 | Sequence: | 52208534 | Sequence: | 52208535 |
Name | Shoulder Pain Chronic | Name | Shoulder Pain | Name | Rotator Cuff Tear | Name | Rotator Cuff Injury |
Downcase Name | shoulder pain chronic | Downcase Name | shoulder pain | Downcase Name | rotator cuff tear | Downcase Name | rotator cuff injury |
Id Information
Sequence: | 40186462 |
Id Source | org_study_id |
Id Value | IRB00046834 |
Countries
Sequence: | 42599953 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55635150 | Sequence: | 55635151 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Tensor Tunnler | Title | Smith and Nephew PEEK Helicoil Anchor |
Description | The Tensor Tunneler (Chattanooga, TN) will be used to create the bone tunnels during the arthroscopic procedure. This is an FDA approved device and is used currently in routine clinical practice. | Description | The anchors used in this trial are FDA approved and are used currently in routine clinical practice (Anchor Rotator Cuff Repair). |
Interventions
Sequence: | 52522488 | Sequence: | 52522489 |
Intervention Type | Device | Intervention Type | Procedure |
Name | Tensor Tunnler | Name | Anchor Rotator Cuff Repair |
Description | Create the bone tunnels during the arthroscopic rotator cuff repair procedure | Description | The suture anchors (Smith and Nephew PEEK Helicoil Anchor) are inserted in bone and the sutures are then used to sew the tendons to bone arthroscopically. |
Design Outcomes
Sequence: | 177512865 | Sequence: | 177512866 | Sequence: | 177512867 | Sequence: | 177512868 | Sequence: | 177512869 | Sequence: | 177512870 | Sequence: | 177512871 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in condition of the shoulder as assessed by American Shoulder and Elbow Surgeon (ASES) Score | Measure | Change in shoulder pain as assessed by Visual Analog Pain Score | Measure | Change in Range of Motion (ROM) | Measure | Change in Strength Testing | Measure | Change in quality of life as assessed by the Western Ontario Rotator Cuff (WORC) Index | Measure | Change in health related quality of life as assessed by Short-Form Six-Dimension (SF-6D) | Measure | Implant Cost |
Time Frame | Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery | Time Frame | Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery | Time Frame | Before surgery, within 1 month after surgery, 3 months, 6 months, 1 year | Time Frame | Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery | Time Frame | Before surgery, 1 year after surgery, 2 years after surgery | Time Frame | Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery | Time Frame | Within 1 month after surgery |
Description | 10 separate questions is scored on an ordinal scale from 0-3 for a maximal raw functional score of 30 (no difficulties). | Description | Patients are asked to identify whether they are having pain in the shoulder and are asked to record the location of their pain on a 10 cm line that ranges from 0(no pain at all) to 10 (pain as bad as it can be) | Description | Total (combined glenohumeral and scapulothoracic) shoulder motion is measured. Both active and passive motion for both shoulders is recorded. Forward elevation is measured as the maximum arm-trunk angle viewed from any direction. External rotation is measured with the arm comfortably at the side and also with the arm at 90° of abduction. Internal rotation is measured by noting the highest segment of spinal anatomy reached with the thumb. Cross-body adduction is measured by measuring the distance of the antecubital fossa from the opposite acromion. | Description | Strength is graded according to the Medical Research Council grade. Strength is measured in forward elevation, abduction, external rotation with the arm comfortably at the side, and internal rotation with the arm comfortably at the side. A perfect score is a 5 in each category. | Description | Quality of Life Measurement tool for patients with rotator cuff disease where patients mark a line on 21 visual analogue scale (VAS) lines labeled 0 (not affected) – 100 (affected). These items will ask about physical symptoms, sports and recreation, work, social function, and emotions. The maximum score is 2100 for worst possible symptoms and 0 represents no symptoms at all. | Description | Measures of health related quality of life (HRQoL) using 11 items from the SF-36 or SF-12. Patients are asked about their physical functioning, role limitations, social functioning, pain, mental health, and vitality. A score of 1 represents full health. | Description | Review of costs through our billing department |
Browse Conditions
Sequence: | 193628731 | Sequence: | 193628732 | Sequence: | 193628733 | Sequence: | 193628734 | Sequence: | 193628735 | Sequence: | 193628736 | Sequence: | 193628737 | Sequence: | 193628738 | Sequence: | 193628739 | Sequence: | 193628740 | Sequence: | 193628741 |
Mesh Term | Shoulder Pain | Mesh Term | Rotator Cuff Injuries | Mesh Term | Arthralgia | Mesh Term | Joint Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Pain | Mesh Term | Neurologic Manifestations | Mesh Term | Rupture | Mesh Term | Wounds and Injuries | Mesh Term | Shoulder Injuries | Mesh Term | Tendon Injuries |
Downcase Mesh Term | shoulder pain | Downcase Mesh Term | rotator cuff injuries | Downcase Mesh Term | arthralgia | Downcase Mesh Term | joint diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | pain | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | rupture | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | shoulder injuries | Downcase Mesh Term | tendon injuries |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48354144 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Johns Hopkins University |
Overall Officials
Sequence: | 29306219 |
Role | Principal Investigator |
Name | Uma Srikumaran, MD, MBA |
Affiliation | Johns Hopkins University |
Design Group Interventions
Sequence: | 68199752 | Sequence: | 68199753 |
Design Group Id | 55635150 | Design Group Id | 55635151 |
Intervention Id | 52522488 | Intervention Id | 52522489 |
Eligibilities
Sequence: | 30787125 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 75 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Adults age 18-75 years old Exclusion Criteria: Patients with partial tears, massive rotator cuff tears that are irreparable, isolated subscapularis tears, and associated pathology (advanced degenerative changes) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253990069 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 75 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30533195 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28899487 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797274
2019-02-08
https://zephyrnet.com/?p=NCT03797274
NCT03797274https://www.clinicaltrials.gov/study/NCT03797274?tab=tableNANANAMost drugs used in general anesthesia work on various receptors in the human brain, causing unconsciousness, loss of memory, and loss of reflection of the autonomic nervous system. After the anesthesia, baseline physiological function will be attained by administration of some reversal drugs or as the time goes by. In this process, various side effects may occur.
Emergence delirium (ED) is a representative behavioral disturbance after general anesthesia in children and that can cause several problems during the recovery period. Previous EEG studies reported that this phenomenon is related to hyperexcitation of the brain, and occurrence of epileptiform discharges during anesthesia induction may indicate an increased vulnerability for the development of a functional brain disorder in these children.
However, to the best of our knowledge, there is no studies concern evaluating quantitative EEG parameters for prediction of this postoperative negative behavior in children.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-05 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-09-04 |
Start Month Year | February 8, 2019 |
Primary Completion Month Year | May 29, 2019 |
Verification Month Year | September 2019 |
Verification Date | 2019-09-30 |
Last Update Posted Date | 2019-09-04 |
Facilities
Sequence: | 200390867 |
Name | Eugene Kim |
City | Daegu |
State | Nam-gu |
Zip | 42472 |
Country | Korea, Republic of |
Conditions
Sequence: | 52256822 | Sequence: | 52256823 | Sequence: | 52256824 | Sequence: | 52256825 | Sequence: | 52256826 |
Name | Anesthesia, General | Name | Electroencephalography | Name | Brain Waves | Name | Psychology, Children | Name | Child Behavior |
Downcase Name | anesthesia, general | Downcase Name | electroencephalography | Downcase Name | brain waves | Downcase Name | psychology, children | Downcase Name | child behavior |
Id Information
Sequence: | 40221009 |
Id Source | org_study_id |
Id Value | DCMC#7 |
Countries
Sequence: | 42636632 |
Name | Korea, Republic of |
Removed | False |
Design Outcomes
Sequence: | 177693373 | Sequence: | 177693367 | Sequence: | 177693368 | Sequence: | 177693369 | Sequence: | 177693370 | Sequence: | 177693371 | Sequence: | 177693372 | Sequence: | 177693374 | Sequence: | 177693375 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Delta-theta to alpha-beta ratio (DTABR) | Measure | Occurrence of Emergence delirium | Measure | Relative power of each brain waves | Measure | modified Yale preoperative anxiety score (mYPAS) | Measure | PAED score during PACU stay | Measure | FLACC score on initial, 10, 20, and 30 min | Measure | Watcha scale on initial, 10, 20, and 30 min | Measure | Delta to alpha ratio | Measure | Theta to beta ratio (TBR) |
Time Frame | From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway | Time Frame | During 60 minutes after PACU admission | Time Frame | From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway | Time Frame | before anesthesia induction (about 30 min before the surgery) | Time Frame | During 60 min after PACU admission | Time Frame | During 60 minutes after PACU admission] | Time Frame | During 60 minutes after PACU admission | Time Frame | From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway | Time Frame | From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway |
Description | From the relative power of each brain waves, the investigators calculated the ratio as follows:
DTABR = (Delta wave + Theta wave)/(alpha wave + beta wave) |
Description | On arrival at post-anesthesia care unit (PACU), patients are checked post-anesthesia emergence delirium (PAED). The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity.
If the PAED score is greater than 12, investigators define emergence delirium. |
Description | Original frontal EEG segments are attained via 2 channel bispectral index monitoring (BIS VISTA™, Aspect Medical Systems, Inc. MA, USA) during the anesthesia period. The EEG is then segmented into 4 s epochs and fast Fourier transform (FFT) analysis is performed for each of these segments. FFT of all these selected EEG segments are computed in the following frequency bands:
Delta: 1-4 Hz Theta: 4-8 Hz Alpha: 8-13 Hz Beta: 13-30 Hz And then, the relative power of each frequency bands to the total power of the sum is calculated. |
Description | mYPAS is the assessment tool for measure the anxiety before induction. Higher score indicates higher anxiety. | Description | On arrival at post-anesthesia care unit (PACU) and every 10 min from then, patients were checked PAED. The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity. | Description | Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission | Description | On arrival and 10, 20, and 30 min after PACU admission, patients were checked Watcha scale as following 4-point scale
calm Higher score indicates higher agitation. |
Description | From the relative power of each brain waves, the investigators calculated the ratio as follows:
DAR = Delta wave / alpha wave |
Description | From the relative power of each brain waves, the investigators calculated the ratio as follows:
TBR = Theta wave / beta wave |
Sponsors
Sequence: | 48399390 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Daegu Catholic University Medical Center |
Overall Officials
Sequence: | 29331738 |
Role | Study Chair |
Name | Eugene Kim, MD, PhD |
Affiliation | Assistant professor |
Eligibilities
Sequence: | 30815169 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 2 Years |
Maximum Age | 10 Years |
Healthy Volunteers | No |
Population | This study collects subjects from a tertiary university hospital. |
Criteria | Inclusion Criteria:
Children aged between 2 and 10 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive surgery under general anesthesia Exclusion Criteria: If the guardian and the subject are difficult to evaluate normally due to language barriers/language disorders/delay or autistic disorder |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254077172 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 3 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 2 |
Maximum Age Num | 10 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 7 |
Designs
Sequence: | 30561132 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28927536 |
Responsible Party Type | Principal Investigator |
Name | Eugene Kim |
Title | Assistant professor |
Affiliation | Daegu Catholic University Medical Center |
Study References
Sequence: | 52155703 |
Pmid | 33010926 |
Reference Type | derived |
Citation | Kim J, Lee HC, Byun SH, Lim H, Lee M, Choung Y, Kim E. Frontal electroencephalogram activity during emergence from general anaesthesia in children with and without emergence delirium. Br J Anaesth. 2021 Jan;126(1):293-303. doi: 10.1016/j.bja.2020.07.060. Epub 2020 Oct 1. |
]]>
https://zephyrnet.com/NCT03797261
2019-03-18
https://zephyrnet.com/?p=NCT03797261
NCT03797261https://www.clinicaltrials.gov/study/NCT03797261?tab=tableNANANAThis dose-escalation study evaluating the safety, pharmacokinetics and preliminary efficacy of venetoclax in combination with AMG 176 in participants with relapsed or refractory acute myeloid leukemia (AML) and participants with Non-Hodgkin’s lymphoma (NHL)/diffuse large B-cell lymphoma (DLBCL).
This study will include a dose escalation phase to identify the maximum tolerated dose/recommended phase 2 dose (MTD/RPTD) of venetoclax plus AMG 176 as well as a dose expansion phase to confirm safety, explore efficacy, and confirm the suitability of the preliminary RPTD.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2021-12-07 |
Start Month Year | March 18, 2019 |
Primary Completion Month Year | December 30, 2019 |
Verification Month Year | December 2021 |
Verification Date | 2021-12-31 |
Last Update Posted Date | 2021-12-07 |
Facilities
Sequence: | 200754557 | Sequence: | 200754558 | Sequence: | 200754559 | Sequence: | 200754560 | Sequence: | 200754561 | Sequence: | 200754562 | Sequence: | 200754563 | Sequence: | 200754564 | Sequence: | 200754565 | Sequence: | 200754566 | Sequence: | 200754567 | Sequence: | 200754568 | Sequence: | 200754569 | Sequence: | 200754570 | Sequence: | 200754571 | Sequence: | 200754572 | Sequence: | 200754573 |
Name | City of Hope /ID# 207393 | Name | USC Norris Cancer Center /ID# 207396 | Name | University of Iowa Hospitals and Clinics /ID# 207459 | Name | Univ Kansas Med Ctr /ID# 207480 | Name | Duplicate_Dana-Farber Cancer Institute /ID# 207367 | Name | Washington University-School of Medicine /ID# 206995 | Name | NYU Langone Medical Center /ID# 207390 | Name | Unc /Id# 207388 | Name | UPMC Hillman Cancer Ctr /ID# 208482 | Name | Calvary Mater Newcastle /ID# 211455 | Name | Royal Adelaide Hospital /ID# 210602 | Name | Alfred Health /ID# 210350 | Name | Universitaetsklinikum Frankfurt /ID# 207984 | Name | Universitaetsklinikum Leipzig /ID# 209824 | Name | Charite Universitaetsklinikum Berlin – Campus Virchow /ID# 207987 | Name | Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 207803 | Name | Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 207788 |
City | Duarte | City | Los Angeles | City | Iowa City | City | Kansas City | City | Boston | City | Saint Louis | City | New York | City | Chapel Hill | City | Pittsburgh | City | Waratah | City | Adelaide | City | Melbourne | City | Frankfurt am Main | City | Leipzig | City | Berlin | City | Dresden | City | Hamburg |
State | California | State | California | State | Iowa | State | Kansas | State | Massachusetts | State | Missouri | State | New York | State | North Carolina | State | Pennsylvania | State | New South Wales | State | South Australia | State | Victoria | State | Hessen | State | Sachsen | ||||||
Zip | 91010 | Zip | 90033 | Zip | 52242 | Zip | 66160 | Zip | 02215 | Zip | 63110 | Zip | 10016-6402 | Zip | 27599 | Zip | 15232 | Zip | 2298 | Zip | 5000 | Zip | 3004 | Zip | 60590 | Zip | 04103 | Zip | 13353 | Zip | 01307 | Zip | 20246 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | Australia | Country | Australia | Country | Australia | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany |
Browse Interventions
Sequence: | 96346690 | Sequence: | 96346691 |
Mesh Term | Venetoclax | Mesh Term | Antineoplastic Agents |
Downcase Mesh Term | venetoclax | Downcase Mesh Term | antineoplastic agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52358496 | Sequence: | 52358497 | Sequence: | 52358498 |
Name | Acute Myeloid Leukemia | Name | Non-Hodgkin's Lymphoma | Name | Diffuse Large B-cell Lymphoma |
Downcase Name | acute myeloid leukemia | Downcase Name | non-hodgkin's lymphoma | Downcase Name | diffuse large b-cell lymphoma |
Id Information
Sequence: | 40292744 | Sequence: | 40292745 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | M16-785 | Id Value | 2018-003314-41 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42715852 | Sequence: | 42715853 | Sequence: | 42715854 |
Name | United States | Name | Australia | Name | Germany |
Removed | False | Removed | False | Removed | False |
Design Groups
Sequence: | 55801453 |
Group Type | Experimental |
Title | Venetoclax + AMG 176 |
Description | Venetoclax and AMG 176 will be administered in combination. Different combinations of dose levels for venetoclax and AMG 176 will be explored. |
Interventions
Sequence: | 52669438 | Sequence: | 52669439 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Venetoclax | Name | AMG 176 |
Description | tablet, oral | Description | solution, intravenous |
Keywords
Sequence: | 80126133 | Sequence: | 80126134 | Sequence: | 80126135 | Sequence: | 80126136 | Sequence: | 80126137 | Sequence: | 80126138 |
Name | Acute Myeloid Leukemia | Name | Non-Hodgkin's Lymphoma | Name | Cancer | Name | Venetoclax | Name | AMG 176 | Name | diffuse large B-cell lymphoma (DLBCL) |
Downcase Name | acute myeloid leukemia | Downcase Name | non-hodgkin's lymphoma | Downcase Name | cancer | Downcase Name | venetoclax | Downcase Name | amg 176 | Downcase Name | diffuse large b-cell lymphoma (dlbcl) |
Design Outcomes
Sequence: | 178070364 | Sequence: | 178070365 | Sequence: | 178070366 | Sequence: | 178070367 | Sequence: | 178070368 | Sequence: | 178070369 | Sequence: | 178070370 | Sequence: | 178070371 | Sequence: | 178070372 | Sequence: | 178070373 | Sequence: | 178070374 | Sequence: | 178070375 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RPTD) for Venetoclax + AMG 176 | Measure | Number of Participants With Adverse Events | Measure | Composite Complete Remission Rate (CRc) for Participants with AML | Measure | Objective Response Rate (ORR) for Participants with AML | Measure | ORR for Participants with NHL | Measure | Maximum Plasma Concentration (Cmax) of Venetoclax | Measure | Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax | Measure | AUC of Venetoclax | Measure | Maximum Plasma Concentration (Cmax) of AMG 176 | Measure | Half-life (t1/2) of AMG 176 | Measure | AUC of AMG 176 | Measure | Clearance (CL) of AMG 176 |
Time Frame | Up to 28 days after first dose of study drug in a dose-escalation phase | Time Frame | From first dose of study drug until 30 days or 5 half-lives after discontinuation of study drug administration will be collected (up to approximately 4 years). | Time Frame | Up to approximately 2 years from last subject first dose | Time Frame | Up to approximately 2 years from last subject first dose | Time Frame | Up to approximately 2 years from last subject first dose | Time Frame | Up to approximately 28 days after first dose of study drug | Time Frame | Up to approximately 28 days after first dose of study drug | Time Frame | Up to approximately 28 days after first dose of study drug | Time Frame | Up to approximately 16 days after first dose of study drug | Time Frame | Approximately 16 days after first dose of study drug | Time Frame | Approximately 16 days after first dose of study drug | Time Frame | Approximately 16 days after first dose of study drug |
Description | The MTD and/or RPTD of venetoclax and of AMG 176 will be determined during the dose escalation phase of the study. | Description | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Description | CRc rate is defined as CR + CRi (CR with incomplete blood count recovery). | Description | ORR is defined as the percentage of participants with documented partial response (PR) or better (CR + CRi + partial response [PR]) based on International Working Group (IWG) criteria for AML | Description | ORR is defined as the percentage of participants with documented CR + PR based on Lugano criteria for NHL. | Description | Maximum observed plasma concentration (Cmax) of venetoclax. | Description | Time to maximum plasma concentration (Tmax) of Venetoclax. | Description | Area under the plasma concentration-time curve (AUC) of venetoclax. | Description | Maximum observed plasma concentration (Cmax) of AMG 176 | Description | Terminal phase elimination half-life (t1/2) | Description | Area Under the Plasma Concentration-time Curve (AUC) of AMG 176 | Description | Clearance (CL) is defined the volume of plasma cleared of the drug per unit time. |
Browse Conditions
Sequence: | 194199540 | Sequence: | 194199541 | Sequence: | 194199542 | Sequence: | 194199543 | Sequence: | 194199544 | Sequence: | 194199545 | Sequence: | 194199546 | Sequence: | 194199547 | Sequence: | 194199548 | Sequence: | 194199549 | Sequence: | 194199550 | Sequence: | 194199551 | Sequence: | 194199552 | Sequence: | 194199553 | Sequence: | 194199554 | Sequence: | 194199555 |
Mesh Term | Lymphoma | Mesh Term | Leukemia, Myeloid | Mesh Term | Leukemia, Myeloid, Acute | Mesh Term | Lymphoma, Non-Hodgkin | Mesh Term | Lymphoma, B-Cell | Mesh Term | Lymphoma, Large B-Cell, Diffuse | Mesh Term | Hematologic Neoplasms | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Lymphoproliferative Disorders | Mesh Term | Lymphatic Diseases | Mesh Term | Immunoproliferative Disorders | Mesh Term | Immune System Diseases | Mesh Term | Leukemia | Mesh Term | Neoplasms by Site | Mesh Term | Hematologic Diseases |
Downcase Mesh Term | lymphoma | Downcase Mesh Term | leukemia, myeloid | Downcase Mesh Term | leukemia, myeloid, acute | Downcase Mesh Term | lymphoma, non-hodgkin | Downcase Mesh Term | lymphoma, b-cell | Downcase Mesh Term | lymphoma, large b-cell, diffuse | Downcase Mesh Term | hematologic neoplasms | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lymphoproliferative disorders | Downcase Mesh Term | lymphatic diseases | Downcase Mesh Term | immunoproliferative disorders | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | leukemia | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | hematologic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48493518 | Sequence: | 48493519 | Sequence: | 48493520 |
Agency Class | INDUSTRY | Agency Class | INDUSTRY | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | AbbVie | Name | Genentech, Inc. | Name | Amgen |
Overall Officials
Sequence: | 29384380 |
Role | Study Director |
Name | ABBVIE INC. |
Affiliation | AbbVie |
Design Group Interventions
Sequence: | 68404723 | Sequence: | 68404724 |
Design Group Id | 55801453 | Design Group Id | 55801453 |
Intervention Id | 52669438 | Intervention Id | 52669439 |
Eligibilities
Sequence: | 30873332 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Adequate kidney, liver and hematology values as described in the protocol. Exclusion Criteria: History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254045098 |
Number Of Facilities | 17 |
Registered In Calendar Year | 2019 |
Actual Duration | 9 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 10 |
Designs
Sequence: | 30619126 |
Allocation | N/A |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26768509 |
Intervention Id | 52669438 |
Name | ABT-199 |
Links
Sequence: | 4402705 |
Url | http://www.rxabbvie.com |
Description | Related Info |
Responsible Parties
Sequence: | 28985653 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797248
2018-11-12
https://zephyrnet.com/?p=NCT03797248
NCT03797248https://www.clinicaltrials.gov/study/NCT03797248?tab=tableMing-Yen Tsai, PhDmissuriae@yahoo.com.tw+886975056534This 2-year trial is intended to be used to study breast cancer patients through forward-looking generation design through collaboration between Chinese and Western medical teams. The whole study consists of 2 stages, stage I comprises a cross-sectional study-baseline and stage II is a cohort for outcome evaluation and follow-up study across a 3-year period. To provide an empirical basis for combined TCM treatment in the Breast Cancer Research Team and to publish that as a reference for future TCM and Western medicine in integrative cancer treatment.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-05 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-09-17 |
Start Month Year | November 12, 2018 |
Primary Completion Month Year | October 24, 2020 |
Verification Month Year | September 2019 |
Verification Date | 2019-09-30 |
Last Update Posted Date | 2019-09-17 |
Detailed Descriptions
Sequence: | 20710014 |
Description | Breast cancer is a major health issue for women worldwide and has increased exponentially in the last decades. Improved earlier detection combined with adjuvant systemic therapy is responsible for much of the reduction in cause-specific mortality from breast cancer. Chemotherapy after surgery can decrease the risk of recurrence and is often used as routine treatment in clinic. Because of the fact that a considerable number of patients seek for traditional Chinese medicine (TCM) during adjuvant chemotherapy, it is thus need to evaluate the correlation between TCM treatment and prognosis. The investigators design a single center, prospective cohort study began in November 2018 in Kaohsiung, Taiwan. A sample of 104 participants diagnosed with early breast cancer was recruited from Breast Cancer Research Team and are followed up every 3 to 6 months till October 2023. Detailed information of participants includes general information, history of cancer, quality of life, side effects of chemotherapy and safety of treatment, body constitution of TCM and meridian energy analysis is taken face-to-face at baseline. |
Facilities
Sequence: | 199965204 |
Status | Recruiting |
Name | Kaohsiung Chang Gung Memorial Hospital |
City | Kaohsiung |
Zip | 83301 |
Country | Taiwan |
Facility Contacts
Sequence: | 28086689 |
Facility Id | 199965204 |
Contact Type | primary |
Name | Ming-Yen Tsai |
missuriae@yahoo.com.tw | |
Phone | +886975056534 |
Phone Extension | +886975056534 |
Conditions
Sequence: | 52139076 |
Name | Early-stage Breast Cancer |
Downcase Name | early-stage breast cancer |
Id Information
Sequence: | 40135115 |
Id Source | org_study_id |
Id Value | 201801559A3 |
Countries
Sequence: | 42542741 |
Name | Taiwan |
Removed | False |
Design Groups
Sequence: | 55559430 | Sequence: | 55559431 |
Title | Cohort 1 | Title | Cohort 2 |
Description | adjuvant chemotherapy combined with Chinese herbal medicine | Description | adjuvant chemotherapy only |
Interventions
Sequence: | 52454987 |
Intervention Type | Combination Product |
Name | Chinese herbal medicine |
Description | All Chinese herbal products prescribed from TCM physicians in our hospital during patients receiving adjuvant chemotherapy |
Keywords
Sequence: | 79822913 | Sequence: | 79822914 | Sequence: | 79822915 | Sequence: | 79822916 | Sequence: | 79822917 |
Name | traditional Chinese medicine | Name | quality of life | Name | disease-free survival | Name | adjuvant chemotherapy | Name | breast cancer |
Downcase Name | traditional chinese medicine | Downcase Name | quality of life | Downcase Name | disease-free survival | Downcase Name | adjuvant chemotherapy | Downcase Name | breast cancer |
Design Outcomes
Sequence: | 177264076 | Sequence: | 177264077 | Sequence: | 177264078 | Sequence: | 177264079 | Sequence: | 177264080 | Sequence: | 177264081 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | disease-free survival | Measure | QOLs measurement-1 | Measure | QOLs measurement-2 | Measure | TCM pattern | Measure | meridian energy | Measure | Side effects of adjuvant chemotherapy |
Time Frame | 3 years | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months |
Description | 3-year disease-free survival | Description | Functional Assessment of Cancer Therapy – Breast Cancer(FACT-B) | Description | Eastern Cooperative Oncology Group (ECOG) | Description | Body Constitution Questionnaire (BCQ) | Description | Meridian Energy Analysis Device (MEAD) | Description | Common Terminology Criteria for Adverse Events (CTCAE) |
Browse Conditions
Sequence: | 193366816 | Sequence: | 193366817 | Sequence: | 193366818 | Sequence: | 193366819 | Sequence: | 193366815 |
Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Breast Diseases | Mesh Term | Skin Diseases | Mesh Term | Breast Neoplasms |
Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | breast diseases | Downcase Mesh Term | skin diseases | Downcase Mesh Term | breast neoplasms |
Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list |
Sponsors
Sequence: | 48290774 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Chang Gung Memorial Hospital |
Overall Officials
Sequence: | 29268565 |
Role | Principal Investigator |
Name | Chien-Ting Liu, MD |
Affiliation | Division of Oncology, Department of Internal Medicine |
Central Contacts
Sequence: | 12000505 |
Contact Type | primary |
Name | Ming-Yen Tsai, PhD |
Phone | +886975056534 |
missuriae@yahoo.com.tw | |
Role | Contact |
Design Group Interventions
Sequence: | 68107550 | Sequence: | 68107551 |
Design Group Id | 55559430 | Design Group Id | 55559431 |
Intervention Id | 52454987 | Intervention Id | 52454987 |
Eligibilities
Sequence: | 30747767 |
Sampling Method | Non-Probability Sample |
Gender | Female |
Minimum Age | 20 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Patients with breast cancer aged over 20 years with histologically diagnosed stage 1-3 after radical surgery are enrolled from an academic medical center. All participants need to complete the 6-8 cycle of adjuvant chemotherapy, which may last 6 months. |
Criteria | Inclusion Criteria:
Aged > 20 years old female patients; Exclusion Criteria: Combined with inadequate heart, liver, kidney and hematopoietic function and other serious diseases; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254122087 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 20 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30494050 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28860330 |
Responsible Party Type | Principal Investigator |
Name | Ming-Yen Tsai |
Title | Department of Chinese medicine |
Affiliation | Chang Gung Memorial Hospital |
Study References
Sequence: | 52032796 |
Pmid | 31847861 |
Reference Type | derived |
Citation | Liu CT, Chen YH, Huang YC, Chen SY, Tsai MY. Chemotherapy in conjunction with traditional Chinese medicine for survival of patients with early female breast cancer: protocol for a non-randomized, single center prospective cohort study. Trials. 2019 Dec 17;20(1):741. doi: 10.1186/s13063-019-3848-8. |
]]>
https://zephyrnet.com/NCT03797235
2019-01-19
https://zephyrnet.com/?p=NCT03797235
NCT03797235https://www.clinicaltrials.gov/study/NCT03797235?tab=tableNANANAThe study aims to describe a correlation between the nerve cross section and the sensory or motor block onset time. Therefore, different nerve cross sections with their Motor and sensory onset times are compared in order to find a correlation.
In the case of discovering a correlation, this could be translated into clinical practice, where a more tailored and individualized approach to performing peripheral nerve blocks would be possible, thus lowering the risks of adverse events occurring.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-05 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2020-05-22 |
Start Month Year | January 19, 2019 |
Primary Completion Month Year | June 20, 2019 |
Verification Month Year | May 2020 |
Verification Date | 2020-05-31 |
Last Update Posted Date | 2020-05-22 |
Facilities
Sequence: | 200159508 |
Name | Der Balgrist |
City | Zürich |
Zip | 8008 |
Country | Switzerland |
Conditions
Sequence: | 52185583 |
Name | Regional Anesthesia |
Downcase Name | regional anesthesia |
Id Information
Sequence: | 40169132 |
Id Source | org_study_id |
Id Value | BASEC 2018-00939 |
Countries
Sequence: | 42580719 |
Name | Switzerland |
Removed | False |
Design Groups
Sequence: | 55609215 | Sequence: | 55609216 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Dominant Arm | Title | Non-dominant arm |
Description | Two ultrasound guided nerve blocks (block of the ulnar and median nerve) on the dominant forearm | Description | Two ultrasound guided nerve blocks (block of the ulnar and median nerve) on the non-dominant forearm. |
Interventions
Sequence: | 52499517 | Sequence: | 52499518 |
Intervention Type | Procedure | Intervention Type | Procedure |
Name | Dominant Arm | Name | Non-dominant arm |
Description | The volume of local anesthetic used for the block of the ulnar and median nerve will be 5 times the estimated 95% effective dose (ED 95 ) of LA needed to block the nerve relative to the nerve cross-sectional area. The ED 95 for the ulnar nerve has been elucidated to be 0,11ml/mm2. The same ED 95 will be used for the median nerve. | Description | The volume of local anesthetic used for the block of the ulnar and median nerve will be 5 times the estimated 95% effective dose (ED 95 ) of LA needed to block the nerve relative to the nerve cross-sectional area. The ED 95 for the ulnar nerve has been elucidated to be 0,11ml/mm2. The same ED 95 will be used for the median nerve. |
Keywords
Sequence: | 79888898 |
Name | Ultrasound-guided regional anesthesia |
Downcase Name | ultrasound-guided regional anesthesia |
Design Outcomes
Sequence: | 177432337 | Sequence: | 177432338 | Sequence: | 177432339 | Sequence: | 177432340 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Correlation between nerve cross-section and time to complete sensory block of a nerve | Measure | Correlation between nerve cross-section and time to complete motor block of a nerve | Measure | Correlation between nerve cross-section and the duration of sensory nerve block | Measure | Correlation between the nerve cross-section and duration of motor nerve block |
Time Frame | Sensory evaluation will be carried out before the block and every 2 minutes after the start of the injection of LA until complete sensory loss to both cold and pinprick. Expected time frame: 10-60 minutes | Time Frame | Motor evaluation will be carried out before the block and every 2 minutes after the start of the injection of LA until complete motor block. Expected time frame: 10-100 minutes | Time Frame | The evaluation of the duration of block will start one hour after the determined complete sensory loss and will be tested every 10 minutes until complete resolution of the sensory block. Expected time frame: 10-300 minutes | Time Frame | The evaluation of the duration of sensory block will start one hour after the determined complete motor loss and will be tested every 10 minutes until complete resolution of the motor block. Expected time frame: 10-300min |
Description | Correlation between the nerve cross-section in mm2 of both nerves (median and ulnar) measured with an ultrasound system and time in minutes from the moment the investigator starts injecting the local anesthetic (LA) around the respective nerves to complete sensory loss in the innervation area of the blocked nerve, assessed by response to light touch, pinprick and cold sensation. This correlation will be expressed in min/ mm2. | Description | The correlation between the nerve cross-section area in mm2 of both nerves (median and ulnar) measured with an ultrasound system and time in minutes from the start of the LA injection around the nerve median and ulnar nerves to the respective onset of the motor block, assessed with a numerical scale ranging from 0 to 5 (0-no muscle contraction visible, 5-normal muscle strength, maximal force against resistance and gravity). This correlation will be expressed in min/ mm2. | Description | The correlation between the nerve cross-section area in mm2 of both nerves (median and ulnar) measured with an ultrasound system and the duration of the respective sensory block in minutes, as reflected by the return of normal sensation in the innervation area of the respective nerve. This correlation will be expressed in min/ mm2. | Description | The correlation between the nerve cross-section area in mm2 of both nerves (median and ulnar) measured with an ultrasound system and the duration of the respective motor block in minutes, as reflected by the return of normal muscle strength in the innervation area of the respective nerve. This correlation will be expressed in min/ mm2. |
Sponsors
Sequence: | 48332410 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Jose Aguirre |
Overall Officials
Sequence: | 29293043 |
Role | Principal Investigator |
Name | José Aguirre, PD Dr Med |
Affiliation | Der Balgrist |
Design Group Interventions
Sequence: | 68168288 | Sequence: | 68168289 |
Design Group Id | 55609215 | Design Group Id | 55609216 |
Intervention Id | 52499517 | Intervention Id | 52499518 |
Eligibilities
Sequence: | 30773629 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 64 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
ASA I – II, both sexes Exclusion Criteria: Known allergy or hypersensitivity to a study drug or class of drug. |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253952969 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 5 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 64 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30519760 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Single |
Subject Masked | True |
Responsible Parties
Sequence: | 28886061 |
Responsible Party Type | Sponsor-Investigator |
Name | Jose Aguirre |
Title | PD Dr. med. |
Affiliation | Balgrist University Hospital |
Study References
Sequence: | 52079059 | Sequence: | 52079060 | Sequence: | 52079061 | Sequence: | 52079062 | Sequence: | 52079063 | Sequence: | 52079064 | Sequence: | 52079065 | Sequence: | 52079066 | Sequence: | 52079067 | Sequence: | 52079068 | Sequence: | 52079069 | Sequence: | 52079070 | Sequence: | 52079071 | Sequence: | 52079072 |
Pmid | 19051446 | Pmid | 26361135 | Pmid | 19587623 | Pmid | 25644578 | Pmid | 25376973 | Pmid | 26423050 | Pmid | 14504153 | Pmid | 22664978 | Pmid | 20034967 | Pmid | 24809480 | Pmid | 21148659 | Pmid | 16857551 | Pmid | 2899106 | Pmid | 20121770 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Capdevila X, Biboulet P, Morau D, Mannion S, Choquet O. How and why to use ultrasound for regional blockade. Acta Anaesthesiol Belg. 2008;59(3):147-54. | Citation | Lewis SR, Price A, Walker KJ, McGrattan K, Smith AF. Ultrasound guidance for upper and lower limb blocks. Cochrane Database Syst Rev. 2015 Sep 11;2015(9):CD006459. doi: 10.1002/14651858.CD006459.pub3. | Citation | Eichenberger U, Stockli S, Marhofer P, Huber G, Willimann P, Kettner SC, Pleiner J, Curatolo M, Kapral S. Minimal local anesthetic volume for peripheral nerve block: a new ultrasound-guided, nerve dimension-based method. Reg Anesth Pain Med. 2009 May-Jun;34(3):242-6. doi: 10.1097/AAP.0b013e31819a7225. | Citation | Keplinger M, Marhofer P, Marhofer D, Schroegendorfer K, Haslik W, Zeitlinger M, Mayer CV, Kettner SC. Effective local anaesthetic volumes for sciatic nerve blockade: a clinical evaluation of the ED99. Anaesthesia. 2015 May;70(5):585-90. doi: 10.1111/anae.13013. Epub 2015 Jan 20. | Citation | Choi S, McCartney CJ. Evidence Base for the Use of Ultrasound for Upper Extremity Blocks: 2014 Update. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):242-50. doi: 10.1097/AAP.0000000000000155. | Citation | Fenten MG, Schoenmakers KP, Heesterbeek PJ, Scheffer GJ, Stienstra R. Effect of local anesthetic concentration, dose and volume on the duration of single-injection ultrasound-guided axillary brachial plexus block with mepivacaine: a randomized controlled trial. BMC Anesthesiol. 2015 Sep 30;15:130. doi: 10.1186/s12871-015-0110-0. | Citation | Serradell A, Herrero R, Villanueva JA, Santos JA, Moncho JM, Masdeu J. Comparison of three different volumes of mepivacaine in axillary plexus block using multiple nerve stimulation. Br J Anaesth. 2003 Oct;91(4):519-24. doi: 10.1093/bja/aeg215. | Citation | Fredrickson MJ, Abeysekera A, White R. Randomized study of the effect of local anesthetic volume and concentration on the duration of peripheral nerve blockade. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):495-501. doi: 10.1097/AAP.0b013e3182580fd0. | Citation | Latzke D, Marhofer P, Zeitlinger M, Machata A, Neumann F, Lackner E, Kettner SC. Minimal local anaesthetic volumes for sciatic nerve block: evaluation of ED 99 in volunteers. Br J Anaesth. 2010 Feb;104(2):239-44. doi: 10.1093/bja/aep368. Epub 2009 Dec 23. | Citation | Ecoffey C, Oger E, Marchand-Maillet F, Cimino Y, Rannou JJ, Beloeil H; SOS French Regional Anaesthesia Hotline. Complications associated with 27 031 ultrasound-guided axillary brachial plexus blocks: a web-based survey of 36 French centres. Eur J Anaesthesiol. 2014 Nov;31(11):606-10. doi: 10.1097/EJA.0000000000000063. | Citation | Jeng CL, Torrillo TM, Rosenblatt MA. Complications of peripheral nerve blocks. Br J Anaesth. 2010 Dec;105 Suppl 1:i97-107. doi: 10.1093/bja/aeq273. | Citation | Hebl JR. The importance and implications of aseptic techniques during regional anesthesia. Reg Anesth Pain Med. 2006 Jul-Aug;31(4):311-23. doi: 10.1016/j.rapm.2006.04.004. No abstract available. | Citation | Rotter ML, Hirschl AM, Koller W. Effect of chlorhexidine-containing detergent, non-medicated soap or isopropanol and the influence of neutralizer on bacterial pathogenicity. J Hosp Infect. 1988 Apr;11(3):220-5. doi: 10.1016/0195-6701(88)90100-4. | Citation | Marhofer P, Eichenberger U, Stockli S, Huber G, Kapral S, Curatolo M, Kettner S. Ultrasonographic guided axillary plexus blocks with low volumes of local anaesthetics: a crossover volunteer study. Anaesthesia. 2010 Mar;65(3):266-71. doi: 10.1111/j.1365-2044.2010.06247.x. Epub 2010 Jan 29. |
]]>
https://zephyrnet.com/NCT03797222
2019-04-15
https://zephyrnet.com/?p=NCT03797222
NCT03797222https://www.clinicaltrials.gov/study/NCT03797222?tab=tableNANANAInvestigators will assess the tolerability of oral Vitamin E supplementation in subjects with congenital hyperinsulinism (HI) and hyperammonemia (HA) syndrome.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-11-25 |
Start Month Year | April 15, 2019 |
Primary Completion Month Year | March 23, 2020 |
Verification Month Year | November 2022 |
Verification Date | 2022-11-30 |
Last Update Posted Date | 2022-11-25 |
Results First Posted Date | 2022-11-25 |
Detailed Descriptions
Sequence: | 20756417 |
Description | Congenital hyperinsulinism (HI) is a rare disorder of pancreatic beta cell insulin secretion that causes persistent and severe hypoglycemia starting at birth. Hyperinsulinism/hyperammonemia (HI/HA) syndrome is the second most common type of congenital HI and is caused by activating mutations in glutamate dehydrogenase (GDH). Patients with HI/HA exhibit fasting hyperinsulinemic hypoglycemia, protein-induced hypoglycemia, hyperammonemia, seizures, and intellectual disability independent of hypoglycemia. These effects result from abnormal GDH activity in the beta cells, liver and kidney cells, neurons, and astrocytes. The only available treatment for HI/HA syndrome is diazoxide, which acts on the beta cells to decrease insulin secretion but has no effect on GDH activity itself or on other cell types. Thus, there remains a significant unmet need for improved therapies for this disorder. Preliminary data show that Vitamin E (alpha-tocopherol) inhibits GDH activity in cell lines and improves hypoglycemia in a GDH HI mouse model. Based on these preclinical studies, Investigators hypothesize that Vitamin E will inhibit GDH activity and may impact hyperinsulinemic hypoglycemia and hyperammonemia in subjects with HI/HA syndrome. This hypothesis will be tested in a future study. In this initial pilot study, investigators will assess the tolerability of oral Vitamin E supplementation in subjects with HI/HA syndrome. |
Facilities
Sequence: | 200403436 |
Name | Children's Hospital of Philadelphia |
City | Philadelphia |
State | Pennsylvania |
Zip | 19104 |
Country | United States |
Browse Interventions
Sequence: | 96195107 | Sequence: | 96195105 | Sequence: | 96195106 | Sequence: | 96195108 | Sequence: | 96195109 | Sequence: | 96195110 | Sequence: | 96195111 | Sequence: | 96195112 | Sequence: | 96195113 |
Mesh Term | alpha-Tocopherol | Mesh Term | Vitamin E | Mesh Term | Tocopherols | Mesh Term | Vitamins | Mesh Term | Micronutrients | Mesh Term | Physiological Effects of Drugs | Mesh Term | Antioxidants | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Protective Agents |
Downcase Mesh Term | alpha-tocopherol | Downcase Mesh Term | vitamin e | Downcase Mesh Term | tocopherols | Downcase Mesh Term | vitamins | Downcase Mesh Term | micronutrients | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | antioxidants | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | protective agents |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52260446 |
Name | Hyperinsulinism-Hyperammonemia Syndrome |
Downcase Name | hyperinsulinism-hyperammonemia syndrome |
Id Information
Sequence: | 40223701 | Sequence: | 40223702 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 17-014550 | Id Value | T32DK063688 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/T32DK063688 |
Countries
Sequence: | 42639712 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55693336 |
Group Type | Experimental |
Title | Vitamin E Supplementation |
Description | Daily oral supplementation with Vitamin E (alpha-tocopherol) for 2 weeks. |
Interventions
Sequence: | 52573213 |
Intervention Type | Dietary Supplement |
Name | Vitamin E |
Description | Subjects will take an oral Vitamin E (alpha-tocopherol) supplement once daily with a fat-containing meal for 2 weeks. The dose will be based on subject age (150 IU if 1-3 years old, 300 IU if 4-8 years old, 450 IU if 9-17 years old, 600 IU if >17 years old). Formulations include 50 IU/mL liquid and 200 IU capsules. The liquid formulation will be used for subjects who will receive <600 IU daily, or for any subjects who prefer liquid medication to capsules. |
Keywords
Sequence: | 79995914 | Sequence: | 79995915 | Sequence: | 79995916 | Sequence: | 79995917 |
Name | hyperinsulinism | Name | hyperammonemia | Name | hypoglycemia | Name | vitamin e |
Downcase Name | hyperinsulinism | Downcase Name | hyperammonemia | Downcase Name | hypoglycemia | Downcase Name | vitamin e |
Design Outcomes
Sequence: | 177707526 | Sequence: | 177707527 | Sequence: | 177707528 | Sequence: | 177707529 | Sequence: | 177707530 | Sequence: | 177707531 | Sequence: | 177707532 | Sequence: | 177707533 | Sequence: | 177707534 | Sequence: | 177707535 | Sequence: | 177707536 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Tolerability of Vitamin E Based on Responses to a Subject/Parent-reported Symptom Questionnaire After Vitamin E Supplementation Compared to Baseline | Measure | Plasma Alpha-tocopherol Concentration | Measure | Delta-plasma Glucose Concentration | Measure | Fasting Plasma Glucose Concentration | Measure | Nadir Plasma Glucose Concentration | Measure | Fasting Plasma Insulin Concentration | Measure | Peak Plasma Insulin Concentration | Measure | Delta-plasma Insulin Concentration | Measure | Fasting Plasma Ammonia Concentration | Measure | Delta-plasma Ammonia Concentration | Measure | Hypoglycemia Frequency |
Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks |
Description | The following symptoms will be scored as either "none" (did not occur)=0, "mild" (minimal symptoms, no treatment needed)=1, "moderate" (symptoms requiring treatment at home or as an outpatient=2, or "severe" (symptoms requiring hospitalization or emergency room visit, or life-threatening or potentially life-threatening symptoms)=4:
Seizure, Headache, Vision change/blurred vision, Weakness, Fatigue, Nausea, Vomiting, Diarrhea, Stomach pain, Constipation, Bruising, Bleeding, Rash, Itching, Other Symptom scores will be summed to yield a Tolerability Questionnaire Score for each participant. The Tolerability Questionnaire Score has a minimum score of 0 (symptoms did not occur) and a maximum score of 60 (all of the measured symptoms occurred, each with severe designation). The number (count) of participants with an increase in Tolerability Questionnaire Score from baseline to 2 weeks (following Vitamin E supplementation) will be reported. |
Description | change in fasting plasma alpha-tocopherol concentration following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in delta-glucose concentration (fasting plasma glucose – nadir plasma glucose during oral protein tolerance test) following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in fasting plasma glucose concentration following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in nadir plasma glucose concentration during oral protein tolerance test following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in fasting plasma insulin concentration following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in peak plasma insulin concentration during oral protein tolerance test following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in delta-plasma insulin concentration (peak plasma insulin – fasting plasma insulin during oral protein tolerance test) following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in fasting plasma ammonia concentration following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in delta-plasma ammonia concentration (plasma ammonia at 60 minutes – fasting plasma ammonia during oral protein tolerance test) following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in frequency of hypoglycemia (plasma glucose <70 mg/dL) detected on home glucose meter following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) |
Browse Conditions
Sequence: | 193828218 | Sequence: | 193828219 | Sequence: | 193828220 | Sequence: | 193828221 | Sequence: | 193828222 | Sequence: | 193828223 | Sequence: | 193828224 |
Mesh Term | Hyperinsulinism | Mesh Term | Syndrome | Mesh Term | Hyperammonemia | Mesh Term | Disease | Mesh Term | Pathologic Processes | Mesh Term | Glucose Metabolism Disorders | Mesh Term | Metabolic Diseases |
Downcase Mesh Term | hyperinsulinism | Downcase Mesh Term | syndrome | Downcase Mesh Term | hyperammonemia | Downcase Mesh Term | disease | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | glucose metabolism disorders | Downcase Mesh Term | metabolic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48402816 | Sequence: | 48402817 | Sequence: | 48402818 | Sequence: | 48402819 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Elizabeth A Rosenfeld | Name | University of Pennsylvania | Name | Lawson Wilkins Pediatric Endocrine Society | Name | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Overall Officials
Sequence: | 29333879 |
Role | Principal Investigator |
Name | Elizabeth Rosenfeld, MD |
Affiliation | Children's Hospital of Philadelphia |
Design Group Interventions
Sequence: | 68269834 |
Design Group Id | 55693336 |
Intervention Id | 52573213 |
Eligibilities
Sequence: | 30817373 |
Gender | All |
Minimum Age | 1 Year |
Maximum Age | 40 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Individuals age ≥12 months and ≤40 years Exclusion Criteria: Individuals age <12 months or >40 years |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254095062 |
Number Of Facilities | 1 |
Number Of Nsae Subjects | 34 |
Registered In Calendar Year | 2019 |
Actual Duration | 11 |
Were Results Reported | True |
Months To Report Results | 27 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 1 |
Maximum Age Num | 40 |
Minimum Age Unit | Year |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 10 |
Designs
Sequence: | 30563328 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | This open-label tolerability and feasibility pilot clinical study will use a before-and-after design, with blood tests and fasting oral protein tolerance test performed prior to and after 2 weeks of daily oral Vitamin E supplementation in individuals with HI/HA syndrome. |
Drop Withdrawals
Sequence: | 29040592 |
Result Group Id | 56158765 |
Ctgov Group Code | FG000 |
Period | Overall Study |
Reason | Withdrawal by Subject |
Count | 1 |
Intervention Other Names
Sequence: | 26715346 |
Intervention Id | 52573213 |
Name | alpha-tocopherol |
Milestones
Sequence: | 41077649 | Sequence: | 41077650 | Sequence: | 41077651 |
Result Group Id | 56158765 | Result Group Id | 56158765 | Result Group Id | 56158765 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG000 |
Title | STARTED | Title | COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 14 | Count | 13 | Count | 1 |
Participant Flows
Sequence: | 3926683 |
Outcome Counts
Sequence: | 74131006 | Sequence: | 74131007 | Sequence: | 74131008 | Sequence: | 74131009 | Sequence: | 74131010 | Sequence: | 74131011 | Sequence: | 74131012 | Sequence: | 74131013 | Sequence: | 74131014 | Sequence: | 74131015 | Sequence: | 74131016 |
Outcome Id | 30857536 | Outcome Id | 30857537 | Outcome Id | 30857538 | Outcome Id | 30857539 | Outcome Id | 30857540 | Outcome Id | 30857541 | Outcome Id | 30857542 | Outcome Id | 30857543 | Outcome Id | 30857544 | Outcome Id | 30857545 | Outcome Id | 30857546 |
Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 13 | Count | 12 | Count | 6 | Count | 12 | Count | 6 | Count | 12 | Count | 6 | Count | 6 | Count | 12 | Count | 5 | Count | 10 |
Provided Documents
Sequence: | 2588063 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2019-12-11 |
Url | https://ClinicalTrials.gov/ProvidedDocs/22/NCT03797222/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27986167 | Sequence: | 27986168 | Sequence: | 27986169 | Sequence: | 27986170 | Sequence: | 27986171 | Sequence: | 27986172 | Sequence: | 27986173 | Sequence: | 27986174 | Sequence: | 27986175 | Sequence: | 27986176 | Sequence: | 27986177 | Sequence: | 27986178 | Sequence: | 27986179 | Sequence: | 27986180 | Sequence: | 27986181 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG003 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG004 | Ctgov Group Code | EG004 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 9 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 3 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 3 | Subjects Affected | 0 |
Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 2 | Subjects At Risk | 2 | Subjects At Risk | 2 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 3 | Subjects At Risk | 3 | Subjects At Risk | 3 | Subjects At Risk | 4 | Subjects At Risk | 4 | Subjects At Risk | 4 |
Created At | 2023-08-09 15:19:48.411011 | Created At | 2023-08-09 15:19:48.411011 | Created At | 2023-08-09 15:19:48.411011 | Created At | 2023-08-09 15:19:48.411011 | Created At | 2023-08-09 15:19:48.411011 | Created At | 2023-08-09 15:19:48.411011 | Created At | 2023-08-09 15:19:48.411011 | Created At | 2023-08-09 15:19:48.411011 | Created At | 2023-08-09 15:19:48.411011 | Created At | 2023-08-09 15:19:48.411011 | Created At | 2023-08-09 15:19:48.411011 | Created At | 2023-08-09 15:19:48.411011 | Created At | 2023-08-09 15:19:48.411011 | Created At | 2023-08-09 15:19:48.411011 | Created At | 2023-08-09 15:19:48.411011 |
Updated At | 2023-08-09 15:19:48.411011 | Updated At | 2023-08-09 15:19:48.411011 | Updated At | 2023-08-09 15:19:48.411011 | Updated At | 2023-08-09 15:19:48.411011 | Updated At | 2023-08-09 15:19:48.411011 | Updated At | 2023-08-09 15:19:48.411011 | Updated At | 2023-08-09 15:19:48.411011 | Updated At | 2023-08-09 15:19:48.411011 | Updated At | 2023-08-09 15:19:48.411011 | Updated At | 2023-08-09 15:19:48.411011 | Updated At | 2023-08-09 15:19:48.411011 | Updated At | 2023-08-09 15:19:48.411011 | Updated At | 2023-08-09 15:19:48.411011 | Updated At | 2023-08-09 15:19:48.411011 | Updated At | 2023-08-09 15:19:48.411011 |
Reported Events
Sequence: | 529030973 | Sequence: | 529030974 | Sequence: | 529030975 | Sequence: | 529030976 | Sequence: | 529030977 | Sequence: | 529030978 | Sequence: | 529030979 | Sequence: | 529030971 | Sequence: | 529030972 | Sequence: | 529030963 | Sequence: | 529030964 | Sequence: | 529030965 | Sequence: | 529030966 | Sequence: | 529030967 | Sequence: | 529030968 | Sequence: | 529030969 | Sequence: | 529030970 | Sequence: | 529030980 | Sequence: | 529030981 | Sequence: | 529030982 | Sequence: | 529030983 | Sequence: | 529030984 | Sequence: | 529030985 | Sequence: | 529030986 | Sequence: | 529030987 | Sequence: | 529030988 | Sequence: | 529030989 | Sequence: | 529030990 | Sequence: | 529030991 | Sequence: | 529030992 | Sequence: | 529030993 | Sequence: | 529030994 | Sequence: | 529030995 | Sequence: | 529030996 | Sequence: | 529030997 | Sequence: | 529030998 | Sequence: | 529030999 | Sequence: | 529031000 | Sequence: | 529031001 | Sequence: | 529031002 |
Result Group Id | 56158767 | Result Group Id | 56158768 | Result Group Id | 56158769 | Result Group Id | 56158770 | Result Group Id | 56158771 | Result Group Id | 56158767 | Result Group Id | 56158768 | Result Group Id | 56158770 | Result Group Id | 56158771 | Result Group Id | 56158767 | Result Group Id | 56158768 | Result Group Id | 56158769 | Result Group Id | 56158770 | Result Group Id | 56158771 | Result Group Id | 56158767 | Result Group Id | 56158768 | Result Group Id | 56158769 | Result Group Id | 56158769 | Result Group Id | 56158770 | Result Group Id | 56158771 | Result Group Id | 56158767 | Result Group Id | 56158768 | Result Group Id | 56158769 | Result Group Id | 56158770 | Result Group Id | 56158771 | Result Group Id | 56158767 | Result Group Id | 56158768 | Result Group Id | 56158769 | Result Group Id | 56158770 | Result Group Id | 56158771 | Result Group Id | 56158767 | Result Group Id | 56158768 | Result Group Id | 56158769 | Result Group Id | 56158770 | Result Group Id | 56158771 | Result Group Id | 56158767 | Result Group Id | 56158768 | Result Group Id | 56158769 | Result Group Id | 56158770 | Result Group Id | 56158771 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 |
Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. | Time Frame | Adverse event data were collected over the 2 week study period. |
Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other |
Subjects Affected | 4 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 3 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 5 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 14 | Subjects At Risk | 2 | Subjects At Risk | 5 | Subjects At Risk | 3 | Subjects At Risk | 4 | Subjects At Risk | 14 | Subjects At Risk | 0 | Subjects At Risk | 3 | Subjects At Risk | 4 | Subjects At Risk | 14 | Subjects At Risk | 2 | Subjects At Risk | 5 | Subjects At Risk | 3 | Subjects At Risk | 4 | Subjects At Risk | 14 | Subjects At Risk | 2 | Subjects At Risk | 5 | Subjects At Risk | 0 | Subjects At Risk | 2 | Subjects At Risk | 3 | Subjects At Risk | 14 | Subjects At Risk | 2 | Subjects At Risk | 5 | Subjects At Risk | 3 | Subjects At Risk | 4 | Subjects At Risk | 14 | Subjects At Risk | 2 | Subjects At Risk | 5 | Subjects At Risk | 3 | Subjects At Risk | 4 | Subjects At Risk | 14 | Subjects At Risk | 2 | Subjects At Risk | 5 | Subjects At Risk | 3 | Subjects At Risk | 4 | Subjects At Risk | 14 | Subjects At Risk | 2 | Subjects At Risk | 5 | Subjects At Risk | 3 | Subjects At Risk | 4 |
Event Count | 6 | Event Count | 1 | Event Count | 0 | Event Count | 3 | Event Count | 2 | Event Count | 1 | Event Count | 0 | Event Count | 2 | Event Count | 4 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 6 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 2 | Event Count | 0 | Event Count | 0 | Event Count | 2 | Event Count | 0 | Event Count | 2 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 |
Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders |
Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Increased menstrual bleeding | Adverse Event Term | Increased menstrual bleeding | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Otitis externa | Adverse Event Term | Otitis externa | Adverse Event Term | Otitis externa | Adverse Event Term | Otitis externa | Adverse Event Term | Otitis externa | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Increased menstrual bleeding | Adverse Event Term | Increased menstrual bleeding | Adverse Event Term | Increased menstrual bleeding | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Diarrhea | Adverse Event Term | Diarrhea | Adverse Event Term | Diarrhea | Adverse Event Term | Diarrhea | Adverse Event Term | Diarrhea | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Rash | Adverse Event Term | Rash | Adverse Event Term | Rash | Adverse Event Term | Rash | Adverse Event Term | Rash |
Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 |
Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment |
Responsible Parties
Sequence: | 28929725 |
Responsible Party Type | Sponsor-Investigator |
Name | Elizabeth A Rosenfeld |
Title | Attending Physician |
Affiliation | Children's Hospital of Philadelphia |
Result Agreements
Sequence: | 3857427 |
Pi Employee | No |
Result Contacts
Sequence: | 3857392 |
Organization | Children's Hospital of Philadelphia |
Name | Lauren Mitteer |
Phone | 215-590-3174 |
mitteerl@chop.edu | |
Outcomes
Sequence: | 30857536 | Sequence: | 30857537 | Sequence: | 30857538 | Sequence: | 30857539 | Sequence: | 30857540 | Sequence: | 30857541 | Sequence: | 30857542 | Sequence: | 30857543 | Sequence: | 30857544 | Sequence: | 30857545 | Sequence: | 30857546 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Tolerability of Vitamin E Based on Responses to a Subject/Parent-reported Symptom Questionnaire After Vitamin E Supplementation Compared to Baseline | Title | Plasma Alpha-tocopherol Concentration | Title | Delta-plasma Glucose Concentration | Title | Fasting Plasma Glucose Concentration | Title | Nadir Plasma Glucose Concentration | Title | Fasting Plasma Insulin Concentration | Title | Peak Plasma Insulin Concentration | Title | Delta-plasma Insulin Concentration | Title | Fasting Plasma Ammonia Concentration | Title | Delta-plasma Ammonia Concentration | Title | Hypoglycemia Frequency |
Description | The following symptoms will be scored as either "none" (did not occur)=0, "mild" (minimal symptoms, no treatment needed)=1, "moderate" (symptoms requiring treatment at home or as an outpatient=2, or "severe" (symptoms requiring hospitalization or emergency room visit, or life-threatening or potentially life-threatening symptoms)=4:
Seizure, Headache, Vision change/blurred vision, Weakness, Fatigue, Nausea, Vomiting, Diarrhea, Stomach pain, Constipation, Bruising, Bleeding, Rash, Itching, Other Symptom scores will be summed to yield a Tolerability Questionnaire Score for each participant. The Tolerability Questionnaire Score has a minimum score of 0 (symptoms did not occur) and a maximum score of 60 (all of the measured symptoms occurred, each with severe designation). The number (count) of participants with an increase in Tolerability Questionnaire Score from baseline to 2 weeks (following Vitamin E supplementation) will be reported. |
Description | change in fasting plasma alpha-tocopherol concentration following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in delta-glucose concentration (fasting plasma glucose – nadir plasma glucose during oral protein tolerance test) following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in fasting plasma glucose concentration following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in nadir plasma glucose concentration during oral protein tolerance test following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in fasting plasma insulin concentration following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in peak plasma insulin concentration during oral protein tolerance test following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in delta-plasma insulin concentration (peak plasma insulin – fasting plasma insulin during oral protein tolerance test) following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in fasting plasma ammonia concentration following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in delta-plasma ammonia concentration (plasma ammonia at 60 minutes – fasting plasma ammonia during oral protein tolerance test) following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in frequency of hypoglycemia (plasma glucose <70 mg/dL) detected on home glucose meter following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) |
Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | 2 weeks |
Population | The 2 week (visit 2) laboratory draw was unable to be obtained for 1 participant, yielding n=12 analyzed for this outcome | Population | Per the study protocol, the oral protein tolerance test was not repeated at 2 weeks (visit 2) if the baseline (visit 1) oral protein tolerance test was not tolerated. Of the 13 participants who completed the study, 7 did not tolerate the baseline (visit 1) oral protein tolerance test. The 2 week (visit 2) oral protein tolerance test was performed in 6 participants. Oral protein tolerance test parameters were analyzed for these 6 participants. | Population | The 2 week (visit 2) laboratory draw was unable to be obtained for 1 participant, yielding n=12 analyzed for this outcome | Population | Per the study protocol, the oral protein tolerance test was not repeated at 2 weeks (visit 2) if the baseline (visit 1) oral protein tolerance test was not tolerated. Of the 13 participants who completed the study, 7 did not tolerate the baseline (visit 1) oral protein tolerance test. The 2 week (visit 2) oral protein tolerance test was performed in 6 participants. Oral protein tolerance test parameters were analyzed for these 6 participants. | Population | The 2 week (visit 2) laboratory draw was unable to be obtained for 1 participant, yielding n=12 analyzed for this outcome | Population | Per the study protocol, the oral protein tolerance test was not repeated at 2 weeks (visit 2) if the baseline (visit 1) oral protein tolerance test was not tolerated. Of the 13 participants who completed the study, 7 did not tolerate the baseline (visit 1) oral protein tolerance test. The 2 week (visit 2) oral protein tolerance test was performed in 6 participants. Oral protein tolerance test parameters were analyzed for these 6 participants. | Population | Per the study protocol, the oral protein tolerance test was not repeated at 2 weeks (visit 2) if the baseline (visit 1) oral protein tolerance test was not tolerated. Of the 13 participants who completed the study, 7 did not tolerate the baseline (visit 1) oral protein tolerance test. The 2 week (visit 2) oral protein tolerance test was performed in 6 participants. Oral protein tolerance test parameters were analyzed for these 6 participants. | Population | The 2 week (visit 2) laboratory draw was unable to be obtained for 1 participant, yielding n=12 analyzed for this outcome | Population | The 2 week (visit 2) plasma ammonia at 60 minutes was not obtained in 1 participant in whom the visit 2 oral protein tolerance test was performed, yielding n=5 for analysis of this outcome. | Population | Home glucose meter testing was not performed by 3 participants, yielding n=10 analyzed for this outcome. | ||
Units | Participants | Units | micromolar | Units | mg/dL | Units | mg/dL | Units | mg/dL | Units | uIU/mL | Units | uIU/mL | Units | uIU/mL | Units | micromolar | Units | micromolar | Units | Hypoglycemia events |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Error | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||
Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 236095088 | Sequence: | 236095089 | Sequence: | 236095090 | Sequence: | 236095091 | Sequence: | 236095092 | Sequence: | 236095093 | Sequence: | 236095094 | Sequence: | 236095095 | Sequence: | 236095096 | Sequence: | 236095097 | Sequence: | 236095098 |
Outcome Id | 30857536 | Outcome Id | 30857537 | Outcome Id | 30857538 | Outcome Id | 30857539 | Outcome Id | 30857540 | Outcome Id | 30857541 | Outcome Id | 30857542 | Outcome Id | 30857543 | Outcome Id | 30857544 | Outcome Id | 30857545 | Outcome Id | 30857546 |
Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 | Result Group Id | 56158766 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Title | Tolerability of Vitamin E Based on Responses to a Subject/Parent-reported Symptom Questionnaire After Vitamin E Supplementation Compared to Baseline | Title | Plasma Alpha-tocopherol Concentration | Title | Delta-plasma Glucose Concentration | Title | Fasting Plasma Glucose Concentration | Title | Nadir Plasma Glucose Concentration | Title | Fasting Plasma Insulin Concentration | Title | Peak Plasma Insulin Concentration | Title | Delta-plasma Insulin Concentration | Title | Fasting Plasma Ammonia Concentration | Title | Delta-plasma Ammonia Concentration | Title | Hypoglycemia Frequency |
Description | The following symptoms will be scored as either "none" (did not occur)=0, "mild" (minimal symptoms, no treatment needed)=1, "moderate" (symptoms requiring treatment at home or as an outpatient=2, or "severe" (symptoms requiring hospitalization or emergency room visit, or life-threatening or potentially life-threatening symptoms)=4:
Seizure, Headache, Vision change/blurred vision, Weakness, Fatigue, Nausea, Vomiting, Diarrhea, Stomach pain, Constipation, Bruising, Bleeding, Rash, Itching, Other Symptom scores will be summed to yield a Tolerability Questionnaire Score for each participant. The Tolerability Questionnaire Score has a minimum score of 0 (symptoms did not occur) and a maximum score of 60 (all of the measured symptoms occurred, each with severe designation). The number (count) of participants with an increase in Tolerability Questionnaire Score from baseline to 2 weeks (following Vitamin E supplementation) will be reported. |
Description | change in fasting plasma alpha-tocopherol concentration following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in delta-glucose concentration (fasting plasma glucose – nadir plasma glucose during oral protein tolerance test) following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in fasting plasma glucose concentration following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in nadir plasma glucose concentration during oral protein tolerance test following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in fasting plasma insulin concentration following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in peak plasma insulin concentration during oral protein tolerance test following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in delta-plasma insulin concentration (peak plasma insulin – fasting plasma insulin during oral protein tolerance test) following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in fasting plasma ammonia concentration following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in delta-plasma ammonia concentration (plasma ammonia at 60 minutes – fasting plasma ammonia during oral protein tolerance test) following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) | Description | change in frequency of hypoglycemia (plasma glucose <70 mg/dL) detected on home glucose meter following Vitamin E supplementation (2 weeks [visit 2] – baseline [visit 1]) |
Units | Participants | Units | micromolar | Units | mg/dL | Units | mg/dL | Units | mg/dL | Units | uIU/mL | Units | uIU/mL | Units | uIU/mL | Units | micromolar | Units | micromolar | Units | Hypoglycemia events |
Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 2 | Param Value | 18.6 | Param Value | 1.1 | Param Value | -0.3 | Param Value | 0.01 | Param Value | -2.4 | Param Value | -6.3 | Param Value | -5.2 | Param Value | 1.0 | Param Value | -3.4 | Param Value | 0.6 |
Param Value Num | 2.0 | Param Value Num | 18.6 | Param Value Num | 1.1 | Param Value Num | -0.3 | Param Value Num | 0.01 | Param Value Num | -2.4 | Param Value Num | -6.3 | Param Value Num | -5.2 | Param Value Num | 1.0 | Param Value Num | -3.4 | Param Value Num | 0.6 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Error | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||
Dispersion Value | 12.5 | Dispersion Value | 8.3 | Dispersion Value | 6.5 | Dispersion Value | 9.46 | Dispersion Value | 4.4 | Dispersion Value | 18.2 | Dispersion Value | 16.5 | Dispersion Value | 31.6 | Dispersion Value | 15.5 | Dispersion Value | 2.3 | ||
Dispersion Value Num | 12.5 | Dispersion Value Num | 8.3 | Dispersion Value Num | 6.5 | Dispersion Value Num | 9.46 | Dispersion Value Num | 4.4 | Dispersion Value Num | 18.2 | Dispersion Value Num | 16.5 | Dispersion Value Num | 31.6 | Dispersion Value Num | 15.5 | Dispersion Value Num | 2.3 | ||
Study References
Sequence: | 52159675 | Sequence: | 52159676 | Sequence: | 52159677 | Sequence: | 52159678 | Sequence: | 52159679 | Sequence: | 52159680 | Sequence: | 52159681 | Sequence: | 52159682 | Sequence: | 52159683 | Sequence: | 52159684 |
Pmid | 20936362 | Pmid | 23275527 | Pmid | 11241047 | Pmid | 940710 | Pmid | 19531491 | Pmid | 26287975 | Pmid | 23642196 | Pmid | 23596164 | Pmid | 8429120 | Pmid | 20332361 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Palladino AA, Stanley CA. The hyperinsulinism/hyperammonemia syndrome. Rev Endocr Metab Disord. 2010 Sep;11(3):171-8. doi: 10.1007/s11154-010-9146-0. | Citation | Snider KE, Becker S, Boyajian L, Shyng SL, MacMullen C, Hughes N, Ganapathy K, Bhatti T, Stanley CA, Ganguly A. Genotype and phenotype correlations in 417 children with congenital hyperinsulinism. J Clin Endocrinol Metab. 2013 Feb;98(2):E355-63. doi: 10.1210/jc.2012-2169. Epub 2012 Dec 28. | Citation | Hsu BY, Kelly A, Thornton PS, Greenberg CR, Dilling LA, Stanley CA. Protein-sensitive and fasting hypoglycemia in children with the hyperinsulinism/hyperammonemia syndrome. J Pediatr. 2001 Mar;138(3):383-9. doi: 10.1067/mpd.2001.111818. | Citation | Stanley CA, Baker L. Hyperinsulinism in infancy: diagnosis by demonstration of abnormal response to fasting hypoglycemia. Pediatrics. 1976 May;57(5):702-11. | Citation | Li M, Smith CJ, Walker MT, Smith TJ. Novel inhibitors complexed with glutamate dehydrogenase: allosteric regulation by control of protein dynamics. J Biol Chem. 2009 Aug 21;284(34):22988-3000. doi: 10.1074/jbc.M109.020222. Epub 2009 Jun 15. | Citation | McBurney MI, Yu EA, Ciappio ED, Bird JK, Eggersdorfer M, Mehta S. Suboptimal Serum alpha-Tocopherol Concentrations Observed among Younger Adults and Those Depending Exclusively upon Food Sources, NHANES 2003-20061-3. PLoS One. 2015 Aug 19;10(8):e0135510. doi: 10.1371/journal.pone.0135510. eCollection 2015. | Citation | Ulatowski L, Manor D. Vitamin E trafficking in neurologic health and disease. Annu Rev Nutr. 2013;33:87-103. doi: 10.1146/annurev-nutr-071812-161252. Epub 2013 Apr 29. | Citation | Pfeiffer CM, Sternberg MR, Schleicher RL, Haynes BM, Rybak ME, Pirkle JL. The CDC's Second National Report on Biochemical Indicators of Diet and Nutrition in the U.S. Population is a valuable tool for researchers and policy makers. J Nutr. 2013 Jun;143(6):938S-47S. doi: 10.3945/jn.112.172858. Epub 2013 Apr 17. | Citation | Ferslew KE, Acuff RV, Daigneault EA, Woolley TW, Stanton PE Jr. Pharmacokinetics and bioavailability of the RRR and all racemic stereoisomers of alpha-tocopherol in humans after single oral administration. J Clin Pharmacol. 1993 Jan;33(1):84-8. doi: 10.1002/j.1552-4604.1993.tb03909.x. | Citation | Treberg JR, Clow KA, Greene KA, Brosnan ME, Brosnan JT. Systemic activation of glutamate dehydrogenase increases renal ammoniagenesis: implications for the hyperinsulinism/hyperammonemia syndrome. Am J Physiol Endocrinol Metab. 2010 Jun;298(6):E1219-25. doi: 10.1152/ajpendo.00028.2010. Epub 2010 Mar 23. |
Baseline Counts
Sequence: | 11400192 |
Result Group Id | 56158764 |
Ctgov Group Code | BG000 |
Units | Participants |
Scope | overall |
Count | 14 |
Result Groups
Sequence: | 56158764 | Sequence: | 56158765 | Sequence: | 56158766 | Sequence: | 56158767 | Sequence: | 56158768 | Sequence: | 56158769 | Sequence: | 56158770 | Sequence: | 56158771 |
Ctgov Group Code | BG000 | Ctgov Group Code | FG000 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 |
Result Type | Baseline | Result Type | Participant Flow | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event |
Title | Vitamin E Supplementation | Title | Vitamin E Supplementation | Title | Vitamin E Supplementation | Title | Vitamin E Supplementation (All Doses) | Title | Vitamin E 150 IU | Title | Vitamin E 300 IU | Title | Vitamin E 450 IU | Title | Vitamin E 600 IU |
Description | Daily oral supplementation with Vitamin E (alpha-tocopherol) for 2 weeks.
Vitamin E: Subjects will take an oral Vitamin E (alpha-tocopherol) supplement once daily with a fat-containing meal for 2 weeks. The dose will be based on subject age (150 IU if 1-3 years old, 300 IU if 4-8 years old, 450 IU if 9-17 years old, 600 IU if >17 years old). Formulations include 50 IU/mL liquid and 200 IU capsules. The liquid formulation will be used for subjects who will receive <600 IU daily, or for any subjects who prefer liquid medication to capsules. |
Description | Daily oral supplementation with Vitamin E (alpha-tocopherol) for 2 weeks.
Vitamin E: Subjects will take an oral Vitamin E (alpha-tocopherol) supplement once daily with a fat-containing meal for 2 weeks. The dose will be based on subject age (150 IU if 1-3 years old, 300 IU if 4-8 years old, 450 IU if 9-17 years old, 600 IU if >17 years old). Formulations include 50 IU/mL liquid and 200 IU capsules. The liquid formulation will be used for subjects who will receive <600 IU daily, or for any subjects who prefer liquid medication to capsules. |
Description | Daily oral supplementation with Vitamin E (alpha-tocopherol) for 2 weeks.
Vitamin E: Subjects will take an oral Vitamin E (alpha-tocopherol) supplement once daily with a fat-containing meal for 2 weeks. The dose will be based on subject age (150 IU if 1-3 years old, 300 IU if 4-8 years old, 450 IU if 9-17 years old, 600 IU if >17 years old). Formulations include 50 IU/mL liquid and 200 IU capsules. The liquid formulation will be used for subjects who will receive <600 IU daily, or for any subjects who prefer liquid medication to capsules. |
Description | Daily oral supplementation with Vitamin E (alpha-tocopherol) for 2 weeks.
Vitamin E: Subjects will take an oral Vitamin E (alpha-tocopherol) supplement once daily with a fat-containing meal for 2 weeks. The dose will be based on subject age (150 IU if 1-3 years old, 300 IU if 4-8 years old, 450 IU if 9-17 years old, 600 IU if >17 years old). Formulations include 50 IU/mL liquid and 200 IU capsules. The liquid formulation will be used for subjects who will receive <600 IU daily, or for any subjects who prefer liquid medication to capsules. |
Description | Daily oral supplementation with Vitamin E (alpha-tocopherol) 150 IU for 2 weeks. | Description | Daily oral supplementation with Vitamin E (alpha-tocopherol) 300 IU for 2 weeks. | Description | Daily oral supplementation with Vitamin E (alpha-tocopherol) 450 IU for 2 weeks. | Description | Daily oral supplementation with Vitamin E (alpha-tocopherol) 600 IU for 2 weeks. |
Baseline Measurements
Sequence: | 125823470 | Sequence: | 125823471 | Sequence: | 125823472 | Sequence: | 125823473 | Sequence: | 125823474 | Sequence: | 125823475 | Sequence: | 125823476 | Sequence: | 125823477 | Sequence: | 125823478 | Sequence: | 125823479 | Sequence: | 125823480 | Sequence: | 125823481 | Sequence: | 125823482 |
Result Group Id | 56158764 | Result Group Id | 56158764 | Result Group Id | 56158764 | Result Group Id | 56158764 | Result Group Id | 56158764 | Result Group Id | 56158764 | Result Group Id | 56158764 | Result Group Id | 56158764 | Result Group Id | 56158764 | Result Group Id | 56158764 | Result Group Id | 56158764 | Result Group Id | 56158764 | Result Group Id | 56158764 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 |
Category | Female | Category | Male | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Unknown or Not Reported | Category | American Indian or Alaska Native | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | White | Category | More than one race | Category | Unknown or Not Reported | ||
Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) |
Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Median | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 8 | Param Value | 9 | Param Value | 5 | Param Value | 1 | Param Value | 12 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 5 | Param Value | 6 | Param Value | 0 | Param Value | 2 |
Param Value Num | 8.0 | Param Value Num | 9.0 | Param Value Num | 5.0 | Param Value Num | 1.0 | Param Value Num | 12.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 5.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 2.0 |
Dispersion Type | Full Range | ||||||||||||||||||||||||
Dispersion Lower Limit | 2.0 | ||||||||||||||||||||||||
Dispersion Upper Limit | 28.0 | ||||||||||||||||||||||||
Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 |
]]>
https://zephyrnet.com/NCT03797209
2019-01-15
https://zephyrnet.com/?p=NCT03797209
NCT03797209https://www.clinicaltrials.gov/study/NCT03797209?tab=tableNANANATo detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.
<![CDATA[
Studies
Study First Submitted Date | 2018-09-25 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-03-18 |
Start Month Year | January 15, 2019 |
Primary Completion Month Year | October 30, 2020 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-03-18 |
Facilities
Sequence: | 201260406 | Sequence: | 201260407 | Sequence: | 201260408 | Sequence: | 201260409 | Sequence: | 201260410 | Sequence: | 201260411 | Sequence: | 201260412 | Sequence: | 201260413 | Sequence: | 201260414 | Sequence: | 201260415 | Sequence: | 201260416 | Sequence: | 201260417 | Sequence: | 201260418 | Sequence: | 201260419 | Sequence: | 201260420 | Sequence: | 201260421 | Sequence: | 201260422 | Sequence: | 201260423 | Sequence: | 201260424 | Sequence: | 201260425 | Sequence: | 201260426 | Sequence: | 201260427 | Sequence: | 201260428 | Sequence: | 201260429 | Sequence: | 201260430 | Sequence: | 201260431 | Sequence: | 201260432 | Sequence: | 201260433 | Sequence: | 201260434 | Sequence: | 201260435 | Sequence: | 201260436 | Sequence: | 201260437 | Sequence: | 201260438 | Sequence: | 201260439 | Sequence: | 201260440 | Sequence: | 201260441 | Sequence: | 201260442 | Sequence: | 201260443 | Sequence: | 201260444 | Sequence: | 201260445 |
Name | Aichi Medical University Hospital | Name | Aichi Cancer Center Hospital | Name | Nagoya University Hospital | Name | Chiba University Hospital | Name | Kameda Medical Center | Name | National Cancer Center Hospital East | Name | Tokyo Women's Medical University Yachiyo Medical Center | Name | National Hospital Organization Kyushu Medical Center | Name | Kyushu University Hospital | Name | Teine Keijinkai Hospital | Name | Kobe University Hospital | Name | Hyogo College of Medicine Hospital | Name | Kagoshima University Hospital | Name | Shonan Kamakura General Hospital | Name | Kitasato University Hospital | Name | Yokohama Rosai Hospital | Name | Yokohama City University Medical Center | Name | Mie University Hospital | Name | Tohoku University Hospital | Name | Sendai Open Hospital | Name | University of Miyazaki Hospital | Name | Niigata University Medical and Dental Hospital | Name | Kawasaki Medical School General Medical Center | Name | Okayama University Hospital | Name | Osaka City University Hospital | Name | Kindai University Hospital | Name | Osaka Medical College Hospital | Name | Saitama Medical Universtity International Medical Center | Name | Saitama Medical Center | Name | Kitasato University Medical Center | Name | Tokyo Medical University Hospital | Name | Jichi Medical University Hospital | Name | Saiseikai Utsunomiya Hospital | Name | Juntendo University Hospital | Name | Toho University Ohashi Medical Center | Name | The Jikei University Hospital | Name | Kyorin University Hospital | Name | Keio University Hospital | Name | Tokyo Women's Medical University Hospital | Name | Wakayama Medical University Hospital |
City | Nagakute-Shi | City | Nagoya-Shi | City | Nagoya-Shi | City | Chiba-Shi | City | Kamogawa-Shi | City | Kashiwa-Shi | City | Yachiyo-Shi | City | Fukuoka-Shi | City | Fukuoka-Shi | City | Sapporo-Shi | City | Kobe-Shi | City | Nishinomiya-Shi | City | Kagoshima-Shi | City | Kamakura-Shi | City | Sagamihara-Shi | City | Yokohama-Shi | City | Yokohama-Shi | City | Tsu-Shi | City | Sendai-Shi | City | Sendai-Shi | City | Miyazaki-Shi | City | Niigata-Shi | City | Okayama-Shi | City | Okayama-Shi | City | Osaka-Shi | City | Osakasayama-Shi | City | Takatsuki-Shi | City | Hidaka-Shi | City | Kawagoe-Shi | City | Kitamoto-Shi | City | Tokyo | City | Shimotsuke-Shi | City | Utsunomiya-Shi | City | Bunkyo-Ku | City | Meguro-Ku | City | Minato-Ku | City | Mitaka-Shi | City | Shinjuku-Ku | City | Shinjuku-Ku | City | Wakayama-Shi |
State | Aichi | State | Aichi | State | Aichi | State | Chiba | State | Chiba | State | Chiba | State | Chiba | State | Fukuoka | State | Fukuoka | State | Hokkaido | State | Hyogo | State | Hyogo | State | Kagoshima | State | Kanagawa | State | Kanagawa | State | Kanagawa | State | Kanagawa | State | Mie | State | Miyagi | State | Miyagi | State | Miyazaki | State | Niigata | State | Okayama | State | Okayama | State | Osaka | State | Osaka | State | Osaka | State | Saitama | State | Saitama | State | Saitama | State | Shinjuku-Ku | State | Tochigi | State | Tochigi | State | Tokyo | State | Tokyo | State | Tokyo | State | Tokyo | State | Tokyo | State | Tokyo | State | Wakayama |
Zip | 480-1195 | Zip | 464-8681 | Zip | 466-8560 | Zip | 260-8677 | Zip | 296-8602 | Zip | 277-8577 | Zip | 276-8524 | Zip | 810-8563 | Zip | 812-8582 | Zip | 006-8555 | Zip | 650-0017 | Zip | 663-8501 | Zip | 890-8520 | Zip | 247-8533 | Zip | 252-0375 | Zip | 222-0036 | Zip | 232-0024 | Zip | 514-8507 | Zip | 980-8574 | Zip | 983-0824 | Zip | 889-1692 | Zip | 951-8520 | Zip | 700-8505 | Zip | 700-8558 | Zip | 545-8586 | Zip | 589-8511 | Zip | 569-8686 | Zip | 350-1298 | Zip | 350-8550 | Zip | 364-8501 | Zip | 160-0023 | Zip | 329-0498 | Zip | 321-0974 | Zip | 113-8431 | Zip | 153-8515 | Zip | 105-8471 | Zip | 181-8611 | Zip | 160-8582 | Zip | 162-8666 | Zip | 641-8510 |
Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan |
Conditions
Sequence: | 52498478 | Sequence: | 52498479 | Sequence: | 52498480 | Sequence: | 52498481 |
Name | Pancreatic Pseudocyst Infection | Name | Pancreatic Pseudocyst | Name | Walled Off Necrosis Infection | Name | Walled Off Necrosis |
Downcase Name | pancreatic pseudocyst infection | Downcase Name | pancreatic pseudocyst | Downcase Name | walled off necrosis infection | Downcase Name | walled off necrosis |
Id Information
Sequence: | 40392583 |
Id Source | org_study_id |
Id Value | E7121 |
Countries
Sequence: | 42828516 |
Name | Japan |
Removed | False |
Design Groups
Sequence: | 55954442 |
Title | AXIOS Patient |
Interventions
Sequence: | 52806558 |
Intervention Type | Device |
Name | EUS-guided fistulization AXIOS |
Description | By using a convex type ultrasonic endoscope to form a fistula by gastrointestinal puncture, to perform various drainage. |
Keywords
Sequence: | 80312101 | Sequence: | 80312102 |
Name | PPC | Name | WON |
Downcase Name | ppc | Downcase Name | won |
Design Outcomes
Sequence: | 178601361 | Sequence: | 178601362 | Sequence: | 178601363 | Sequence: | 178601364 | Sequence: | 178601365 | Sequence: | 178601366 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Safety (Adverse Events and Device Malfunction) | Measure | Placement success | Measure | Stent retention | Measure | Stent lumen patency | Measure | Decreased cyst size | Measure | Removal success |
Time Frame | From implant procedure to 7 days after removal | Time Frame | During implant procedure | Time Frame | From implant procedure to removal (a maximum of 60 days) | Time Frame | From implant procedure to removal (a maximum of 60 days) | Time Frame | From implant procedure to final observation (a maximum of 60 days) | Time Frame | Removal procedure (a maximum of 60 days after implant procedure) |
Description | AXIOS stent is placed in an appropriate position using the delivery system. | Description | AXIOS stent stays at the position where it was implanted during the implant procedure. | Description | The lumen of AXIOS stent is patent, and it can be used for drainage etc. | Description | AXIOS stent can be removed using standard endoscopic snares or forceps. |
Browse Conditions
Sequence: | 194735127 | Sequence: | 194735128 | Sequence: | 194735129 | Sequence: | 194735130 | Sequence: | 194735131 | Sequence: | 194735132 | Sequence: | 194735133 | Sequence: | 194735134 | Sequence: | 194735135 | Sequence: | 194735136 | Sequence: | 194735137 |
Mesh Term | Infections | Mesh Term | Communicable Diseases | Mesh Term | Pancreatic Pseudocyst | Mesh Term | Necrosis | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes | Mesh Term | Pancreatic Cyst | Mesh Term | Cysts | Mesh Term | Neoplasms | Mesh Term | Pancreatic Diseases | Mesh Term | Digestive System Diseases |
Downcase Mesh Term | infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | pancreatic pseudocyst | Downcase Mesh Term | necrosis | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | pancreatic cyst | Downcase Mesh Term | cysts | Downcase Mesh Term | neoplasms | Downcase Mesh Term | pancreatic diseases | Downcase Mesh Term | digestive system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48622573 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Boston Scientific Japan K.K. |
Design Group Interventions
Sequence: | 68594973 |
Design Group Id | 55954442 |
Intervention Id | 52806558 |
Eligibilities
Sequence: | 30952156 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Patient who received implant procedure using study device at Japanese site. |
Criteria | Inclusion Criteria:
Patient who received implant procedure using study device at Japanese site. Exclusion Criteria: NA |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 253860908 |
Number Of Facilities | 40 |
Registered In Calendar Year | 2018 |
Actual Duration | 21 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Number Of Primary Outcomes To Measure | 6 |
Designs
Sequence: | 30697742 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 29064500 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797196
2019-07-29
https://zephyrnet.com/?p=NCT03797196
NCT03797196https://www.clinicaltrials.gov/study/NCT03797196?tab=tableNANANAOpen label, randomized, multicenter, intervention trial comparing standard immunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen in combination with everolimus.
The primary objective is to test the hypothesis that an age-adapted immunosuppressive regimen targeted at reduced immunosuppression with low calcineurin inhibitor (tacrolimus) exposure in combination with everolimus will result in improved outcome in elderly recipients of A: Kidneys from older deceased donors (>64 years) and B: Kidneys from living donors (all ages) and younger deceased donors (<65 years).
<![CDATA[
Studies
Study First Submitted Date | 2018-12-11 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-05-10 |
Start Month Year | July 29, 2019 |
Primary Completion Month Year | June 2025 |
Verification Month Year | May 2023 |
Verification Date | 2023-05-31 |
Last Update Posted Date | 2023-05-10 |
Detailed Descriptions
Sequence: | 20842151 |
Description | In this study two immunosuppressive regimes will be tested; In both groups basiliximab induction will be applied. Additionally, the standard therapy consisting of prednisolone, mycophenolic acid and tacrolimus once-daily (Envarsus®), or the comparator in which mycophenolic acid will be replaced by everolimus combined with strongly reduced levels of tacrolimus once-daily (Envarsus®). When not tolerated,tacrolimus may be replaced by ciclosporin. The hypothesis is that reduced calcineurin inhibitor (CNI) exposure in combination with everolimus will lead to improved allograft function, a reduced incidence of complications and improved quality of life.
This study will consist of two strata: Stratum A: Elderly recipients (≥65 years) of kidneys from elderly deceased donors (≥65 years) within the Eurotransplant Senior Program. Stratum B: Elderly recipients (≥65 years) of kidneys from living donors (all ages) or deceased donors (<65 years). The primary endpoint will be "successful transplantation" which is defined as survival with a functioning allograft with a minimum estimated GFR of 30 ml/min per 1.73 m2 in stratum A and 45 ml/min per 1.73 m2 in stratum B, after 2 years. The study will be performed by the Dutch transplant centers and the Dutch Kidney Patient Organization (NVN) will participate. |
Facilities
Sequence: | 201202008 | Sequence: | 201202009 | Sequence: | 201202010 | Sequence: | 201202011 | Sequence: | 201202012 | Sequence: | 201202013 | Sequence: | 201202014 |
Name | Leuven University Hospital | Name | Amsterdam UMC | Name | UMCG | Name | LUMC | Name | Radboud University Hospital | Name | Erasmus MC | Name | UMCU |
City | Leuven | City | Amsterdam | City | Groningen | City | Leiden | City | Nijmegen | City | Rotterdam | City | Utrecht |
Country | Belgium | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands |
Browse Interventions
Sequence: | 96551523 | Sequence: | 96551524 | Sequence: | 96551525 | Sequence: | 96551526 | Sequence: | 96551527 | Sequence: | 96551528 | Sequence: | 96551529 | Sequence: | 96551530 | Sequence: | 96551531 | Sequence: | 96551532 | Sequence: | 96551533 | Sequence: | 96551534 | Sequence: | 96551535 | Sequence: | 96551536 | Sequence: | 96551537 | Sequence: | 96551538 | Sequence: | 96551539 |
Mesh Term | Mycophenolic Acid | Mesh Term | Everolimus | Mesh Term | Tacrolimus | Mesh Term | Immunosuppressive Agents | Mesh Term | Immunologic Factors | Mesh Term | Physiological Effects of Drugs | Mesh Term | Calcineurin Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | MTOR Inhibitors | Mesh Term | Protein Kinase Inhibitors | Mesh Term | Antineoplastic Agents | Mesh Term | Antibiotics, Antineoplastic | Mesh Term | Antibiotics, Antitubercular | Mesh Term | Antitubercular Agents | Mesh Term | Anti-Bacterial Agents | Mesh Term | Anti-Infective Agents |
Downcase Mesh Term | mycophenolic acid | Downcase Mesh Term | everolimus | Downcase Mesh Term | tacrolimus | Downcase Mesh Term | immunosuppressive agents | Downcase Mesh Term | immunologic factors | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | calcineurin inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | mtor inhibitors | Downcase Mesh Term | protein kinase inhibitors | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | antibiotics, antineoplastic | Downcase Mesh Term | antibiotics, antitubercular | Downcase Mesh Term | antitubercular agents | Downcase Mesh Term | anti-bacterial agents | Downcase Mesh Term | anti-infective agents |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52480057 | Sequence: | 52480058 | Sequence: | 52480059 |
Name | Renal Transplant Recipients | Name | Elderly Patients | Name | Immunosuppression |
Downcase Name | renal transplant recipients | Downcase Name | elderly patients | Downcase Name | immunosuppression |
Id Information
Sequence: | 40379676 |
Id Source | org_study_id |
Id Value | OPTIMIZE |
Countries
Sequence: | 42815397 | Sequence: | 42815398 |
Name | Belgium | Name | Netherlands |
Removed | False | Removed | False |
Design Groups
Sequence: | 55936121 | Sequence: | 55936122 |
Group Type | Active Comparator | Group Type | Experimental |
Title | group 1 | Title | group 2 |
Description | standard tacrolimus with mycophenolate mofetil | Description | low dose tacrolimus with everolimus |
Interventions
Sequence: | 52789740 | Sequence: | 52789741 |
Intervention Type | Drug | Intervention Type | Drug |
Name | low dose tacrolimus in combination with everolimus | Name | standard dose tacrolimus with mycophenolate mofetil |
Description | a low exposure Tacrolimus once-daily (Envarsus®) regimen in combination with Everolimus will be evaluated in elderly transplant recipients | Description | A standard Tacrolimus once-daily (Envarsus) regimen in combination with Everolimus will be evaluated in elderly transplant recipients |
Design Outcomes
Sequence: | 178538074 | Sequence: | 178538075 | Sequence: | 178538076 | Sequence: | 178538077 | Sequence: | 178538078 | Sequence: | 178538079 | Sequence: | 178538080 | Sequence: | 178538081 | Sequence: | 178538082 | Sequence: | 178538083 | Sequence: | 178538084 | Sequence: | 178538085 | Sequence: | 178538086 | Sequence: | 178538087 | Sequence: | 178538088 | Sequence: | 178538089 | Sequence: | 178538090 | Sequence: | 178538091 | Sequence: | 178538092 | Sequence: | 178538093 | Sequence: | 178538094 | Sequence: | 178538095 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other |
Measure | successful transplantation | Measure | death | Measure | graft loss | Measure | acute rejection | Measure | eGFR | Measure | type of rejection treatment | Measure | The evolution of renal function (eGFR) and creatinine clearance over time by slope analysis | Measure | The incidence of adverse events, serious adverse events and adverse reactions | Measure | The incidence of clinically relevant infections, post transplantation diabetes mellitus, malignancies and cardiovascular events | Measure | Presence of frailty after transplantation and change in frailty from baseline frailty from baseline | Measure | Physical functioning and changes over time | Measure | Cognitive functioning and changes over time | Measure | Presence of T-cell immunosenescence at 12 and 24 months and changes from baseline | Measure | HRQoL at 0, 12 and 24 months and changes from baseline | Measure | Development of donor-specific anti-HLA antibodies (DSA) | Measure | Difference in illness perception at 0, 12 and 24 months and changes from baseline | Measure | Difference in adherence of immunosuppressive medication at 12 and 24 months | Measure | Difference in symptoms at 0, 12 and 24 months and changes from baseline | Measure | Difference in iBOX predicted outcome at 3, 5 and 7 years | Measure | Development of a pharmacokinetic model for tacrolimus once-daily (Envarsus®), using data on AUC's | Measure | o evaluate the response to the COIVD-19 vaccine and identify possible differences between both treatment groups at the University Medical Center Groningen. | Measure | Evaluation of Cost-effectiveness of the new immunosuppressive regimen, and comparison to the current standard of care |
Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 12 and 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 12 and 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months |
Description | The overall primary study endpoint "successful transplantation" as defined for the individual strata and analyzed for the whole study population.
Stratum A: Primary endpoint: successful transplantation at two years after transplantation defined as: absence of graft or patient loss in the presence of an eGFR above 30 ml/min/1.73m2. Stratum B: Primary endpoint: successful transplantation at two years after transplantation defined as absence of graft or patient loss in the presence of an eGFR above 45 ml/min/1.73m2 |
Description | patient survival | Description | graft survival | Description | treated biopsy-proven rejection (tBPAR) | Description | estimated Glomerular Filtration Rate below 30 and 45 ml/min/1.73m2 | Description | type of rejection treatment will be scored by questionnaire to the treating nephrologist | Description | The evolution of renal function (eGFR) and creatinine clearance over time by slope analysis | Description | The incidence of adverse events, serious adverse events and adverse reactions | Description | The incidence of clinically relevant infections, post transplantation diabetes, malignancies and cardiovascular events | Description | frailty is measured by clinical frailty score, hand grip strength and fried frailty index | Description | Short Physical Performance Battery | Description | Montreal Cognitive Assessment | Description | T cell differentiation, exhaustion and telomere length will be assessed by flowcytometry | Description | Questionnaire: EQ-5D and SF-12 | Description | DSA as measured by Luminex | Description | Questionnaire: Brief Illness Perception Questionnaire | Description | Questionnaire: Basel Assessment of Adherence to Immunosuppressive Medication Scale | Description | Questionnaire: Dialysis Symptom Index with additional items from the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59 | Description | Based on the available data | Description | In addition to trough levels, additional AUC's will be withdrawn at the Leiden University Medical Center as routine patient care on week 2 and 6. | Description | Humoral and T-cell response | Description | Cost-effectiveness of the immunosuppressive regimen will be evaluated using state-of-the-art health-economic techniques; costs and effectiveness of immunosuppressive therapy will be derived from the study |
Sponsors
Sequence: | 48606319 | Sequence: | 48606320 | Sequence: | 48606321 | Sequence: | 48606322 | Sequence: | 48606323 | Sequence: | 48606324 | Sequence: | 48606325 | Sequence: | 48606326 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | University Medical Center Groningen | Name | Radboud University Medical Center | Name | Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA) | Name | Amsterdam UMC, location VUmc | Name | UMC Utrecht | Name | Leiden University Medical Center | Name | Erasmus Medical Center | Name | Universitaire Ziekenhuizen KU Leuven |
Overall Officials
Sequence: | 29447209 | Sequence: | 29447210 | Sequence: | 29447211 | Sequence: | 29447212 | Sequence: | 29447213 | Sequence: | 29447214 | Sequence: | 29447215 | Sequence: | 29447216 | Sequence: | 29447217 |
Role | Principal Investigator | Role | Principal Investigator | Role | Study Chair | Role | Study Director | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator |
Name | Dennis Hesselink, MD, PhD | Name | Frederike Bemelman, Md, PhD | Name | Stefan Berger, Md, PhD | Name | Jan-Stephan Sanders, MD, PhD | Name | Azam Nurmohamed, Md, PhD | Name | Aiko De Vries, MD, PhD | Name | Luuk Hilbrands, Md, PhD | Name | Arjan Van Zuilen, MD, PhD | Name | Dirk Kuypers, MD, PhD |
Affiliation | EMC | Affiliation | AIDS Malignancy Consortium | Affiliation | UMCG | Affiliation | UMCG | Affiliation | VUMC | Affiliation | LUMC | Affiliation | Radboud MC | Affiliation | UMCU | Affiliation | Leuven MC |
Design Group Interventions
Sequence: | 68572130 | Sequence: | 68572131 |
Design Group Id | 55936122 | Design Group Id | 55936121 |
Intervention Id | 52789740 | Intervention Id | 52789741 |
Eligibilities
Sequence: | 30942493 |
Gender | All |
Minimum Age | 65 Years |
Maximum Age | 99 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Written informed consent must be obtained before any assessment is performed Exclusion Criteria: Exclusion criteria for both stratum A and B Subject is a multi-organ transplant recipient |
Adult | False |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254283175 |
Number Of Facilities | 7 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 65 |
Maximum Age Num | 99 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 20 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30688103 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29054840 |
Responsible Party Type | Principal Investigator |
Name | J.S.F. Sanders |
Title | principal investigator, head of renal transplant program UMCG |
Affiliation | University Medical Center Groningen |
Study References
Sequence: | 52389469 |
Pmid | 34078323 |
Reference Type | derived |
Citation | de Boer SE, Sanders JSF, Bemelman FJ, Betjes MGH, Burgerhof JGM, Hilbrands L, Kuypers D, van Munster BC, Nurmohamed SA, de Vries APJ, van Zuilen AD, Hesselink DA, Berger SP. Rationale and design of the OPTIMIZE trial: OPen label multicenter randomized trial comparing standard IMmunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen In combination with everolimus in de novo renal transplantation in Elderly patients. BMC Nephrol. 2021 Jun 2;22(1):208. doi: 10.1186/s12882-021-02409-8. |
]]>
https://zephyrnet.com/NCT03797183
2019-05-03
https://zephyrnet.com/?p=NCT03797183
NCT03797183https://www.clinicaltrials.gov/study/NCT03797183?tab=tableEmily DeBoer, MDemily.deboer@childrenscolorado.org720-777-4953The purpose of this study is to evaluate the Genesis Electrical Impedance Tomography (EIT) imaging system for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls. The EIT does not use radiation, and is read through electrodes.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-28 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-07-27 |
Start Month Year | May 3, 2019 |
Primary Completion Month Year | November 30, 2023 |
Verification Month Year | July 2023 |
Verification Date | 2023-07-31 |
Last Update Posted Date | 2023-07-27 |
Detailed Descriptions
Sequence: | 20580086 |
Description | The purpose of this study is to evaluate EIT for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls.
Researchers will use EIT to determine changes in regional ventilation with pulmonary interventions including airway clearance and invasive and noninvasive ventilation in a pediatric respiratory disease population. |
Facilities
Sequence: | 198680614 |
Status | Recruiting |
Name | Children's Hospital Colorado |
City | Aurora |
State | Colorado |
Zip | 80045 |
Country | United States |
Facility Contacts
Sequence: | 27949979 | Sequence: | 27949980 |
Facility Id | 198680614 | Facility Id | 198680614 |
Contact Type | primary | Contact Type | backup |
Name | Emily DeBoer, MD | Name | Allison Keck |
emily.deboer@childrenscolorado.org | allison.keck@childrenscolorado.org | ||
Phone | 720-777-4953 | Phone | 720-777-0734 |
Conditions
Sequence: | 51805985 | Sequence: | 51805986 | Sequence: | 51805987 | Sequence: | 51805988 | Sequence: | 51805989 | Sequence: | 51805990 |
Name | Premature Infant | Name | Chronic Respiratory Disease | Name | Neuromuscular Diseases | Name | Healthy | Name | Bronchopulmonary Dysplasia | Name | Pulmonary Vein Stenoses |
Downcase Name | premature infant | Downcase Name | chronic respiratory disease | Downcase Name | neuromuscular diseases | Downcase Name | healthy | Downcase Name | bronchopulmonary dysplasia | Downcase Name | pulmonary vein stenoses |
Id Information
Sequence: | 39867740 |
Id Source | org_study_id |
Id Value | 18-1843 |
Countries
Sequence: | 42266301 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55226126 | Sequence: | 55226127 | Sequence: | 55226128 | Sequence: | 55226129 | Sequence: | 55226130 | Sequence: | 55226131 | Sequence: | 55226132 |
Title | Premature Infants | Title | Chronic Respiratory Disease | Title | Neuromuscular Disease | Title | Healthy Controls | Title | V/Q Scan validation | Title | Premature Infants (Longitudinal Cohort) | Title | Pulmonary Vein/Artery Stenosis |
Description | Premature infants >1 month of age currently hospitalized with bronchopulmonary dysplasia (BPD) without acute respiratory infection | Description | Participants ages >1 month-21 years with chronic respiratory disease due to underlying neuromuscular disease | Description | Participants ages 21-40 years with confirmed neuromuscular disease with an echo completed within the preceding 12 months of study participation of Duchenne muscular dystrophy (DMD) or other diagnoses associated with mild cardiomyopathy | Description | Age and height matched healthy controls | Description | Adults or children who are having or have recently had a V/Q scan | Description | Premature infants ages 2 weeks to 1 year with diagnosed or suspected bronchopulmonary dysplasia | Description | Children age 2 months to 18 years, who will be undergoing cardiac catheterization for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis |
Design Outcomes
Sequence: | 176201925 | Sequence: | 176201926 | Sequence: | 176201927 | Sequence: | 176201928 | Sequence: | 176201929 | Sequence: | 176201930 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung. | Measure | Regional conductivity changes due to ventilation | Measure | Waveform for a mesh element | Measure | Regional conductivity changes due to perfusion | Measure | Regional pulsatile perfusion imaging at the end of systole | Measure | Power waveform (computed as the inner product of measured voltages and applied currents) |
Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 5 minutes | Time Frame | 24 months |
Description | These images will be analyzed both visually for qualitative abnormalities and through quantitative pixel analysis that can provide information regarding lung volume, blood volume, and changes in either based on respiratory cycle, cardiac cycle, or intervention. Areas of low ventilation (atelectasis and consolidation) will be identified. | Description | Describe regional ventilation in pediatric respiratory disease populations including neuromuscular weakness, skeletal/chest wall disorders, and chronic airway and parenchymal lung disease including bronchopulmonary dysplasia.
This is a qualitative aim and will summarize EIT images pictorially. Pixel densities will be evaluated for normality and summarized as mean (SD) or median (interquartile range). EIT images will be qualitatively compared between cases and controls. |
Description | Time-series waveform indicated by time in seconds compared to Recon signal (au). | Description | This is a qualitative and quantitative aim. Results will qualitatively compare EIT images with CXR and CT scan images when available. Images will be displayed side by side and interpreted by both the clinician and the EIT study staff. Various summary measures of EIT outcomes will be calculated including pixel heterogeneity, summary changes over tidal breath and variation between tidal peaks. Pearson and Spearman correlation will be calculated between summary EIT outcomes and continuous primary clinical values. Linear and logistic regression will be used to estimate associations (with 95% CI) between EIT measures and clinical outcomes. Summary data will be presented in tables and figures using basic descriptive statistics stratified by study group. |
Browse Conditions
Sequence: | 192015435 | Sequence: | 192015429 | Sequence: | 192015430 | Sequence: | 192015431 | Sequence: | 192015432 | Sequence: | 192015433 | Sequence: | 192015434 | Sequence: | 192015436 | Sequence: | 192015437 | Sequence: | 192015438 | Sequence: | 192015439 | Sequence: | 192015440 | Sequence: | 192015441 |
Mesh Term | Lung Injury | Mesh Term | Respiratory Tract Diseases | Mesh Term | Respiration Disorders | Mesh Term | Bronchopulmonary Dysplasia | Mesh Term | Neuromuscular Diseases | Mesh Term | Stenosis, Pulmonary Vein | Mesh Term | Ventilator-Induced Lung Injury | Mesh Term | Lung Diseases | Mesh Term | Infant, Premature, Diseases | Mesh Term | Infant, Newborn, Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases |
Downcase Mesh Term | lung injury | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | respiration disorders | Downcase Mesh Term | bronchopulmonary dysplasia | Downcase Mesh Term | neuromuscular diseases | Downcase Mesh Term | stenosis, pulmonary vein | Downcase Mesh Term | ventilator-induced lung injury | Downcase Mesh Term | lung diseases | Downcase Mesh Term | infant, premature, diseases | Downcase Mesh Term | infant, newborn, diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47978754 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Colorado, Denver |
Central Contacts
Sequence: | 11935320 |
Contact Type | primary |
Name | Emily DeBoer, MD |
Phone | 720-777-4953 |
emily.deboer@childrenscolorado.org | |
Role | Contact |
Eligibilities
Sequence: | 30550792 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 14 Days |
Maximum Age | 40 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls. Populations who will be undergoing cardiac catheterization for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis |
Criteria | Inclusion Criteria:
2 weeks old – 40 years old Exclusion Criteria: <2 weeks of age |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254231767 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 14 |
Maximum Age Num | 40 |
Minimum Age Unit | Days |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30299161 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28677729 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797170
2019-04-02
https://zephyrnet.com/?p=NCT03797170
NCT03797170https://www.clinicaltrials.gov/study/NCT03797170?tab=tableNANANAIn Europe diffuse large B-cell lymphoma (DLBCL) is a rare disease whereas in Italy it is not. Approximately 40% of DLBCL patients has refractory disease or will relapse after initial response. In onco-hematology, a role for gut microbiota (GM) in mediating immune activation in response to chemotherapy, has been suggested. In this scenario, the Investigators hypothesized that GM could play an important role in DLBCL prognosis and response to treatment, establishing a connection between lifestyle and clinical response. The project is aimed to the study of the functional GM layout in association with specific patterns of treatment response in de novo DLBCL undergoing standard first line chemo-immunotherapy. Results may build the scientific basis to design new and personalized intervention strategies (both in treatment approach and in life-style recommendations), to enhance clinical response and reduction of disease refractoriness through modulation of the gut microbial ecosystem.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-19 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-02-08 |
Start Month Year | April 2, 2019 |
Primary Completion Month Year | July 20, 2023 |
Verification Month Year | February 2023 |
Verification Date | 2023-02-28 |
Last Update Posted Date | 2023-02-08 |
Facilities
Sequence: | 201130765 | Sequence: | 201130766 |
Name | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) | Name | Institute Of Hematology "Seràgnoli" |
City | Meldola | City | Bologna |
State | FC | ||
Zip | 40138 | ||
Country | Italy | Country | Italy |
Conditions
Sequence: | 52459377 |
Name | Diffuse Large B Cell Lymphoma |
Downcase Name | diffuse large b cell lymphoma |
Id Information
Sequence: | 40364771 | Sequence: | 40364772 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | Oncopassport | Id Value | RF-2016-02363730 |
Id Type | Other Grant/Funding Number | ||
Id Type Description | Italian Ministry of Health | ||
Countries
Sequence: | 42798704 |
Name | Italy |
Removed | False |
Interventions
Sequence: | 52769172 |
Intervention Type | Other |
Name | Gut microbiota samples |
Description | Gut microbiota analysis from diagnosis to follow up after first line-chemo-immuntherapy |
Keywords
Sequence: | 80259309 | Sequence: | 80259310 | Sequence: | 80259311 | Sequence: | 80259312 | Sequence: | 80259313 | Sequence: | 80259314 |
Name | RCHOP | Name | first line | Name | microbiota | Name | response | Name | disease control | Name | therapy toxicity |
Downcase Name | rchop | Downcase Name | first line | Downcase Name | microbiota | Downcase Name | response | Downcase Name | disease control | Downcase Name | therapy toxicity |
Design Outcomes
Sequence: | 178460398 | Sequence: | 178460399 |
Outcome Type | primary | Outcome Type | secondary |
Measure | GM dysbiosis assessment (bacterial DNA of gut microbiota in all patients) | Measure | Response to therapy |
Time Frame | 18 months | Time Frame | 2 years |
Description | dysbiosis index: the dysbiosis index relies on the calculation of the weighted ratio between health-promoting and disease-associated GM components relative abundance of GM biomarkers of an eubiotic GM state: all GM dysbiotic states share a common feature, i.e. the depletion of strategic health-promoting GM components such as Faecalibacterium prausnitzii and Lachnospiraceae. Thus, a GM dysbiotic state is determined by the assessment of a reduction of the abundance of these GM biomarkers below the thresholds characteristic of an eubiotc GM state. |
Description | Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted as long as it is PET negative and all lymph nodes and nodal masses must have regressed on CT to normal size ( 1.5 cm in their greatest transverse diameter for nodes 1.5 cm before therapy). |
Browse Conditions
Sequence: | 194586748 | Sequence: | 194586749 | Sequence: | 194586750 | Sequence: | 194586751 | Sequence: | 194586752 | Sequence: | 194586753 | Sequence: | 194586754 | Sequence: | 194586755 | Sequence: | 194586756 | Sequence: | 194586757 |
Mesh Term | Lymphoma | Mesh Term | Lymphoma, B-Cell | Mesh Term | Lymphoma, Large B-Cell, Diffuse | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Lymphoproliferative Disorders | Mesh Term | Lymphatic Diseases | Mesh Term | Immunoproliferative Disorders | Mesh Term | Immune System Diseases | Mesh Term | Lymphoma, Non-Hodgkin |
Downcase Mesh Term | lymphoma | Downcase Mesh Term | lymphoma, b-cell | Downcase Mesh Term | lymphoma, large b-cell, diffuse | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lymphoproliferative disorders | Downcase Mesh Term | lymphatic diseases | Downcase Mesh Term | immunoproliferative disorders | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | lymphoma, non-hodgkin |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48587155 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Bologna |
Overall Officials
Sequence: | 29436082 |
Role | Principal Investigator |
Name | Pier Luigi L Zinzani, Professor |
Affiliation | Institute of Hematology "L. e A. Seràgnoli", University of Bologna |
Eligibilities
Sequence: | 30930675 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Patients affected by diffuse large B-cell lymphoma (DLBCL) undergoing therapy with front-line R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone). |
Criteria | Inclusion Criteria:
Age ≥18 years Exclusion Criteria: Concomitant second malignancy, other than lymphoma. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254212468 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30676319 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 29043035 |
Responsible Party Type | Principal Investigator |
Name | Pier Luigi Zinzani |
Title | Full Professor, MD (Hematologist) |
Affiliation | University of Bologna |
]]>
https://zephyrnet.com/NCT03797157
2019-02-01
https://zephyrnet.com/?p=NCT03797157
NCT03797157https://www.clinicaltrials.gov/study/NCT03797157?tab=tableNANANAThis is a randomised controlled multi-centre trial comparing the effect of diet supplementation of a human breast milk-based nutrient fortifier (H2MF®) with standard bovine protein-based nutrient fortifier in 222 extremely preterm infants (born before gestational week 28+0) exclusively fed with human breast milk (own mother´s milk and/or donor milk). The infants will be randomised to receive either the human breast-milk based H2MF® or the standard bovine protein-based nutrient fortifier when oral feeds have reached <100 ml/kg/day.
The randomised intervention, stratified by centre, will continue until the target gestational week 34+0. The infant must not be fed with formula during the intervention period. The allocation will be concealed before inclusion, but after randomisation the study is not blinded.
Primary endpoint of the intervention is the composite variable necrotizing enterocolitis (NEC), sepsis and mortality.
The enrolled infants are characterised with clinical data including growth, feeding intolerance, use of enteral and parenteral nutrition, treatment, antibiotics and complications collected daily in a study specific case report form from birth until discharge from the hospital (not longer than gestational week 44+0). A follow up focusing on neurological development, growth and feeding problems will be performed at 2 years of age (corrected) and 5.5 years of age.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-17 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-12-13 |
Start Month Year | February 1, 2019 |
Primary Completion Month Year | September 1, 2022 |
Verification Month Year | December 2022 |
Verification Date | 2022-12-31 |
Last Update Posted Date | 2022-12-13 |
Detailed Descriptions
Sequence: | 20816433 |
Description | This is a randomised controlled multi-centre trial comparing the effect of diet supplementation of a human breast milk-based nutrient fortifier (H2MF®) with standard bovine protein-based nutrient fortifier in 222 extremely preterm infants (born before gestational week 28+0) exclusively fed with human breast milk (own mother´s milk and/or donor milk). The infants will be randomised to receive either the human breast-milk based H2MF® or the standard bovine protein-based nutrient fortifier when oral feeds have reached <100 ml/kg/day. If fortification with extra enteral lipids is needed during the intervention period, the infants receiving H2MF® will be supplemented with the human milk-based Prolact CR®, while the infants receiving standard bovine protein-based fortification will be supplemented with the standard lipid products used at the unit. The study subject will be enrolled at level III neonatal intensive care unit (NICU)s. Only infants with a home clinic with the logistics to maintain the intervention until gestational week 34+0 will be included.
The randomised intervention, stratified by centre, will continue until the target gestational week 34+0. The infant must not be fed with formula during the intervention period. The allocation will be concealed before inclusion, but after randomisation the study is not blinded. It would not be possible to prescribe the fortifier and prepare of the breast milk in a blinded fashion, since the fortifiers are not exactly equal in nutrient content and also look different. Instead the assessment of several of the outcomes will be made blinded, such as the assessment of X-ray images in NEC cases. The enrolled infants are characterised with clinical data including growth, feeding intolerance, use of enteral and parenteral nutrition, treatment, antibiotics and complications collected daily in a study specific case report form from birth until discharge from the hospital (not longer than gestational week 44+0). A follow up focusing on neurological development, growth and feeding problems will be performed at 2 years of age (corrected). Since it is often difficult to distinguish between the diagnoses of NEC and sepsis, and their clinical consequences, the investigator's primary endpoint of the intervention is the composite variable NEC, sepsis and mortality. Secondary endpoints are feeding intolerance and other severe complication such as Bronchopulmonary dysplasia (BPD), Retinopathy of prematurity (ROP) and neurological impairment. Stool, urine and blood samples are also collected for microbiology, metabolomic and immunology analysis in order to study underlying mechanisms. Health economic analyses will be made to evaluate the costs and benefits of an introduction of human milk-based fortifier in NICUs in the Nordic countries. Analyses will be conducted using an intention to treat approach. An evaluation will be performed when 20 infants have been included to evaluate feasibility and make it possible to adjust the protocol for the remaining part of the study. Safety analyses will be performed by an independent data and safety monitoring board (DSMB) when 50, 100 and 150 infants have been included. A sample size re-estimation will be made by an independent statistician when 150 infants have been included. Thus, the definitive sample size might be increased (never decreased) based on this interim analysis. The study can be terminated before 322 infants have been enrolled based on a decision of the sponsor and the DSMB, if the primary outcome is significantly lower (with a significance level <0.001) in the H2MF® than in the standard fortification group in the interim analysis made after 150 infants have completed the neonatal period. The study subject will be enrolled at level III NICUs in the Nordic Countries. All study subjects will be followed during the neonatal period until discharge (not longer than gestational week 44+0) and also be included in a follow up at 2 and 5.5 years of age based on the national follow up program for extremely preterm infants. |
Facilities
Sequence: | 200903281 | Sequence: | 200903282 | Sequence: | 200903283 | Sequence: | 200903284 | Sequence: | 200903285 |
Name | Queen Silvia Children´s Hospital | Name | Crown Princess Victoria Children´s Hospital | Name | Karolinska Hospital | Name | Norrlands Universitetssjukhus | Name | Akademiska Barnsjukhuset |
City | Göteborg | City | Linköping | City | Stockholm | City | Umeå | City | Uppsala |
Country | Sweden | Country | Sweden | Country | Sweden | Country | Sweden | Country | Sweden |
Conditions
Sequence: | 52413241 | Sequence: | 52413242 | Sequence: | 52413243 |
Name | Necrotizing Enterocolitis | Name | Sepsis | Name | Mortality |
Downcase Name | necrotizing enterocolitis | Downcase Name | sepsis | Downcase Name | mortality |
Id Information
Sequence: | 40329600 |
Id Source | org_study_id |
Id Value | RegionOstergotland |
Countries
Sequence: | 42753473 |
Name | Sweden |
Removed | False |
Design Groups
Sequence: | 55861040 | Sequence: | 55861041 |
Group Type | Experimental | Group Type | Active Comparator |
Title | H2MF | Title | Standard fortifier |
Description | Human milk-based breast milk fortifier | Description | Standard care: bovine milk-based breast milk fortifier |
Interventions
Sequence: | 52721117 | Sequence: | 52721118 |
Intervention Type | Dietary Supplement | Intervention Type | Dietary Supplement |
Name | H2MF | Name | Bovine milk-based fortifier |
Description | H2MF is a human milk-based breastmilk fortifier for preterm infants | Description | Bovine milk-based fortifier is the standard breast milk fortifier in Sweden |
Design Outcomes
Sequence: | 178276043 | Sequence: | 178276044 | Sequence: | 178276045 | Sequence: | 178276046 | Sequence: | 178276047 | Sequence: | 178276048 | Sequence: | 178276049 | Sequence: | 178276050 | Sequence: | 178276051 | Sequence: | 178276052 | Sequence: | 178276053 | Sequence: | 178276054 | Sequence: | 178276055 | Sequence: | 178276056 | Sequence: | 178276057 | Sequence: | 178276058 | Sequence: | 178276059 | Sequence: | 178276060 | Sequence: | 178276061 | Sequence: | 178276062 | Sequence: | 178276063 | Sequence: | 178276064 | Sequence: | 178276065 | Sequence: | 178276066 | Sequence: | 178276067 | Sequence: | 178276068 | Sequence: | 178276069 | Sequence: | 178276093 | Sequence: | 178276070 | Sequence: | 178276071 | Sequence: | 178276072 | Sequence: | 178276073 | Sequence: | 178276074 | Sequence: | 178276075 | Sequence: | 178276076 | Sequence: | 178276077 | Sequence: | 178276078 | Sequence: | 178276079 | Sequence: | 178276080 | Sequence: | 178276081 | Sequence: | 178276082 | Sequence: | 178276083 | Sequence: | 178276084 | Sequence: | 178276085 | Sequence: | 178276086 | Sequence: | 178276087 | Sequence: | 178276088 | Sequence: | 178276089 | Sequence: | 178276090 | Sequence: | 178276091 | Sequence: | 178276092 | Sequence: | 178276094 | Sequence: | 178276095 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The incidence of the composite of necrotizing enterocolitis, culture-proven sepsis and mortality | Measure | The incidence of the composite of necrotizing enterocolitis and culture-proven sepsis | Measure | The incidence of the composite of necrotizing enterocolitis culture-proven sepsis, bronchopulmonary dysplasia, retinopathy of prematurity and mortality (Mortality and morbidity index) | Measure | Time to reach full enteral feeds | Measure | Number of feeding interruptions | Measure | Numbers of days with parenteral nutrition | Measure | Number of large gastric aspirates per day | Measure | Stool frequency | Measure | Time to regain birth weight | Measure | Change in head circumference in centimeters | Measure | Change in weight in gram | Measure | Change in length in centimeters | Measure | The mortality incidence | Measure | The incidence of necrotising enterocolitis: Bell´s stage II-III | Measure | The incidence spontaneous intestinal perforation | Measure | The incidence of abdominal surgery | Measure | The incidence culture-proven sepsis | Measure | The incidence of suspected sepsis, not culture-proven | Measure | The incidence of pneumonia | Measure | The incidence of bronchopulmonary dysplasia | Measure | The incidence of retinopathy of the prematurity | Measure | The incidence of intraventricular haemorrhage | Measure | The incidence of periventricular leukomalacia | Measure | Number of days with intensive care | Measure | Length of stay at the hospital | Measure | Length of need of feeding tube | Measure | Neurocognitive development at 2 years | Measure | Levels of proteins in breast milk samples | Measure | Prevalence of cerebral palsy at 2 years | Measure | Prevalence of epilepsy at 2 years | Measure | Prevalence of squint and/or impaired vision at 2 years | Measure | Prevalence of impaired hearing at 2 years | Measure | The number of infants needing extra oxygen and/or ventilatory support after discharge from the hospital at the neonatal period | Measure | The incidence of wheeze and/or asthma | Measure | The incidence of severe infections after discharge from the neonatal unit | Measure | The number of infants needing feeding tube after discharge from the hospital at the neonatal period | Measure | The number of infants needing extra nutritional support after discharge from the hospital at the neonatal period | Measure | The prevalence of neurocognitive development at 5.5 years | Measure | The prevalence of cerebral palsy at 5.5 years | Measure | The prevalence of epilepsy at 5.5 years of age | Measure | The prevalence of squint and/or impaired vision at 5.5 years of age | Measure | The prevalence of children with impaired hearing at 5.5 years of age | Measure | The prevalence of wheeze and/or asthma at 5.5 years of age | Measure | Microbiome composition in stool samples | Measure | Levels of subclasses of T and B cells and granulocytes in blood samples | Measure | Levels of immune markers in plasma | Measure | Levels of growth factors in plasma samples | Measure | Levels of lipids in plasma samples | Measure | Levels of neurotransmitters in plasma samples | Measure | Levels of metabolic peptides in urine samples | Measure | Levels of markers of central nervous system (CNS) damage in plasma samples | Measure | Levels of human milk oligosaccharides in breast milk samples | Measure | Health care costs |
Time Frame | From birth until discharge from hospital (but not longer than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not longer than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not longer than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not longer than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not longer than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not longer than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not longer than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not longer than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not longer than gestational week 44+0) | Time Frame | At 7, 14, 21 and 28 days, the end of intervention (gestational week 34+0), gestational week 36+0, at discharge from neonatal ward (or at gestational week 44+0, whatever comes first) and at 2 years of age (corrected) and 5.5 years of age (uncorrected). | Time Frame | At 7, 14, 21 and 28 days, the end of intervention (gestational week 34+0), gestational week 36+0, at discharge from neonatal ward (or at gestational week 44+0, whatever comes first) and at 2 years of age (corrected) and 5.5 years of age (uncorrected). | Time Frame | At 7, 14, 21 and 28 days, the end of intervention (gestational week 34+0), gestational week 36+0, at discharge from neonatal ward (or at gestational week 44+0, whatever comes first) and at 2 years of age (corrected) and 5.5 years of age (uncorrected). | Time Frame | From birth until discharge from hospital (but not loner than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not loner than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not loner than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not loner than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not loner than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not loner than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not loner than gestational week 44+0) | Time Frame | At gestational week 36+0 | Time Frame | From birth until gestational week 42+0 | Time Frame | From birth until discharge from hospital (but not loner than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not loner than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not loner than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not loner than gestational week 44+0) | Time Frame | From birth until discharge from hospital (but not loner than gestational week 44+0) | Time Frame | At 2 years of age | Time Frame | At 1, 2, 3 and 4 weeks of age and gestational week 36+0 | Time Frame | At 2 years of age | Time Frame | At 2 years of age | Time Frame | At 2 years of age | Time Frame | At 2 years of age | Time Frame | From gestational week 44 until 2 years of age | Time Frame | From birth until 2 years of life | Time Frame | From gestational week 44 until 2 years of age | Time Frame | From gestational week 44 until 2 years of age | Time Frame | From gestational week 44 until 2 years of age | Time Frame | At 5.5 years of age | Time Frame | At 5.5 years of age | Time Frame | At 5.5 years of age | Time Frame | At 5.5 years of age | Time Frame | At 5.5 years of age | Time Frame | At 5.5 years of age | Time Frame | At 1, 2, 3 and 4 weeks of age and gestational week 36+0 | Time Frame | At 1, 2 and 4 weeks of age and gestational week 36+0 | Time Frame | At 1, 2 and 4 weeks of age and gestational week 36+0 | Time Frame | At 1, 2 and 4 weeks of age and gestational week 36+0 | Time Frame | At 1, 2 and 4 weeks of age and gestational week 36+0 | Time Frame | At 1, 2 and 4 weeks of age and gestational week 36+0 | Time Frame | At 1, 2, 3 and 4 weeks of age and gestational week 36+0 | Time Frame | At 1, 2 and 4 weeks of age and gestational week 36+0 | Time Frame | At 1, 2, 3 and 4 weeks of age and gestational week 36+0 | Time Frame | From birth until discharge from hospital (but not loner than gestational week 44+0) |
Description | An infant should have had any of these diagnoses to fulfil the criterion | Description | An infant should have had any of these diagnoses to fulfil the criterion | Description | An infant should have had any of these diagnoses to fulfil the criterion | Description | The day of life the infant has received at least 150 mL/kg enteral feeds | Description | Number of days feedings held for ≥12 hours or feeds reduced by >50% (ml/kg/d) not due to a clinical procedure or transitioning to the breast | Description | Number of days of parental amino acid and/or lipid infusion. Only days when the enteral feed <150mL/kg/day should be included | Description | ≥100% pre-feed volume (2 hours feeding volume if continuous feeding). Lower limit=2 ml/kg. | Description | Pathological X-ray confirmed by an independent radiologist, need of increased respiratory support/oxygen and laboratory inflammatory response | Description | Need of extra oxygen, continuous positive air pressure (CPAP) or ventilator at gestational week 36+0 | Description | Classified into stage I-V. The diagnosis is set after gestational week 42+0 | Description | Classified into grade I-IV according to Papile | Description | Criteria according to de Vries | Description | Need of respirator or CPAP until discharge (not later than gestational week 44+0). | Description | Gestational week and day at discharge (not later than gestational week 44+0). | Description | Gestational week and day when the infant does not need it anymore (not later than gestational week 44+0) | Description | Bayleys III, PARCA-R (Parental Report of Children´s Abilities-Revised) and ASQ-3 (Ages and stages questionnaire) | Description | Protein composition will be measured with multiplex methods | Description | Wechsler Preschool and Primary Scale of Intelligence IV (WPPSI-IV TM) and Movement ABC-2: the total scale points as well as the points of sub scales (motor, cognitive, language) will be presented. The prevalence of infants with a realist below 2 standard deviations will be defined to have mental retardation. | Description | The relative abundance and diversity of microbial taxa will be analyses with next generation sequencing and be related till the study intervention | Description | T helper subsets (TH1, Th2, TH17, Treg), T cells subsets associated with the intestinal mucosa (gamma/delta-T cells, MAIT cells) and neutrophils will be assessed using masscytometry | Description | Pre planned analyses are anti-inflammatory (e.g. IL-10) and proinflammatory (e.g. TNF) cytokines and chemokines (e.g. CXCL11, CCL18). | Description | The levels of growth factors such as IGF-1 and the associated IGFBP-3 will be analysed. | Description | Fatty acids in plasma | Description | Neurotransmitters such as GABA and serotonin in plasma | Description | Metabolic peptide will be measured with proton nuclear magnetic resonance spectroscopy (NMR), liquid chromatography (LC) and mass spectroscopy couple to gas chromatography (GC-MC). | Description | Markers of CNS damage such as neurofilament light protein will be measured in plasma | Description | The levels of human milk oligosaccharides will be measured with high-performance anion-exchange chromatography with pulsed amperometric detection. | Description | The number of days at each level of care will be recorded until discharge from the hospital (not longer than gestational week 44+0). The cost will be calculated by multiplying the number of days at each level of care by the average cost |
Browse Conditions
Sequence: | 194405145 | Sequence: | 194405146 | Sequence: | 194405147 | Sequence: | 194405148 | Sequence: | 194405149 | Sequence: | 194405150 |
Mesh Term | Enterocolitis | Mesh Term | Enterocolitis, Necrotizing | Mesh Term | Gastroenteritis | Mesh Term | Gastrointestinal Diseases | Mesh Term | Digestive System Diseases | Mesh Term | Intestinal Diseases |
Downcase Mesh Term | enterocolitis | Downcase Mesh Term | enterocolitis, necrotizing | Downcase Mesh Term | gastroenteritis | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | intestinal diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48544071 | Sequence: | 48544072 | Sequence: | 48544073 | Sequence: | 48544074 | Sequence: | 48544075 | Sequence: | 48544076 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | UNKNOWN | Agency Class | INDUSTRY | Agency Class | OTHER_GOV |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Thomas Abrahamsson, MD, PhD | Name | Sahlgrenska University Hospital, Sweden | Name | Region Uppsala | Name | Vasterbottens lans landsting | Name | Prolacta Bioscience | Name | Region Stockholm |
Overall Officials
Sequence: | 29410668 |
Role | Principal Investigator |
Name | Thomas R Abrahamsson, MD, PhD |
Affiliation | Region Ostergotland |
Design Group Interventions
Sequence: | 68476375 | Sequence: | 68476376 |
Design Group Id | 55861040 | Design Group Id | 55861041 |
Intervention Id | 52721117 | Intervention Id | 52721118 |
Eligibilities
Sequence: | 30904505 |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Gestational age at birth 22+0-27+6: based on prenatal ultrasonography. Exclusion Criteria: Lethal or complicated malformation known at the time of inclusion |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254161045 |
Number Of Facilities | 5 |
Registered In Calendar Year | 2018 |
Actual Duration | 43 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 52 |
Designs
Sequence: | 30650221 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29016871 |
Responsible Party Type | Sponsor-Investigator |
Name | Thomas Abrahamsson, MD, PhD |
Title | Principal Investigator, MD PhD |
Affiliation | Ostergotland County Council, Sweden |
Study References
Sequence: | 52323740 |
Pmid | 34815288 |
Reference Type | derived |
Citation | Jensen GB, Ahlsson F, Domellof M, Elfvin A, Naver L, Abrahamsson T. Nordic study on human milk fortification in extremely preterm infants: a randomised controlled trial-the N-forte trial. BMJ Open. 2021 Nov 23;11(11):e053400. doi: 10.1136/bmjopen-2021-053400. |
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https://zephyrnet.com/NCT03797144
2019-04-18
https://zephyrnet.com/?p=NCT03797144
NCT03797144https://www.clinicaltrials.gov/study/NCT03797144?tab=tableNANANAThe primary objective of this post-market study is to demonstrate that Oswestry disability index (ODI) score improved significantly at 12 months post-operatively as compared to baseline for each indication (degenerative spinal disease and deformity) in subjects with compromised bone quality, who will receive a surgical procedure requiring posterior stabilization and/or immobilization of one or more spinal segments using CD HORIZON® Fenestrated Screw Spinal System with Fenestrated Screw Cement.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-14 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2021-08-24 |
Start Month Year | April 18, 2019 |
Primary Completion Month Year | July 15, 2020 |
Verification Month Year | July 2021 |
Verification Date | 2021-07-31 |
Last Update Posted Date | 2021-08-24 |
Results First Posted Date | 2021-08-24 |
Facilities
Sequence: | 200032178 | Sequence: | 200032179 | Sequence: | 200032180 | Sequence: | 200032181 | Sequence: | 200032182 | Sequence: | 200032183 |
Name | UZ Leuven – Campus Gasthuisberg | Name | Tyks Surgical Hospital | Name | Hôpital de la Pitié Salpétrière | Name | Athens Medical Center | Name | Mediterraneo Hospital | Name | IRCCS Istituto Clinico Humanitas di Milano |
City | Leuven | City | Turku | City | Paris Cedex 13 | City | Marousi | City | Athens | City | Rozzano |
State | Athens | ||||||||||
Zip | 3000 | Zip | 20700 | Zip | 75651 | Zip | 15125 | Zip | 16675 | Zip | 20086 |
Country | Belgium | Country | Finland | Country | France | Country | Greece | Country | Greece | Country | Italy |
Conditions
Sequence: | 52149443 | Sequence: | 52149444 |
Name | Degenerative Spinal Disease | Name | Deformity of Spine |
Downcase Name | degenerative spinal disease | Downcase Name | deformity of spine |
Id Information
Sequence: | 40142890 |
Id Source | org_study_id |
Id Value | MDT17040SD1703 |
Countries
Sequence: | 42552236 | Sequence: | 42552237 | Sequence: | 42552238 | Sequence: | 42552239 | Sequence: | 42552240 |
Name | Belgium | Name | Finland | Name | France | Name | Greece | Name | Italy |
Removed | False | Removed | False | Removed | False | Removed | False | Removed | False |
Design Groups
Sequence: | 55570113 |
Group Type | Experimental |
Title | Fenestrated Screw System |
Interventions
Sequence: | 52465141 |
Intervention Type | Device |
Name | CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement |
Description | The CD HORIZON® Legacy™ and Solera™ Fenestrated Screw Spinal System consists of a variety of cannulated screws with a series of fenestrations to allow polymethylmethacrylate (PMMA) bone cement (Fenestrated Screw Cement) to be injected into the treated site. The Fenestrated Screw Cement is used to augment screw fixation in subjects with compromised bone quality. |
Design Outcomes
Sequence: | 177303715 | Sequence: | 177303716 | Sequence: | 177303717 | Sequence: | 177303718 | Sequence: | 177303719 | Sequence: | 177303720 | Sequence: | 177303721 | Sequence: | 177303722 | Sequence: | 177303723 | Sequence: | 177303724 | Sequence: | 177303725 | Sequence: | 177303726 | Sequence: | 177303727 | Sequence: | 177303728 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline | Measure | Change in ODI From Baseline at 3 Months Visit | Measure | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Measure | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Measure | Rate of Neurological Success at 12-month Visit | Measure | Rate of Intraoperative Cement Extravasation/Leakage. Patients | Measure | Rate of Intraoperative Cement Extravasation/Leakage. Screws | Measure | Device and/or Procedure Related Adverse Events Through 12 Months. | Measure | Rate of Secondary Spinal Surgeries at Index and/or Adjacent Level(s), Resulting From an AE up to 12 Months After Surgery | Measure | Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit. | Measure | Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended. | Measure | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Measure | For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit. | Measure | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months |
Time Frame | Baseline to 12 months | Time Frame | Baseline, 3 months | Time Frame | Baseline, 3, 12 months | Time Frame | Baseline, 3, 12 months | Time Frame | Baseline to 12 months. | Time Frame | Surgery to 12 months. | Time Frame | Surgery to 12 months. | Time Frame | Surgery to 12 months. | Time Frame | Surgery to 12 months. | Time Frame | Surgery to 12 months. | Time Frame | Surgery to 12 months. | Time Frame | Baseline to 12 months | Time Frame | Baseline to 12 months | Time Frame | Baseline to 12 months |
Description | Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections.
Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 2 subjects who completed the 12 month follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 12 months time point. |
Description | Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. [23]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders.
ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures. | Description | The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures. | Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of insufficient outcomes of the initial surgery.
Secondary spinal surgical procedures resulted from AE(s) could be classified into four categories: revision, removal, reoperation, and other. One subject belonging to the Deformity group underwent a reoperation for a foraminal stenosis at index level L5-S1. |
Description | The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months.
The following were considered as signs of instrumentation instability: Screw pullout |
Description | The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays.
The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as "No fusion success". For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine. |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Sagittal alignment – Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Coronal alignment : Distance between C7 plumb line and the central sacral vertical line |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray: – Coronal Curve Type Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as: Curve type L: patients with a lumbar or thoracolumbar major curve >30˚ (apical level of T10 or lower) |
Browse Conditions
Sequence: | 193405170 | Sequence: | 193405171 | Sequence: | 193405172 |
Mesh Term | Spinal Diseases | Mesh Term | Bone Diseases | Mesh Term | Musculoskeletal Diseases |
Downcase Mesh Term | spinal diseases | Downcase Mesh Term | bone diseases | Downcase Mesh Term | musculoskeletal diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48299639 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Medtronic Spinal and Biologics |
Design Group Interventions
Sequence: | 68121862 |
Design Group Id | 55570113 |
Intervention Id | 52465141 |
Eligibilities
Sequence: | 30753219 |
Gender | All |
Minimum Age | 22 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
A subject must meet the following inclusion criteria to participate in this trial: One or more of the following diagnostic indications: Degenerative Spinal Disease (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis) Exclusion Criteria: A subject will be excluded from participating in this trial for any of the following reasons: Has undergone stabilization and/or fusion procedure at the index or adjacent levels. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254200395 |
Number Of Facilities | 6 |
Number Of Nsae Subjects | 3 |
Number Of Sae Subjects | 7 |
Registered In Calendar Year | 2018 |
Actual Duration | 15 |
Were Results Reported | True |
Months To Report Results | 9 |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 22 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 13 |
Designs
Sequence: | 30499481 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Drop Withdrawals
Sequence: | 28977099 | Sequence: | 28977100 | Sequence: | 28977101 | Sequence: | 28977102 | Sequence: | 28977103 | Sequence: | 28977104 | Sequence: | 28977105 | Sequence: | 28977106 | Sequence: | 28977107 | Sequence: | 28977108 |
Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Period | Enrollment | Period | Enrollment | Period | Surgery | Period | Surgery | Period | 3 Month | Period | 3 Month | Period | 12 Month | Period | 12 Month | Period | 24 Month | Period | 24 Month |
Reason | Protocol Violation | Reason | Protocol Violation | Reason | Protocol Violation | Reason | Protocol Violation | Reason | Early termination cut-off date | Reason | Early termination cut-off date | Reason | Early termination cut-off date | Reason | Early termination cut-off date | Reason | Early termination cut-off date | Reason | Early termination cut-off date |
Count | 4 | Count | 1 | Count | 1 | Count | 0 | Count | 2 | Count | 0 | Count | 8 | Count | 9 | Count | 1 | Count | 1 |
Milestones
Sequence: | 40993394 | Sequence: | 40993395 | Sequence: | 40993396 | Sequence: | 40993397 | Sequence: | 40993398 | Sequence: | 40993399 | Sequence: | 40993400 | Sequence: | 40993401 | Sequence: | 40993402 | Sequence: | 40993403 | Sequence: | 40993404 | Sequence: | 40993405 | Sequence: | 40993406 | Sequence: | 40993407 | Sequence: | 40993408 | Sequence: | 40993409 | Sequence: | 40993410 | Sequence: | 40993411 | Sequence: | 40993412 | Sequence: | 40993413 | Sequence: | 40993414 | Sequence: | 40993415 | Sequence: | 40993416 | Sequence: | 40993417 | Sequence: | 40993418 | Sequence: | 40993419 | Sequence: | 40993420 | Sequence: | 40993421 | Sequence: | 40993422 | Sequence: | 40993423 |
Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 | Result Group Id | 56080752 | Result Group Id | 56080753 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Enrollment | Period | Enrollment | Period | Enrollment | Period | Enrollment | Period | Enrollment | Period | Enrollment | Period | Surgery | Period | Surgery | Period | Surgery | Period | Surgery | Period | Surgery | Period | Surgery | Period | 3 Month | Period | 3 Month | Period | 3 Month | Period | 3 Month | Period | 3 Month | Period | 3 Month | Period | 12 Month | Period | 12 Month | Period | 12 Month | Period | 12 Month | Period | 12 Month | Period | 12 Month | Period | 24 Month | Period | 24 Month | Period | 24 Month | Period | 24 Month | Period | 24 Month | Period | 24 Month |
Count | 16 | Count | 11 | Count | 12 | Count | 10 | Count | 4 | Count | 1 | Count | 12 | Count | 10 | Count | 11 | Count | 10 | Count | 1 | Count | 0 | Count | 11 | Count | 10 | Count | 9 | Count | 10 | Count | 2 | Count | 0 | Count | 9 | Count | 10 | Count | 1 | Count | 1 | Count | 8 | Count | 9 | Count | 1 | Count | 1 | Count | 0 | Count | 0 | Count | 1 | Count | 1 |
Outcome Analyses
Sequence: | 16563210 | Sequence: | 16563211 | Sequence: | 16563212 | Sequence: | 16563213 | Sequence: | 16563214 | Sequence: | 16563215 | Sequence: | 16563216 | Sequence: | 16563217 | Sequence: | 16563218 | Sequence: | 16563219 |
Outcome Id | 30794526 | Outcome Id | 30794526 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 |
Non Inferiority Type | Other | Non Inferiority Type | Other | Non Inferiority Type | Other | Non Inferiority Type | Other | Non Inferiority Type | Other | Non Inferiority Type | Other | Non Inferiority Type | Other | Non Inferiority Type | Other | Non Inferiority Type | Other | Non Inferiority Type | Other |
Non Inferiority Description | A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.
The normality of the data distribution was assessed with the Shapiro-Wilk test. |
Non Inferiority Description | A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.
The normality of the data distribution was assessed with the Shapiro-Wilk test. |
Non Inferiority Description | A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.
The normality of the data distribution was assessed with the Shapiro-Wilk test. |
Non Inferiority Description | A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.
The normality of the data distribution was assessed with the Shapiro-Wilk test. |
Non Inferiority Description | A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.
The normality of the data distribution was assessed with the Shapiro-Wilk test. |
Non Inferiority Description | A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.
The normality of the data distribution was assessed with the Shapiro-Wilk test. |
Non Inferiority Description | A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.
The normality of the data distribution was assessed with the Shapiro-Wilk test. |
Non Inferiority Description | A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.
The normality of the data distribution was assessed with the Shapiro-Wilk test. |
Non Inferiority Description | A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.
The normality of the data distribution was assessed with the Shapiro-Wilk test. |
Non Inferiority Description | A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.
The normality of the data distribution was assessed with the Shapiro-Wilk test. |
P Value Modifier | P Value Modifier | P Value Modifier | P Value Modifier | < | P Value Modifier | < | P Value Modifier | < | P Value Modifier | P Value Modifier | P Value Modifier | P Value Modifier | |||||||
P Value | 0.06 | P Value | 0.012 | P Value | 0.002 | P Value | 0.001 | P Value | 0.001 | P Value | 0.001 | P Value | 0.174 | P Value | 0.002 | P Value | 0.003 | P Value | 0.012 |
P Value Description | Back Pain | P Value Description | Back Pain | P Value Description | Leg Pain | P Value Description | Leg Pain | P Value Description | Health State Score | P Value Description | Health State Score | P Value Description | Index score | P Value Description | Index score | ||||
Method | t-test, 1 sided | Method | t-test, 1 sided | Method | t-test, 1 sided | Method | t-test, 1 sided | Method | t-test, 1 sided | Method | t-test, 1 sided | Method | t-test, 1 sided | Method | t-test, 1 sided | Method | t-test, 1 sided | Method | t-test, 1 sided |
Groups Description | To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.
The null hypothesis was H0: μ_ODI ≤ 0, and the alternative hypothesis was Ha: μ_ODI > 0 where μ_ODI is the mean improvement of ODI score at 3 months from baseline. |
Groups Description | To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.
The null hypothesis was H0: μ_ODI ≤ 0, and the alternative hypothesis was Ha: μ_ODI > 0 where μ_ODI is the mean improvement of ODI score at 3 months from baseline. |
Groups Description | To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.
The null hypothesis was H0: μ_VAS ≤ 0, and the alternative hypothesis was Ha: μ_VAS > 0 where μ_VAS is the mean improvement of VAS score at 3 months from baseline. |
Groups Description | To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.
The null hypothesis was H0: μ_VAS ≤ 0, and the alternative hypothesis was Ha: μ_VAS > 0 where μ_VAS is the mean improvement of VAS score at 3 months from baseline. |
Groups Description | To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.
The null hypothesis was H0: μ_VAS ≤ 0, and the alternative hypothesis was Ha: μ_VAS > 0 where μ_VAS is the mean improvement of VAS score at 3 months from baseline. |
Groups Description | To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.
The null hypothesis was H0: μ_VAS ≤ 0, and the alternative hypothesis was Ha: μ_VAS > 0 where μ_VAS is the mean improvement of VAS score at 3 months from baseline. |
Groups Description | To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.
The null hypothesis was H0: μ_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ_EQ-5D 5L > 0 where μ_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline. |
Groups Description | To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.
The null hypothesis was H0: μ_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ_EQ-5D 5L > 0 where μ_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline. |
Groups Description | To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.
The null hypothesis was H0: μ_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ_EQ-5D 5L > 0 where μ_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline. |
Groups Description | To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.
The null hypothesis was H0: μ_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ_EQ-5D 5L > 0 where μ_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline. |
Outcome Analysis Groups
Sequence: | 32122751 | Sequence: | 32122752 | Sequence: | 32122753 | Sequence: | 32122754 | Sequence: | 32122755 | Sequence: | 32122756 | Sequence: | 32122757 | Sequence: | 32122758 | Sequence: | 32122759 | Sequence: | 32122760 |
Outcome Analysis Id | 16563210 | Outcome Analysis Id | 16563211 | Outcome Analysis Id | 16563212 | Outcome Analysis Id | 16563213 | Outcome Analysis Id | 16563214 | Outcome Analysis Id | 16563215 | Outcome Analysis Id | 16563216 | Outcome Analysis Id | 16563217 | Outcome Analysis Id | 16563218 | Outcome Analysis Id | 16563219 |
Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Participant Flows
Sequence: | 3920197 |
Recruitment Details | The study aimed at evaluating overall 100 subjects with around 50 subjects (no less than 48 subjects) in each indication subgroup at approximately 10 study sites in Europe. Due to the premature closure of the study, the number of enrolled subjects was 27 (16 belonging to the degenerative spinal disease group and 11 to the deformity group) in 6 sites in Europe. |
Outcome Counts
Sequence: | 73976125 | Sequence: | 73976126 | Sequence: | 73976127 | Sequence: | 73976128 | Sequence: | 73976129 | Sequence: | 73976130 | Sequence: | 73976131 | Sequence: | 73976132 | Sequence: | 73976133 | Sequence: | 73976134 | Sequence: | 73976135 | Sequence: | 73976136 | Sequence: | 73976137 | Sequence: | 73976138 | Sequence: | 73976139 | Sequence: | 73976140 | Sequence: | 73976141 | Sequence: | 73976142 | Sequence: | 73976143 | Sequence: | 73976144 | Sequence: | 73976145 | Sequence: | 73976146 | Sequence: | 73976147 | Sequence: | 73976148 | Sequence: | 73976149 |
Outcome Id | 30794525 | Outcome Id | 30794525 | Outcome Id | 30794526 | Outcome Id | 30794526 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794529 | Outcome Id | 30794529 | Outcome Id | 30794530 | Outcome Id | 30794530 | Outcome Id | 30794531 | Outcome Id | 30794531 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794533 | Outcome Id | 30794533 | Outcome Id | 30794534 | Outcome Id | 30794534 | Outcome Id | 30794535 | Outcome Id | 30794535 | Outcome Id | 30794536 | Outcome Id | 30794537 | Outcome Id | 30794538 |
Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 1 | Count | 1 | Count | 11 | Count | 10 | Count | 11 | Count | 10 | Count | 11 | Count | 10 | Count | 1 | Count | 1 | Count | 11 | Count | 10 | Count | 11 | Count | 10 | Count | 11 | Count | 10 | Count | 11 | Count | 10 | Count | 1 | Count | 1 | Count | 1 | Count | 1 | Count | 1 | Count | 1 | Count | 1 |
Provided Documents
Sequence: | 2577885 | Sequence: | 2577886 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2018-09-19 | Document Date | 2020-07-13 |
Url | https://ClinicalTrials.gov/ProvidedDocs/44/NCT03797144/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/44/NCT03797144/SAP_001.pdf |
Reported Event Totals
Sequence: | 27935020 | Sequence: | 27935021 | Sequence: | 27935022 | Sequence: | 27935023 | Sequence: | 27935024 | Sequence: | 27935025 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 4 | Subjects Affected | 1 | Subjects Affected | 0 |
Subjects At Risk | 11 | Subjects At Risk | 11 | Subjects At Risk | 11 | Subjects At Risk | 10 | Subjects At Risk | 10 | Subjects At Risk | 10 |
Created At | 2023-08-08 21:49:29.816882 | Created At | 2023-08-08 21:49:29.816882 | Created At | 2023-08-08 21:49:29.816882 | Created At | 2023-08-08 21:49:29.816882 | Created At | 2023-08-08 21:49:29.816882 | Created At | 2023-08-08 21:49:29.816882 |
Updated At | 2023-08-08 21:49:29.816882 | Updated At | 2023-08-08 21:49:29.816882 | Updated At | 2023-08-08 21:49:29.816882 | Updated At | 2023-08-08 21:49:29.816882 | Updated At | 2023-08-08 21:49:29.816882 | Updated At | 2023-08-08 21:49:29.816882 |
Reported Events
Sequence: | 528049833 | Sequence: | 528049834 | Sequence: | 528049835 | Sequence: | 528049836 | Sequence: | 528049837 | Sequence: | 528049838 | Sequence: | 528049839 | Sequence: | 528049840 | Sequence: | 528049841 | Sequence: | 528049842 | Sequence: | 528049843 | Sequence: | 528049844 | Sequence: | 528049845 | Sequence: | 528049846 | Sequence: | 528049847 | Sequence: | 528049848 | Sequence: | 528049849 | Sequence: | 528049850 | Sequence: | 528049851 | Sequence: | 528049852 |
Result Group Id | 56080757 | Result Group Id | 56080758 | Result Group Id | 56080757 | Result Group Id | 56080758 | Result Group Id | 56080757 | Result Group Id | 56080758 | Result Group Id | 56080757 | Result Group Id | 56080758 | Result Group Id | 56080757 | Result Group Id | 56080758 | Result Group Id | 56080757 | Result Group Id | 56080758 | Result Group Id | 56080757 | Result Group Id | 56080758 | Result Group Id | 56080757 | Result Group Id | 56080758 | Result Group Id | 56080757 | Result Group Id | 56080758 | Result Group Id | 56080757 | Result Group Id | 56080758 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit | Time Frame | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: – 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit – 8 DSD patients completed up to their 3 month follow-up visit – 1 DSD patient completed up to their 12 month follow-up visit – 9 Deformity patients completed up to their 3-month follow-up visit – 1 Deformity patient completed up to their 12 month follow-up visit |
Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other |
Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 |
Subjects At Risk | 11 | Subjects At Risk | 10 | Subjects At Risk | 11 | Subjects At Risk | 10 | Subjects At Risk | 11 | Subjects At Risk | 10 | Subjects At Risk | 11 | Subjects At Risk | 10 | Subjects At Risk | 11 | Subjects At Risk | 10 | Subjects At Risk | 11 | Subjects At Risk | 10 | Subjects At Risk | 11 | Subjects At Risk | 10 | Subjects At Risk | 11 | Subjects At Risk | 10 | Subjects At Risk | 11 | Subjects At Risk | 10 | Subjects At Risk | 11 | Subjects At Risk | 10 |
Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Vascular disorders | Organ System | Vascular disorders |
Adverse Event Term | SPINAL CSF LEAK | Adverse Event Term | SPINAL CSF LEAK | Adverse Event Term | PULMONARY EDEMA | Adverse Event Term | PULMONARY EDEMA | Adverse Event Term | FORAMINAL STENOSIS | Adverse Event Term | FORAMINAL STENOSIS | Adverse Event Term | INCISION WOUND DEHISCENCE | Adverse Event Term | INCISION WOUND DEHISCENCE | Adverse Event Term | SPINAL FRACTURE AT LEVEL T12 | Adverse Event Term | SPINAL FRACTURE AT LEVEL T12 | Adverse Event Term | PULMONARY EMBOLISM | Adverse Event Term | PULMONARY EMBOLISM | Adverse Event Term | INGUINAL HERNIA | Adverse Event Term | INGUINAL HERNIA | Adverse Event Term | PROXIMAL JUNCTIONAL KYPHOSIS | Adverse Event Term | PROXIMAL JUNCTIONAL KYPHOSIS | Adverse Event Term | ANXIETY | Adverse Event Term | ANXIETY | Adverse Event Term | HEMATOMA AT INDEX LEVEL CAUSING FEVER ABOVE 37.8°C | Adverse Event Term | HEMATOMA AT INDEX LEVEL CAUSING FEVER ABOVE 37.8°C |
Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 |
Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment |
Responsible Parties
Sequence: | 28865759 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3850941 |
Pi Employee | No |
Restriction Type | GT60 |
Result Contacts
Sequence: | 3850906 |
Organization | Medtronic |
Name | Clinical Research Specialist |
Phone | +39 3450225929 |
francesca.molineris@medtronic.com | |
Outcomes
Sequence: | 30794525 | Sequence: | 30794526 | Sequence: | 30794527 | Sequence: | 30794528 | Sequence: | 30794529 | Sequence: | 30794530 | Sequence: | 30794531 | Sequence: | 30794532 | Sequence: | 30794533 | Sequence: | 30794534 | Sequence: | 30794535 | Sequence: | 30794536 | Sequence: | 30794537 | Sequence: | 30794538 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline | Title | Change in ODI From Baseline at 3 Months Visit | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Intraoperative Cement Extravasation/Leakage. Patients | Title | Rate of Intraoperative Cement Extravasation/Leakage. Screws | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Rate of Secondary Spinal Surgeries at Index and/or Adjacent Level(s), Resulting From an AE up to 12 Months After Surgery | Title | Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit. | Title | Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended. | Title | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months |
Description | Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections.
Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 2 subjects who completed the 12 month follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 12 months time point. |
Description | Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. [23]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders.
ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures. | Description | The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures. | Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of insufficient outcomes of the initial surgery.
Secondary spinal surgical procedures resulted from AE(s) could be classified into four categories: revision, removal, reoperation, and other. One subject belonging to the Deformity group underwent a reoperation for a foraminal stenosis at index level L5-S1. |
Description | The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months.
The following were considered as signs of instrumentation instability: Screw pullout |
Description | The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays.
The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as "No fusion success". For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine. |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Sagittal alignment – Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Coronal alignment : Distance between C7 plumb line and the central sacral vertical line |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray: – Coronal Curve Type Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as: Curve type L: patients with a lumbar or thoracolumbar major curve >30˚ (apical level of T10 or lower) |
Time Frame | Baseline to 12 months | Time Frame | Baseline, 3 months | Time Frame | Baseline, 3, 12 months | Time Frame | Baseline, 3, 12 months | Time Frame | Baseline to 12 months. | Time Frame | Surgery to 12 months. | Time Frame | Surgery to 12 months. | Time Frame | Surgery to 12 months. | Time Frame | Surgery to 12 months. | Time Frame | Surgery to 12 months. | Time Frame | Surgery to 12 months. | Time Frame | Baseline to 12 months | Time Frame | Baseline to 12 months | Time Frame | Baseline to 12 months |
Population | Due to the premature termination of the study, the number of subjects who completed the 12 month follow-up visit was very low (N=2/21, 9.5%). | Population | The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit.
The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point. |
Population | The results are summarized for 21 subjects who were assessed at Baseline,19 subjects who completed the 3 months follow-up visit and 2 subjects who completed the 12 months follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.
The 24 months follow-up visit did not have data collected and are not reported. |
Population | The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow-up visit and 2 subjects who completed the 12 months follow-up visit.
The 24 months follow-up visit did not have data collected and are not reported. The reported EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. |
Population | 21 subjects were assessed at Baseline,19 subjects completed the 3 months follow-up visit and 2 subjects completed the 12 months follow-up visit. Due to the premature termination of the study, the number of subjects who completed the 12 months follow-up visit was very low (N=2/21, 9.5%). | Population | 21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 months follow-up visit. | Population | 21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 months follow-up visit. | Population | 21 subjects were assessed at surgery,19 subjects completed the 3 months follow-up visit and 2 subjects completed the 12 months follow-up visit. Adverse events up to 12 month follow-up visits are reported in the Outcome Measure Data Table. | Population | 21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. | Population | 2 subjects completed the 12 month follow-up visit. | Population | 2 subjects who completed the 12 month follow-up visit were analyzed for fusion assessment with radiographic images. | Population | 1 subject who completed the 12 month follow-up visit was analyzed. | Population | 1 subject who completed the 12 month follow-up visit was analyzed. | Population | 1 subject who completed the 12 month follow-up visit was analyzed. |
Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | participants | Units | Screws | Units | Events | Units | Participants | Units | Participants | Units | Participants | Units | Degrees | Units | mm | Units | Participants |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||
Param Type | Number | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Count of Participants |
Outcome Measurements
Sequence: | 235577197 | Sequence: | 235577198 | Sequence: | 235577199 | Sequence: | 235577200 | Sequence: | 235577201 | Sequence: | 235577202 | Sequence: | 235577203 | Sequence: | 235577204 | Sequence: | 235577205 | Sequence: | 235577206 | Sequence: | 235577207 | Sequence: | 235577208 | Sequence: | 235577209 | Sequence: | 235577210 | Sequence: | 235577211 | Sequence: | 235577212 | Sequence: | 235577213 | Sequence: | 235577214 | Sequence: | 235577215 | Sequence: | 235577216 | Sequence: | 235577217 | Sequence: | 235577218 | Sequence: | 235577219 | Sequence: | 235577220 | Sequence: | 235577221 | Sequence: | 235577222 | Sequence: | 235577223 | Sequence: | 235577224 | Sequence: | 235577225 | Sequence: | 235577226 | Sequence: | 235577227 | Sequence: | 235577228 | Sequence: | 235577229 | Sequence: | 235577230 | Sequence: | 235577231 | Sequence: | 235577232 | Sequence: | 235577233 | Sequence: | 235577234 | Sequence: | 235577235 | Sequence: | 235577236 | Sequence: | 235577237 | Sequence: | 235577238 | Sequence: | 235577239 | Sequence: | 235577240 | Sequence: | 235577241 | Sequence: | 235577242 | Sequence: | 235577292 | Sequence: | 235577243 | Sequence: | 235577244 | Sequence: | 235577245 | Sequence: | 235577246 | Sequence: | 235577247 | Sequence: | 235577248 | Sequence: | 235577249 | Sequence: | 235577250 | Sequence: | 235577251 | Sequence: | 235577252 | Sequence: | 235577253 | Sequence: | 235577254 | Sequence: | 235577255 | Sequence: | 235577256 | Sequence: | 235577257 | Sequence: | 235577258 | Sequence: | 235577259 | Sequence: | 235577260 | Sequence: | 235577261 | Sequence: | 235577262 | Sequence: | 235577263 | Sequence: | 235577264 | Sequence: | 235577265 | Sequence: | 235577266 | Sequence: | 235577267 | Sequence: | 235577268 | Sequence: | 235577269 | Sequence: | 235577270 | Sequence: | 235577271 | Sequence: | 235577272 | Sequence: | 235577273 | Sequence: | 235577274 | Sequence: | 235577275 | Sequence: | 235577276 | Sequence: | 235577277 | Sequence: | 235577278 | Sequence: | 235577279 | Sequence: | 235577280 | Sequence: | 235577281 | Sequence: | 235577282 | Sequence: | 235577283 | Sequence: | 235577284 | Sequence: | 235577285 | Sequence: | 235577286 | Sequence: | 235577287 | Sequence: | 235577288 | Sequence: | 235577289 | Sequence: | 235577290 | Sequence: | 235577291 | Sequence: | 235577293 | Sequence: | 235577294 | Sequence: | 235577295 | Sequence: | 235577296 | Sequence: | 235577297 | Sequence: | 235577298 | Sequence: | 235577299 | Sequence: | 235577300 | Sequence: | 235577301 | Sequence: | 235577302 | Sequence: | 235577303 | Sequence: | 235577304 | Sequence: | 235577305 | Sequence: | 235577306 | Sequence: | 235577307 | Sequence: | 235577308 | Sequence: | 235577309 | Sequence: | 235577310 | Sequence: | 235577311 | Sequence: | 235577312 | Sequence: | 235577313 | Sequence: | 235577314 | Sequence: | 235577315 | Sequence: | 235577316 | Sequence: | 235577317 | Sequence: | 235577318 | Sequence: | 235577319 | Sequence: | 235577320 | Sequence: | 235577321 | Sequence: | 235577322 | Sequence: | 235577177 | Sequence: | 235577178 | Sequence: | 235577179 | Sequence: | 235577180 | Sequence: | 235577181 | Sequence: | 235577182 | Sequence: | 235577183 | Sequence: | 235577184 | Sequence: | 235577185 | Sequence: | 235577186 | Sequence: | 235577187 | Sequence: | 235577188 | Sequence: | 235577189 | Sequence: | 235577190 | Sequence: | 235577191 | Sequence: | 235577192 | Sequence: | 235577193 | Sequence: | 235577194 | Sequence: | 235577195 | Sequence: | 235577196 |
Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794528 | Outcome Id | 30794529 | Outcome Id | 30794529 | Outcome Id | 30794529 | Outcome Id | 30794529 | Outcome Id | 30794529 | Outcome Id | 30794529 | Outcome Id | 30794529 | Outcome Id | 30794529 | Outcome Id | 30794529 | Outcome Id | 30794529 | Outcome Id | 30794529 | Outcome Id | 30794529 | Outcome Id | 30794529 | Outcome Id | 30794529 | Outcome Id | 30794529 | Outcome Id | 30794529 | Outcome Id | 30794530 | Outcome Id | 30794530 | Outcome Id | 30794534 | Outcome Id | 30794530 | Outcome Id | 30794530 | Outcome Id | 30794531 | Outcome Id | 30794531 | Outcome Id | 30794531 | Outcome Id | 30794531 | Outcome Id | 30794531 | Outcome Id | 30794531 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794532 | Outcome Id | 30794533 | Outcome Id | 30794533 | Outcome Id | 30794534 | Outcome Id | 30794534 | Outcome Id | 30794534 | Outcome Id | 30794535 | Outcome Id | 30794535 | Outcome Id | 30794535 | Outcome Id | 30794535 | Outcome Id | 30794535 | Outcome Id | 30794535 | Outcome Id | 30794536 | Outcome Id | 30794536 | Outcome Id | 30794536 | Outcome Id | 30794536 | Outcome Id | 30794536 | Outcome Id | 30794536 | Outcome Id | 30794536 | Outcome Id | 30794536 | Outcome Id | 30794536 | Outcome Id | 30794536 | Outcome Id | 30794536 | Outcome Id | 30794536 | Outcome Id | 30794537 | Outcome Id | 30794537 | Outcome Id | 30794537 | Outcome Id | 30794537 | Outcome Id | 30794538 | Outcome Id | 30794538 | Outcome Id | 30794538 | Outcome Id | 30794538 | Outcome Id | 30794538 | Outcome Id | 30794538 | Outcome Id | 30794538 | Outcome Id | 30794538 | Outcome Id | 30794525 | Outcome Id | 30794525 | Outcome Id | 30794526 | Outcome Id | 30794526 | Outcome Id | 30794526 | Outcome Id | 30794526 | Outcome Id | 30794526 | Outcome Id | 30794526 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 | Outcome Id | 30794527 |
Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080756 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 | Result Group Id | 56080754 | Result Group Id | 56080755 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Classification | Leg Pain_3 Months | Classification | Leg Pain_3 Months | Classification | Leg Pain_Change from Baseline at 3 Months | Classification | Leg Pain_Change from Baseline at 3 Months | Classification | Leg Pain_12 Months | Classification | Leg Pain_12 Months | Classification | Leg Pain_Change form Baseline at 12 Months | Classification | Leg Pain_Change form Baseline at 12 Months | Classification | Index score_Baseline | Classification | Index score_Baseline | Classification | Index score_3 Months | Classification | Index score_3 Months | Classification | Index score_Change from Baseline at 3 Months | Classification | Index score_Change from Baseline at 3 Months | Classification | Index score_12 Months | Classification | Index score_12 Months | Classification | Index score_Change from Baseline at 12 Months | Classification | Index score_Change from Baseline at 12 Months | Classification | Health State score_Baseline | Classification | Health State score_Baseline | Classification | Health State score_3 Months | Classification | Health State score_3 Months | Classification | Health State score_Change from Baseline | Classification | Health State score_Change from Baseline | Classification | Health State score_12 Months | Classification | Health State score_12 Months | Classification | Health State score_Change from Baseline at 12 Months | Classification | Health State score_Change from Baseline at 12 Months | Classification | Motor Functions_Baseline | Classification | Motor Functions_Baseline | Classification | Motor Functions_12 Months | Classification | Motor Functions_12 Months | Classification | Sensory Functions_Baseline | Classification | Sensory Functions_Baseline | Classification | Sensory Functions_12 Months | Classification | Sensory Functions_12 Months | Classification | Reflexes_Baseline | Classification | Reflexes_Baseline | Classification | Reflexes_12 Months | Classification | Reflexes_12 Months | Classification | Straight Leg Raise_Baseline | Classification | Straight Leg Raise_Baseline | Classification | Straight Leg Raise_12 Months | Classification | Straight Leg Raise_12 Months | Classification | Patients with cement extravasation | Classification | Patients with cement extravasation | Classification | Patients with symptomatic extravasation | Classification | Patients with symptomatic extravasation | Classification | Number of Cemented Fenestrated Screws | Classification | Number of Cemented Fenestrated Screws | Classification | Fenestrated Screws with cement extravasation | Classification | Fenestrated Screws with cement extravasation | Classification | Fenestrated screws with symptomatic cement extravasation | Classification | Fenestrated screws with symptomatic cement extravasation | Classification | Adverse Event (AE) | Classification | Adverse Event (AE) | Classification | Serious Adverse Event (SAE) | Classification | Serious Adverse Event (SAE) | Classification | Serious Adverse Device Effect (SADE) | Classification | Serious Adverse Device Effect (SADE) | Classification | Unexpected Serious Adverse Device Effect (USADE) | Classification | Unexpected Serious Adverse Device Effect (USADE) | Classification | SAEs Related to Procedure | Classification | SAEs Related to Procedure | Classification | SAEs Related to Access System | Classification | SAEs Related to Access System | Classification | SAEs Related to Cage/Interbody | Classification | SAEs Related to Cage/Interbody | Classification | SAEs Related to Anterior Plate | Classification | SAEs Related to Anterior Plate | Classification | SAEs Related to Bone Grafts and Substitutes | Classification | SAEs Related to Bone Grafts and Substitutes | Classification | SAEs Related to Rods | Classification | SAEs Related to Rods | Classification | SAEs Related to Fenestrated Screw Cement_Investigator assessment | Classification | SAEs Related to Fenestrated Screw Cement_Investigator assessment | Classification | SAEs Related to Fenestrated Screw Cement_Sponsor assessment | Classification | SAEs Related to Fenestrated Screw Cement_Sponsor assessment | Classification | SAEs Related to Fenestrated Screw(s) | Classification | SAEs Related to Fenestrated Screw(s) | Classification | SAEs Related to other components of the Fixation (stabilization) System | Classification | SAEs Related to other components of the Fixation (stabilization) System | Classification | SAEs Related to an underlying condition or disease_Investigator assessment | Classification | SAEs Related to an underlying condition or disease_Investigator assessment | Classification | SAEs Related to an underlying condition or disease_Sponsor assessment | Classification | SAEs Related to an underlying condition or disease_Sponsor assessment | Classification | Not Related SAEs_Investigator assessment | Classification | Not Related SAEs_Investigator assessment | Classification | Not Related SAEs_Sponsor assessment | Classification | Not Related SAEs_Sponsor assessment | Classification | Baseline Thoracic Kyphosis (TK) (degrees) | Classification | 12-months Thoracic Kyphosis (TK) (degrees) | Classification | Baseline Thoracolumbar kyphosis (TLK) (degrees) | Classification | 12-months Thoracolumbar kyphosis (TLK) (degrees) | Classification | Baseline Lumbar lordosis (LL) (degrees) | Classification | 12-months Lumbar Lordosis (LL) (degrees) | Classification | Baseline Pelvic Incidence (PI) (degrees) | Classification | 12-months Pelvic Incidence (PI) (degrees) | Classification | Baseline Pelvic Tilt (PT) (degrees) | Classification | 12-months Pelvic Tilt (PT) (degrees) | Classification | Baseline Sacral Slope (SS) (degrees) | Classification | 12-months Sacral Slope (SS) (degrees) | Classification | Baseline Coronal alignment (mm) | Classification | 12-months Coronal alignment (mm) | Classification | Baseline Sagittal vertical axis (SVA) (mm) | Classification | 12-months Sagittal vertical axis (SVA) (mm) | Classification | Baseline curve type L | Classification | 12-months curve type L | Classification | Baseline curve type T | Classification | 12-months curve type T | Classification | Baseline curve type D | Classification | 12-months curve type D | Classification | Baseline curve type N | Classification | 12-months curve type N | Classification | Baseline | Classification | Baseline | Classification | 3 Month | Classification | 3 Month | Classification | Change from Baseline | Classification | Change from Baseline | Classification | Back Pain_Baseline | Classification | Back Pain_Baseline | Classification | Back Pain_3 Months | Classification | Back Pain_3 Months | Classification | Back Pain_Change from Baseline at 3 Months | Classification | Back Pain_Change from Baseline at 3 Months | Classification | Back Pain_12 Months | Classification | Back Pain_12 Months | Classification | Back Pain_Change from Baseline at 12 Months | Classification | Back Pain_Change from Baseline at 12 Months | Classification | Leg Pain_Baseline | Classification | Leg Pain_Baseline | ||||||||||||||||||||||||||||
Category | Unstable Construct | Category | Stable Construct | Category | Stable Construct | Category | Unstable Construct | Category | Fusion success | Category | Fusion success | Category | No fusion success | Category | No fusion success | Category | Unable to determine | Category | Unable to determine | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Neurological Success at 12-month Visit | Title | Rate of Intraoperative Cement Extravasation/Leakage. Patients | Title | Rate of Intraoperative Cement Extravasation/Leakage. Patients | Title | Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit. | Title | Rate of Intraoperative Cement Extravasation/Leakage. Patients | Title | Rate of Intraoperative Cement Extravasation/Leakage. Patients | Title | Rate of Intraoperative Cement Extravasation/Leakage. Screws | Title | Rate of Intraoperative Cement Extravasation/Leakage. Screws | Title | Rate of Intraoperative Cement Extravasation/Leakage. Screws | Title | Rate of Intraoperative Cement Extravasation/Leakage. Screws | Title | Rate of Intraoperative Cement Extravasation/Leakage. Screws | Title | Rate of Intraoperative Cement Extravasation/Leakage. Screws | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Device and/or Procedure Related Adverse Events Through 12 Months. | Title | Rate of Secondary Spinal Surgeries at Index and/or Adjacent Level(s), Resulting From an AE up to 12 Months After Surgery | Title | Rate of Secondary Spinal Surgeries at Index and/or Adjacent Level(s), Resulting From an AE up to 12 Months After Surgery | Title | Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit. | Title | Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit. | Title | Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit. | Title | Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended. | Title | Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended. | Title | Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended. | Title | Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended. | Title | Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended. | Title | Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended. | Title | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit. | Title | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | Title | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | Title | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | Title | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | Title | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | Title | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | Title | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | Title | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | Title | Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline | Title | Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline | Title | Change in ODI From Baseline at 3 Months Visit | Title | Change in ODI From Baseline at 3 Months Visit | Title | Change in ODI From Baseline at 3 Months Visit | Title | Change in ODI From Baseline at 3 Months Visit | Title | Change in ODI From Baseline at 3 Months Visit | Title | Change in ODI From Baseline at 3 Months Visit | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Title | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
Description | The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures. | Description | The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures. | Description | The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months.
The following were considered as signs of instrumentation instability: Screw pullout |
Description | The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures. | Description | The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures. | Description | The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures. | Description | The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures. | Description | The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures. | Description | The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures. | Description | The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures. | Description | The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures. | Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Description | When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of insufficient outcomes of the initial surgery.
Secondary spinal surgical procedures resulted from AE(s) could be classified into four categories: revision, removal, reoperation, and other. One subject belonging to the Deformity group underwent a reoperation for a foraminal stenosis at index level L5-S1. |
Description | When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of insufficient outcomes of the initial surgery.
Secondary spinal surgical procedures resulted from AE(s) could be classified into four categories: revision, removal, reoperation, and other. One subject belonging to the Deformity group underwent a reoperation for a foraminal stenosis at index level L5-S1. |
Description | The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months.
The following were considered as signs of instrumentation instability: Screw pullout |
Description | The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months.
The following were considered as signs of instrumentation instability: Screw pullout |
Description | The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months.
The following were considered as signs of instrumentation instability: Screw pullout |
Description | The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays.
The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as "No fusion success". For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine. |
Description | The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays.
The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as "No fusion success". For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine. |
Description | The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays.
The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as "No fusion success". For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine. |
Description | The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays.
The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as "No fusion success". For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine. |
Description | The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays.
The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as "No fusion success". For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine. |
Description | The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays.
The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as "No fusion success". For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine. |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Sagittal alignment – Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Sagittal alignment – Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Sagittal alignment – Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Sagittal alignment – Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Sagittal alignment – Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Sagittal alignment – Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Sagittal alignment – Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Sagittal alignment – Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Sagittal alignment – Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Sagittal alignment – Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Sagittal alignment – Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Sagittal alignment – Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Coronal alignment : Distance between C7 plumb line and the central sacral vertical line |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Coronal alignment : Distance between C7 plumb line and the central sacral vertical line |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Coronal alignment : Distance between C7 plumb line and the central sacral vertical line |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: Coronal alignment : Distance between C7 plumb line and the central sacral vertical line |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray: – Coronal Curve Type Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as: Curve type L: patients with a lumbar or thoracolumbar major curve >30˚ (apical level of T10 or lower) |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray: – Coronal Curve Type Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as: Curve type L: patients with a lumbar or thoracolumbar major curve >30˚ (apical level of T10 or lower) |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray: – Coronal Curve Type Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as: Curve type L: patients with a lumbar or thoracolumbar major curve >30˚ (apical level of T10 or lower) |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray: – Coronal Curve Type Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as: Curve type L: patients with a lumbar or thoracolumbar major curve >30˚ (apical level of T10 or lower) |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray: – Coronal Curve Type Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as: Curve type L: patients with a lumbar or thoracolumbar major curve >30˚ (apical level of T10 or lower) |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray: – Coronal Curve Type Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as: Curve type L: patients with a lumbar or thoracolumbar major curve >30˚ (apical level of T10 or lower) |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray: – Coronal Curve Type Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as: Curve type L: patients with a lumbar or thoracolumbar major curve >30˚ (apical level of T10 or lower) |
Description | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray: – Coronal Curve Type Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as: Curve type L: patients with a lumbar or thoracolumbar major curve >30˚ (apical level of T10 or lower) |
Description | Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections.
Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 2 subjects who completed the 12 month follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 12 months time point. |
Description | Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections.
Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 2 subjects who completed the 12 month follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 12 months time point. |
Description | Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. [23]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders.
ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point. |
Description | Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. [23]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders.
ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point. |
Description | Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. [23]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders.
ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point. |
Description | Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. [23]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders.
ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point. |
Description | Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. [23]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders.
ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point. |
Description | Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. [23]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders.
ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Description | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | participants | Units | participants | Units | Participants | Units | participants | Units | participants | Units | Screws | Units | Screws | Units | Screws | Units | Screws | Units | Screws | Units | Screws | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Events | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Degrees | Units | Degrees | Units | Degrees | Units | Degrees | Units | Degrees | Units | Degrees | Units | Degrees | Units | Degrees | Units | Degrees | Units | Degrees | Units | Degrees | Units | Degrees | Units | mm | Units | mm | Units | mm | Units | mm | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 0.9 | Param Value | 1.3 | Param Value | 6.2 | Param Value | 5.8 | Param Value | 0.0 | Param Value | 1.0 | Param Value | 6.0 | Param Value | 1.0 | Param Value | 0.24 | Param Value | 0.39 | Param Value | 0.66 | Param Value | 0.68 | Param Value | 0.43 | Param Value | 0.28 | Param Value | 0.910 | Param Value | 0.910 | Param Value | 0.423 | Param Value | 0.423 | Param Value | 64.8 | Param Value | 57.5 | Param Value | 72.8 | Param Value | 82.2 | Param Value | 11.9 | Param Value | 24.7 | Param Value | 90.0 | Param Value | 70.0 | Param Value | 50.0 | Param Value | 20.0 | Param Value | 5 | Param Value | 5 | Param Value | 5 | Param Value | 5 | Param Value | 3 | Param Value | 3 | Param Value | 3 | Param Value | 3 | Param Value | 2 | Param Value | 2 | Param Value | 2 | Param Value | 2 | Param Value | 2 | Param Value | 2 | Param Value | 2 | Param Value | 2 | Param Value | 3 | Param Value | 5 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 39 | Param Value | 97 | Param Value | 3 | Param Value | 8 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 8 | Param Value | 1 | Param Value | 6 | Param Value | 1 | Param Value | 5 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 5 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 66 | Param Value | 78 | Param Value | 41 | Param Value | 5 | Param Value | 50 | Param Value | 58 | Param Value | 46 | Param Value | 50 | Param Value | 23 | Param Value | 23 | Param Value | 23 | Param Value | 27 | Param Value | 19.0 | Param Value | 4.0 | Param Value | 43.0 | Param Value | 49.0 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 46.0 | Param Value | 17.8 | Param Value | 49.7 | Param Value | 39.6 | Param Value | 20.9 | Param Value | 23.0 | Param Value | 31.5 | Param Value | 16.6 | Param Value | 4.9 | Param Value | 6.8 | Param Value | 2.0 | Param Value | 1.7 | Param Value | 3.3 | Param Value | 5.1 | Param Value | 2.0 | Param Value | 3.0 | Param Value | 3.0 | Param Value | 0.0 | Param Value | 7.5 | Param Value | 7.1 |
Param Value Num | 0.9 | Param Value Num | 1.3 | Param Value Num | 6.2 | Param Value Num | 5.8 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 6.0 | Param Value Num | 1.0 | Param Value Num | 0.24 | Param Value Num | 0.39 | Param Value Num | 0.66 | Param Value Num | 0.68 | Param Value Num | 0.43 | Param Value Num | 0.28 | Param Value Num | 0.91 | Param Value Num | 0.91 | Param Value Num | 0.423 | Param Value Num | 0.423 | Param Value Num | 64.8 | Param Value Num | 57.5 | Param Value Num | 72.8 | Param Value Num | 82.2 | Param Value Num | 11.9 | Param Value Num | 24.7 | Param Value Num | 90.0 | Param Value Num | 70.0 | Param Value Num | 50.0 | Param Value Num | 20.0 | Param Value Num | 5.0 | Param Value Num | 5.0 | Param Value Num | 5.0 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 3.0 | Param Value Num | 3.0 | Param Value Num | 3.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 3.0 | Param Value Num | 5.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 39.0 | Param Value Num | 97.0 | Param Value Num | 3.0 | Param Value Num | 8.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 8.0 | Param Value Num | 1.0 | Param Value Num | 6.0 | Param Value Num | 1.0 | Param Value Num | 5.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 5.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 66.0 | Param Value Num | 78.0 | Param Value Num | 41.0 | Param Value Num | 5.0 | Param Value Num | 50.0 | Param Value Num | 58.0 | Param Value Num | 46.0 | Param Value Num | 50.0 | Param Value Num | 23.0 | Param Value Num | 23.0 | Param Value Num | 23.0 | Param Value Num | 27.0 | Param Value Num | 19.0 | Param Value Num | 4.0 | Param Value Num | 43.0 | Param Value Num | 49.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 46.0 | Param Value Num | 17.8 | Param Value Num | 49.7 | Param Value Num | 39.6 | Param Value Num | 20.9 | Param Value Num | 23.0 | Param Value Num | 31.5 | Param Value Num | 16.6 | Param Value Num | 4.9 | Param Value Num | 6.8 | Param Value Num | 2.0 | Param Value Num | 1.7 | Param Value Num | 3.3 | Param Value Num | 5.1 | Param Value Num | 2.0 | Param Value Num | 3.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 7.5 | Param Value Num | 7.1 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 1.3 | Dispersion Value | 1.8 | Dispersion Value | 2.7 | Dispersion Value | 2.5 | Dispersion Value | 0.0 | Dispersion Value | 0.0 | Dispersion Value | 0.0 | Dispersion Value | 0.0 | Dispersion Value | 0.25 | Dispersion Value | 0.19 | Dispersion Value | 0.37 | Dispersion Value | 0.34 | Dispersion Value | 0.36 | Dispersion Value | 0.33 | Dispersion Value | 0.0 | Dispersion Value | 0.0 | Dispersion Value | 0.0 | Dispersion Value | 0.0 | Dispersion Value | 20.3 | Dispersion Value | 15.9 | Dispersion Value | 21.7 | Dispersion Value | 16.5 | Dispersion Value | 35.8 | Dispersion Value | 20.3 | Dispersion Value | 0.0 | Dispersion Value | 0.0 | Dispersion Value | 0.0 | Dispersion Value | 0.0 | Dispersion Value | 20.0 | Dispersion Value | 13.0 | Dispersion Value | 24.9 | Dispersion Value | 21.7 | Dispersion Value | 28.9 | Dispersion Value | 19.3 | Dispersion Value | 2.9 | Dispersion Value | 2.3 | Dispersion Value | 2.8 | Dispersion Value | 1.8 | Dispersion Value | 2.6 | Dispersion Value | 3.2 | Dispersion Value | 0.0 | Dispersion Value | 0.0 | Dispersion Value | 0.0 | Dispersion Value | 0.0 | Dispersion Value | 2.2 | Dispersion Value | 2.2 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 1.3 | Dispersion Value Num | 1.8 | Dispersion Value Num | 2.7 | Dispersion Value Num | 2.5 | Dispersion Value Num | 0.0 | Dispersion Value Num | 0.0 | Dispersion Value Num | 0.0 | Dispersion Value Num | 0.0 | Dispersion Value Num | 0.25 | Dispersion Value Num | 0.19 | Dispersion Value Num | 0.37 | Dispersion Value Num | 0.34 | Dispersion Value Num | 0.36 | Dispersion Value Num | 0.33 | Dispersion Value Num | 0.0 | Dispersion Value Num | 0.0 | Dispersion Value Num | 0.0 | Dispersion Value Num | 0.0 | Dispersion Value Num | 20.3 | Dispersion Value Num | 15.9 | Dispersion Value Num | 21.7 | Dispersion Value Num | 16.5 | Dispersion Value Num | 35.8 | Dispersion Value Num | 20.3 | Dispersion Value Num | 0.0 | Dispersion Value Num | 0.0 | Dispersion Value Num | 0.0 | Dispersion Value Num | 0.0 | Dispersion Value Num | 20.0 | Dispersion Value Num | 13.0 | Dispersion Value Num | 24.9 | Dispersion Value Num | 21.7 | Dispersion Value Num | 28.9 | Dispersion Value Num | 19.3 | Dispersion Value Num | 2.9 | Dispersion Value Num | 2.3 | Dispersion Value Num | 2.8 | Dispersion Value Num | 1.8 | Dispersion Value Num | 2.6 | Dispersion Value Num | 3.2 | Dispersion Value Num | 0.0 | Dispersion Value Num | 0.0 | Dispersion Value Num | 0.0 | Dispersion Value Num | 0.0 | Dispersion Value Num | 2.2 | Dispersion Value Num | 2.2 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline Counts
Sequence: | 11380132 | Sequence: | 11380133 | Sequence: | 11380134 |
Result Group Id | 56080749 | Result Group Id | 56080750 | Result Group Id | 56080751 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 11 | Count | 10 | Count | 21 |
Result Groups
Sequence: | 56080749 | Sequence: | 56080750 | Sequence: | 56080751 | Sequence: | 56080752 | Sequence: | 56080753 | Sequence: | 56080754 | Sequence: | 56080755 | Sequence: | 56080756 | Sequence: | 56080757 | Sequence: | 56080758 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Degenerative Spinal Disease | Title | Deformity | Title | Total | Title | Degenerative Spinal Disease | Title | Deformity | Title | Degenerative Spinal Disease | Title | Deformity | Title | Deformity | Title | Degenerative Spinal Disease | Title | Deformity |
Description | Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis). | Description | Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity). | Description | Total of all reporting groups | Description | Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis). | Description | Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity). | Description | Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis). | Description | Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity). | Description | Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity). | Description | Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis). | Description | Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity). |
Baseline Measurements
Sequence: | 125544856 | Sequence: | 125544850 | Sequence: | 125544851 | Sequence: | 125544852 | Sequence: | 125544853 | Sequence: | 125544854 | Sequence: | 125544848 | Sequence: | 125544849 | Sequence: | 125544855 | Sequence: | 125544857 | Sequence: | 125544858 | Sequence: | 125544859 | Sequence: | 125544860 | Sequence: | 125544861 | Sequence: | 125544862 | Sequence: | 125544863 | Sequence: | 125544864 | Sequence: | 125544865 | Sequence: | 125544866 | Sequence: | 125544867 | Sequence: | 125544868 | Sequence: | 125544869 | Sequence: | 125544870 | Sequence: | 125544871 | Sequence: | 125544872 | Sequence: | 125544873 | Sequence: | 125544874 | Sequence: | 125544875 | Sequence: | 125544876 | Sequence: | 125544877 | Sequence: | 125544878 | Sequence: | 125544879 | Sequence: | 125544880 | Sequence: | 125544881 | Sequence: | 125544882 | Sequence: | 125544883 | Sequence: | 125544884 |
Result Group Id | 56080751 | Result Group Id | 56080751 | Result Group Id | 56080749 | Result Group Id | 56080750 | Result Group Id | 56080751 | Result Group Id | 56080749 | Result Group Id | 56080749 | Result Group Id | 56080750 | Result Group Id | 56080750 | Result Group Id | 56080751 | Result Group Id | 56080749 | Result Group Id | 56080750 | Result Group Id | 56080751 | Result Group Id | 56080749 | Result Group Id | 56080750 | Result Group Id | 56080751 | Result Group Id | 56080749 | Result Group Id | 56080750 | Result Group Id | 56080751 | Result Group Id | 56080749 | Result Group Id | 56080750 | Result Group Id | 56080751 | Result Group Id | 56080749 | Result Group Id | 56080750 | Result Group Id | 56080751 | Result Group Id | 56080749 | Result Group Id | 56080750 | Result Group Id | 56080751 | Result Group Id | 56080749 | Result Group Id | 56080750 | Result Group Id | 56080751 | Result Group Id | 56080749 | Result Group Id | 56080750 | Result Group Id | 56080751 | Result Group Id | 56080749 | Result Group Id | 56080750 | Result Group Id | 56080751 |
Ctgov Group Code | BG002 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Category | Male | Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Title | Sex: Female, Male | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Race and Ethnicity Not Collected | Title | Weight | Title | Weight | Title | Weight | Title | Height | Title | Height | Title | Height | Title | Body Max Index (BMI) | Title | Body Max Index (BMI) | Title | Body Max Index (BMI) | Title | Duration of conservative treatment | Title | Duration of conservative treatment | Title | Duration of conservative treatment | Title | Duration of Back Pain Resulting in Planned Surgery | Title | Duration of Back Pain Resulting in Planned Surgery | Title | Duration of Back Pain Resulting in Planned Surgery | Title | Duration of Leg Pain Resulting in Planned Surgery | Title | Duration of Leg Pain Resulting in Planned Surgery | Title | Duration of Leg Pain Resulting in Planned Surgery | Title | Duration of Other Generalized Pain Resulting in Planned Surgery | Title | Duration of Other Generalized Pain Resulting in Planned Surgery | Title | Duration of Other Generalized Pain Resulting in Planned Surgery | Title | Patients with previous surgeries | Title | Patients with previous surgeries | Title | Patients with previous surgeries | Title | Bone Density Assessment | Title | Bone Density Assessment | Title | Bone Density Assessment |
Description | DXA scan of the Hip. A T-score within 1 SD (+1 or -1) of the young adult mean indicates normal bone density.
A T-score of 1 to 2.5 SD below the young adult mean (-1 to -2.5 SD) indicates low bone mass. A T-score of 2.5 SD or more below the young adult mean (more than -2.5 SD) indicates the presence of osteoporosis. |
Description | DXA scan of the Hip. A T-score within 1 SD (+1 or -1) of the young adult mean indicates normal bone density.
A T-score of 1 to 2.5 SD below the young adult mean (-1 to -2.5 SD) indicates low bone mass. A T-score of 2.5 SD or more below the young adult mean (more than -2.5 SD) indicates the presence of osteoporosis. |
Description | DXA scan of the Hip. A T-score within 1 SD (+1 or -1) of the young adult mean indicates normal bone density.
A T-score of 1 to 2.5 SD below the young adult mean (-1 to -2.5 SD) indicates low bone mass. A T-score of 2.5 SD or more below the young adult mean (more than -2.5 SD) indicates the presence of osteoporosis. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Units | Participants | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | years | Units | years | Units | Participants | Units | Participants | Units | Kg | Units | Kg | Units | Kg | Units | cm | Units | cm | Units | cm | Units | kg/m^2 | Units | kg/m^2 | Units | kg/m^2 | Units | months | Units | months | Units | months | Units | months | Units | months | Units | months | Units | months | Units | months | Units | months | Units | months | Units | months | Units | months | Units | participants | Units | participants | Units | participants | Units | T-score | Units | T-score | Units | T-score |
Param Type | Count of Participants | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 0 | Param Value | 70.7 | Param Value | 11 | Param Value | 10 | Param Value | 21 | Param Value | 0 | Param Value | 70.5 | Param Value | 70.9 | Param Value | 0 | Param Value | 0 | Param Value | 60.8 | Param Value | 66.6 | Param Value | 63.5 | Param Value | 159.3 | Param Value | 158.6 | Param Value | 159.0 | Param Value | 23.9 | Param Value | 26.4 | Param Value | 25.1 | Param Value | 21.6 | Param Value | 20.9 | Param Value | 21.3 | Param Value | 13.5 | Param Value | 17.5 | Param Value | 15.4 | Param Value | 11.0 | Param Value | 9.2 | Param Value | 10.1 | Param Value | 0.0 | Param Value | 12.0 | Param Value | 5.7 | Param Value | 4 | Param Value | 2 | Param Value | 6 | Param Value | -1.9 | Param Value | -1.9 | Param Value | -1.9 |
Param Value Num | 0.0 | Param Value Num | 70.7 | Param Value Num | 11.0 | Param Value Num | 10.0 | Param Value Num | 21.0 | Param Value Num | 0.0 | Param Value Num | 70.5 | Param Value Num | 70.9 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 60.8 | Param Value Num | 66.6 | Param Value Num | 63.5 | Param Value Num | 159.3 | Param Value Num | 158.6 | Param Value Num | 159.0 | Param Value Num | 23.9 | Param Value Num | 26.4 | Param Value Num | 25.1 | Param Value Num | 21.6 | Param Value Num | 20.9 | Param Value Num | 21.3 | Param Value Num | 13.5 | Param Value Num | 17.5 | Param Value Num | 15.4 | Param Value Num | 11.0 | Param Value Num | 9.2 | Param Value Num | 10.1 | Param Value Num | 0.0 | Param Value Num | 12.0 | Param Value Num | 5.7 | Param Value Num | 4.0 | Param Value Num | 2.0 | Param Value Num | 6.0 | Param Value Num | -1.9 | Param Value Num | -1.9 | Param Value Num | -1.9 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||
Dispersion Value | 8.3 | Dispersion Value | 10 | Dispersion Value | 6.6 | Dispersion Value | 13.3 | Dispersion Value | 10.8 | Dispersion Value | 12.2 | Dispersion Value | 7.3 | Dispersion Value | 8.2 | Dispersion Value | 7.6 | Dispersion Value | 4.1 | Dispersion Value | 3.6 | Dispersion Value | 4.0 | Dispersion Value | 49.0 | Dispersion Value | 22.7 | Dispersion Value | 37.8 | Dispersion Value | 13.6 | Dispersion Value | 17.9 | Dispersion Value | 15.5 | Dispersion Value | 11.4 | Dispersion Value | 6.1 | Dispersion Value | 9.1 | Dispersion Value | 0.0 | Dispersion Value | 37.9 | Dispersion Value | 26.2 | Dispersion Value | 0.8 | Dispersion Value | 0.8 | Dispersion Value | 0.7 | ||||||||||||||||||||
Dispersion Value Num | 8.3 | Dispersion Value Num | 10.0 | Dispersion Value Num | 6.6 | Dispersion Value Num | 13.3 | Dispersion Value Num | 10.8 | Dispersion Value Num | 12.2 | Dispersion Value Num | 7.3 | Dispersion Value Num | 8.2 | Dispersion Value Num | 7.6 | Dispersion Value Num | 4.1 | Dispersion Value Num | 3.6 | Dispersion Value Num | 4.0 | Dispersion Value Num | 49.0 | Dispersion Value Num | 22.7 | Dispersion Value Num | 37.8 | Dispersion Value Num | 13.6 | Dispersion Value Num | 17.9 | Dispersion Value Num | 15.5 | Dispersion Value Num | 11.4 | Dispersion Value Num | 6.1 | Dispersion Value Num | 9.1 | Dispersion Value Num | 0.0 | Dispersion Value Num | 37.9 | Dispersion Value Num | 26.2 | Dispersion Value Num | 0.8 | Dispersion Value Num | 0.8 | Dispersion Value Num | 0.7 | ||||||||||||||||||||
Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 11 | Number Analyzed | 10 | Number Analyzed | 21 | Number Analyzed | 11 | Number Analyzed | 11 | Number Analyzed | 10 | Number Analyzed | 10 | Number Analyzed | 21 | Number Analyzed | 11 | Number Analyzed | 10 | Number Analyzed | 21 | Number Analyzed | 11 | Number Analyzed | 10 | Number Analyzed | 21 | Number Analyzed | 11 | Number Analyzed | 10 | Number Analyzed | 21 | Number Analyzed | 11 | Number Analyzed | 10 | Number Analyzed | 21 | Number Analyzed | 11 | Number Analyzed | 10 | Number Analyzed | 21 | Number Analyzed | 11 | Number Analyzed | 10 | Number Analyzed | 21 | Number Analyzed | 11 | Number Analyzed | 10 | Number Analyzed | 21 | Number Analyzed | 11 | Number Analyzed | 10 | Number Analyzed | 21 | Number Analyzed | 11 | Number Analyzed | 10 | Number Analyzed | 21 |
Population Description | Race and Ethnicity were not collected from any participant. | Population Description | For 3 subjects the Bone Density Assessment was missing, and compromised bone quality was confirmed during surgery. | Population Description | For 3 subjects the Bone Density Assessment was missing, and compromised bone quality was confirmed during surgery. | Population Description | For 3 subjects the Bone Density Assessment was missing, and compromised bone quality was confirmed during surgery. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
]]>
https://zephyrnet.com/NCT03797131
2019-01-06
https://zephyrnet.com/?p=NCT03797131
NCT03797131https://www.clinicaltrials.gov/study/NCT03797131?tab=tableNANANAThis clinical food study aims to explore the effect of KB195, a novel mixture of oligosaccharides, on the metabolism of nitrogen by the microbiome in patients with urea cycle disorders (UCDs). This will be done using a stable isotope to assess nitrogen metabolism in the blood, urine, and stool. The study will also assess the safety and tolerability of KB195 in patients with UCDs.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2020-01-10 |
Start Month Year | January 6, 2019 |
Primary Completion Month Year | September 1, 2019 |
Verification Month Year | January 2020 |
Verification Date | 2020-01-31 |
Last Update Posted Date | 2020-01-10 |
Facilities
Sequence: | 200245277 |
Name | University Children's Hospital Zurich |
City | Zürich |
Zip | CH-8032 |
Country | Switzerland |
Conditions
Sequence: | 52208594 |
Name | Urea Cycle Disorders |
Downcase Name | urea cycle disorders |
Id Information
Sequence: | 40186510 |
Id Source | org_study_id |
Id Value | K013-118 |
Countries
Sequence: | 42600006 |
Name | Switzerland |
Removed | False |
Design Groups
Sequence: | 55635223 |
Group Type | Experimental |
Title | KB195 Arm |
Interventions
Sequence: | 52522539 |
Intervention Type | Other |
Name | KB195 (a novel mixture of oligosaccharides) |
Description | KB195 (a novel mixture of oligosaccharides) for oral intake for 21 days. |
Keywords
Sequence: | 79923662 | Sequence: | 79923663 | Sequence: | 79923664 | Sequence: | 79923665 | Sequence: | 79923666 | Sequence: | 79923667 |
Name | KB195 | Name | Urea Cycle Disorders | Name | UCD | Name | microbiome | Name | Kaleido | Name | ammonia |
Downcase Name | kb195 | Downcase Name | urea cycle disorders | Downcase Name | ucd | Downcase Name | microbiome | Downcase Name | kaleido | Downcase Name | ammonia |
Design Outcomes
Sequence: | 177513094 | Sequence: | 177513095 | Sequence: | 177513096 | Sequence: | 177513097 | Sequence: | 177513098 | Sequence: | 177513099 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other |
Measure | Change in labelled (15N-nitrogen) and total nitrogen excretion in urine | Measure | Change in labelled (15N-urea) and total urea excretion in urine | Measure | Change in labelled (15N-ammonia) and total ammonia excretion in urine | Measure | Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires | Measure | Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires | Measure | Incidence of adverse events |
Time Frame | Baseline to Day 25 | Time Frame | Baseline to Day 25 | Time Frame | Baseline to Day 25 | Time Frame | Baseline to Day 32 | Time Frame | Baseline to Day 32 | Time Frame | Baseline to Day 32 |
Description | Evaluate the effect of KB195 on nitrogen metabolism in the gut of patients with UCD by analyzing the change in labelled (15N-nitrogen) and total nitrogen excretion in urine | Description | Evaluate the effect of KB195 on nitrogen metabolism in the gut of patients with UCD by analyzing the change in labelled (15N-urea) and total urea excretion in urine | Description | Evaluate the effect of KB195 on nitrogen metabolism in the gut of patients with UCD by analyzing the change in labelled (15N-ammonia) and total ammonia excretion in urine | Description | Evaluate the effect of KB195 on self-report questionnaires including the Gastrointestinal Tolerability Questionnaire, an assessment of the frequency and severity of GI symptoms, e.g., gas, abdominal pain, calculated on a scale from 0 (None/Not applicable) to a maximum score of 60 (Severe/Much more than usual) for all questions | Description | Evaluate the effect of KB195 on self-report questionnaires including the Bristol Stool Scale, an assessment of stool consistency on a scale from 1 (separate hard lumps, like nuts, hard to pass) through 7 (watery, no solid pieces, entirely liquid). |
Browse Conditions
Sequence: | 193628993 | Sequence: | 193628994 | Sequence: | 193628995 | Sequence: | 193628996 | Sequence: | 193628997 | Sequence: | 193628998 | Sequence: | 193628999 | Sequence: | 193629000 | Sequence: | 193629001 | Sequence: | 193629002 |
Mesh Term | Urea Cycle Disorders, Inborn | Mesh Term | Brain Diseases, Metabolic, Inborn | Mesh Term | Brain Diseases, Metabolic | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Amino Acid Metabolism, Inborn Errors | Mesh Term | Metabolism, Inborn Errors | Mesh Term | Genetic Diseases, Inborn | Mesh Term | Metabolic Diseases |
Downcase Mesh Term | urea cycle disorders, inborn | Downcase Mesh Term | brain diseases, metabolic, inborn | Downcase Mesh Term | brain diseases, metabolic | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | amino acid metabolism, inborn errors | Downcase Mesh Term | metabolism, inborn errors | Downcase Mesh Term | genetic diseases, inborn | Downcase Mesh Term | metabolic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48354204 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Kaleido Biosciences |
Overall Officials
Sequence: | 29306255 |
Role | Study Director |
Name | Mark Wingertzahn |
Affiliation | Kaleido Biosciences |
Design Group Interventions
Sequence: | 68199835 |
Design Group Id | 55635223 |
Intervention Id | 52522539 |
Eligibilities
Sequence: | 30787162 |
Gender | All |
Minimum Age | 14 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Confirmed UCD patient at any age ≥ 14 years Exclusion Criteria: Any medical condition unrelated to the sequelae of UCD |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 253990130 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 7 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 14 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 2 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30533232 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28899524 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797118
2017-04-05
https://zephyrnet.com/?p=NCT03797118
NCT03797118https://www.clinicaltrials.gov/study/NCT03797118?tab=tableNANANAThis study evaluates the diagnostic efficiency of an automated method of noninvasive assessment of the fractional reserve of coronary blood flow.
Fractional flow reserve is estimated with a one-dimensional mathematical model constructed by means of an automated algorithm. Noninvasive method values are thereafter compared with invasive method values.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-22 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-05-18 |
Start Month Year | April 5, 2017 |
Primary Completion Month Year | June 5, 2019 |
Verification Month Year | May 2020 |
Verification Date | 2020-05-31 |
Last Update Posted Date | 2020-05-18 |
Detailed Descriptions
Sequence: | 20721683 |
Description | Noninvasive assessment of Fractional Flow Reserve is almost never applied in the Russian Federation due to the relative novelty and study insufficiency, lack of the appropriate resource base, specific necessary software and trained qualified personnel.
In 2015, scientists from the Institute of Numerical Mathematics RAS in collaboration with specialists of the I.M. Sechenov First Moscow State Medical University developed a noninvasive method of fractional flow reserve assessment based on a one-dimensional mathematical model. A model is constructed based on images derived from the coronary computed tomography angiography performed by standard protocol; the method is fully automated. The aim of our study is to evaluate the diagnostic efficiency of this technique in clinical practice. This is a pilot study; we are planning to enroll 30 patients: 13 of them underwent 64-slice computed tomography and are included retrospectively; 17 will be included prospectively, with a 640-slice CT scan. Specialists from the Laboratory of Mathematical Modeling will process CT images and evaluate noninvasive FFR. Ischemia is confirmed if FFR < 0.80 and disproved if FFR ≥ 0.80. After that, the prospective group of patients will be hospitalized for invasive FFR assessment as a reference standard; if ischemia is proved, patients will undergo stent implantation. In the retrospective group, patients already have invasive FFR values estimated. Statistical analysis will be performed using R programming language packages (cran-r.project.com). Continuous variables will be presented as mean values ± standard deviations, order variables will be presented as medians with interquartile ranges in parentheses. We are going to use the D'Agostino-Pearson omnibus test for the assessment of normality of distribution and construct a Q-Q Plot. We will compare these two methods with the Bland-Altman analysis and ROC-analysis and will assess the degree of correlation with the Pearson's chi-squared. The study should result in determining the sensitivity, specificity, positive and negative predictive values of the method. After the active phase of the research is done, we are planning to proceed observation on the prospective group of patients to verify the endpoints. |
Facilities
Sequence: | 200108805 |
Name | Daria Gognieva |
City | Moscow |
Zip | 127540 |
Country | Russian Federation |
Conditions
Sequence: | 52171372 |
Name | Coronary Artery Disease |
Downcase Name | coronary artery disease |
Id Information
Sequence: | 40158711 |
Id Source | org_study_id |
Id Value | 17-51-53160 |
Countries
Sequence: | 42569047 |
Name | Russian Federation |
Removed | False |
Design Groups
Sequence: | 55593302 |
Group Type | Experimental |
Title | FFRct |
Description | Patients will receive cCTA, ICA, FFRct, and FFRinv per protocol. |
Interventions
Sequence: | 52485596 |
Intervention Type | Device |
Name | FFR |
Description | Fractional flow reserve measured during cardiac catheterization |
Keywords
Sequence: | 79868736 | Sequence: | 79868737 |
Name | noninvasive assessment of the fractional flow reserve | Name | coronary computed tomography angiography |
Downcase Name | noninvasive assessment of the fractional flow reserve | Downcase Name | coronary computed tomography angiography |
Design Outcomes
Sequence: | 177379283 |
Outcome Type | primary |
Measure | Diagnostic Accuracy of FFRct |
Time Frame | through study completion, an average of 8 months |
Description | Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of FFRct at the vessel level using binary outcomes whith compared to FFR as the reference standard. |
Browse Conditions
Sequence: | 193487206 | Sequence: | 193487207 | Sequence: | 193487208 | Sequence: | 193487209 | Sequence: | 193487210 | Sequence: | 193487211 | Sequence: | 193487212 | Sequence: | 193487213 |
Mesh Term | Coronary Artery Disease | Mesh Term | Coronary Disease | Mesh Term | Myocardial Ischemia | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Arteriosclerosis | Mesh Term | Arterial Occlusive Diseases | Mesh Term | Vascular Diseases |
Downcase Mesh Term | coronary artery disease | Downcase Mesh Term | coronary disease | Downcase Mesh Term | myocardial ischemia | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | arteriosclerosis | Downcase Mesh Term | arterial occlusive diseases | Downcase Mesh Term | vascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319406 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | I.M. Sechenov First Moscow State Medical University |
Overall Officials
Sequence: | 29285414 | Sequence: | 29285415 |
Role | Principal Investigator | Role | Study Director |
Name | Daria Gognieva, MD | Name | Philipp Kopylov, Professor |
Affiliation | I.M. Sechenov First Moscow State Medical University (Sechenov University) | Affiliation | I.M. Sechenov First Moscow State Medical University (Sechenov University) |
Design Group Interventions
Sequence: | 68149274 |
Design Group Id | 55593302 |
Intervention Id | 52485596 |
Eligibilities
Sequence: | 30765420 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 85 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients providing written informed consent Exclusion Criteria: Prior coronary artery bypass graft (CABG) surgery |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253889305 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 26 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 85 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30511586 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Diagnostic |
Time Perspective | |
Masking | None (Open Label) |
Links
Sequence: | 4388099 |
Url | https://www.ncbi.nlm.nih.gov/pubmed?term=Am+J+Case+Rep+%5BJour%5D+AND+One-Dimensional+Mathematical+Model-Based+Automated+Assessment+of+Fractional+Flow+Reserve+in+a+Patient+with+Silent+Myocardial+Ischemia&TransSchema=title&cmd=detailssearch |
Description | Am J Case Rep. 2018 Jun 20;19:724-728. doi: 10.12659/AJCR.908449. |
Responsible Parties
Sequence: | 28877881 |
Responsible Party Type | Principal Investigator |
Name | Daria Gognieva |
Title | Principal Investigator |
Affiliation | I.M. Sechenov First Moscow State Medical University |
Study References
Sequence: | 52063523 |
Pmid | 29921835 |
Reference Type | background |
Citation | Gognieva D, Gamilov T, Pryamonosov R, Betelin V, Ternovoy SK, Serova NS, Abugov S, Shchekochikhin D, Mitina Y, El-Manaa H, Kopylov P. One-Dimensional Mathematical Model-Based Automated Assessment of Fractional Flow Reserve in a Patient with Silent Myocardial Ischemia. Am J Case Rep. 2018 Jun 20;19:724-728. doi: 10.12659/AJCR.908449. |
]]>
https://zephyrnet.com/NCT03797105
2012-08-01
https://zephyrnet.com/?p=NCT03797105
NCT03797105https://www.clinicaltrials.gov/study/NCT03797105?tab=tableNANANAThis randomized controlled trial compared changes in Mexican-American, adolescent standardized body mass index (zBMI) from a school-based obesity intervention given zero, one, three, or five days a week.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | August 1, 2012 |
Primary Completion Month Year | September 30, 2014 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-08 |
Detailed Descriptions
Sequence: | 20741318 |
Description | Efficacious school-based interventions have been intensive making it difficult for interventions to be scaled. The more components there are to an intervention, typically the better the results. Instead of decreasing intensity via the removal of intervention components, this randomized controlled trial aimed to compare changes in Mexican-American adolescent standardized body mass index (zBMI) based on the number of days per week they received a multi-component intervention. Mexican-American middle school students (n=203) with overweight or obesity were recruited from an independent school district in Houston. Students were randomized to receive an obesity intervention with established efficacy zero (control), one, three, or five days/week. In each condition, 80% of intervention time was allocated to physical activity and 20% to nutrition. Directly measured height and weight were used to calculate zBMI. |
Facilities
Sequence: | 200281860 |
Name | YES Prep Brays Oaks |
City | Houston |
State | Texas |
Zip | 77031 |
Country | United States |
Conditions
Sequence: | 52221868 |
Name | Obesity, Child |
Downcase Name | obesity, child |
Id Information
Sequence: | 40195877 |
Id Source | org_study_id |
Id Value | STUDY00000487 |
Countries
Sequence: | 42609894 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55650187 | Sequence: | 55650188 | Sequence: | 55650189 | Sequence: | 55650190 |
Group Type | No Intervention | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | Control, 0 days | Title | 1 day | Title | 3 days | Title | 5 days |
Description | control group, no intervention | Description | received the intervention 1 day/week | Description | received the intervention 3 days/week | Description | received the intervention 5 days/week |
Interventions
Sequence: | 52535686 |
Intervention Type | Behavioral |
Name | School-Based Obesity Intervention (FLOW) |
Description | The intervention consisted of nutrition lessons based on the traffic light diet, circuit-based physical activity, behavior modification techniques (token economy system, goal setting, self-monitoring), and parental involvement (materials sent home and monthly parent meetings). 80% of time was spent on physical activity and 20% was spent on nutrition. Behavior modification was incorporated into both physical activity and nutrition time. Specifically, instruction and activity time during PE class lasted approximately 40 minutes. |
Design Outcomes
Sequence: | 177562735 |
Outcome Type | primary |
Measure | Change in Standardized Body Mass Index (zBMI) |
Time Frame | baseline, 6, and 12 months |
Description | standardized body mass index |
Browse Conditions
Sequence: | 193679801 | Sequence: | 193679802 | Sequence: | 193679803 | Sequence: | 193679804 | Sequence: | 193679805 | Sequence: | 193679806 |
Mesh Term | Obesity | Mesh Term | Pediatric Obesity | Mesh Term | Overweight | Mesh Term | Overnutrition | Mesh Term | Nutrition Disorders | Mesh Term | Body Weight |
Downcase Mesh Term | obesity | Downcase Mesh Term | pediatric obesity | Downcase Mesh Term | overweight | Downcase Mesh Term | overnutrition | Downcase Mesh Term | nutrition disorders | Downcase Mesh Term | body weight |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366762 | Sequence: | 48366763 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Houston | Name | Baylor College of Medicine |
Overall Officials
Sequence: | 29313070 |
Role | Principal Investigator |
Name | Craig A Johnston, PhD |
Affiliation | University of Houston |
Design Group Interventions
Sequence: | 68217849 | Sequence: | 68217850 | Sequence: | 68217851 |
Design Group Id | 55650188 | Design Group Id | 55650189 | Design Group Id | 55650190 |
Intervention Id | 52535686 | Intervention Id | 52535686 | Intervention Id | 52535686 |
Eligibilities
Sequence: | 30794917 |
Gender | All |
Minimum Age | 10 Years |
Maximum Age | 17 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
BMI-for-age (Body Mass Index) percentile ≥ 85 Exclusion Criteria: Student who is pregnant, planning to become pregnant, or becomes pregnant |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254004646 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 26 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 10 |
Maximum Age Num | 17 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30540957 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28907277 |
Responsible Party Type | Principal Investigator |
Name | Craig A Johnston |
Title | Associate Professor |
Affiliation | University of Houston |
]]>
https://zephyrnet.com/NCT03797092
2019-10-01
https://zephyrnet.com/?p=NCT03797092
NCT03797092https://www.clinicaltrials.gov/study/NCT03797092?tab=tableAbbas A Qayyum, MD, PhDabbas.ali.qayyum@regionh.dk004535451076The overall aim of the project is to test the feasibility and safety of allogeneic adipose-derived stromal cells (CSCC_ASC) investigational medicinal product, to improve myocardial function in patients with non-ischemic dilated cardiomyopathies (NIDCM) and heart failure.
<![CDATA[
Studies
Study First Submitted Date | 2018-06-28 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-01-19 |
Start Month Year | October 1, 2019 |
Primary Completion Month Year | July 1, 2021 |
Verification Month Year | January 2021 |
Verification Date | 2021-01-31 |
Last Update Posted Date | 2021-01-19 |
Detailed Descriptions
Sequence: | 20710016 |
Description | Study design
The primary objective of the study is to investigate safety and regenerative capacity of direct intra-myocardial injection of 100 million allogeneic CSCC_ASCs in NIDCM patients with reduced left ventricular EF (≤ 40%) and heart failure. It is a proof of concept study enrolling a total of 30 NIDCM patients with heart failure who will be randomly allocated in a 2:1 ratio to either CSCC_ASC cell therapy (Stem Cell Group) or no cell therapy (Control Group). The treatment period is estimated to be 6 months (efficacy end-point) with a 12-month follow-up period for safety end-points. Patient treatment and follow-up The cell IMP will be delivered by a courier service to from REGIONH to UKCL using validated portable dry liquid nitrogen shipping containers. It will then be stored in nitrogen vapour containers until treatment. Primary and secondary endpoints The primary endpoint is change in left ventricle end-systolic volume (LVESV) at 6 months follow-up measured by Echocardiography. The secondary endpoints are safety evaluated by development of allogeneic antibodies and laboratory safety measurements 1, 3 and 6 months after treatment and changes in left ventricular ejection fraction (LVEF), end-diastolic volume and myocardial mass at 6 months follow-up. Additional secondary endpoints are changes in NYHA, Kansas City Cardiomyopathy Questionnaire, EQ-5D3L Questionnaire, 6 min walking test, additional echocardiographic measures (Global strain %) and NT-pro-BNP. Safety of allogeneic CSCC_ASCs with respect to incidence and severity of serious adverse events and suspected unrelated serious adverse events will be evaluated at 12 months follow-up. Outcome measures for safety Safety endpoints will be collected, reported to the authorities and monitored according to legislation during the entire study period. Adverse event (AE) is defined as any untoward medical occurrence in a subject who was treated with an investigational product, and does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease, whether or not related to the investigational product. Serious adverse event (SAE) is defined as any untoward medical occurrence that: results in death Suspected unexpected serious adverse event reactions (SUSAR) is defined as a SAE occurring in a subject in an interventional study that is assessed as both causally related to the suspect product under clinical investigation and unexpected per the Investigator's Brochure (IB). An independent Data Safety Monitoring Board (DSMB) will be established to evaluate the safety of the treatment. The DSMB will report directly to the director of the Project Management Board, which will take the necessary action upon the DSMB's recommendations. Study medication The investigational cell product, CSCC_ASC, will be produced in an approved GMP facility in Cardiology Stem Cell Centre at Rigshospitalet University Hospital, Copenhagen, Denmark. The production of the allogeneic CSCC_ASCs will follow the description in an approved Investigational Medicinal Product Dossier. The cell product will come from healthy donors. The production unit will label the investigational medicinal product (IMP) in accordance with the legislation and keep the randomisation code until finalisation of the clinical trial. The final cell products will be stored in nitrogen vapour containers until clinical use. Allogeneic MSCs and ASCs have been administered to more than 600 patients with heart disease. In the conducted clinical trials there has not been any serious adverse event due to the treatment. A few patients have developed transient donor specific HLA-antibodies in serum within the first months after treatment. However, none of the patients had any symptoms related to the presence of antibodies. Transient fever was registered in a few patients, but it could as well be due to the treatment procedure or the disease for treatment. Based on the accumulated safety and efficacy evidence with clinical use of allogeneic MSCs and ASCs in conducted clinical trials and the safety data from the CSCC_ASC phase I trial and the two ongoing phase II trials then it is concluded that it is safe to conduct a pilot CSCC_ASC trial in patients with NIDCM and HF. Echocardiography The echocardiography data will be recorded at pre-defined intervals according to American Society of Echocardiography (ASE) and European Association of Cardiovascular Imaging (EACVI) recommendations. For each patient at least five end-expiratory full cardiac cycles will be recorded for each protocol specified view. All acquired images will be de-identified and transferred to independent imaging core-lab (Stanford Cardiovascular Institute Clinical Biomarker & Phenotyping Core Lab). The recordings will be analyzed at the end of the study by an independent echocardiographer who will be blinded to the patient's treatment status and the timing of the recordings. All measurements will be performed according to ASE/EACVI recommendations. All echocardiographic measurements will be averaged over 5 cardiac cycles. Left ventricular end-systolic dimension (LVESD) and end-diastolic dimension (LVEDD) will be measured in the parasternal long-axis view. Left ventricular end-systolic volume (LVESV), left ventricular end-diastolic volume (LVEDV), and LVEF will be estimated using the Simpson's biplane method. Peak longitudinal strains will be computed automatically to generate regional data from each of the 17 segments and then averaged to calculate global longitudinal strain. |
Facilities
Sequence: | 199965404 |
Status | Recruiting |
Name | The Heart Centre, Rigshospitalet University Hospital Copenhagen, |
City | Copenhagen |
Zip | 2100 |
Country | Denmark |
Facility Investigators
Sequence: | 18318901 |
Facility Id | 199965404 |
Role | Principal Investigator |
Name | Jens Kastrup, MD |
Conditions
Sequence: | 52139081 |
Name | Non-ischemic Dilated Cardiomyopathy |
Downcase Name | non-ischemic dilated cardiomyopathy |
Id Information
Sequence: | 40135119 |
Id Source | org_study_id |
Id Value | SCIENCE II – Pilot |
Countries
Sequence: | 42542779 |
Name | Denmark |
Removed | False |
Design Groups
Sequence: | 55559437 | Sequence: | 55559438 |
Group Type | Active Comparator | Group Type | No Intervention |
Title | Active | Title | Control group |
Description | Allogeneic adipose-derived stromal cells (CSCC_ASC) | Description | No treatment |
Interventions
Sequence: | 52454992 | Sequence: | 52454993 |
Intervention Type | Biological | Intervention Type | Other |
Name | Allogeneic adipose-derived stromal cells (CSCC_ASC) | Name | Control group |
Description | Active group | Description | No treatment |
Keywords
Sequence: | 79822924 | Sequence: | 79822925 | Sequence: | 79822926 | Sequence: | 79822927 |
Name | Stem cell therapy | Name | Heart failure | Name | Clinical trial | Name | Allogeneic |
Downcase Name | stem cell therapy | Downcase Name | heart failure | Downcase Name | clinical trial | Downcase Name | allogeneic |
Design Outcomes
Sequence: | 177264117 | Sequence: | 177264118 | Sequence: | 177264111 | Sequence: | 177264112 | Sequence: | 177264113 | Sequence: | 177264114 | Sequence: | 177264115 | Sequence: | 177264116 |
Outcome Type | secondary | Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | EQ-5D3L Questionnaire | Measure | 6 min walking test | Measure | Left ventricle end-systolic volume | Measure | Allogeneic antibodies | Measure | Left ventricular ejection fraction | Measure | Myocardial mass of left ventricle | Measure | NYHA | Measure | Kansas City Cardiomyopathy Questionnaire |
Time Frame | 6 months after treatment | Time Frame | 6 months | Time Frame | 6 months after treatment | Time Frame | Up to 12 months after treatment | Time Frame | 6 months after treatment | Time Frame | 6 months after treatment | Time Frame | 6 months after treatment | Time Frame | 6 months after treatment |
Description | Questionnaire | Description | Test | Description | Measured using echocardiography | Description | Development of allogeneic antibodies and laboratory safety measurements 1, 3 and 6 months after treatment | Description | Changes in LVEF | Description | Change in echo measured global myocardial mass | Description | Symptoms | Description | Questionnaire |
Browse Conditions
Sequence: | 193366839 | Sequence: | 193366840 | Sequence: | 193366841 | Sequence: | 193366842 | Sequence: | 193366843 | Sequence: | 193366844 | Sequence: | 193366845 |
Mesh Term | Cardiomyopathies | Mesh Term | Cardiomyopathy, Dilated | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Cardiomegaly | Mesh Term | Laminopathies | Mesh Term | Genetic Diseases, Inborn |
Downcase Mesh Term | cardiomyopathies | Downcase Mesh Term | cardiomyopathy, dilated | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | cardiomegaly | Downcase Mesh Term | laminopathies | Downcase Mesh Term | genetic diseases, inborn |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290778 | Sequence: | 48290779 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | JKastrup | Name | University Medical Centre Ljubljana |
Overall Officials
Sequence: | 29268569 |
Role | Principal Investigator |
Name | Bojan Vrtovec, MD, PhD |
Affiliation | Dep. of Cardiology, Uni. Medical Center Ljubljana, Slovenia |
Central Contacts
Sequence: | 12000506 | Sequence: | 12000507 |
Contact Type | primary | Contact Type | backup |
Name | Jens Kastrup, MD, DMSc | Name | Abbas A Qayyum, MD, PhD |
Phone | 004535452819 | Phone | 004535451076 |
jens.akstrup@regionh.dk | abbas.ali.qayyum@regionh.dk | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68107556 | Sequence: | 68107557 |
Design Group Id | 55559437 | Design Group Id | 55559437 |
Intervention Id | 52454992 | Intervention Id | 52454993 |
Eligibilities
Sequence: | 30747771 |
Gender | All |
Minimum Age | 30 Years |
Maximum Age | 80 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
30 to 80 years of age Exclusion Criteria: Heart Failure NYHA I |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254122101 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 30 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 7 |
Designs
Sequence: | 30494054 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Masking Description | The patients will be randomized to either IMP or control in a 2:1 randomization.
The outcome ECHO investigations will be analyzed blinded by an independent core lab. |
Intervention Model Description | Open randomized treatment group and control group clinical trial |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26655454 |
Intervention Id | 52454992 |
Name | Investigational medicinal product |
Links
Sequence: | 4385409 |
Url | https://www.ncbi.nlm.nih.gov/pubmed/28880460 |
Description | PubMed abstract related to the used allogeneic stem cell product |
Responsible Parties
Sequence: | 28860334 |
Responsible Party Type | Sponsor-Investigator |
Name | JKastrup |
Title | Professor, Doctor |
Affiliation | Rigshospitalet, Denmark |
Study References
Sequence: | 52032799 |
Pmid | 28880460 |
Reference Type | result |
Citation | Kastrup J, Haack-Sorensen M, Juhl M, Harary Sondergaard R, Follin B, Drozd Lund L, Monsted Johansen E, Ali Qayyum A, Bruun Mathiasen A, Jorgensen E, Helqvist S, Jorgen Elberg J, Bruunsgaard H, Ekblond A. Cryopreserved Off-the-Shelf Allogeneic Adipose-Derived Stromal Cells for Therapy in Patients with Ischemic Heart Disease and Heart Failure-A Safety Study. Stem Cells Transl Med. 2017 Nov;6(11):1963-1971. doi: 10.1002/sctm.17-0040. Epub 2017 Sep 7. |
]]>
https://zephyrnet.com/NCT03797079
2019-01-20
https://zephyrnet.com/?p=NCT03797079
NCT03797079https://www.clinicaltrials.gov/study/NCT03797079?tab=tableNANANARib fractures are very common as a consequence of blunt chest trauma which is associated with severe pain, morbidity and mortality. The key to managing these patients is prompt and effective analgesia, early mobilization, respiratory support, with chest physiotherapy. The aim of this study is to compare and evaluate the differences between either continuous erector spinae plane (ESP) block, or thoracic epidural analgesia (TEA) as analgesic modalities in patients with chest trauma. It is hypothesized that ESP block will be comparable to TEA as a promising effective analgesic alternative with fewer side effects.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-06-10 |
Start Month Year | January 20, 2019 |
Primary Completion Month Year | February 20, 2020 |
Verification Month Year | June 2021 |
Verification Date | 2021-06-30 |
Last Update Posted Date | 2021-06-10 |
Detailed Descriptions
Sequence: | 20727200 |
Description | Trauma is a major cause of morbidity and mortality worldwide as a leading cause of death. Rib fractures are very common and are detected in at least 10% of all injured patients, the majority of which are as a consequence of blunt chest trauma. Chest trauma are associated with severe pain, morbidity and mortality, as it contributes to atelectasis, lobar collapse, pneumonia, effusion, aspiration, acute respiratory distress syndrome pulmonary embolism, increased intensive care admissions, and poor overall clinical outcomes. Trauma is associated with release of cytokines, which contribute to the development of hemodynamic instability and metabolic derangement, which can worsen prognosis. The efficacy of utilizing different modalities for analgesia in controlling extent of tissue damage can be compared by measuring these cytokines levels. Multiple analgesic modalities have been used in these patients with chest trauma, such as oral analgesics, intravenous opioids, patient-controlled opioid analgesia, inter-pleural blocks, intercostal blocks, serratus plane blocks, paravertebral blocks, and TEA. In trauma patients with rib fractures, retrospective studies showed that TEA has become the gold standard of care, while ultrasound-guided paravertebral and serratus plane blocks are possible alternatives. However, no single best analgesic modality could be recommended or established, based on available data in this population, as no meta-analysis on this topic has yet been completed. Ultrasound has been the fundamental tool for a significant improvement in the progress of regional analgesic techniques of inter-fascial chest wall blocks, allowing their description and introduction into clinical practice. Ultrasound-guided ESP block is a new technique that has been recently described in the control of both chronic neuropathic pain as well as acute postsurgical or post-traumatic pain of the chest wall. The ESP block holds promise as a simple, easy, fast and safe technique for thoracic analgesia in the context of pain associated with chest trauma.
Aim of the Study: The aim of this study is to assess the quality of pain relief and improvement of pulmonary function in patients with chest trauma receiving either continuous ESP block or TEA by comparing and evaluating the differences between the two techniques. It is hypothesized that ESP block will be comparable to TEA as a promising effective analgesic alternative with fewer side effects. Sample Size Calculation: The literature available on ESP block is limited to some sporadic case reports and editorials. Hence, this clinical trial will be conducted on 50 patients and post hoc analysis will be performed using pain scores obtained from the present study with an α (type I error) = 0.05 and β (type II error) = 0.2 (power = 80%). Methods: The study will be conducted in Mansoura Emergency Hospital on fifty patients admitted with chest trauma. They will be randomly assigned to two equal groups (ESP group and TEA group) according to computer-generated table of random numbers using the permuted block randomization method. The group allocation will be concealed in sequentially numbered, sealed opaque envelopes which will be opened only after obtaining the written informed consent. Patient demographic data including age, sex, body weight, and status of American Society of Anesthesiologists (ASA) will be recorded. A written informed consent will be obtained from all study subjects after ensuring confidentiality. The study protocol will be explained to all patients after enrollment into the study. In both groups, catheter-based analgesia will be performed with a bolus dose of bupivacaine followed by a continuous infusion for 48 hours. Later on, the catheters will be removed, and the pain management will be switched to parental or oral analgesics. Statistical Methods: The collected data will be coded, processed, and analyzed using Statistical Package for the Social Sciences (SPSS) program (version 22) for Windows. Normality of numerical data distribution will be tested by Shapiro-Wilk test. Continuous data of normal distribution will be presented as mean ± standard deviation, and compared with the unpaired student's t test. Non-normally distributed data will be presented as median (range), and compared with the Mann-Whitney U test. Repeated measures analysis of variance (ANOVA) test will be used for comparisons within the same group. Categorical data will be presented as number (percentage), and compared with the Chi-square test. All data will be considered statistically significant if P value is ≤ 0.05. |
Facilities
Sequence: | 200159461 |
Name | Mansoura University Hospitals |
City | Mansoura |
State | Dakahlia |
Zip | 35511 |
Country | Egypt |
Browse Interventions
Sequence: | 96074250 | Sequence: | 96074251 | Sequence: | 96074252 | Sequence: | 96074253 | Sequence: | 96074254 | Sequence: | 96074255 | Sequence: | 96074256 |
Mesh Term | Bupivacaine | Mesh Term | Anesthetics, Local | Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents |
Downcase Mesh Term | bupivacaine | Downcase Mesh Term | anesthetics, local | Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52185552 |
Name | Chest Trauma |
Downcase Name | chest trauma |
Id Information
Sequence: | 40169113 |
Id Source | org_study_id |
Id Value | ESP Block for Chest Trauma |
Countries
Sequence: | 42580699 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55609179 | Sequence: | 55609180 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | Group A (ESP block) | Title | Group B (TEA) |
Description | Ultrasound-guided ESP block will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered. | Description | TEA will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered. |
Interventions
Sequence: | 52499478 | Sequence: | 52499479 | Sequence: | 52499480 | Sequence: | 52499481 |
Intervention Type | Procedure | Intervention Type | Procedure | Intervention Type | Device | Intervention Type | Drug |
Name | ESP block | Name | TEA | Name | Catheter insertion | Name | Bupivacaine |
Description | A high-frequency linear ultrasound probe will be placed superficial to erector spinae muscle (ESM) in a parasagittal plane 3 cm lateral to the midline at the level of fifth thoracic vertebra. Three muscles will be identified superficial to the hyperechoic transverse process shadow: trapezius (uppermost), rhomboids major (middle), and ESM (lowermost). After local infiltration of skin and using in-plane approach, an 18 G Tuohy needle will be inserted, until the tip lay between the rhomboid major muscle and ESM. | Description | Skin will be locally infiltrated at the site of needle insertion, and 18 G Tuohy needle will be introduced until its tip lay in the epidural space of the T5-T6 thoracic intervertebral space. | Description | After obtaining loss of resistance, 20 G epidural catheter will be threaded for 5 cm and then fixed on the skin. | Description | After the negative aspiration for blood, a bolus dose of 15 ml 0.125% plain bupivacaine will be injected in the catheter, followed by a continuous infusion of 0.25% plain bupivacaine at the rate of 0.1 ml/kg/h for 48 hours |
Keywords
Sequence: | 79888852 |
Name | Erector spinae plane block |
Downcase Name | erector spinae plane block |
Design Outcomes
Sequence: | 177432230 | Sequence: | 177432231 | Sequence: | 177432232 | Sequence: | 177432233 | Sequence: | 177432234 | Sequence: | 177432235 | Sequence: | 177432236 | Sequence: | 177432237 | Sequence: | 177432238 | Sequence: | 177432239 | Sequence: | 177432240 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Improvement in pain scores by Visual analogue scale (VAS) | Measure | Total analgesic requirements of fentanyl | Measure | First analgesic request | Measure | Changes in heart rate (HR) | Measure | Changes in mean arterial blood pressure (MAP) | Measure | Improvement in forced expiratory volume in one second (FEV1) | Measure | Improvement in forced vital capacity (FVC) | Measure | Improvement in forced expiratory flow (FEF 25-75%) | Measure | Improvement in the level of tumor necrosis factor alpha (TNF-α) | Measure | Improvement in the level of interleukin 6 (IL-6) | Measure | Incidence of adverse effects |
Time Frame | Up to 48 hours after the procedure | Time Frame | Up to 48 hours after the procedure | Time Frame | Up to 48 hours after the procedure | Time Frame | Up to 48 hours after the procedure | Time Frame | Up to 48 hours after the procedure | Time Frame | Up to 48 hours after the procedure | Time Frame | Up to 48 hours after the procedure | Time Frame | Up to 48 hours after the procedure | Time Frame | Up to 48 hours after the procedure | Time Frame | Up to 48 hours after the procedure | Time Frame | Up to 48 hours after the procedure |
Description | VAS score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) will be assessed every two hours for 48 hours after the procedure. | Description | The amount of fentanyl consumption given as a rescue analgesia to patients will be measured all over the 48 hours. | Description | The time of the first analgesic request for fentanyl will be recorded. | Description | HR will be recorded every two hours for 48 hours after the procedure. | Description | MAP will be recorded every two hours for 48 hours after the procedure. | Description | FEV1 will be assessed by spirometry before and 48 hours after the procedure. | Description | FVC will be assessed by spirometry before and 48 hours after the procedure. | Description | FEF 25-75% will be assessed by spirometry before and 48 hours after the procedure. | Description | TNF-α will be measured before, 24, 48 hours after the procedure. | Description | IL-6 will be measured before, 24, 48 hours after the procedure. | Description | Any adverse effects like pneumothorax, respiratory depression, nausea, vomiting, hematoma, or allergic reactions will be recorded. |
Browse Conditions
Sequence: | 193540386 | Sequence: | 193540387 |
Mesh Term | Wounds and Injuries | Mesh Term | Thoracic Injuries |
Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | thoracic injuries |
Mesh Type | mesh-list | Mesh Type | mesh-list |
Sponsors
Sequence: | 48332381 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Sameh Fathy |
Overall Officials
Sequence: | 29293028 |
Role | Principal Investigator |
Name | Sameh M El-Sherbiny, MD |
Affiliation | Faculty of Medicine, Mansoura University |
Design Group Interventions
Sequence: | 68168244 | Sequence: | 68168245 | Sequence: | 68168246 | Sequence: | 68168247 | Sequence: | 68168248 | Sequence: | 68168249 |
Design Group Id | 55609179 | Design Group Id | 55609180 | Design Group Id | 55609179 | Design Group Id | 55609180 | Design Group Id | 55609179 | Design Group Id | 55609180 |
Intervention Id | 52499478 | Intervention Id | 52499479 | Intervention Id | 52499480 | Intervention Id | 52499480 | Intervention Id | 52499481 | Intervention Id | 52499481 |
Eligibilities
Sequence: | 30773610 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
American Society of Anesthesiologists (ASA) status: 1 or 2 . Exclusion Criteria: Bilateral chest trauma. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952811 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 13 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 10 |
Designs
Sequence: | 30519741 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Masking Description | The study subjects and the resident assessing the outcomes will be blinded to the study group. A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation, perform the block, and administer bupivacaine solution. |
Intervention Model Description | Prospective, randomized, double blind study |
Subject Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26680443 |
Intervention Id | 52499481 |
Name | Marcaine |
Responsible Parties
Sequence: | 28886042 |
Responsible Party Type | Sponsor-Investigator |
Name | Sameh Fathy |
Title | Lecturer of anesthesia, ICU & pain management; Faculty of Medicine |
Affiliation | Mansoura University |
Study References
Sequence: | 52079032 | Sequence: | 52079033 | Sequence: | 52079034 | Sequence: | 52079035 | Sequence: | 52079036 | Sequence: | 52079037 | Sequence: | 52079038 | Sequence: | 52079039 |
Pmid | 27501016 | Pmid | 24368355 | Pmid | 27533913 | Pmid | 30052229 | Pmid | 28924315 | Pmid | 29102405 | Pmid | 29766081 | Pmid | 22704784 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. | Citation | Gage A, Rivara F, Wang J, Jurkovich GJ, Arbabi S. The effect of epidural placement in patients after blunt thoracic trauma. J Trauma Acute Care Surg. 2014 Jan;76(1):39-45; discussion 45-6. doi: 10.1097/TA.0b013e3182ab1b08. | Citation | Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209. | Citation | Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18. | Citation | Singh S, Jacob M, Hasnain S, Krishnakumar M. Comparison between continuous thoracic epidural block and continuous thoracic paravertebral block in the management of thoracic trauma. Med J Armed Forces India. 2017 Apr;73(2):146-151. doi: 10.1016/j.mjafi.2016.11.005. Epub 2016 Dec 24. | Citation | Veiga M, Costa D, Brazao I. Erector spinae plane block for radical mastectomy: A new indication? Rev Esp Anestesiol Reanim (Engl Ed). 2018 Feb;65(2):112-115. doi: 10.1016/j.redar.2017.08.004. Epub 2017 Nov 2. English, Spanish. | Citation | Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017. | Citation | Yeh DD, Kutcher ME, Knudson MM, Tang JF. Epidural analgesia for blunt thoracic injury–which patients benefit most? Injury. 2012 Oct;43(10):1667-71. doi: 10.1016/j.injury.2012.05.022. Epub 2012 Jun 16. |
]]>
https://zephyrnet.com/NCT03797066
2019-03-23
https://zephyrnet.com/?p=NCT03797066
NCT03797066https://www.clinicaltrials.gov/study/NCT03797066?tab=tableNANANAThe study is looking at the potential of utilizing a “point of care” test and treat pathway; using the DDA called Zepatier for achieving SVR in an homeless population who have tested positive for genotype 1 or 4 HCV.
<![CDATA[
Studies
Study First Submitted Date | 2018-10-30 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-05-06 |
Start Month Year | March 23, 2019 |
Primary Completion Month Year | July 28, 2020 |
Verification Month Year | May 2023 |
Verification Date | 2023-05-31 |
Last Update Posted Date | 2023-05-06 |
Detailed Descriptions
Sequence: | 20718754 |
Description | Direct acting antivirals (DAA) are new medications that have been approved for the management of HCV. These drugs have proven to be very effective in curing the HCV, without the need for interferon injections; which have always been used in the past. There are many combinations of DAAs, which treat specific types of HCV. Persons who test positive for the virus are typically referred to be seen and treated by a specialist hepatitis service based in hospital. This means that individuals may sometimes not attend the hospital to commence treatment; or follow up on their management.
The study is designed to explore if testing and treating individuals close to their own "local" setting will be an improvement to the current treatment pathway and encourage better involvement with the health care team; as well as looking at what the health care team can do to ensure participants in this test-and-treat trial receive the entire course of drug treatment prescribed to treat their HCV infection. Participants infected with either genotype 1 or 4 HCV infection will be treated with Zepatier, a DAA which works by stopping the hepatitis C virus from (multiplying). The study medication is taken for 12 or 16 weeks depending on the genotype (or strain of HCV). Some participants will be given an additional drug called ribavirin. The study will examine the effectiveness of Zepatier at clearing the hepatitis C virus from the blood and body; and also what particular effects may be experienced by participants who may also be taking treatment for other conditions. Participants affected with other genotypes (not 1 and 4)will be offered standard NHS treatment with the appropriate antiviral combination for these strains. |
Facilities
Sequence: | 200075482 |
Name | Kings College Hospital NHS Trust |
City | London |
Zip | SE5 9RS |
Country | United Kingdom |
Browse Interventions
Sequence: | 96037960 | Sequence: | 96037961 | Sequence: | 96037962 |
Mesh Term | Elbasvir-grazoprevir drug combination | Mesh Term | Antiviral Agents | Mesh Term | Anti-Infective Agents |
Downcase Mesh Term | elbasvir-grazoprevir drug combination | Downcase Mesh Term | antiviral agents | Downcase Mesh Term | anti-infective agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52162910 |
Name | Hepatitis C, Chronic |
Downcase Name | hepatitis c, chronic |
Id Information
Sequence: | 40152905 |
Id Source | org_study_id |
Id Value | KCHATTIC01 |
Countries
Sequence: | 42562368 |
Name | United Kingdom |
Removed | False |
Design Groups
Sequence: | 55585028 |
Group Type | Other |
Title | Single arm |
Description | A phase 4, open label, non-randomised study, conducted in hostels and homeless shelters in London; as well as mobile clinics in collaboration with the Hep C trust and the NHS Find and Treat program.
Treatment: 12 or 16 weeks of Zepatier, based on genotypes; with Ribavarin for certain subtypes. The study drug is administered as a single tablet; which is a combination of 100 mg of grazoprevir and 50 mg of elbasvir; as outlined below: Genotypes 1a/b and 4: once daily dose for 12 weeks, taken with / without food. Genotype 1a and 4: (HCV RNA> 800,000 iu/ml or baseline NS5A resistance): once daily dose for 16 weeks, taken with / without food. NO dose modifications with the study drug. |
Interventions
Sequence: | 52478185 |
Intervention Type | Drug |
Name | ZEPATIER 50Mg-100Mg Tablet |
Description | Zepatier 50/100 OD , with addition of Ribavarin in patients with Genotype 1a and 4 with HCV RNA> 800,000 iu/ml or baseline NS5A resistance. |
Keywords
Sequence: | 79857083 | Sequence: | 79857084 |
Name | hepatitis C virus | Name | homeless |
Downcase Name | hepatitis c virus | Downcase Name | homeless |
Design Outcomes
Sequence: | 177351362 | Sequence: | 177351363 | Sequence: | 177351364 | Sequence: | 177351365 | Sequence: | 177351366 | Sequence: | 177351367 | Sequence: | 177351368 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | SVR | Measure | prevalence of HCV infection | Measure | Baseline knowledge evaluation | Measure | Change From Baseline (BL) to SVR12 timepoint in 36-Item Short-Form Health Survey (SF-36) Scores | Measure | Change From Baseline (BL) to SVR 12 in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | Measure | Percentage of Participants Who Were Compliant With Treatment According To Moriskey, Green And Levine Adherence Scale (MAS4)(Subset Analysis) | Measure | Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis) |
Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | baseline, SVR 12 (twelve weeks post end of active treatment/ last dose of study drug) | Time Frame | baseline , SVR 12 (twelve weeks post end of active treatment/last dose of study drug) | Time Frame | 12 or 16 weeks | Time Frame | 12 or 16 weeks |
Description | The percentage of participants achieving an SVR, defined as an HCV RNA evel less than the lower limit of quantification by sensitive PCR; by means of a short directed test and treat program in the homeless community. | Description | Reduction in local prevalence of of viraemic hepatitis C, after a pilot trial of treatment in three to four homeless hostels. | Description | Participant knowledge of their hepatitis C status (disease, diagnosis, and current available approved treatments) will be assessed by means of a questionnaire completed at baseline. The researchers will also review participants willingness to engage in a test and treat protocol and correlate these findings with demographic and sociological data. This will be done using a questionnaire designed by the researchers; containing simple questions with respect to currently available testing and treatment of HCV infection. | Description | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. The survey addresses eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL.
Data will be analysed ffg the guidelines suggested by the developers https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html |
Description | Impact of a localized test and treat protocol on health related quality of life will be assessed using the CLDQ-HCV instruments. The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency ("all of the time") and 7 to the minimum ("none of the time"). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life | Description | Adherence to treatment measured by Moriskey, Green and Levine Adherence scale. This is a 4 item questionnaire that is easy to administer and score (using a yes/no format); and quickly identifies barriers to adherence.An answer of yes to zero questions indicates high adherence behavior, answering yes to one or two questions indicates medium adherence behavior, and answering yes to three or four questions indicates low adherence behavior | Description | Compliance will be calculated as the amount of dispensed medication minus the amount of medication returned by participants at each visit. |
Browse Conditions
Sequence: | 193456736 | Sequence: | 193456737 | Sequence: | 193456738 | Sequence: | 193456739 | Sequence: | 193456740 | Sequence: | 193456741 | Sequence: | 193456742 | Sequence: | 193456743 | Sequence: | 193456744 | Sequence: | 193456745 | Sequence: | 193456746 | Sequence: | 193456747 | Sequence: | 193456748 | Sequence: | 193456749 | Sequence: | 193456750 | Sequence: | 193456751 | Sequence: | 193456752 | Sequence: | 193456753 | Sequence: | 193456754 |
Mesh Term | Hepatitis A | Mesh Term | Hepatitis C | Mesh Term | Hepatitis C, Chronic | Mesh Term | Hepatitis | Mesh Term | Liver Diseases | Mesh Term | Digestive System Diseases | Mesh Term | Hepatitis, Viral, Human | Mesh Term | Virus Diseases | Mesh Term | Infections | Mesh Term | Enterovirus Infections | Mesh Term | Picornaviridae Infections | Mesh Term | RNA Virus Infections | Mesh Term | Blood-Borne Infections | Mesh Term | Communicable Diseases | Mesh Term | Flaviviridae Infections | Mesh Term | Hepatitis, Chronic | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | hepatitis a | Downcase Mesh Term | hepatitis c | Downcase Mesh Term | hepatitis c, chronic | Downcase Mesh Term | hepatitis | Downcase Mesh Term | liver diseases | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | hepatitis, viral, human | Downcase Mesh Term | virus diseases | Downcase Mesh Term | infections | Downcase Mesh Term | enterovirus infections | Downcase Mesh Term | picornaviridae infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | blood-borne infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | flaviviridae infections | Downcase Mesh Term | hepatitis, chronic | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48312066 | Sequence: | 48312067 | Sequence: | 48312068 |
Agency Class | OTHER | Agency Class | INDUSTRY | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | King's College Hospital NHS Trust | Name | Merck Sharp & Dohme LLC | Name | Hepatitis C Trust |
Design Group Interventions
Sequence: | 68139322 |
Design Group Id | 55585028 |
Intervention Id | 52478185 |
Eligibilities
Sequence: | 30761050 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 90 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Participants 18 years or older with chronic hepatitis C genotype 1 or 4 will be eligible. Exclusion Criteria: Persons with prior HCV DAA treatment |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254304727 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 16 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 90 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30507250 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | non-randomised, open label |
Responsible Parties
Sequence: | 28873531 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797053
2015-04-06
https://zephyrnet.com/?p=NCT03797053
NCT03797053https://www.clinicaltrials.gov/study/NCT03797053?tab=tableMatthieu RESCHE-RIGON, MD PhDmatthieu.resche-rigon@univ-paris-diderot.fr142499742Several studies conducted over the past decade have shown that Circulating tumor cells (CTCs) can be used as a marker for predicting disease progression and survival in patients with early or metastatic cancer. A high number of CTCs correlate with aggressive disease, increased metastasis and decreased survival rates.
Knowledge of metastasis mechanisms was mainly obtained from mouse models with CTCs after orthotopic transplants. The only possibility to study the patient’s CTC subpopulations is to carry out ex-vivo expansion and develop an animal model with CTC xenograft. Because circulating blood collection is simple and non-invasive, CTCs can be used as a marker to track disease progression and survival in real time. CTCs could also guide therapeutic choice.
<![CDATA[
Studies
Study First Submitted Date | 2018-03-09 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | April 6, 2015 |
Primary Completion Month Year | June 30, 2019 |
Verification Month Year | March 2018 |
Verification Date | 2018-03-31 |
Last Update Posted Date | 2019-01-08 |
Facilities
Sequence: | 200245138 |
Status | Recruiting |
Name | Saint-Louis Hospital |
City | Paris |
Zip | 75010 |
Country | France |
Facility Contacts
Sequence: | 28128161 | Sequence: | 28128162 |
Facility Id | 200245138 | Facility Id | 200245138 |
Contact Type | primary | Contact Type | backup |
Name | Celeste Lebbe, MD PhD | Name | laetitia Da Meda |
celeste.lebbe@aphp.fr | laetitia.da-meda@aphp.fr | ||
Phone | 142499590 | Phone | 142499392 |
Phone Extension | +33 | Phone Extension | +33 |
Conditions
Sequence: | 52208572 | Sequence: | 52208573 |
Name | Melanoma | Name | Circulating Tumor Cell |
Downcase Name | melanoma | Downcase Name | circulating tumor cell |
Id Information
Sequence: | 40186485 |
Id Source | org_study_id |
Id Value | NI15009 |
Countries
Sequence: | 42599972 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55635185 | Sequence: | 55635186 |
Title | Cohort 1 : metastatic cohort | Title | Cohort 2 : adjuvant cohort |
Description | Cohort1: Cohort of patients with stage III inoperable or IV metastatic melanoma This cohort will enable the achievement of objectives 1 (proof of concept) and 2 (establishment of prognostic and predictive value). | Description | Cohort 2: Cohort of patients with melanoma who are candidates for sentinel lymph node analysis.
This group includes patients with melanoma in whom sentinel lymph node testing is performed. According to current French recommendations, these are patients whose primary melanoma has a Breslow index (thickness) of more than 1 mm or ulcerated primary melanoma (loss of the epidermis). |
Interventions
Sequence: | 52522518 |
Intervention Type | Procedure |
Name | Biological sample |
Description | Biological sample performed :
before treatment |
Design Outcomes
Sequence: | 177513012 | Sequence: | 177513013 | Sequence: | 177513014 | Sequence: | 177513015 | Sequence: | 177513016 | Sequence: | 177513017 | Sequence: | 177513018 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Therapeutical response | Measure | Survival | Measure | Survival | Measure | Survival | Measure | Disease free Survival | Measure | Disease free Survival | Measure | Disease free Survival |
Time Frame | 6 months | Time Frame | 1 year | Time Frame | 3 years | Time Frame | 5 years | Time Frame | 1 year | Time Frame | 3 years | Time Frame | 5 years |
Description | Occurrence of clinical benefit (defined as Complete Response (CR), Partial Response (PR) or stable disease (SD)) and progressive disease based on the best overall response which depends on the tumour evaluations assessed using RECIST 1.1 criteria. |
Browse Conditions
Sequence: | 193628908 | Sequence: | 193628909 | Sequence: | 193628910 | Sequence: | 193628911 | Sequence: | 193628912 |
Mesh Term | Neoplastic Cells, Circulating | Mesh Term | Neoplasms | Mesh Term | Neoplasm Metastasis | Mesh Term | Neoplastic Processes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | neoplastic cells, circulating | Downcase Mesh Term | neoplasms | Downcase Mesh Term | neoplasm metastasis | Downcase Mesh Term | neoplastic processes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48354179 | Sequence: | 48354180 | Sequence: | 48354181 | Sequence: | 48354182 | Sequence: | 48354183 |
Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | UNKNOWN | Agency Class | UNKNOWN | Agency Class | OTHER_GOV |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Assistance Publique – Hôpitaux de Paris | Name | ScreenCell | Name | Celenys | Name | Imstar | Name | Institut National de la Santé Et de la Recherche Médicale, France |
Central Contacts
Sequence: | 12017339 | Sequence: | 12017340 |
Contact Type | primary | Contact Type | backup |
Name | Celeste Lebbe, MD PhD | Name | Matthieu RESCHE-RIGON, MD PhD |
Phone | 142499590 | Phone | 142499742 |
celeste.lebbe@aphp.fr | matthieu.resche-rigon@univ-paris-diderot.fr | ||
Phone Extension | +33 | Phone Extension | +33 |
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68199793 | Sequence: | 68199794 |
Design Group Id | 55635185 | Design Group Id | 55635186 |
Intervention Id | 52522518 | Intervention Id | 52522518 |
Eligibilities
Sequence: | 30787146 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Cohort1: Cohort of patients with stage III unresectable or IV metastatic melanoma patients Cohort 2: Cohort of patients with melanoma candidates for sentinel lymph node analysis |
Criteria | COHORT 1
Inclusion Criteria: Histologically confirmed cutaneous or mucosal melanoma (per American joint committee on cancer (AJCC) staging system) that is unresectable or metastatic Exclusion Criteria: None COHORT 2 : Inclusion Criteria : Histologically confirmed cutaneous or mucosal melanoma Exclusion Criteria: None |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253990102 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30533216 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28899508 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797040
2021-01-31
https://zephyrnet.com/?p=NCT03797040
NCT03797040https://www.clinicaltrials.gov/study/NCT03797040?tab=tableNANANAThe objective of the study is to evaluate the safety of intramuscular (IM) administration of PLX-R18 in subjects exposed to ionizing radiation and who are at risk of developing HS-ARS.
Indication:Post-Exposure Prevention (PEP) or treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS) in subjects suspected to have been exposed to ionizing radiation.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-17 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-07-28 |
Start Month Year | January 2021 |
Primary Completion Month Year | December 2021 |
Verification Month Year | July 2020 |
Verification Date | 2020-07-31 |
Last Update Posted Date | 2020-07-28 |
Detailed Descriptions
Sequence: | 20721690 |
Description | This will be a Phase I, open-label safety study; each subject will receive two administrations of PLX-R18, 4 days apart. Each administration of PLX-R18 will contain 4 million cells/kg (up to a maximal dose of 400 million cells). The first administration should be preferably within 48 hours after suspected exposure and no later than 4 days after suspected exposure. The second administration will be provided 4 days after first administration.
All subjects will be hospitalized for at least 24 hours after each administration of PLX-R18,for close monitoring.In order to minimize risks, subjects will be divided in 3 sequential cohorts: Cohort 1: 9 subjects, treated as soon as possible Cohort 2: 18 subjects, treated at least 12 hours following the first dose administered to the 9th subject Cohort 3: 33 subjects, treated at least 12 hours following the first dose administered to the 27th subject After the completion of each Cohort, stopping rules will be assessed. All subjects will receive PLX-R18 in addition to recommended care per physician discretion, based on the REMM guidelines (APPENDIX 2). The study will be comprised of 2 periods: Main study period – Subjects will be followed-up for 12 months and evaluated at the following time points after the first administration: Day 0 (first administration),Day 1, Day 2, Day 3, Day 4 (second administration), Day 5, Day 14 (2 weeks),Day 21 (3 weeks), Day 28 (4 weeks), Day 49 (7 weeks), Day 63 (9 weeks), Day 119(17 weeks), Day 182 (26 weeks), and Day 364 (52 weeks).Long-term survival follow-up -Week 52 to Week 260: During this period, patients will be followed-up for overall survival at: 104 weeks, 156 weeks, 208 weeks and 260 weeks. |
Conditions
Sequence: | 52171390 |
Name | Ionizing Radiation Exposure |
Downcase Name | ionizing radiation exposure |
Id Information
Sequence: | 40158721 |
Id Source | org_study_id |
Id Value | PLX-R18-ARS-01 |
Design Groups
Sequence: | 55593317 |
Group Type | Experimental |
Title | 4 million PLX-R18 cells/kg-up to a maximal dose of 400 million |
Interventions
Sequence: | 52485611 |
Intervention Type | Biological |
Name | Cell therapy |
Description | PLX-R18: Allogeneic ex vivo expanded placental stromal cells |
Design Outcomes
Sequence: | 177379334 | Sequence: | 177379335 | Sequence: | 177379336 | Sequence: | 177379337 | Sequence: | 177379338 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Any Adverse Reaction | Measure | Recovered with no sequelae | Measure | Recovered with sequelae | Measure | Ongoing AE | Measure | Overall survival |
Time Frame | From Week 52 to Week 260 patients will be followed-up for overall survival once a year (every 52 weeks±2 after visit 14) | Time Frame | From Week 52 to Week 260 patients will be followed-up for overall survival once a year (every 52 weeks±2 after visit 14) | Time Frame | From Week 52 to Week 260 patients will be followed-up for overall survival once a year (every 52 weeks±2 after visit 14) | Time Frame | From Week 52 to Week 260 patients will be followed-up for overall survival once a year (every 52 weeks±2 after visit 14) | Time Frame | From Week 52 to Week 260 patients will be followed-up for overall survival once a year (every 52 weeks±2 after visit 14) |
Description | The subject has fully recovered from the AE with no residual effects observable. | Description | The event resolved but the subject has sequelae, which is a condition following a consequence of a disease | Description | AE is still ongoing | Description | Overall survival |
Browse Conditions
Sequence: | 193487251 | Sequence: | 193487252 | Sequence: | 193487253 |
Mesh Term | Radiation Injuries | Mesh Term | Acute Radiation Syndrome | Mesh Term | Wounds and Injuries |
Downcase Mesh Term | radiation injuries | Downcase Mesh Term | acute radiation syndrome | Downcase Mesh Term | wounds and injuries |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319420 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Pluristem Ltd. |
Design Group Interventions
Sequence: | 68149287 |
Design Group Id | 55593317 |
Intervention Id | 52485611 |
Eligibilities
Sequence: | 30765430 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Subject was exposed or suspected to have been exposed to ionizing radiation of ≥1Gy and is at risk of developing HS-ARS, as assessed by the treating physician, based on REMM guidelines (see APPENDIX 1). PLX-R18 treatment can be initiated within 4 days of exposure. Exclusion Criteria: Known active malignancy or history of malignancy within 3 years prior to screening except for successfully resected skin basal cell carcinoma or skin squamous cell carcinoma not located at the injection sites. In the opinion of the treating physician, the subject is unsuitable for participating in the study. – |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253890308 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30511596 |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26673791 |
Intervention Id | 52485611 |
Name | PLX-R18 |
Responsible Parties
Sequence: | 28877891 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797027
2019-01-01
https://zephyrnet.com/?p=NCT03797027
NCT03797027https://www.clinicaltrials.gov/study/NCT03797027?tab=tableChao Cai, PH.D & MD673059209@qq.com+86 13512780911Percutaneous nephrolithotomy (PCNL) is the first choice for the treatment of ≥ 2cm renal stones. The positions of PCNL includes supine, prone and lateral. PCNL has been performed in my center for nearly twenty years. The prone position is routinely used. Generally speaking, an abdominal cushion is used to raise the abdominal in the prone position, in order to provide an adequate exposure of kidney, increase the intercostal space, decrease the mobility of kidney and lower the risk of pleura injury. However, there is no consensus and criterion on the height of abdominal cushion. With largely increased PCNL procedures and various BMI, precise evaluation of abdominal cushion is needed. In the preliminary work, the investigators measured the sunken height of waist of 100 patients in the prone position without a abdominal cushion. The results showed that the mean BMI of 100 patients was 23.45 (16.79-36.98) and the range of sunken height of waist was 2-7 cm. Therefore, the investigators are planning to conduct a randomized controlled study to compare the safety and efficacy among no cushion group, 5 cm cushion group and 10 cm cushion group. To clarify the relationship between height of abdominal cushion and BMI, the nurse could prepare the appropriate cushion the day before surgery, which would decrease operating time and accelerate postoperative recovery.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-05 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | January 1, 2019 |
Primary Completion Month Year | January 1, 2021 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20741332 |
Description | Background Percutaneous nephrolithotomy (PCNL) is the first choice for the treatment of ≥ 2cm renal stones.The positions of PCNL includes supine, prone and lateral. PCNL has been performed in my center for nearly twenty years. The prone position is routinely used. Generally speaking, an abdominal cushion is used to raise the abdominal in the prone position, in order to provide an adequate exposure of kidney, increase the intercostal space, decrease the mobility of kidney and lower the risk of pleura injury. However, there is no consensus and criterion on the height of abdominal cushion. With largely increased PCNL procedures and various BMI, precise evaluation of abdominal cushion is needed. In the preliminary work, the investigators measured the sunken height of waist of 100 patients in the prone position without a abdominal cushion. The results showed that the mean BMI of 100 patients was 23.45 (16.79-36.98) and the range of sunken height of waist was 2-7 cm. Therefore, the investigators are planning to conduct a randomized controlled study to compare the safety and efficacy among no cushion group, 5 cm cushion group and 10 cm cushion group. To clarify the relationship between height of abdominal cushion and BMI, the nurse could prepare the appropriate cushion the day before surgery, which would decrease operating time and accelerate postoperative recovery. Purpose To investigate effects of different height of abdominal cushion on prone PCNL, in terms of intraoperative parameters. Our study could provide high quality of evidences on making criteria of perioperative nurse. Design 3.1 Participant: A single randomized controlled study 3.2 Number of cases: 180 patients who are candidates for PCNL will be enrolled in this study. By 1:2 simple random sampling technique, patients will be assigned to 60-patient no cushion PCNL and 120-patient cushion PCNL (60-patient for 5 cm cushion and 60-patient for 10 cm cushion). *(Assuming SFR (1 month after procedure) with cushion PCNL of 90% and expected rate of 70% with no cushion PCNL, the sample size for each group are calculated as 120 and 60 [power > 0.90 with a type I error rate < 0.05.] Candidate: 4.1 Included criterion: Willing to receive PCNL Patients with positive preoperative urine culture should be treated with suitable antibiotics based on the culture sensitivity result for at least 72 h before PCNL. Patients who have negative urine culture should receive a single dose of broad spectrum antibiotic prophylaxis just prior to the procedure. Patients who are going to receive PCNL would get a envelope including a randomized number and consent letter. Surgical technique Under general anaesthesia, each patient is initially placed in the lithotomy position, and a 5 Fr or 6Fr ureteral catheter is inserted to the kidney and fixed with a 16 Fr Foley catheter. Then the patient is turned to the prone position. An abdominal cushion is used according to the randomized number. The choice of using C-arm fluoroscopic or ultrasonography guidance or a combination fashion for the percutaneous access was made at the discretion of the treating urologist. The length of the needle from skin to the collecting system is measured to ensure that the length of dilator is appropriate. No patient underwent bilateral simultaneous PCNL and patients with bilateral stones underwent surgery 4 weeks apart. The access tract is dilated with a fascial dilator from 8F up to 18F. The investigators defined access to the collecting system as gaining entry to the targeted urinary system and desired calix. For some complex cases, when indicated requiring multiple tracts, additional tracts were created in the same session. The stone was fragmented by pneumatic lithotripsy or Holmium:YAG laser lithotripsy through 8/9.8F semirigid ureteroscope (Richard Wolf, Germany). The large fragments were extracted with a forceps and small fragments were flushed out with an endoscopic pulsed perfusion pump. A silastic nephrostomy tube was placed at the end of procedure and a 4-6Fr double pigtail ureteral stent was left for 2 weeks after operation. X-ray check for residual stone fragments is also performed at the end of the procedure. Patients were candidates for the tubeless procedure only when the following strict conditions were met: single percutaneous tract, absence of major perforation of collecting system and bleeding, complete stone clearance assessed by intraoperative nephroscopy and fluoroscopy at the end of the procedure. For a tubeless procedure, the flank was compressed for 5 min. Patient was monitored for postoperative complications. Data collection Data for the 2 groups -demographic characteristics, time of puncture and dilation, site of target calix, site of access, S.T.O.N.E score, hemoglobin drop, postoperative pain, duration of procedure, hospital stay, cases of tubeless, complications (modified Clavin system), stone clearance (SFR of postoperative day 1 and 1 month follow-up) and the need for auxiliary treatment (for example, re-PCNL, RIRS and ESWL) – are compared. |
Facilities
Sequence: | 200281897 |
Status | Recruiting |
Name | Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University |
City | Guangzhou |
State | Guangdong |
Zip | 510230 |
Country | China |
Facility Contacts
Sequence: | 28132963 |
Facility Id | 200281897 |
Contact Type | primary |
Name | Guohua Zeng, Ph.D & MD. |
gzgyzgh@vip.tom.com | |
Phone | +86 13802916676 |
Facility Investigators
Sequence: | 18346323 | Sequence: | 18346324 |
Facility Id | 200281897 | Facility Id | 200281897 |
Role | Principal Investigator | Role | Sub-Investigator |
Name | Guohua Zeng, Ph.D & MD. | Name | Hongling Sun, Ph.D & MD. |
Conditions
Sequence: | 52221907 |
Name | Kidney Stone |
Downcase Name | kidney stone |
Id Information
Sequence: | 40195910 |
Id Source | org_study_id |
Id Value | Honglin Sun |
Countries
Sequence: | 42609910 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55650217 | Sequence: | 55650218 | Sequence: | 55650219 |
Group Type | Other | Group Type | Other | Group Type | Other |
Title | No cushion | Title | 5 cm cushion | Title | 10 cm cushion |
Description | Patients in no cushion group undergo prone percutaneous nephrolithotomy without an abdominal cushion | Description | Patients in 5 cm cushion group undergo prone percutaneous nephrolithotomy with an 5 cm abdominal cushion | Description | Patients in 10 cm cushion group undergo prone percutaneous nephrolithotomy with an 10 cm abdominal cushion |
Interventions
Sequence: | 52535725 | Sequence: | 52535726 | Sequence: | 52535727 |
Intervention Type | Device | Intervention Type | Device | Intervention Type | Device |
Name | Percutaneous Nephrolithotomy without an abdominal cushion | Name | Percutaneous Nephrolithotomy with an 5 cm abdominal cushion | Name | Percutaneous Nephrolithotomy with an 5 cm abdominal cushion |
Description | patients undergo prone PNCL without an abdominal cushion | Description | patients undergo prone PNCL with an 5 cm abdominal cushion | Description | patients undergo prone PNCL with an 10 cm abdominal cushion |
Keywords
Sequence: | 79942291 | Sequence: | 79942292 |
Name | Percutaneous nephrolithotomy | Name | cushion |
Downcase Name | percutaneous nephrolithotomy | Downcase Name | cushion |
Design Outcomes
Sequence: | 177562931 |
Outcome Type | primary |
Measure | time of puncture and dilation |
Time Frame | intraoperatively |
Browse Conditions
Sequence: | 193679949 | Sequence: | 193679950 | Sequence: | 193679951 | Sequence: | 193679952 | Sequence: | 193679953 | Sequence: | 193679954 | Sequence: | 193679955 | Sequence: | 193679956 | Sequence: | 193679957 | Sequence: | 193679958 | Sequence: | 193679959 | Sequence: | 193679960 |
Mesh Term | Kidney Calculi | Mesh Term | Nephrolithiasis | Mesh Term | Kidney Diseases | Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Urolithiasis | Mesh Term | Urinary Calculi | Mesh Term | Male Urogenital Diseases | Mesh Term | Calculi | Mesh Term | Pathological Conditions, Anatomical |
Downcase Mesh Term | kidney calculi | Downcase Mesh Term | nephrolithiasis | Downcase Mesh Term | kidney diseases | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | urolithiasis | Downcase Mesh Term | urinary calculi | Downcase Mesh Term | male urogenital diseases | Downcase Mesh Term | calculi | Downcase Mesh Term | pathological conditions, anatomical |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366794 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | The First Affiliated Hospital of Guangzhou Medical University |
Overall Officials
Sequence: | 29313089 |
Role | Principal Investigator |
Name | Guohua Zeng, PH.D & MD |
Affiliation | The First Affiliated Hospital of Guangzhou Medical University |
Central Contacts
Sequence: | 12020673 | Sequence: | 12020674 |
Contact Type | primary | Contact Type | backup |
Name | Guohua Zeng, PH.D & MD | Name | Chao Cai, PH.D & MD |
Phone | +86 13802916676 | Phone | +86 13512780911 |
gzgyzgh@vip.tom.com | 673059209@qq.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68217893 | Sequence: | 68217894 | Sequence: | 68217895 |
Design Group Id | 55650217 | Design Group Id | 55650218 | Design Group Id | 55650219 |
Intervention Id | 52535725 | Intervention Id | 52535726 | Intervention Id | 52535727 |
Eligibilities
Sequence: | 30794935 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Willing to receive PCNL Exclusion Criteria: Uncorrected coagulopathy and active urinary tract infection (UTI) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004666 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30540974 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28907295 |
Responsible Party Type | Principal Investigator |
Name | Guohua Zeng |
Title | Vice president |
Affiliation | The First Affiliated Hospital of Guangzhou Medical University |
]]>
https://zephyrnet.com/NCT03797014
2019-04-30
https://zephyrnet.com/?p=NCT03797014
NCT03797014https://www.clinicaltrials.gov/study/NCT03797014?tab=tableNANANAThe primary objective of this study is to evaluate the efficacy and safety of fixed dose combination (FDC) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in adults coinfected with both HIV-1 and hepatitis B. As this is a switch study, all eligible subjects enrolled will be switched from their current antiretroviral regimen to B/F/TAF will be followed on treatment for 48 weeks.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-07-18 |
Start Month Year | April 30, 2019 |
Primary Completion Month Year | November 22, 2022 |
Verification Month Year | July 2023 |
Verification Date | 2023-07-31 |
Last Update Posted Date | 2023-07-18 |
Results First Posted Date | 2023-07-18 |
Facilities
Sequence: | 201256511 | Sequence: | 201256512 |
Name | Institute of Human Virology Clinical Research Unit | Name | Newlands Health |
City | Baltimore | City | Philadelphia |
State | Maryland | State | Pennsylvania |
Zip | 21201 | Zip | 19114 |
Country | United States | Country | United States |
Browse Interventions
Sequence: | 96579461 | Sequence: | 96579462 | Sequence: | 96579463 | Sequence: | 96579464 | Sequence: | 96579465 | Sequence: | 96579466 | Sequence: | 96579467 | Sequence: | 96579468 | Sequence: | 96579469 | Sequence: | 96579470 | Sequence: | 96579471 |
Mesh Term | Tenofovir | Mesh Term | Emtricitabine | Mesh Term | Emtricitabine tenofovir alafenamide | Mesh Term | Antiviral Agents | Mesh Term | Anti-Infective Agents | Mesh Term | Reverse Transcriptase Inhibitors | Mesh Term | Nucleic Acid Synthesis Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Anti-HIV Agents | Mesh Term | Anti-Retroviral Agents |
Downcase Mesh Term | tenofovir | Downcase Mesh Term | emtricitabine | Downcase Mesh Term | emtricitabine tenofovir alafenamide | Downcase Mesh Term | antiviral agents | Downcase Mesh Term | anti-infective agents | Downcase Mesh Term | reverse transcriptase inhibitors | Downcase Mesh Term | nucleic acid synthesis inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | anti-hiv agents | Downcase Mesh Term | anti-retroviral agents |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52497710 | Sequence: | 52497711 |
Name | HIV-1-infection | Name | Hepatitis B |
Downcase Name | hiv-1-infection | Downcase Name | hepatitis b |
Id Information
Sequence: | 40391955 |
Id Source | org_study_id |
Id Value | HP00083844 |
Countries
Sequence: | 42827749 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55953682 |
Group Type | Experimental |
Title | B/F/TAF |
Description | Treatment group (1-arm study) |
Interventions
Sequence: | 52805816 |
Intervention Type | Drug |
Name | B/F/TAF |
Description | Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food. |
Keywords
Sequence: | 80311041 | Sequence: | 80311042 | Sequence: | 80311043 | Sequence: | 80311044 | Sequence: | 80311045 | Sequence: | 80311046 | Sequence: | 80311047 |
Name | HIV-1 | Name | Hepatitis B | Name | HIV-HBV coinfection | Name | Bictegravir | Name | B/F/TAF | Name | Tenofovir alafenamide | Name | Biktarvy |
Downcase Name | hiv-1 | Downcase Name | hepatitis b | Downcase Name | hiv-hbv coinfection | Downcase Name | bictegravir | Downcase Name | b/f/taf | Downcase Name | tenofovir alafenamide | Downcase Name | biktarvy |
Design Outcomes
Sequence: | 178598811 | Sequence: | 178598812 | Sequence: | 178598813 | Sequence: | 178598814 | Sequence: | 178598815 | Sequence: | 178598816 | Sequence: | 178598817 | Sequence: | 178598818 | Sequence: | 178598819 | Sequence: | 178598820 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | HIV-1 RNA at Week 24 | Measure | HBV DNA at Week 24 | Measure | HIV-1 RNA at Week 48 | Measure | HBV DNA at Week 48 | Measure | CD4 Cell Count Change at Week 24 | Measure | CD4 Cell Count Change at Week 48 | Measure | ALT Normalization at Week 24 | Measure | ALT Normalization at Week 48 | Measure | HBeAg Loss at Week 48 | Measure | HBsAg Loss at Week 48 |
Time Frame | Week 24 | Time Frame | Week 24 | Time Frame | Week 48 | Time Frame | Week 48 | Time Frame | Baseline; Week 24 | Time Frame | Baseline; Week 48 | Time Frame | Week 24 | Time Frame | Week 48 | Time Frame | Week 48 | Time Frame | Week 48 |
Description | Proportion of participants with HIV-1 RNA <50 copies/mL at Week 24 by US FDA Snapshot Algorithm | Description | Proportion of participants with plasma HBV DNA <29 IU/mL at Week 24 as defined by Missing=Failure Approach | Description | Proportion of participants with HIV-1 RNA <50 copies/mL at Week 48 by US FDA Snapshot Algorithm | Description | Proportion of participants with plasma HBV DNA <29 IU/mL at Week 48 as defined by Missing=Failure Approach | Description | Change from baseline in CD4 cell count at Week 24 | Description | Change from baseline in CD4 cell count at Week 48 | Description | Proportion of participants with normal ALT at Week 24 | Description | Proportion of participants with normal ALT at Week 48 | Description | Proportion of participants with hepatitis B envelop antigen (HBeAg) loss at Week 48 visit. | Description | Proportion of participants with hepatitis B surface antigen (HBsAg) loss at Week 48 visit. |
Browse Conditions
Sequence: | 194732095 | Sequence: | 194732093 | Sequence: | 194732094 | Sequence: | 194732096 | Sequence: | 194732097 | Sequence: | 194732098 | Sequence: | 194732099 | Sequence: | 194732100 | Sequence: | 194732101 | Sequence: | 194732102 | Sequence: | 194732103 | Sequence: | 194732104 |
Mesh Term | Hepatitis | Mesh Term | Hepatitis B | Mesh Term | Coinfection | Mesh Term | Liver Diseases | Mesh Term | Digestive System Diseases | Mesh Term | Hepatitis, Viral, Human | Mesh Term | Virus Diseases | Mesh Term | Infections | Mesh Term | Blood-Borne Infections | Mesh Term | Communicable Diseases | Mesh Term | Hepadnaviridae Infections | Mesh Term | DNA Virus Infections |
Downcase Mesh Term | hepatitis | Downcase Mesh Term | hepatitis b | Downcase Mesh Term | coinfection | Downcase Mesh Term | liver diseases | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | hepatitis, viral, human | Downcase Mesh Term | virus diseases | Downcase Mesh Term | infections | Downcase Mesh Term | blood-borne infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | hepadnaviridae infections | Downcase Mesh Term | dna virus infections |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48621919 | Sequence: | 48621920 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Maryland, Baltimore | Name | Gilead Sciences |
Overall Officials
Sequence: | 29455752 |
Role | Principal Investigator |
Name | Joel V Chua, MD |
Affiliation | Institute of Human Virology, University of Maryland |
Design Group Interventions
Sequence: | 68593950 |
Design Group Id | 55953682 |
Intervention Id | 52805816 |
Eligibilities
Sequence: | 30951749 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age 18 years or older at enrollment. Exclusion Criteria: Females who are pregnant or breastfeeding. Abnormal hematological and biochemical parameters at screening, including: Absolute neutrophil count (ANC) < 750 cells/mm3. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253859787 |
Number Of Facilities | 2 |
Number Of Nsae Subjects | 19 |
Registered In Calendar Year | 2019 |
Actual Duration | 43 |
Were Results Reported | True |
Months To Report Results | 6 |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30697335 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Masking Description | This is an open label study |
Intervention Model Description | This is an open-label phase 4 switch study to evaluate the efficacy, safety, and tolerability of FDC B/F/TAF in adults with HIV-1 and HBV coinfection. |
Drop Withdrawals
Sequence: | 29188568 | Sequence: | 29188569 | Sequence: | 29188570 |
Result Group Id | 56373371 | Result Group Id | 56373371 | Result Group Id | 56373371 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG000 |
Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Withdrawal by Subject | Reason | Lost to Follow-up | Reason | Protocol Violation |
Count | 1 | Count | 1 | Count | 1 |
Intervention Other Names
Sequence: | 26835750 |
Intervention Id | 52805816 |
Name | Bictegravir/emtricitabine/tenofovir alafenamide |
Milestones
Sequence: | 41283876 | Sequence: | 41283877 | Sequence: | 41283878 |
Result Group Id | 56373371 | Result Group Id | 56373371 | Result Group Id | 56373371 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG000 |
Title | STARTED | Title | COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 28 | Count | 25 | Count | 3 |
Participant Flows
Sequence: | 3945221 |
Outcome Counts
Sequence: | 74502324 | Sequence: | 74502325 | Sequence: | 74502326 | Sequence: | 74502327 | Sequence: | 74502328 | Sequence: | 74502329 | Sequence: | 74502330 | Sequence: | 74502331 | Sequence: | 74502332 | Sequence: | 74502333 |
Outcome Id | 31008818 | Outcome Id | 31008819 | Outcome Id | 31008820 | Outcome Id | 31008821 | Outcome Id | 31008822 | Outcome Id | 31008823 | Outcome Id | 31008824 | Outcome Id | 31008825 | Outcome Id | 31008826 | Outcome Id | 31008827 |
Result Group Id | 56373372 | Result Group Id | 56373372 | Result Group Id | 56373372 | Result Group Id | 56373372 | Result Group Id | 56373372 | Result Group Id | 56373372 | Result Group Id | 56373372 | Result Group Id | 56373372 | Result Group Id | 56373372 | Result Group Id | 56373372 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 28 | Count | 28 | Count | 28 | Count | 28 | Count | 26 | Count | 25 | Count | 4 | Count | 4 | Count | 26 | Count | 25 |
Provided Documents
Sequence: | 2602223 | Sequence: | 2602224 |
Document Type | Study Protocol and Statistical Analysis Plan | Document Type | Informed Consent Form |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | True |
Has Sap | True | Has Sap | False |
Document Date | 2021-03-16 | Document Date | 2021-03-31 |
Url | https://ClinicalTrials.gov/ProvidedDocs/14/NCT03797014/Prot_SAP_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/14/NCT03797014/ICF_001.pdf |
Reported Event Totals
Sequence: | 28124485 | Sequence: | 28124486 | Sequence: | 28124487 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 16 | Subjects Affected | 0 |
Subjects At Risk | 28 | Subjects At Risk | 28 | Subjects At Risk | 28 |
Created At | 2023-08-11 01:54:41.465431 | Created At | 2023-08-11 01:54:41.465431 | Created At | 2023-08-11 01:54:41.465431 |
Updated At | 2023-08-11 01:54:41.465431 | Updated At | 2023-08-11 01:54:41.465431 | Updated At | 2023-08-11 01:54:41.465431 |
Reported Events
Sequence: | 531830767 | Sequence: | 531830762 | Sequence: | 531830763 | Sequence: | 531830764 | Sequence: | 531830765 | Sequence: | 531830766 | Sequence: | 531830760 | Sequence: | 531830761 |
Result Group Id | 56373373 | Result Group Id | 56373373 | Result Group Id | 56373373 | Result Group Id | 56373373 | Result Group Id | 56373373 | Result Group Id | 56373373 | Result Group Id | 56373373 | Result Group Id | 56373373 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Time Frame | Adverse events were collected during the entire study participation (48 weeks). | Time Frame | Adverse events were collected during the entire study participation (48 weeks). | Time Frame | Adverse events were collected during the entire study participation (48 weeks). | Time Frame | Adverse events were collected during the entire study participation (48 weeks). | Time Frame | Adverse events were collected during the entire study participation (48 weeks). | Time Frame | Adverse events were collected during the entire study participation (48 weeks). | Time Frame | Adverse events were collected during the entire study participation (48 weeks). | Time Frame | Adverse events were collected during the entire study participation (48 weeks). |
Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other |
Subjects Affected | 2 | Subjects Affected | 2 | Subjects Affected | 2 | Subjects Affected | 2 | Subjects Affected | 2 | Subjects Affected | 2 | Subjects Affected | 5 | Subjects Affected | 2 |
Subjects At Risk | 28 | Subjects At Risk | 28 | Subjects At Risk | 28 | Subjects At Risk | 28 | Subjects At Risk | 28 | Subjects At Risk | 28 | Subjects At Risk | 28 | Subjects At Risk | 28 |
Description | Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017). | Description | Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017). | Description | Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017). | Description | Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017). | Description | Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017). | Description | Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017). | Description | Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017). | Description | Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017). |
Event Count | 2 | Event Count | 2 | Event Count | 2 | Event Count | 2 | Event Count | 2 | Event Count | 2 | Event Count | 5 | Event Count | 2 |
Organ System | Skin and subcutaneous tissue disorders | Organ System | Infections and infestations | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Nervous system disorders | Organ System | Vascular disorders | Organ System | Gastrointestinal disorders | Organ System | Infections and infestations | Organ System | Gastrointestinal disorders |
Adverse Event Term | Rash | Adverse Event Term | Abscess, extremity | Adverse Event Term | Back pain | Adverse Event Term | Headache | Adverse Event Term | Hypertension | Adverse Event Term | Nausea | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Abdominal pain |
Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 |
Vocab | MedDRA (26.0) | Vocab | MedDRA (26.0) | Vocab | MedDRA (26.0) | Vocab | MedDRA (26.0) | Vocab | MedDRA (26.0) | Vocab | MedDRA (26.0) | Vocab | MedDRA (26.0) | Vocab | MedDRA (26.0) |
Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment |
Responsible Parties
Sequence: | 29064094 |
Responsible Party Type | Principal Investigator |
Name | Joel Chua |
Title | Assistant Professor of Medicine |
Affiliation | University of Maryland, Baltimore |
Result Agreements
Sequence: | 3875965 |
Pi Employee | Yes |
Result Contacts
Sequence: | 3875930 |
Organization | Institute of Human Virology, University of Maryland Baltimore |
Name | Dr. Joel Chua |
Phone | 14107065704 |
jchua@ihv.umaryland.edu | |
Outcomes
Sequence: | 31008818 | Sequence: | 31008819 | Sequence: | 31008820 | Sequence: | 31008821 | Sequence: | 31008822 | Sequence: | 31008823 | Sequence: | 31008824 | Sequence: | 31008825 | Sequence: | 31008826 | Sequence: | 31008827 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | HIV-1 RNA at Week 24 | Title | HBV DNA at Week 24 | Title | HIV-1 RNA at Week 48 | Title | HBV DNA at Week 48 | Title | CD4 Cell Count Change at Week 24 | Title | CD4 Cell Count Change at Week 48 | Title | ALT Normalization at Week 24 | Title | ALT Normalization at Week 48 | Title | HBeAg Loss at Week 48 | Title | HBsAg Loss at Week 48 |
Description | Proportion of participants with HIV-1 RNA <50 copies/mL at Week 24 by US FDA Snapshot Algorithm | Description | Proportion of participants with plasma HBV DNA <29 IU/mL at Week 24 as defined by Missing=Failure Approach | Description | Proportion of participants with HIV-1 RNA <50 copies/mL at Week 48 by US FDA Snapshot Algorithm | Description | Proportion of participants with plasma HBV DNA <29 IU/mL at Week 48 as defined by Missing=Failure Approach | Description | Change from baseline in CD4 cell count at Week 24 | Description | Change from baseline in CD4 cell count at Week 48 | Description | Proportion of participants with normal ALT at Week 24 | Description | Proportion of participants with normal ALT at Week 48 | Description | Proportion of participants with hepatitis B envelop antigen (HBeAg) loss at Week 48 visit. | Description | Proportion of participants with hepatitis B surface antigen (HBsAg) loss at Week 48 visit. |
Time Frame | Week 24 | Time Frame | Week 24 | Time Frame | Week 48 | Time Frame | Week 48 | Time Frame | Baseline; Week 24 | Time Frame | Baseline; Week 48 | Time Frame | Week 24 | Time Frame | Week 48 | Time Frame | Week 48 | Time Frame | Week 48 |
Population | Intention-to-Treat (ITT) population: Enrolled subjects who received at least one study drug. | Population | Intention-to-Treat Population: All enrolled subjects who received at least one study drug. | Population | Intention-to-Treat Population: All enrolled subjects who received at least one study drug. | Population | Intention-to-Treat Population: All enrolled subjects who received at least one study drug. | Population | All enrolled subjects with CD4 count values at baseline and at week 24. | Population | All enrolled subjects with CD4 count results available at baseline and week 48. | Population | Enrolled subjects with abnormal ALT at baseline | Population | All enrolled subjects with abnormal baseline LFTs | ||||
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | cells/microliter | Units | cells/microliter | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Outcome Measurements
Sequence: | 237262725 | Sequence: | 237262726 | Sequence: | 237262727 | Sequence: | 237262728 | Sequence: | 237262729 | Sequence: | 237262730 | Sequence: | 237262731 | Sequence: | 237262732 | Sequence: | 237262733 | Sequence: | 237262734 |
Outcome Id | 31008818 | Outcome Id | 31008819 | Outcome Id | 31008820 | Outcome Id | 31008821 | Outcome Id | 31008822 | Outcome Id | 31008823 | Outcome Id | 31008824 | Outcome Id | 31008825 | Outcome Id | 31008826 | Outcome Id | 31008827 |
Result Group Id | 56373372 | Result Group Id | 56373372 | Result Group Id | 56373372 | Result Group Id | 56373372 | Result Group Id | 56373372 | Result Group Id | 56373372 | Result Group Id | 56373372 | Result Group Id | 56373372 | Result Group Id | 56373372 | Result Group Id | 56373372 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Title | HIV-1 RNA at Week 24 | Title | HBV DNA at Week 24 | Title | HIV-1 RNA at Week 48 | Title | HBV DNA at Week 48 | Title | CD4 Cell Count Change at Week 24 | Title | CD4 Cell Count Change at Week 48 | Title | ALT Normalization at Week 24 | Title | ALT Normalization at Week 48 | Title | HBeAg Loss at Week 48 | Title | HBsAg Loss at Week 48 |
Description | Proportion of participants with HIV-1 RNA <50 copies/mL at Week 24 by US FDA Snapshot Algorithm | Description | Proportion of participants with plasma HBV DNA <29 IU/mL at Week 24 as defined by Missing=Failure Approach | Description | Proportion of participants with HIV-1 RNA <50 copies/mL at Week 48 by US FDA Snapshot Algorithm | Description | Proportion of participants with plasma HBV DNA <29 IU/mL at Week 48 as defined by Missing=Failure Approach | Description | Change from baseline in CD4 cell count at Week 24 | Description | Change from baseline in CD4 cell count at Week 48 | Description | Proportion of participants with normal ALT at Week 24 | Description | Proportion of participants with normal ALT at Week 48 | Description | Proportion of participants with hepatitis B envelop antigen (HBeAg) loss at Week 48 visit. | Description | Proportion of participants with hepatitis B surface antigen (HBsAg) loss at Week 48 visit. |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | cells/microliter | Units | cells/microliter | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 25 | Param Value | 24 | Param Value | 22 | Param Value | 22 | Param Value | 32.8 | Param Value | 76.6 | Param Value | 4 | Param Value | 4 | Param Value | 0 | Param Value | 0 |
Param Value Num | 25.0 | Param Value Num | 24.0 | Param Value Num | 22.0 | Param Value Num | 22.0 | Param Value Num | 32.8 | Param Value Num | 76.6 | Param Value Num | 4.0 | Param Value Num | 4.0 | Param Value Num | 0.0 | Param Value Num | 0.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||
Dispersion Value | 169.1 | Dispersion Value | 184.2 | ||||||||||||||||
Dispersion Value Num | 169.1 | Dispersion Value Num | 184.2 | ||||||||||||||||
Baseline Counts
Sequence: | 11455446 |
Result Group Id | 56373370 |
Ctgov Group Code | BG000 |
Units | Participants |
Scope | overall |
Count | 28 |
Result Groups
Sequence: | 56373370 | Sequence: | 56373371 | Sequence: | 56373372 | Sequence: | 56373373 |
Ctgov Group Code | BG000 | Ctgov Group Code | FG000 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 |
Result Type | Baseline | Result Type | Participant Flow | Result Type | Outcome | Result Type | Reported Event |
Title | B/F/TAF | Title | B/F/TAF | Title | B/F/TAF | Title | B/F/TAF |
Description | Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food. |
Description | Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food. |
Description | Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food. |
Description | Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food. |
Baseline Measurements
Sequence: | 126468098 | Sequence: | 126468099 | Sequence: | 126468100 | Sequence: | 126468101 | Sequence: | 126468102 | Sequence: | 126468103 | Sequence: | 126468104 | Sequence: | 126468105 | Sequence: | 126468106 | Sequence: | 126468107 | Sequence: | 126468108 | Sequence: | 126468109 | Sequence: | 126468110 | Sequence: | 126468111 | Sequence: | 126468112 | Sequence: | 126468113 | Sequence: | 126468114 | Sequence: | 126468115 | Sequence: | 126468116 | Sequence: | 126468117 | Sequence: | 126468118 | Sequence: | 126468119 | Sequence: | 126468120 | Sequence: | 126468121 |
Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 | Result Group Id | 56373370 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 |
Classification | United States | ||||||||||||||||||||||||||||||||||||||||||||||
Category | <=18 years | Category | Between 18 and 65 years | Category | >=65 years | Category | Female | Category | Male | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Unknown or Not Reported | Category | American Indian or Alaska Native | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | White | Category | More than one race | Category | Unknown or Not Reported | ||||||||||||||||||
Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Region of Enrollment | Title | HIV RNA PCR <50 copies/mL | Title | CD4 count <200 cells/microliter | Title | HBV DNA PCR <29 IU/mL | Title | HBeAg positive | Title | Anti-HBe antibody positive | Title | Abnormal ALT | Title | Hepatitis D antibody positive |
Units | Participants | Units | Participants | Units | Participants | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 0 | Param Value | 25 | Param Value | 3 | Param Value | 50.1 | Param Value | 4 | Param Value | 24 | Param Value | 0 | Param Value | 28 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 25 | Param Value | 3 | Param Value | 0 | Param Value | 0 | Param Value | 28 | Param Value | 20 | Param Value | 1 | Param Value | 22 | Param Value | 12 | Param Value | 10 | Param Value | 4 | Param Value | 5 |
Param Value Num | 0.0 | Param Value Num | 25.0 | Param Value Num | 3.0 | Param Value Num | 50.1 | Param Value Num | 4.0 | Param Value Num | 24.0 | Param Value Num | 0.0 | Param Value Num | 28.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 25.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 28.0 | Param Value Num | 20.0 | Param Value Num | 1.0 | Param Value Num | 22.0 | Param Value Num | 12.0 | Param Value Num | 10.0 | Param Value Num | 4.0 | Param Value Num | 5.0 |
Dispersion Type | Full Range | ||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Lower Limit | 28.0 | ||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Upper Limit | 71.0 | ||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 | Number Analyzed | 28 |
]]>
https://zephyrnet.com/NCT03797001
2019-01-04
https://zephyrnet.com/?p=NCT03797001
NCT03797001https://www.clinicaltrials.gov/study/NCT03797001?tab=tableBenjamin Van Tassell, PharmDbvantassell@vcu.edu804-828-4583REDHART2 is a randomized, double-blinded, placebo-controlled trial to determine the effects of Anakinra on peak aerobic exercise capacity measured with a cardiopulmonary test after 24 weeks in patients with recently decompensated systolic heart failure and increased systemic inflammation.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-05-03 |
Start Month Year | January 4, 2019 |
Primary Completion Month Year | December 2023 |
Verification Month Year | May 2023 |
Verification Date | 2023-05-31 |
Last Update Posted Date | 2023-05-03 |
Detailed Descriptions
Sequence: | 20583729 |
Description | The REDHART2 (REcently Decompensated Heart failure Anakinra Response 2 Trial) study is a phase II clinical trial of anakinra or placebo to determine improvement in aerobic exercise capacity (by measuring maximal oxygen uptake (VO2)) in patients with recently decompensated systolic heart failure (HF). The recently completed pilot REDHART study showed anakinra treatment for 12 weeks led to a significant improvement in peak aerobic exercise capacity, whereas anakinra treatment for 2 weeks did not, and no significant changes were seen in placebo. The REDHART2 study is designed to expand and confirm the beneficial effect of sustained anakinra treatment (24 weeks) on peak VO2, and to explore the potential effect size on hospital readmissions for HF. The rationale of Interleukin-1 (IL-1) blockade with anakinra in heart failure stems from the evidence of a) reduced adverse cardiac remodeling and heart failure in animal models of acute myocardial infarction (AMI); b) reduced incidence of heart failure in patients with ST-segment elevation AMI; c) enhanced IL-1 activity in patients with heart failure, d) quenching of the acute inflammatory response in patients with acute decompensated heart failure, e) direct cardiodepressant effects of IL-1 in animal models, f) improved exercise capacity in pilot studies including patients with stable systolic heart failure, stable diastolic heart failure, and, recently decompensated systolic heart failure in the pilot REDHART study. Patients will be randomized 2:1 to active treatment, such that patients will be twice as likely to receive anakinra versus placebo. |
Facilities
Sequence: | 198704874 |
Status | Recruiting |
Name | Virginia Commonwealth University |
City | Richmond |
State | Virginia |
Zip | 23298 |
Country | United States |
Facility Contacts
Sequence: | 27952203 |
Facility Id | 198704874 |
Contact Type | primary |
Name | Benjamin Van Tassell, PharmD |
bvantassell@vcu.edu | |
Phone | 804-828-4583 |
Browse Interventions
Sequence: | 95355226 | Sequence: | 95355227 |
Mesh Term | Interleukin 1 Receptor Antagonist Protein | Mesh Term | Antirheumatic Agents |
Downcase Mesh Term | interleukin 1 receptor antagonist protein | Downcase Mesh Term | antirheumatic agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51815693 | Sequence: | 51815694 |
Name | Heart Failure, Systolic | Name | Inflammation |
Downcase Name | heart failure, systolic | Downcase Name | inflammation |
Id Information
Sequence: | 39875422 |
Id Source | org_study_id |
Id Value | REDHART2 HM20014686 |
Countries
Sequence: | 42274031 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55237400 | Sequence: | 55237401 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | anakinra | Title | placebo |
Description | Anakinra subcutaneous injection, 100 mg daily for 24 weeks | Description | Placebo subcutaneous injection, daily for 24 weeks |
Interventions
Sequence: | 52137476 | Sequence: | 52137477 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Anakinra | Name | Placebo |
Description | 100 mg subcutaneous injection, daily for 24 weeks | Description | subcutaneous injection, daily for 24 weeks |
Keywords
Sequence: | 79287848 | Sequence: | 79287849 | Sequence: | 79287850 | Sequence: | 79287851 |
Name | heart failure | Name | inflammation | Name | anakinra | Name | exercise capacity |
Downcase Name | heart failure | Downcase Name | inflammation | Downcase Name | anakinra | Downcase Name | exercise capacity |
Design Outcomes
Sequence: | 176229488 | Sequence: | 176229489 | Sequence: | 176229490 | Sequence: | 176229491 | Sequence: | 176229492 | Sequence: | 176229493 | Sequence: | 176229494 | Sequence: | 176229495 | Sequence: | 176229496 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | changes in peak oxygen consumption (VO2) | Measure | changes in peak VO2 at earlier endpoints | Measure | echocardiography assessments | Measure | hemodynamic assessments | Measure | Quality of Life Assessments | Measure | Biomarker – high sensitivity C-reactive protein (CRP) | Measure | Biomarker – N-terminal pro b-type Natriuretic Peptide (NT-proBNP) | Measure | Clinical Outcome – cardiac death | Measure | Clinical Outcome – hospitalization for heart failure |
Time Frame | baseline – 24 weeks | Time Frame | baseline – 6 weeks and baseline – 12 weeks | Time Frame | baseline – 24 weeks | Time Frame | baseline – 24 weeks | Time Frame | baseline – 24 weeks | Time Frame | baseline – 24 weeks | Time Frame | baseline – 24 weeks | Time Frame | baseline – 24 weeks | Time Frame | baseline – 24 weeks |
Description | changes in peak oxygen consumption (VO2) after 24 weeks of treatment | Description | changes in peak VO2 at earlier endpoints (6 and 12 weeks) | Description | evaluation of heart function by standard echocardiography assessments at 24 weeks | Description | estimates of arterial elastance at 6, 12 and 24 weeks | Description | Duke Activity Status Index will be administered at 6, 12 and 24 weeks to provide patient perception of changes. Responses are yes or no, with yes responses corresponding to better clinical condition. | Description | The change in blood levels of CRP will be measured from baseline to 24 weeks. | Description | The change in blood levels of NT-proBNP will be measured from baseline to 24 weeks. | Description | Instances of cardiac death during the study will be recorded | Description | Instances of hospitalization for heart failure during the study will be recorded |
Browse Conditions
Sequence: | 192054816 | Sequence: | 192054817 | Sequence: | 192054818 | Sequence: | 192054819 | Sequence: | 192054820 | Sequence: | 192054821 | Sequence: | 192054822 | Sequence: | 192054823 |
Mesh Term | Heart Failure | Mesh Term | Heart Failure, Systolic | Mesh Term | Inflammation | Mesh Term | Systolic Murmurs | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Pathologic Processes | Mesh Term | Heart Murmurs |
Downcase Mesh Term | heart failure | Downcase Mesh Term | heart failure, systolic | Downcase Mesh Term | inflammation | Downcase Mesh Term | systolic murmurs | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | heart murmurs |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47988176 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Virginia Commonwealth University |
Overall Officials
Sequence: | 29076357 |
Role | Principal Investigator |
Name | Benjamin Van Tassell, PharmD |
Affiliation | Virginia Commonwealth University |
Central Contacts
Sequence: | 11936691 |
Contact Type | primary |
Name | Benjamin Van Tassell, PharmD |
Phone | 804-828-4583 |
bvantassell@vcu.edu | |
Role | Contact |
Design Group Interventions
Sequence: | 67719693 | Sequence: | 67719694 |
Design Group Id | 55237400 | Design Group Id | 55237401 |
Intervention Id | 52137476 | Intervention Id | 52137477 |
Eligibilities
Sequence: | 30556786 |
Gender | All |
Minimum Age | 21 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
All 6 criteria need to be met for enrollment of the patient in the study Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of both conditions listed below: dyspnea or respiratory distress or tachypnea at rest or with minimal exertion; The patient is now clinically stable, euvolemic, and meets standard criteria for hospital discharge as documented by all the 3 conditions listed below: absence of dyspnea or pulmonary congestion/distress at rest; Exclusion Criteria: Subjects will not be eligible if they meet any of the following 15 exclusion criteria. The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254239739 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 21 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30305115 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28683704 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 51709332 | Sequence: | 51709333 |
Pmid | 35706006 | Pmid | 35283262 |
Reference Type | derived | Reference Type | derived |
Citation | Van Tassell B, Mihalick V, Thomas G, Marawan A, Talasaz AH, Lu J, Kang L, Ladd A, Damonte JI, Dixon DL, Markley R, Turlington J, Federmann E, Del Buono MG, Biondi-Zoccai G, Canada JM, Arena R, Abbate A. Rationale and design of interleukin-1 blockade in recently decompensated heart failure (REDHART2): a randomized, double blind, placebo controlled, single center, phase 2 study. J Transl Med. 2022 Jun 15;20(1):270. doi: 10.1186/s12967-022-03466-9. | Citation | Sedhai YR, Patel NK, Mihalick V, Talasaz A, Thomas G, Denlinger BL, Damonte JI, Del Buono MG, Federmann E, Hardin M, Ibe I, Harmon M, Van Tassell B, Abbate A. Heart failure clinical trial enrollment at a rural satellite hospital. Contemp Clin Trials. 2022 Apr;115:106731. doi: 10.1016/j.cct.2022.106731. Epub 2022 Mar 11. |
]]>
https://zephyrnet.com/NCT03796988
2018-09-14
https://zephyrnet.com/?p=NCT03796988
NCT03796988https://www.clinicaltrials.gov/study/NCT03796988?tab=tableNANANAThe purpose of this research study is to learn about a new device, Autologous Regeneration of Tissue (ART), for collecting skin grafts from participant’s own skin.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-06-09 |
Start Month Year | September 14, 2018 |
Primary Completion Month Year | December 31, 2023 |
Verification Month Year | June 2023 |
Verification Date | 2023-06-30 |
Last Update Posted Date | 2023-06-09 |
Facilities
Sequence: | 199111588 |
Name | University of Miami |
City | Miami |
State | Florida |
Zip | 33136 |
Country | United States |
Conditions
Sequence: | 51929467 |
Name | Wound of Skin |
Downcase Name | wound of skin |
Id Information
Sequence: | 39969730 |
Id Source | org_study_id |
Id Value | 20180154 |
Countries
Sequence: | 42361324 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55333306 |
Group Type | Experimental |
Title | Intervention arm |
Description | The donor area will be anesthetized with injected local anesthesia, harvested with the ART device, and bandaged with an occlusive dressing. The skin harvested will be placed on the recipient wound area. The area will be bandaged will a non-stick silicone dressing (covered by appropriate primary and secondary dressings) and left intact for 1-7 days. |
Interventions
Sequence: | 52242600 |
Intervention Type | Device |
Name | Autologous Regeneration of Tissue (ART) device |
Description | This device will harvest hundreds of full-thickness columns of skin tissue (500 micrometer diameter) using single-needle, fluid-assisted harvesting technology. |
Keywords
Sequence: | 79484384 |
Name | Chronic Wound |
Downcase Name | chronic wound |
Design Outcomes
Sequence: | 176539629 | Sequence: | 176539630 | Sequence: | 176539631 | Sequence: | 176539632 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change of pain on harvesting of skin at donor site. | Measure | Time to healing of donor sites | Measure | Wound healing of recipient site | Measure | Histologic evaluation |
Time Frame | Baseline, Day 56 | Time Frame | Up to Day 56 | Time Frame | Up to Day 56 | Time Frame | Up to Day 56 |
Description | Pain assessed using a Pain Visual Analog Scale (VAS) with a score ranging from 0 (no pain) to 10 (worst possible pain) | Description | At each weekly visit, the donor site will be assessed for wound area in cm^2 | Description | At each weekly visit, the recipient area will be assessed for healing area percentage | Description | As measured by tissue samples from biopsy |
Browse Conditions
Sequence: | 192519543 |
Mesh Term | Wounds and Injuries |
Downcase Mesh Term | wounds and injuries |
Mesh Type | mesh-list |
Sponsors
Sequence: | 48092274 | Sequence: | 48092275 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Miami | Name | Medline Industries |
Overall Officials
Sequence: | 29144149 |
Role | Principal Investigator |
Name | Hadar Lev-Tov, MD |
Affiliation | University of Miami |
Design Group Interventions
Sequence: | 67834435 |
Design Group Id | 55333306 |
Intervention Id | 52242600 |
Eligibilities
Sequence: | 30622038 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 90 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Adults from 18 to 90 years of age. Exclusion Criteria: Pregnant women (Urine hCG test will be performed at baseline on women of child bearing potential). |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254024602 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 90 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30369189 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28738794 |
Responsible Party Type | Principal Investigator |
Name | Hadar Lev-Tov |
Title | Assistant Professor |
Affiliation | University of Miami |
]]>
https://zephyrnet.com/NCT03796975
2018-06-28
https://zephyrnet.com/?p=NCT03796975
NCT03796975https://www.clinicaltrials.gov/study/NCT03796975?tab=tableNANANAThis is an multicenter, randomized, double-blind, parallel-controlled study to evaluated the efficacy of pioglitazone hydrochloride and metformin hydrochloride tablets on the patients with newly diagnosed type 2 diabetes mellitus combined with non-alcoholic fatty liver disease.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-11 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-08-07 |
Start Month Year | June 28, 2018 |
Primary Completion Month Year | April 28, 2019 |
Verification Month Year | July 2020 |
Verification Date | 2020-07-31 |
Last Update Posted Date | 2020-08-07 |
Detailed Descriptions
Sequence: | 20735695 |
Description | Taking metformin monotherapy as a control, we evaluated the efficacy of pioglitazone hydrochloride and metformin hydrochloride tablets on hepatic fat ultrasound and liver enzyme levels, and observed whether the drug can improve fatty liver in patients with newly diagnosed type 2 diabetes combined with non-alcoholic fatty liver disease. This is an multicenter, randomized, double-blind, parallel-controlled study. |
Facilities
Sequence: | 200243904 |
Name | Xijing Hospital, Fourth Military Medical university |
City | Xi'an |
State | Shaanxi |
Zip | 710032 |
Country | China |
Browse Interventions
Sequence: | 96112819 | Sequence: | 96112820 | Sequence: | 96112821 | Sequence: | 96112822 |
Mesh Term | Metformin | Mesh Term | Pioglitazone | Mesh Term | Hypoglycemic Agents | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | metformin | Downcase Mesh Term | pioglitazone | Downcase Mesh Term | hypoglycemic agents | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52207861 | Sequence: | 52207862 | Sequence: | 52207863 |
Name | Type 2 Diabetes Mellitus | Name | Non-alcoholic Fatty Liver Disease | Name | Efficacy |
Downcase Name | type 2 diabetes mellitus | Downcase Name | non-alcoholic fatty liver disease | Downcase Name | efficacy |
Id Information
Sequence: | 40186018 |
Id Source | org_study_id |
Id Value | KY20172053-1 |
Countries
Sequence: | 42599523 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55634470 | Sequence: | 55634471 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Combination of Pioglitazone and Metformin Tablets | Title | Metformin Hydrochloride Tablets |
Description | dosage form: tablet; dosage:15mg/500mg; frequency: the dose in week 1 is 15mg/500mg, once a day, increased to 15mg/500mg in the second week, twice a day and maintain this dose to 24 weeks duration: 24 weeks; type: oral; | Description | dosage form: tablet; dosage: 850mg; frequency: the dose in week 1 is 850mg, once a day, increased to 850mg in the second week, twice a day and maintain this dose to 24 weeks duration: 24 weeks; type: oral; |
Interventions
Sequence: | 52521881 | Sequence: | 52521882 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Combination of Pioglitazone and Metformin Tablets | Name | Metformin Hydrochloride Tablets |
Description | 15mg/500mg, oral, 2/day | Description | Oral metformin 850mg, 2/day in the control group |
Keywords
Sequence: | 79922651 | Sequence: | 79922652 | Sequence: | 79922653 | Sequence: | 79922654 |
Name | Type 2 Diabetes Mellitus | Name | Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets | Name | Randomized Controlled Trial | Name | Non-alcoholic Fatty Liver Disease |
Downcase Name | type 2 diabetes mellitus | Downcase Name | pioglitazone hydrochloride and metformin hydrochloride tablets | Downcase Name | randomized controlled trial | Downcase Name | non-alcoholic fatty liver disease |
Design Outcomes
Sequence: | 177510522 | Sequence: | 177510523 | Sequence: | 177510524 | Sequence: | 177510525 | Sequence: | 177510526 | Sequence: | 177510527 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Decreased of liver fat content of fatty liver after 24 weeks treatment as assessed by B-ultrasound | Measure | Change of B-cell function after 24 weeks treatment as assessed by homeostasis model assessment of insulin resistance index | Measure | Change of liver enzyme after 24 weeks treatment as assessed by blood test | Measure | Decreased of HbA1c after 24 weeks treatment as assessed by blood test | Measure | Decreased of fasting blood glucose after 24 weeks treatment as assessed by blood test | Measure | Change of weight and waistline after 24 weeks treatment as assessed by standard measurement |
Time Frame | up to 24 weeks | Time Frame | up to 24 weeks | Time Frame | up to 24 weeks | Time Frame | up to 24 weeks | Time Frame | up to 24 weeks | Time Frame | up to 24 weeks |
Description | Change from baseline liver fat content to up to 24 weeks after treatment | Description | Change from baseline B-cell function to up to 24 weeks after treatment | Description | Change from baseline liver enzyme to up to 24 weeks after treatment | Description | Change from baseline HbA1c to up to 24 weeks after treatment | Description | Change from baseline fasting blood glucose to up to 24 weeks after treatment | Description | Change from baseline weight and waistline to up to 24 weeks after treatment |
Browse Conditions
Sequence: | 193626270 | Sequence: | 193626271 | Sequence: | 193626272 | Sequence: | 193626273 | Sequence: | 193626274 | Sequence: | 193626275 | Sequence: | 193626276 | Sequence: | 193626277 | Sequence: | 193626278 |
Mesh Term | Liver Diseases | Mesh Term | Fatty Liver | Mesh Term | Non-alcoholic Fatty Liver Disease | Mesh Term | Diabetes Mellitus | Mesh Term | Diabetes Mellitus, Type 2 | Mesh Term | Glucose Metabolism Disorders | Mesh Term | Metabolic Diseases | Mesh Term | Endocrine System Diseases | Mesh Term | Digestive System Diseases |
Downcase Mesh Term | liver diseases | Downcase Mesh Term | fatty liver | Downcase Mesh Term | non-alcoholic fatty liver disease | Downcase Mesh Term | diabetes mellitus | Downcase Mesh Term | diabetes mellitus, type 2 | Downcase Mesh Term | glucose metabolism disorders | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | endocrine system diseases | Downcase Mesh Term | digestive system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48353515 | Sequence: | 48353516 | Sequence: | 48353517 | Sequence: | 48353518 | Sequence: | 48353519 | Sequence: | 48353520 | Sequence: | 48353521 | Sequence: | 48353522 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | UNKNOWN | Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Xijing Hospital | Name | Second Affiliated Hospital of Xi'an Jiaotong University | Name | Shaanxi Aerospace Hospital | Name | Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd | Name | Xi'an Gaoxin Hospital | Name | Chang'An Hospital | Name | Yan'an people's Hospital | Name | Shangluo Central Hospital |
Overall Officials
Sequence: | 29305888 |
Role | Principal Investigator |
Name | Qiuhe Ph.D Ji, M.D. |
Affiliation | Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University |
Design Group Interventions
Sequence: | 68198950 | Sequence: | 68198951 |
Design Group Id | 55634470 | Design Group Id | 55634471 |
Intervention Id | 52521881 | Intervention Id | 52521882 |
Eligibilities
Sequence: | 30786760 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
To meet the new diagnosed type 2 diabetes patients, never received oral hypoglycemic drugs or insulin therapy; Exclusion Criteria: type 1 diabetes or secondary diabetes; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989379 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 10 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30532831 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26691964 | Sequence: | 26691965 |
Intervention Id | 52521881 | Intervention Id | 52521882 |
Name | ka shuang ping | Name | ge hua zhi |
Responsible Parties
Sequence: | 28899124 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796962
2019-01-30
https://zephyrnet.com/?p=NCT03796962
NCT03796962https://www.clinicaltrials.gov/study/NCT03796962?tab=tableNANANAThe XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of increasing doses of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy, followed by an optional open-label extension (OLE).
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-01-17 |
Start Month Year | January 30, 2019 |
Primary Completion Month Year | September 2, 2021 |
Verification Month Year | January 2023 |
Verification Date | 2023-01-31 |
Last Update Posted Date | 2023-01-17 |
Detailed Descriptions
Sequence: | 20568265 |
Description | The XEN1101 Phase 2 clinical trial is designed as a randomized, double-blind, placebo-controlled, multicenter study with an optional open-label extension (OLE) to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in adult patients aged 18 to 75 years diagnosed with focal epilepsy. Approximately 300 patients will be randomized in a blinded manner to one of three active treatment groups or placebo in a 2:1:1:2 fashion (XEN1101 25 mg : 20 mg : 10 mg : Placebo). After screening, patients will have 8 weeks of baseline to assess frequency of seizures, followed by 8 weeks of treatment and a 6-week post treatment follow-up period. In order to be included in the study, patients must already be treated with a stable dose of 1 to 3 allowable current anti-epileptic drugs for at least one month prior to screening, during baseline, and throughout the double-blind portion (DBP) of the study. During the treatment period, patients will be given XEN1101 or placebo once daily in the evening. A five year OLE will be available to eligible patients who complete the DBP. All patients will receive a 20 mg daily dose of XEN1101 during this extension period. |
Facilities
Sequence: | 198590229 | Sequence: | 198590230 | Sequence: | 198590231 | Sequence: | 198590232 | Sequence: | 198590233 | Sequence: | 198590234 | Sequence: | 198590235 | Sequence: | 198590236 | Sequence: | 198590237 | Sequence: | 198590238 | Sequence: | 198590239 | Sequence: | 198590240 | Sequence: | 198590241 | Sequence: | 198590242 | Sequence: | 198590243 | Sequence: | 198590244 | Sequence: | 198590245 | Sequence: | 198590246 | Sequence: | 198590247 | Sequence: | 198590248 | Sequence: | 198590249 | Sequence: | 198590250 | Sequence: | 198590251 | Sequence: | 198590252 | Sequence: | 198590253 | Sequence: | 198590254 | Sequence: | 198590255 | Sequence: | 198590256 | Sequence: | 198590257 | Sequence: | 198590258 | Sequence: | 198590259 | Sequence: | 198590260 | Sequence: | 198590261 | Sequence: | 198590262 | Sequence: | 198590263 | Sequence: | 198590264 | Sequence: | 198590265 | Sequence: | 198590266 | Sequence: | 198590267 | Sequence: | 198590268 | Sequence: | 198590269 | Sequence: | 198590270 | Sequence: | 198590271 | Sequence: | 198590272 | Sequence: | 198590273 | Sequence: | 198590274 | Sequence: | 198590275 | Sequence: | 198590276 | Sequence: | 198590277 | Sequence: | 198590278 | Sequence: | 198590279 | Sequence: | 198590280 | Sequence: | 198590281 | Sequence: | 198590282 | Sequence: | 198590283 | Sequence: | 198590284 | Sequence: | 198590285 | Sequence: | 198590286 | Sequence: | 198590287 | Sequence: | 198590288 | Sequence: | 198590289 | Sequence: | 198590290 | Sequence: | 198590291 | Sequence: | 198590292 | Sequence: | 198590293 | Sequence: | 198590294 | Sequence: | 198590295 | Sequence: | 198590296 | Sequence: | 198590297 | Sequence: | 198590298 | Sequence: | 198590299 | Sequence: | 198590300 | Sequence: | 198590301 | Sequence: | 198590302 | Sequence: | 198590303 | Sequence: | 198590304 | Sequence: | 198590305 | Sequence: | 198590306 | Sequence: | 198590307 | Sequence: | 198590308 | Sequence: | 198590309 | Sequence: | 198590310 | Sequence: | 198590311 | Sequence: | 198590312 | Sequence: | 198590313 | Sequence: | 198590314 | Sequence: | 198590315 | Sequence: | 198590316 | Sequence: | 198590317 | Sequence: | 198590318 | Sequence: | 198590319 | Sequence: | 198590320 | Sequence: | 198590321 | Sequence: | 198590322 | Sequence: | 198590323 |
Name | University of Alabama at Birmingham | Name | Strada Patient Care Center | Name | Xenoscience, Inc. | Name | Clinical Trials, Inc. | Name | Altman Clinical Translational Research Institute (ACTRI) | Name | California Pacific Medical Center (CPMC) – Sutter Pacific Epilepsy Program | Name | University of Colorado Hospital Anschutz Outpatient Pavilion | Name | University of Florida Jacksonville | Name | Mayo Clinic Florida | Name | Visionary Investigators Network | Name | Don Clinical Research Center | Name | The Neurology Research Group, LLC. | Name | Research Institute of Orlando, LLC | Name | Medsol Clinical Research Center | Name | Tallahassee Neurological Clinic | Name | University of South Florida | Name | Georgia Neurology and Sleep Medicine Associate | Name | Hawaii Pacific Neuroscience | Name | Consultants in Epilepsy and Neurology, PLLC | Name | Northwestern Medical Group, Department of Neurology | Name | University of Kansas Medical Center | Name | Bluegrass Epilepsy Research | Name | Maine Medical Partners Neurology | Name | Mid-Atlantic Epilepsy and Sleep Center | Name | Boston Neuro Research Center | Name | Minneapolis Clinic of Neurology, Ltd. | Name | Minnesota Epilepsy Group, P. A. | Name | Northeast Regional Epilepsy Group | Name | Institute of Neurology and Neurosurgery at Saint Barnabas | Name | Northeast Regional Epilepsy Group | Name | Dent Neurosciences Research Center | Name | NYU Langone Medical Center/NYU School of Medicine | Name | Northwell Health – Lenox Hill | Name | SUNY Upstate Medical University Institute for Human Performance | Name | Five Towns Neuroscience Research | Name | Asheville Neurology Specialists, PA | Name | UC Gardner Neuroscience Institute | Name | Miami Valley Hospital | Name | University of Toledo Medical Center | Name | Providence Neurological Specialties East | Name | Hospital of the University of Pennsylvania | Name | Thomas Jefferson University Comprehensive Epilepsy Center | Name | Allegheny Neurological Associates | Name | Vanderbilt Epilepsy Clinic | Name | Austin Epilepsy Care Center | Name | James W. Aston Ambulatory Care Center | Name | The University of Texas Health Science Center at San Antonio | Name | University of Utah Health Clinical Neurosciences Center | Name | University of Virginia | Name | Virginia Commonwealth University | Name | Carilion Neurology Clinic | Name | Winchester Neurological Consultants | Name | UW Medicine Valle Medical Center | Name | University of Washington School of Medicine, Regional Epilepsy Center at Harborview Medical Center | Name | Children's and Women's Health Centre of British Columbia (BC Children's Hospital) | Name | London Health Sciences Center | Name | University Health Network-Toronto Western Hospital | Name | LLC Arensia Exploratory Medicine | Name | Epilepsiezentrum Berlin-Brandenburg | Name | Bethel Epilepsy Centre | Name | Univ.-Klinik Bonn, Klinik und Poliklinik fur Epileptologie | Name | Universitatsklinikym Frankfurt | Name | Universitatsklinikum Freiburg, Neurozentrum/Epilepsiezentrum | Name | University Hospital Munster (UKM) | Name | Klinikum Osnabruck | Name | Krankenhaus Barmherzige Brueder Regensburg | Name | University of Tubingen-Dept. of Neurology and Epileptology | Name | IRCCS- Istituto delle Scienze Neurologiche, Bellaria Hospital | Name | Dipartimento Scienze Mediche e Chirurgiche, Universita Magna Graecia di Catanzaro | Name | Fondazione IRCCS Istituto Neurologico C. Besta | Name | IRCCS Istituto Neurologico Nazionale C. Mondino | Name | Azienda Ospedaliera Universita' Pisana | Name | Azienda Ospedaliera "Bianchi-Melacrino-Morelle"di Reggio Calabria | Name | Policlinico di Roma Umberto I | Name | PMSI Republican Clinical Hospital, ARENSIA Exploratory Medicine | Name | Hospital Virgen Macarena | Name | Centro de Neurologia Avanzada | Name | Hospital Germans Trias I Pujol | Name | Clínica Universidad Navarra | Name | Hospital del Mar | Name | Hospital Universitario Vall d'Hebron | Name | Hospital Vithas La Salud | Name | Hospital U. Ramón y Cajal | Name | Hospital Ruber Internacional | Name | Hospital U. Clínico San Carlos | Name | Hospital Universitario Fundacion Jimenez Diaz | Name | Hospital Universitario 12 de Octubre | Name | Hospital Regional Universitario de Málaga | Name | Hospital Universitario y Politécnico La Fe | Name | Hospital Clínico Universitario Valladolid | Name | Medical Center of Limited Liability Company "Harmoniya Krasy" | Name | Institute of Neurological Sciences | Name | University Hospital of Wales | Name | King's College Hospital NHS Foundation Trust | Name | St. George's University Hospitals NHS Foundation Trust |
City | Birmingham | City | Mobile | City | Phoenix | City | Little Rock | City | La Jolla | City | San Francisco | City | Aurora | City | Jacksonville | City | Jacksonville | City | Miami | City | Miami | City | Miami | City | Orlando | City | Port Charlotte | City | Tallahassee | City | Tampa | City | Suwanee | City | Honolulu | City | Boise | City | Chicago | City | Kansas City | City | Lexington | City | Scarborough | City | Bethesda | City | South Dartmouth | City | Golden Valley | City | Saint Paul | City | Hackensack | City | Livingston | City | Morristown | City | Amherst | City | New York | City | New York | City | Syracuse | City | Woodmere | City | Asheville | City | Cincinnati | City | Dayton | City | Toledo | City | Portland | City | Philadelphia | City | Philadelphia | City | Pittsburgh | City | Nashville | City | Austin | City | Dallas | City | San Antonio | City | Salt Lake City | City | Charlottesville | City | Richmond | City | Roanoke | City | Winchester | City | Renton | City | Seattle | City | Vancouver | City | London | City | Toronto | City | Tbilisi | City | Berlin | City | Bielefeld | City | Bonn | City | Frankfurt | City | Freiburg | City | Muenster | City | Osnabrück | City | Regensburg | City | Tübingen | City | Bologna | City | Catanzaro | City | Milano | City | Pavia | City | Pisa | City | Reggio Calabria | City | Roma | City | Chisinau | City | Sevilla | City | Sevilla | City | Badalona | City | Pamplona | City | Barcelona | City | Barcelona | City | Granada | City | Madrid | City | Madrid | City | Madrid | City | Madrid | City | Madrid | City | Málaga | City | Valencia | City | Valladolid | City | Kyiv | City | Glasgow | City | Cardiff | City | London | City | London |
State | Alabama | State | Alabama | State | Arizona | State | Arkansas | State | California | State | California | State | Colorado | State | Florida | State | Florida | State | Florida | State | Florida | State | Florida | State | Florida | State | Florida | State | Florida | State | Florida | State | Georgia | State | Hawaii | State | Idaho | State | Illinois | State | Kansas | State | Kentucky | State | Maine | State | Maryland | State | Massachusetts | State | Minnesota | State | Minnesota | State | New Jersey | State | New Jersey | State | New Jersey | State | New York | State | New York | State | New York | State | New York | State | New York | State | North Carolina | State | Ohio | State | Ohio | State | Ohio | State | Oregon | State | Pennsylvania | State | Pennsylvania | State | Pennsylvania | State | Tennessee | State | Texas | State | Texas | State | Texas | State | Utah | State | Virginia | State | Virginia | State | Virginia | State | Virginia | State | Washington | State | Washington | State | British Columbia | State | Ontario | State | Ontario | State | Andalusia | State | Andalusia | State | Barcelona | State | Navarra | State | Scotland | State | Wales | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Zip | 35294 | Zip | 36604 | Zip | 85004 | Zip | 72205 | Zip | 92037 | Zip | 94109 | Zip | 80045 | Zip | 32209 | Zip | 32224 | Zip | 33133 | Zip | 33136 | Zip | 33176 | Zip | 32806 | Zip | 33952 | Zip | 32308 | Zip | 33606 | Zip | 30024 | Zip | 96817 | Zip | 83702 | Zip | 60611 | Zip | 66160 | Zip | 40504 | Zip | 04074 | Zip | 20817 | Zip | 02747 | Zip | 55422 | Zip | 55102 | Zip | 07601 | Zip | 07039 | Zip | 07960 | Zip | 14226 | Zip | 10016 | Zip | 10075 | Zip | 13210 | Zip | 11598 | Zip | 28806 | Zip | 45219 | Zip | 45409 | Zip | 43606 | Zip | 97213 | Zip | 19104 | Zip | 19107 | Zip | 15212 | Zip | 37232 | Zip | 78758 | Zip | 75390 | Zip | 78229-3900 | Zip | 84132 | Zip | 22903 | Zip | 23219 | Zip | 24016 | Zip | 22601 | Zip | 98055 | Zip | 98104 | Zip | V6H 3V4 | Zip | N6A 5A5 | Zip | M5T 2S8 | Zip | 0112 | Zip | 10365 | Zip | 33617 | Zip | 53127 | Zip | 60528 | Zip | 79106 | Zip | 48149 | Zip | 49076 | Zip | 93049 | Zip | 72076 | Zip | 40139 | Zip | 88100 | Zip | 20133 | Zip | 27100 | Zip | 56124 | Zip | 89123 | Zip | 00185 | Zip | 2025 | Zip | 41009 | Zip | 41013 | Zip | 08916 | Zip | 31008 | Zip | 08003 | Zip | 08035 | Zip | 18008 | Zip | 28034 | Zip | 28036 | Zip | 28040 | Zip | 28040 | Zip | 28041 | Zip | 29010 | Zip | 46026 | Zip | 47003 | Zip | 01135 | Zip | G514TF | Zip | CF14 4XW | Zip | SE5 9RS | Zip | SW17 0QT |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | Canada | Country | Canada | Country | Canada | Country | Georgia | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Moldova, Republic of | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Ukraine | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom |
Conditions
Sequence: | 51776075 |
Name | Focal Epilepsy |
Downcase Name | focal epilepsy |
Id Information
Sequence: | 39844675 | Sequence: | 39844676 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | XPF-008-201 | Id Value | 2018-003221-29 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42243730 | Sequence: | 42243731 | Sequence: | 42243732 | Sequence: | 42243733 | Sequence: | 42243734 | Sequence: | 42243735 | Sequence: | 42243736 | Sequence: | 42243737 | Sequence: | 42243738 |
Name | United States | Name | Canada | Name | Georgia | Name | Germany | Name | Italy | Name | Moldova, Republic of | Name | Spain | Name | Ukraine | Name | United Kingdom |
Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False |
Design Groups
Sequence: | 55194900 | Sequence: | 55194901 | Sequence: | 55194902 | Sequence: | 55194903 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Placebo Comparator |
Title | 25 mg XEN1101 | Title | 20 mg XEN1101 | Title | 10 mg XEN1101 | Title | Placebo |
Description | Capsule filled with 25 mg XEN1101 | Description | Capsule filled with 20 mg XEN1101 | Description | Capsule filled with 10 mg XEN1101 | Description | Placebo capsule |
Interventions
Sequence: | 52098277 |
Intervention Type | Drug |
Name | XEN1101 |
Description | Oral dose |
Keywords
Sequence: | 79221678 |
Name | Epilepsy |
Downcase Name | epilepsy |
Design Outcomes
Sequence: | 176103354 | Sequence: | 176103355 | Sequence: | 176103356 | Sequence: | 176103357 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | To assess the efficacy of XEN1101 compared to placebo on focal seizure frequency (e.g., median percent change in focal seizure frequency) in adults with focal epilepsy taking 1-3 antiepileptic drugs (AEDs) in the double-blind treatment period (DBP) | Measure | To assess the safety and tolerability of XEN1101 (e.g., adverse events) in adults with focal epilepsy taking 1-3 AEDs | Measure | To evaluate the 50% XEN1101 response rates in comparison to placebo in the DBP | Measure | To evaluate trends in focal seizure frequency over time in the DBP |
Time Frame | From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56) | Time Frame | From screening (up to 28 days prior to baseline) through to 42 days post-final dose | Time Frame | From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56) | Time Frame | From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56) |
Description | Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo | Description | To assess adverse events as criteria for safety and tolerability | Description | Responders are defined as patients experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline to DBP | Description | Percent change from baseline in weekly focal seizure frequency for each week in the DBP |
Browse Conditions
Sequence: | 191896151 | Sequence: | 191896152 | Sequence: | 191896153 | Sequence: | 191896149 | Sequence: | 191896150 |
Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Epilepsy | Mesh Term | Epilepsies, Partial |
Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | epilepsy | Downcase Mesh Term | epilepsies, partial |
Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list |
Sponsors
Sequence: | 47950794 | Sequence: | 47950795 |
Agency Class | INDUSTRY | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Xenon Pharmaceuticals Inc. | Name | Novotech Health Holdings Pte. Ltd. |
Overall Officials
Sequence: | 29052729 |
Role | Study Director |
Name | Study Director |
Affiliation | Xenon Pharmaceuticals Inc. |
Design Group Interventions
Sequence: | 67669722 | Sequence: | 67669723 | Sequence: | 67669724 | Sequence: | 67669725 |
Design Group Id | 55194902 | Design Group Id | 55194901 | Design Group Id | 55194900 | Design Group Id | 55194903 |
Intervention Id | 52098277 | Intervention Id | 52098277 | Intervention Id | 52098277 | Intervention Id | 52098277 |
Eligibilities
Sequence: | 30533728 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 75 Years |
Healthy Volunteers | No |
Criteria | Key Inclusion Criteria:
Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study Key Exclusion Criteria: History of pseudoseizures, psychogenic seizures, primary generalized seizure, or focal aware non-motor seizures only Any clinically significant abnormalities on pre-study physical examination, vital signs, laboratory values or ECG indicating a medical problem that would preclude study participation including but not limited to: History of presence of long QT syndrome; QTcF > 450 msec at baseline; family history of sudden death of unknown cause |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254136387 |
Number Of Facilities | 95 |
Registered In Calendar Year | 2019 |
Actual Duration | 31 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 75 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30282281 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28661219 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796949
2014-05-31
https://zephyrnet.com/?p=NCT03796949
NCT03796949https://www.clinicaltrials.gov/study/NCT03796949?tab=tableNANANAThis study investigates immunological and clinical markers in threatened preterm birth aiming to create a prediction model for preterm birth.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | May 2014 |
Primary Completion Month Year | August 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-08 |
Detailed Descriptions
Sequence: | 20783022 |
Description | Preterm birth is the main cause of neonatal mortality and morbidity and despite a lot of effort the mechanisms leading to preterm birth are poorly understood. In threatened preterm birth it is difficult to identify the true high risk cases ultimately leading to preterm birth. These women are often overtreated.
In this study blood samples are taken from women with threatened preterm birth and from women with normal pregnancies before and during labor. Differences in clinical characteristics and immunological markers between the groups are studied in order to design a prediction model for preterm birth. |
Conditions
Sequence: | 52328256 | Sequence: | 52328257 |
Name | Preterm Birth | Name | Immunologic Activity Alteration |
Downcase Name | preterm birth | Downcase Name | immunologic activity alteration |
Id Information
Sequence: | 40271055 |
Id Source | org_study_id |
Id Value | 960624abc |
Design Groups
Sequence: | 55768084 | Sequence: | 55768085 |
Title | threatened preterm birth | Title | Controls |
Description | Women with either preterm labor or preterm prelabor rupture of the membranes. Blood samples taken at time of inclusion in the study. | Description | Women with normal pregnancies. Blood samples taken at time of inclusion in the study, either prelabor (during pregnancy) or during active phase of labor. |
Design Outcomes
Sequence: | 177959786 |
Outcome Type | primary |
Measure | Time of delivery |
Time Frame | Outcome noted at delivery |
Description | Delivery before 34 weeks of gestation or after 34 weeks of gestation |
Browse Conditions
Sequence: | 194084932 | Sequence: | 194084933 | Sequence: | 194084934 | Sequence: | 194084935 | Sequence: | 194084936 | Sequence: | 194084937 |
Mesh Term | Premature Birth | Mesh Term | Obstetric Labor, Premature | Mesh Term | Obstetric Labor Complications | Mesh Term | Pregnancy Complications | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases |
Downcase Mesh Term | premature birth | Downcase Mesh Term | obstetric labor, premature | Downcase Mesh Term | obstetric labor complications | Downcase Mesh Term | pregnancy complications | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48466391 |
Agency Class | OTHER_GOV |
Lead Or Collaborator | lead |
Name | Linkoeping University |
Overall Officials
Sequence: | 29368853 |
Role | Principal Investigator |
Name | Marie Blomberg, MD PhD |
Affiliation | Department of Obstetrics and Gynecology, Linköping University, Linköping, Sweden |
Eligibilities
Sequence: | 30856305 |
Sampling Method | Non-Probability Sample |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | 80 women with threatened preterm labor before 34 weeks of gestation, 40 women with preterm prelabor rupture of the membranes before 34 weeks of gestation, 40 women with normal pregnancies in labor at term, 44 women with normal pregnancies during pregnancy (before labor) |
Criteria | Inclusion Criteria:
Threatened preterm birth before 34 weeks of gestation; either threatened preterm labor and/or preterm prelabor rupture of the membranes Exclusion Criteria: Multiple gestation |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254313025 |
Registered In Calendar Year | 2019 |
Actual Duration | 51 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30602143 |
Observational Model | Case-Control |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28968659 |
Responsible Party Type | Principal Investigator |
Name | Marie Blomberg |
Title | Professor |
Affiliation | Linkoeping University |
]]>
https://zephyrnet.com/NCT03796936
2019-01-11
https://zephyrnet.com/?p=NCT03796936
NCT03796936https://www.clinicaltrials.gov/study/NCT03796936?tab=tableNANANABackground and Purpose: Posttraumatic stress disorder (PTSD) and mild traumatic brain injury (mTBI) are persistent and frequently comorbid complications of recent combat. There is no proven treatment for mTBI, and standard treatments for PTSD frequently achieve only transient, modest impact. Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) is a novel treatment for PTSD combining aspects of virtual reality exposure therapy (VRET) and Eye Movement Desensitization and Reprocessing (EMDR), within the Computer Assisted Rehabilitation Environment (CAREN). The added benefit of the eye movement (EM) component of EMDR is controversial; the purpose of this pilot study is therefore to: 1) obtain an initial estimate of the efficacy of 3MDR in service members with comorbid PTSD and mTBI, and 2) determine the impact of EM on treatment response. The investigators hypothesize that 3MDR will significantly improve symptom severity, both with and without EM.
Population: Participants will be active or retired service members with a history of mTBI who meet criteria for probable PTSD on the PCL5. It is anticipated that participants will be recruited through the Center for Neuroscience and Regenerative Medicine (CNRM) Recruitment Core and the National Intrepid Center of Excellence (NICoE).
Design type and procedures: This is a pilot, controlled clinical trial in which all 20 participants with comorbid PTSD and mTBI receive 10 sessions (3 preparatory, 6 3MDR treatment, and 1 conclusion), but will be randomized to either include EM (EM+) or not (EM-). In the preparatory sessions, the therapist will help each participant select 2 songs and 14 pictures to be used in their treatment sessions. The therapist will help the participant rate the pictures from least to most impactful. Each 3MDR treatment session will start by playing the first song, to bring them back to the time of their trauma. This will be done while the participant walks on the CAREN’s embedded treadmill through the 3MDR virtual environment (VE) projected onto the system’s curved screen. This is followed by a display of one of their pictures, a manifestation of their trauma, which they directly face and walk down a hallway toward, until the picture looms before them. The therapist, standing next to the participant along the treadmill’s edge, will query the participant about what the picture means to them, how it makes them feel, etc., while the CAREN operator superimposes key words (said by the participant) over the picture, which the therapist later asks the participant to read aloud. Then, for ~60 seconds, the EM+ group will see a red ball “bounce” across the screen in front of the picture, and a number appears on the ball as it touches the screen’s edge. The participant will be asked to recite each number aloud. This element is absent for EM- participants. All participants repeats these procedures for 5-7 pictures in each 3MDR treatment session; the pictures used will be agreed upon by therapist and participant, targeting more impactful pictures, whether repeats or new, in later sessions. The pictures are followed by playing the second song, chosen to bring the participant back to present day. The participant will walk at a comfortable pace throughout the session, with each session lasting typically ~60 minutes. The primary outcome measure will be change in PCL-5 score from pre- to post-intervention, with additional measures at 3 and 6 months.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-25 |
Start Month Year | January 11, 2019 |
Primary Completion Month Year | December 2020 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-25 |
Detailed Descriptions
Sequence: | 20710017 |
Description | This is a pilot prospective, randomized, interventional controlled clinical trial. Our study at the NICoE site will specifically target active or retired SMs who are OIF/OEF/OND veterans of any age and either gender who meet criteria for PTSD and have a lifetime history of mTBI. Comorbid PTSD and mTBI is highly prevalent in SMs and veterans of the recent wars in Afghanistan and Iraq, and having both diagnoses is associated with significantly greater symptom severity than either PTSD or mTBI alone (Brenner et al., 2010). TBI, the great majority of which is mTBI, is one of the most challenging, significant, and costly problems facing the DoD, and inhibiting readiness, whether in times of war or peace. Currently, no therapy has yet been proven efficacious in reducing persistent symptoms after TBI. Many patients with PTSD, particularly when it is combat-related, still suffer from substantial residual symptoms even after undergoing evidence-based psychotherapy (Watts et al., 2013; Bradley et al., 2001; Bison et al., 2007) and many even maintain their PTSD diagnosis (Steenkamp et al., 2015). The novel elements of 3MDR may prove to be particularly beneficial for those with both PTSD and a history of mTBI. If our approach is proven effective, there will be a sizeable population for whom this treatment could be provided, translating into both individual and DoD-wide benefit. Both TBI and PTSD have become signature wounds of the wars in Iraq and Afghanistan and pose significant health concerns for many military personnel. Currently, no intervention has yet been proven efficacious in reducing long-term symptoms of TBI. Furthermore, individuals with PTSD often have persistent symptoms even after completing validated treatments.
The proposed research has the potential to have a significant positive impact on the care of individuals with both PTSD and mTBI. As previously stated, 3MDR combines emotional exposure, dual-task processing, attenuation of working memory resources, and physical activity. Physical activity may be particularly beneficial in enhancing blood flow to the brain and facilitating production of beneficial factors such as brain-derived neurotrophic factor (BDNF). In addition, participants have the opportunity to demonstrate to themselves that they can actively overcome their avoidance by approaching and walking toward, or deliberately confronting, representations of their own traumatic memories. This approach may be particularly useful or of interest to veterans and SMs, who are accustomed to being physically active, may be less inclined to turn to pharmacotherapy than others with PTSD, and also have had high dropout rates and greater resistance to established, more traditional therapies. This relatively short treatment approach could have tremendous implications for improvement in symptoms as well as quality of life in individuals with PTSD and mTBI. Prior to any other study procedures, written informed consent will be obtained from each participant by the principal investigator (PI) or another study staff member trained by the PI to obtain informed consent. The PI will then complete a medical history and a series of questionnaires, to include a review of inclusion and exclusion criteria, to ensure that each participant is eligible to be enrolled in the study. A random number table will be used to randomly assign participants to either the eye movement (EM+) or no eye movement (EM-) group. Table 1 Weeks Months 0 1 2 3 4 5 6 7 8 9 10 3 6 Consent X 3MDR Preparatory Sessions X X X 3MDR CAREN Sessions X X X X X X Wrap-up Session X Post-Therapy Follow-Up X X Intervention All participants will complete 10 treatment sessions (three preparatory sessions, six 3MDR sessions and one concluding session; see Table 1), led by a therapist who has been completed training in the conduct of this form of therapy, with the only difference between the intervention groups being the presence (EM+) or absence (EM-) of the eye movement component. Dr. Eric Vermetten, head of research at the Military Mental Health unit of the Netherlands Ministry of Defense, and one of the developers of the 3MDR system, will conduct the training of all study therapists, will ensure that they are fully prepared to carry out the treatment protocol using the study manual he wrote, and he will provide regular supervision for the study therapists throughout the conduct of the study. Preparatory Session 1: Research personnel will explain the upcoming 3MDR therapy sessions. Participants will be asked to identify 14 photographs, as well as two songs. The photographs may be digital, hard copy, or downloaded from the internet, and should be related to or reminiscent of the participant's traumatic experience. Each of the two songs are selected for specific purposes and will be played in their entirety during each of the 3MDR sessions. The first song is intended to bring them back to the time in which the trauma occurred; for example, for a service member with combat-related PTSD, this might be a song that they listened to a lot during their deployment. This will be played at the start of the 3MDR session while the participant walks at a comfortable pace through a virtual environment, before any of their pictures are displayed. The second song, on the other hand, is specifically chosen in order to bring them back to the present time, to remind them they are safe and are in the present moment. Preparatory Session 2: The participant will share their photographs and music selections with the therapist. If the participant has difficulty identifying a sufficient number of appropriate photographs, the therapist will work with the participant during this session to identify why they may not have been able to come up with a sufficient number, and to help them find suitable options. This could include conducting online searches for publicly available pictures, including such options as Google Maps images of the area in which their trauma occurred. Sometimes, difficulty in the selection of pictures is a manifestation of the avoidance of any reminders of the traumatic, which is a cardinal feature of PTSD. The therapist may at this time explore the avoidance, if it is perceived to be a significant factor, and help the participant to work through and overcome it to a sufficient degree to identify suitable pictures to use in the treatment sessions. While the selection of songs does not usually pose as significant a challenge, the therapist will also review the participant's song selections, discuss why they were chosen, and try to ensure that the songs selected are suitable to take the participant back to the trauma, and then bring them back to the present and help them differentiate past from present, respectively. The therapist will then guide the participant to arrange their photographs according to their subjective units of distress (SUDS; Wolp,1969). The SUDS is a verbal self-report rating of subjective distress on a scale from 0-10, with 0 indicating no distress, and 10 representing maximum distress. The SUDS scale will be explained verbally to the participant and is not given via pencil and paper format. This will be used to rank the pictures for use during 3MDR treatment. Preparatory Session 3: Participants will be introduced to, and familiarized with, the CAREN system (e.g., standing, shifting weight, and walking) located at the National Intrepid Center of Excellence (NICoE). Participants will be fitted by the engineer with a safety harness that will be worn for the entirety of each session that a participant is on the CAREN platform. In this session, a series of introductory applications will be used to familiarize the participant with the CAREN, which will take less than five minutes to perform. A short practice 3MDR session with a non-affecting photograph (e.g., a flower) will be conducted. 3MDR Sessions 1-6: A 3MDR trained therapist, as well as a CAREN engineer, will be present at every 3MDR therapy session. Since sessions only include level treadmill walking, the platform will be disengaged with the bridge extended, as opposed to being separated from the main floor and set up to enable left-right and forward-backward shifts from the horizontal. This will minimize equipment noise and facilitate the communication between the therapist and participant. For participant monitoring and objective data collection, heart rate and kinematic data will be collected. A chest strap heart rate monitor will be worn by the participant throughout the session (Polar Electro Inc., Woodbury, NY; Zephyr Performance Systems, Annapolis, MD). Reflective motion capture markers will be placed on the participant's head, torso, and legs to measure biomechanics collected via motion capture cameras (Motion Analysis Inc., Santa Rosa, CA) that surround the CAREN. Participants will then be fitted with an adjustable safety harness that fits comfortably over the shoulders. There is a risk of skin chafing if there is a lot of movement and the harness is not fitted properly. Each participant will be asked if they are comfortable throughout the study to mitigate this risk. The safety harness will be slipped into the safety support on the CAREN, which allows the participant to walk freely on the treadmill, but it does not allow them to walk off the platform. There is also a safety bar in front of the participant. The therapist will stand next to the participant during the session, on the edge of the platform but not on the treadmill. Up to seven pictures will be selected based on the participant's SUDS scores and/or themes agreed upon for each session. Pictures may be repeated during a session, reducing the number of pictures used for some sessions; this will be at the discretion of the treating therapist. Each session has three phases: warm-up, intervention, and cool-down. The participant's preferred walking speed will be used to start the warm-up phase (2-5 min) and can be adjusted as needed. During this phase, the participant will virtually walk along an outdoor pathway toward a door while their chosen opening song plays to bring them back to a time of their trigger, as verbal guidance from their therapist prepares them for the intervention phase. The CAREN system will be operated by a Biomedical Engineer, Sarah Kruger, who has been operating CAREN systems since 2007, and is certified by Motekforce Link. Motekforce Link is the manufacturer of the CAREN system. Motekforce Link provides CAREN operators with training and also verifies competencies required for system operation. During utilization, the system is operated by a certified CAREN Operator and per protocol, at no time will the system be operated with less than two staff members in the room. System checks are run daily by the CAREN Operator. All equipment is calibrated and maintained. Personnel from Motekforce Link visit annually to verify that everything is working properly and make any changes that are necessary. In the intervention phase (50-55 min), the participant passes through an initial hallway leading to an open door that in turn leads them down a second hallway to approach their first picture, while being guided by the therapist with regard to what to do at each stage. The picture appears in the distance, but gradually becomes larger as they get closer to it, until it fills their field of vision. As soon as the participant is able to see the picture clearly, the therapist will request that they provide a detailed description of what the picture represents to them, and will then go on to ask the participant about their related memories and feelings. The therapist will verbally repeat key feelings and phrases that seem to carry particular meaning and resonance for the participant, so the CAREN engineer can type these words into the computer to have them appear superimposed over the picture (stage 1). For those in the EM+ intervention group, the EM component will start after the participant has confirmed there are no more new feelings or words to be identified with the picture, and the therapist has asked the participant to read each of these words aloud, after which the engineer will remove the words from the screen but retain the picture. At this point a red ball will start at the left edge of the screen, and will move across the screen fairly rapidly from left to right, and upon reaching the right edge of the screen, a 2-digit number will appear superimposed on the red ball in white font (stage 2). The ball will then reverse course, passing from right to left, and the number will change as the ball meets the opposite edge of the screen. The ball will continue to move back and forth and the number will change every time the ball meets either edge of the screen. The participant will be asked to track the ball and call out the numbers displayed on the ball. After approximately 60 seconds, the distractor stimulus (ball image) is removed and a SUDS score is reported by the participant and recorded by the CAREN operator (stage 3). The participant will then walk out of the virtual hallway and onto an outdoor pathway that will lead them to another set of hallways, leading in turn to another picture, and the stages are repeated. There will be no exposure to the distractor stimulus (red ball) for those in the EM- intervention group. After the last picture, the final phase of treatment (cool-down) begins (2-5 min). The session concludes with a piece of music, chosen by the participant to bring them back to the present time, typically a current favorite song of theirs. This music will be used to assist the participant in returning back to the present moment, while the therapist simultaneously provides them with positive feedback regarding their performance during the session, with a goal of achieving a significantly reduced SUDS score, which is reassessed at the end of the song. Following the session, the CAREN operator will remove the safety harness from the participant. Participants will also be able to stop the session at any time if they feel ill or any motion sickness. A therapist-led discussion (approximately 15 minutes) with the participant will then occur in a private room; open questions will be used to elicit how the session was for the participant, and to discuss the purpose of re-experiencing to the participant in this setting. Notes made by the therapist will be stored, identified by study code and session number only, stored in password-protected files on a CAC-requiring computer. The study therapist will ensure the participant has completely returned to the present moment, has a reduced SUDS, and has ideally been able to attach a positive meaning to the 3MDR session. Participants will be asked to write their experiences and reflections down following each session in a diary format. All sessions will be recorded and a report summarizing the behavioral response to the intervention will be produced. Concluding Session: Participants will provide their perception of how beneficial the treatment was, and if the current state of their symptoms will be discussed, with a focus on to what degree they have or have not improved compared to prior to their participation in the study. Participants will return to the laboratory to complete follow-up assessments at 3 and 6 months. If participants are unable to return to the laboratory (i.e., no longer in the area), they will be contacted via phone, and the study questionnaires will be completed telephonically. |
Facilities
Sequence: | 199965405 |
Status | Recruiting |
Name | Walter Reed National Military Medical Center |
City | Bethesda |
State | Maryland |
Zip | 20889 |
Country | United States |
Facility Contacts
Sequence: | 28086690 | Sequence: | 28086691 |
Facility Id | 199965405 | Facility Id | 199965405 |
Contact Type | primary | Contact Type | backup |
Name | Michael J Roy, MD, MPH | Name | Paula Bellini, MA |
michael.roy@usuhs.edu | paula.bellini.ctr@usuhs.edu | ||
Phone | 301-295-9601 | Phone | 301-295-5840 |
Conditions
Sequence: | 52139082 | Sequence: | 52139083 |
Name | Posttraumatic Stress Disorder | Name | Traumatic Brain Injury |
Downcase Name | posttraumatic stress disorder | Downcase Name | traumatic brain injury |
Id Information
Sequence: | 40135120 |
Id Source | org_study_id |
Id Value | WRNMMC-2018-0201 |
Countries
Sequence: | 42542780 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55559439 | Sequence: | 55559440 |
Group Type | Experimental | Group Type | Active Comparator |
Title | 3MDR With Eye Movement Component (EM+) | Title | 3MDR Without Eye Movement Component (EM-) |
Description | All participants will complete 10 treatment sessions (3 preparatory, 6 3MDR and 1 concluding), led by a trained therapist, with the only difference between the intervention groups being the presence (EM+) or absence (EM-) of the eye movement component. For those in the EM+ intervention group, the EM component starts after the participant has thoroughly discussed a picture with the therapist; a red ball starts at one edge of the screen, moves rapidly back and forth across it, and upon reaching either edge, a 2-digit number appears superimposed in white on the ball. The number changes every time the ball meets either edge. The participant is asked to track the ball and call out the displayed numbers. | Description | All participants will complete 10 treatment sessions (three preparatory sessions, six 3MDR sessions and one concluding session; see Table 1), led by a therapist who has been completed training in the conduct of this form of therapy, with the only difference between the intervention groups being the presence (EM+) or absence (EM-) of the eye movement component.There will be no exposure to the distractor stimulus (red ball) for those in the EM- intervention group. |
Interventions
Sequence: | 52454994 |
Intervention Type | Behavioral |
Name | Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) Therapy |
Description | a novel treatment for PTSD combining aspects of virtual reality exposure therapy (VRET) and Eye Movement Desensitization and Reprocessing (EMDR), within the Computer Assisted Rehabilitation Environment (CAREN) |
Keywords
Sequence: | 79822928 | Sequence: | 79822929 | Sequence: | 79822930 | Sequence: | 79822931 |
Name | posttraumatic stress disorder | Name | traumatic brain injury | Name | virtual reality | Name | eye movement desensitization and reprocessing |
Downcase Name | posttraumatic stress disorder | Downcase Name | traumatic brain injury | Downcase Name | virtual reality | Downcase Name | eye movement desensitization and reprocessing |
Design Outcomes
Sequence: | 177264120 | Sequence: | 177264119 | Sequence: | 177264121 | Sequence: | 177264122 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in Neurobehavioral Symptom Inventory (NSI) score | Measure | Change in PTSD Checklist for DSM5 (PCL-5) score | Measure | Change in Patient Health Questionnaire depression module (PHQ-9) score | Measure | Change in Insomnia Severity Index (ISI) score |
Time Frame | Post-intervention session, and 3 and 6 months later, compared to baseline | Time Frame | Post-intervention session 10, as well as 3 and 6 months later, compared to baseline | Time Frame | Post-intervention session 10, as well as pre-intervention session 7, and 3 and 6 months later, compared to baseline | Time Frame | Post-intervention session 10, as well as pre-intervention session 7, 3 and 6 months later, compared to baseline |
Description | measure of postconcussive symptom severity; range 0-88, higher score represents greater severity | Description | The well-validated PCL-5 will assess self-reported PTSD symptom severity; range 0-84, higher score represents greater severity. | Description | measure of depression symptom severity; range 0-27, higher score represents greater severity | Description | measure of insomnia and sleep concerns; range 0-28, higher score represents greater severity |
Browse Conditions
Sequence: | 193366846 | Sequence: | 193366847 | Sequence: | 193366848 | Sequence: | 193366849 | Sequence: | 193366850 | Sequence: | 193366851 | Sequence: | 193366852 | Sequence: | 193366853 | Sequence: | 193366854 | Sequence: | 193366855 | Sequence: | 193366856 | Sequence: | 193366857 |
Mesh Term | Brain Injuries | Mesh Term | Brain Injuries, Traumatic | Mesh Term | Stress Disorders, Traumatic | Mesh Term | Stress Disorders, Post-Traumatic | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Craniocerebral Trauma | Mesh Term | Trauma, Nervous System | Mesh Term | Wounds and Injuries | Mesh Term | Trauma and Stressor Related Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | brain injuries | Downcase Mesh Term | brain injuries, traumatic | Downcase Mesh Term | stress disorders, traumatic | Downcase Mesh Term | stress disorders, post-traumatic | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | craniocerebral trauma | Downcase Mesh Term | trauma, nervous system | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | trauma and stressor related disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290780 | Sequence: | 48290781 |
Agency Class | FED | Agency Class | FED |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Walter Reed National Military Medical Center | Name | Uniformed Services University of the Health Sciences |
Design Group Interventions
Sequence: | 68107558 | Sequence: | 68107559 |
Design Group Id | 55559439 | Design Group Id | 55559440 |
Intervention Id | 52454994 | Intervention Id | 52454994 |
Eligibilities
Sequence: | 30747772 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Military service member or veteran Exclusion Criteria: History of moderate, severe, or penetrating TBI |
Gender Description | we seek to enroll 50% male, 50% female participants |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254122168 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30494055 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | This is a pilot, controlled clinical trial in which all 20 participants with comorbid PTSD and mTBI receive 10 sessions (3 preparatory, 6 3MDR treatment, and 1 conclusion), but will be randomized to either include eye movement, EM (EM+), or not (EM-). |
Responsible Parties
Sequence: | 28860335 |
Responsible Party Type | Principal Investigator |
Name | Michael Roy |
Title | Professor of Medicine & Director, Division of Military Internal Medicine |
Affiliation | Walter Reed National Military Medical Center |
Ipd Information Types
Sequence: | 3331372 |
Name | Clinical Study Report (CSR) |
]]>
https://zephyrnet.com/NCT03796923
2018-01-01
https://zephyrnet.com/?p=NCT03796923
NCT03796923https://www.clinicaltrials.gov/study/NCT03796923?tab=tableNANANAIn most Western countries the elderly population increases rapidly. In Denmark, the population of elderly aged 75 years or older may amount to nearly 15 % of the entire population in 2050 compared to 9 % today (2017). A large part of the elderly population is at high risk of hospitalization including more admissions and increased morbidity and mortality. The number of hospital beds is declining persistently, calling for shorter lengths of stay (LOS). Increasingly complex treatments now take place outside hospital. Presently, many Danish regional hospitals establish geriatric wards and other geriatric in-hospital and outpatient services to overcome these challenges. The aim of the present PhD-study is to investigate the effects of different models of transitional care among the frailest elderly patients.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-04-30 |
Start Month Year | January 1, 2018 |
Primary Completion Month Year | September 16, 2020 |
Verification Month Year | April 2021 |
Verification Date | 2021-04-30 |
Last Update Posted Date | 2021-04-30 |
Detailed Descriptions
Sequence: | 20727216 |
Description | Design Population: The frailest acutely admitted geriatric patients aged +75. Intervention: Early follow-up visits after discharge. Comparison: Usual care follow-up. Outcomes: The primary outcome is readmission within 30 days after discharge. Secondary outcomes are: mortality 30 days after discharge and 90 days after admission, length of stay (LOS), direct discharge from the Emergency Department, time at home before readmission, duration of readmission and physical functional status 30 days after discharge.
Methods The first study is conducted as a randomized controlled trial (RCT) using two different degrees of intervention. The second study is a cohort study of an unexposed control group. The third study is sub-group analyses of the RCT data according to frailty status and type of dwelling. A focus group comprised of included patients and relatives will be set to identify additional patient related outcome measures (PROMs) and to participate in an advisory group throughout the remaining project. |
Facilities
Sequence: | 200159509 |
Name | Aarhus University |
City | Aarhus |
Country | Denmark |
Conditions
Sequence: | 52185586 | Sequence: | 52185584 | Sequence: | 52185585 | Sequence: | 52185587 | Sequence: | 52185588 | Sequence: | 52185589 |
Name | Frailty | Name | Frail Elderly Syndrome | Name | Transitional Care | Name | Readmission | Name | Aging | Name | Elderly |
Downcase Name | frailty | Downcase Name | frail elderly syndrome | Downcase Name | transitional care | Downcase Name | readmission | Downcase Name | aging | Downcase Name | elderly |
Id Information
Sequence: | 40169133 |
Id Source | org_study_id |
Id Value | MOCATRANFRAELRCT |
Countries
Sequence: | 42580720 |
Name | Denmark |
Removed | False |
Design Groups
Sequence: | 55609217 | Sequence: | 55609218 | Sequence: | 55609219 |
Group Type | Active Comparator | Group Type | Experimental | Group Type | Other |
Title | Intervention I | Title | Intervention II | Title | Control |
Description | Intervention (I): early follow-up visit from the community nurse within 24 hours after discharge | Description | Intervention (II): early follow-up by the geriatric team within 24 hours after discharge | Description | Usual care: individualized follow-up performed by the GP and municipality services |
Interventions
Sequence: | 52499521 | Sequence: | 52499519 | Sequence: | 52499520 | Sequence: | 52499522 |
Intervention Type | Other | Intervention Type | Other | Intervention Type | Other | Intervention Type | Other |
Name | Continued geriatric care | Name | Early follow-up visit after discharge | Name | Comprehensive geriatric assessment (CGA) | Name | Possible follow-up visit from GP |
Description | Continued specialized geriatric care after discharge | Description | Early follow-up visit and different degrees of specialized care after discharge | Description | Comprehensive geriatric assessment (CGA) during admission | Description | Usual care: follow up visit from GP within one week after discharge |
Keywords
Sequence: | 79888899 | Sequence: | 79888900 | Sequence: | 79888901 | Sequence: | 79888902 | Sequence: | 79888903 | Sequence: | 79888904 |
Name | Elderly | Name | Hospital at home | Name | Readmission | Name | Transitional care | Name | Frailty | Name | Patient Related Outcome Measures |
Downcase Name | elderly | Downcase Name | hospital at home | Downcase Name | readmission | Downcase Name | transitional care | Downcase Name | frailty | Downcase Name | patient related outcome measures |
Design Outcomes
Sequence: | 177432341 | Sequence: | 177432342 | Sequence: | 177432343 | Sequence: | 177432344 | Sequence: | 177432345 | Sequence: | 177432346 | Sequence: | 177432347 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Readmission | Measure | Mortality | Measure | Length of stay (LOS) | Measure | Physical functional status 30 days after discharge | Measure | Duration of readmission | Measure | Time at home before readmission | Measure | Number of patients discharged directly from the Emergency Department (ED) |
Time Frame | 30 days | Time Frame | 90 days after admission and 30 days after primary discharge | Time Frame | 30 days after primary discharge | Time Frame | 30 days after discharge | Time Frame | 30 days after discharge | Time Frame | 30 days after discharge | Time Frame | 30 days after discharge |
Description | Readmission within 30 days after discharge | Description | Mortality within 90 days after admission and 30 days after discharge | Description | Length of stay during primary admission and total length of stay including following readmissions | Description | Functional Recovery Score ADL and Functional Recovery Score I-ADL: sum-score, range 100-0 (100 is the highest physical functional status score possible, 0 is the lowest) | Description | Duration of readmission | Description | Time at home before readmission | Description | Patients discharged directly from the ED |
Browse Conditions
Sequence: | 193540503 | Sequence: | 193540504 |
Mesh Term | Frailty | Mesh Term | Pathologic Processes |
Downcase Mesh Term | frailty | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332411 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Aarhus |
Overall Officials
Sequence: | 29293044 |
Role | Study Chair |
Name | Else Marie S Damsgaard, Prof., DMSci |
Affiliation | University of Aarhus |
Design Group Interventions
Sequence: | 68168290 | Sequence: | 68168291 | Sequence: | 68168292 | Sequence: | 68168293 | Sequence: | 68168294 | Sequence: | 68168295 |
Design Group Id | 55609217 | Design Group Id | 55609218 | Design Group Id | 55609217 | Design Group Id | 55609218 | Design Group Id | 55609218 | Design Group Id | 55609219 |
Intervention Id | 52499519 | Intervention Id | 52499519 | Intervention Id | 52499520 | Intervention Id | 52499520 | Intervention Id | 52499521 | Intervention Id | 52499522 |
Eligibilities
Sequence: | 30773630 |
Gender | All |
Minimum Age | 75 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria
Aged 75 years or older Exclusion Criteria Included in any other kind of follow-up schemes |
Adult | False |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952971 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 32 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 75 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Number Of Other Outcomes To Measure | 4 |
Designs
Sequence: | 30519761 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | None (Open Label) |
Provided Documents
Sequence: | 2580807 |
Document Type | Study Protocol |
Has Protocol | True |
Has Icf | False |
Has Sap | False |
Document Date | 2019-02-08 |
Url | https://ClinicalTrials.gov/ProvidedDocs/23/NCT03796923/Prot_002.pdf |
Responsible Parties
Sequence: | 28886062 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52079073 |
Pmid | 34479071 |
Reference Type | derived |
Citation | Hansen TK, Pedersen LH, Shahla S, Damsgaard EM, Bruun JM, Gregersen M. Effects of a new early municipality-based versus a geriatric team-based transitional care intervention on readmission and mortality among frail older patients – a randomised controlled trial. Arch Gerontol Geriatr. 2021 Nov-Dec;97:104511. doi: 10.1016/j.archger.2021.104511. Epub 2021 Aug 26. |
]]>
https://zephyrnet.com/NCT03796910
2018-12-18
https://zephyrnet.com/?p=NCT03796910
NCT03796910https://www.clinicaltrials.gov/study/NCT03796910?tab=tableNANANAThe purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) following single and multiple ascending dose administration of SPR720 administered orally in healthy volunteers.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-10-28 |
Start Month Year | December 18, 2018 |
Primary Completion Month Year | September 24, 2019 |
Verification Month Year | October 2019 |
Verification Date | 2019-10-31 |
Last Update Posted Date | 2019-10-28 |
Detailed Descriptions
Sequence: | 20716319 |
Description | This is a single-center, phase I, randomized, double-blind, placebo-controlled, first-in-man study. Up to 120 healthy volunteers may be enrolled in this 2-part, multi-cohort study. In both Part 1 and Part 2, sequential cohorts will be exposed to increasing doses of SPR720. Each cohort will enrol 8 subjects, randomized (3:1) to receive SPR720 (6 subjects) or placebo (2 subjects). Each subject will be assigned to only one cohort.
In Part 1 single ascending dose (SAD): A single oral dose of SPR720 (n=6) or placebo (n=2) will be administered to 8 subjects at an initial dose level of 100 mg. Additional cohorts of 8 subjects will be enrolled to investigate increasing doses of SPR720 ranging from 250 mg to 3000 mg. All subjects will receive SPR720 (or placebo) by oral administration in the fasted state. One Part 1 cohort (the Food Effect Cohort) will receive an additional single dose of SPR720 (or placebo) in the fed state. Part 2 multiple ascending dose (MAD): SPR720 (or placebo) will be administered to approximately 3 planned dose cohorts of 8 subjects each. Subjects will receive SPR720 (or placebo) orally once daily for 7 (or 14) consecutive days starting with a planned initial dose of 500 mg. Additional cohorts of 8 subjects will be enrolled to investigate repeated daily doses of SPR720 ranging from 1000 mg to 1500 mg. For both Part 1 and Part 2, a Safety Monitoring Group (SMG) will review cumulative safety and PK data from each cohort before proceeding to the next cohort/dose level. Doses to be evaluated in each subsequent cohort may be modified by the SMG based on review of safety and PK data from preceding cohorts. Part 2 will run concurrent with Part 1 and will be initiated following SMG review of safety and PK data for the corresponding Part 1 dose level cohort. Part 1 will be conducted in up to 64 subjects (8 planned dose cohorts of 8 subjects each). Part 2 will be conducted in up to 24 subjects (3 planned dose cohorts of 8 subjects each); additional cohorts of 8 subjects each (up to 16 additional subjects) may be enrolled in either Part if further investigation of SPR720 is required. |
Facilities
Sequence: | 200053412 |
Name | Simbec Research, Ltd. |
City | Merthyr Tydfil, |
State | Mid Glamorgan |
Zip | CF48 4DR |
Country | United Kingdom |
Conditions
Sequence: | 52156557 |
Name | Healthy Volunteers |
Downcase Name | healthy volunteers |
Id Information
Sequence: | 40148248 |
Id Source | org_study_id |
Id Value | SPR720-101 |
Countries
Sequence: | 42557782 |
Name | United Kingdom |
Removed | False |
Design Groups
Sequence: | 55577952 | Sequence: | 55577953 | Sequence: | 55577954 | Sequence: | 55577955 |
Group Type | Experimental | Group Type | Placebo Comparator | Group Type | Experimental | Group Type | Placebo Comparator |
Title | SPR720 for SAD | Title | Placebo for SAD | Title | SPR720 for MAD | Title | Placebo for MAD |
Description | 6 out of 8 subjects per cohort will be randomized to receive SPR720 | Description | 2 out of 8 subjects per cohort will be randomized to receive placebo | Description | 6 out of 8 subjects per cohort will be randomized to receive SPR720 | Description | 2 out of 8 subjects per cohort will be randomized to receive placebo |
Interventions
Sequence: | 52472054 | Sequence: | 52472055 | Sequence: | 52472056 | Sequence: | 52472057 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | SPR720 for SAD | Name | Placebo for SAD | Name | SPR720 for MAD | Name | Placebo for MAD |
Description | Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 8 dose ascending cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered as a single dose. | Description | Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 8 dose ascending cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally as a single dose. | Description | Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 3 cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally for a total of 7 (or 14) days of dosing. | Description | Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 3 cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally for a total of 7 (or 14) days of dosing |
Keywords
Sequence: | 79848177 | Sequence: | 79848178 | Sequence: | 79848179 | Sequence: | 79848180 |
Name | safety | Name | tolerability | Name | pharmacokinetics | Name | SPR720 |
Downcase Name | safety | Downcase Name | tolerability | Downcase Name | pharmacokinetics | Downcase Name | spr720 |
Design Outcomes
Sequence: | 177328214 | Sequence: | 177328215 | Sequence: | 177328216 | Sequence: | 177328217 | Sequence: | 177328218 | Sequence: | 177328219 | Sequence: | 177328220 | Sequence: | 177328221 | Sequence: | 177328222 | Sequence: | 177328223 | Sequence: | 177328224 | Sequence: | 177328225 | Sequence: | 177328226 | Sequence: | 177328227 | Sequence: | 177328228 | Sequence: | 177328229 | Sequence: | 177328230 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Treatment emergent adverse events assessments after single and multiple dose administration at baseline and repeatedly until study completion [Safety and Tolerability] | Measure | Assessment of Pharmacokinetic Parameter (plasma): Cmax measurement | Measure | Assessment of Pharmacokinetic Parameter (plasma): CmaxSS measurement | Measure | Assessment of Pharmacokinetic Parameter (plasma): CminSS | Measure | Assessment of Pharmacokinetic Parameter (plasma): Ctrough | Measure | Assessment of Pharmacokinetic Parameter (plasma): CavSS | Measure | Assessment of Pharmacokinetic Parameter (plasma): Tmax | Measure | Assessment of Pharmacokinetic Parameter (plasma): kel | Measure | Assessment of Pharmacokinetic Parameter (plasma): t1/2 | Measure | Assessment of Pharmacokinetic Parameter (plasma): AUC0-24 | Measure | Assessment of Pharmacokinetic Parameter (plasma): AUC0-tau | Measure | Assessment of Parameter (plasma): AUC0-t | Measure | Assessment of Pharmacokinetic Parameter (plasma): AUC0-inf | Measure | Assessment of Parameter (plasma): AUC%extrapolated | Measure | Assessment of Pharmacokinetic Parameter (plasma): Degree of fluctuation | Measure | Assessment of Pharmacokinetic Parameter (plasma): Swing | Measure | Assessment of Pharmacokinetic Parameter (urine): SPR719 |
Time Frame | Day 1 through last follow-up visit (5-7 days after last dose) | Time Frame | From Day 1 pre-dose to 48 hours post last dose | Time Frame | From Day 1 pre-dose to 48 hours post last dose | Time Frame | From Day 1 pre-dose to 48 hours post last dose | Time Frame | From Day 1 pre-dose to 48 hours post last dose | Time Frame | From Day 1 pre-dose to 48 hours post last dose | Time Frame | From Day 1 pre-dose to 48 hours post last dose | Time Frame | From Day 1 pre-dose to 48 hours post last dose | Time Frame | From Day 1 pre-dose to 48 hours post last dose | Time Frame | From Day 1 pre-dose to 48 hours post last dose | Time Frame | From Day 1 pre-dose to 48 hours post last dose | Time Frame | From Day 1 pre-dose to 48 hours post last dose | Time Frame | From Day 1 pre-dose to 48 hours post last dose | Time Frame | From Day 1 pre-dose to 48 hours post last dose | Time Frame | From Day 1 pre-dose to 48 hours post last dose | Time Frame | From Day 1 pre-dose to 48 hours post last dose | Time Frame | From Day 1 pre-dose to 24 hours post last dose |
Description | Incidence and severity of AEs | Description | Maximum concentration of study drug in plasma | Description | Maximum concentration of study drug in plasma at steady state | Description | Lowest concentration of study drug in a dosing interval in plasma | Description | Concentration of study drug at the end of the dosing interval in plasma | Description | Average concentration of study drug in plasma during a dosing interval | Description | The time to maximum observed concentration of study drug in plasma | Description | Elimination rate constant of study drug in plasma | Description | Terminal elimination half-life of study drug in plasma | Description | Area under the concentration-time curve (AUC) of study drug in plasma from 0 to 24 hours post dose (dose escalation) | Description | Area under the concentration-time curve (AUC) from 0 to tau, where tau is the dosing interval (multiple dose only) of study drug in plasma | Description | Area under the concentration-time curve (AUC) of study drug in plasma from the time of dosing to the time of the last measurable concentration | Description | AUC extrapolated to infinity of study drug in plasma | Description | Residual area of study drug in plasma | Description | (Cmax-Cmin)/Cavss of study drug in plasma | Description | (Cmaxss-Cminss)/Cminss of study drug in plasma | Description | amount of SPR719 excreted in urine |
Sponsors
Sequence: | 48306138 | Sequence: | 48306139 |
Agency Class | INDUSTRY | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Spero Therapeutics | Name | Simbec Research |
Overall Officials
Sequence: | 29277958 |
Role | Principal Investigator |
Name | Annelize Koch, MBChB |
Affiliation | Simbec Research |
Design Group Interventions
Sequence: | 68130916 | Sequence: | 68130917 | Sequence: | 68130918 | Sequence: | 68130919 |
Design Group Id | 55577952 | Design Group Id | 55577953 | Design Group Id | 55577954 | Design Group Id | 55577955 |
Intervention Id | 52472054 | Intervention Id | 52472055 | Intervention Id | 52472056 | Intervention Id | 52472057 |
Eligibilities
Sequence: | 30757389 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | KEY INCLUSION CRITERIA:
Healthy adult male or female of non-childbearing potential,18 to 55 or ≥ 65 years of age (inclusive) at the time of screening; Medically healthy without clinically significant (CS) abnormalities as assessed by the Principal Investigator (or deputy) based on the following at screening assessments: a. Detailed medical history, complete physical examination, vital signs, 12-lead ECG, hematology, blood chemistry and urinalysis laboratory variables; Willing and able to provide written informed consent; KEY EXCLUSION CRITERIA: History or presence of any clinically significant disease state in any body system, as assessed by the Principal Investigator (or deputy), that may affect the outcome of the study or compromise the safety of the subject; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254228374 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 9 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 16 |
Designs
Sequence: | 30503614 |
Allocation | Randomized |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Masking Description | Subjects will be randomized in a 3:1 ratio to receive SPR720 or placebo. The randomization code will produced by Simbec using the PROC PLAN procedure of SAS® version 9.3 or higher. The randomization code will include 2 dose-leaders (1 active:1 placebo) in each cohort who will be randomized prior to the remainder of the cohort. The allocation to SPR720 or placebo will be performed using a block randomization algorithm. |
Intervention Model Description | Randomized, double-blind, placebo-controlled, single and multiple ascending dose (SAD and MAD) trial |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26665936 | Sequence: | 26665937 | Sequence: | 26665938 | Sequence: | 26665939 |
Intervention Id | 52472054 | Intervention Id | 52472055 | Intervention Id | 52472056 | Intervention Id | 52472057 |
Name | SPR720 Oral Capsule | Name | Placebo oral Capsule | Name | SPR720 Oral Capsule | Name | Placebo Oral Capsule |
Responsible Parties
Sequence: | 28869892 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52049431 |
Pmid | 34491803 |
Reference Type | derived |
Citation | Talley AK, Thurston A, Moore G, Gupta VK, Satterfield M, Manyak E, Stokes S, Dane A, Melnick D. First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of SPR720, a Novel Oral Bacterial DNA Gyrase (GyrB) Inhibitor for Mycobacterial Infections. Antimicrob Agents Chemother. 2021 Oct 18;65(11):e0120821. doi: 10.1128/AAC.01208-21. Epub 2021 Sep 7. |
]]>
https://zephyrnet.com/NCT03796897
2019-06-01
https://zephyrnet.com/?p=NCT03796897
NCT03796897https://www.clinicaltrials.gov/study/NCT03796897?tab=tableDaniel A Traylor, PhDtraylord@mcmaster.caNAIt is well known that dietary protein transiently stimulates muscle protein synthesis (MPS) whereby changes in MPS in response to feeding may be regulated by specific downstream target proteins of mammalian target of rapamycin signaling, such as S6K1, rpS6, and eIF2B. A meal deficient in protein, however, does not increase the rate of MPS because a rise in the bioavailability of amino acids does not occur. In addition, the source of dietary proteins has been shown to impact postprandial blood levels of amino acids. The concept that certain types of proteins are “fast acting” or “slow acting” has been shown to affect the postprandial profile of amino acids appearing in the systemic circulation. Native whey and micellar casein are both dairy proteins that contain a similar amount of essential (EAA), but blood EAA levels increase faster and to a higher level after the consumption of whey protein. Differences in gastric emptying, digestion and absorption kinetics between micellar casein and native whey are the underlying factors. Nonetheless, micellar casein protein has been shown to protract MPS in humans. Despite the significant amount of information gained with respect to both of these protein sources, the effects of combinatorial formulations on the postprandial profile of amino acids appearing in the blood is less well known.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-02-07 |
Start Month Year | June 1, 2019 |
Primary Completion Month Year | December 2020 |
Verification Month Year | February 2020 |
Verification Date | 2020-02-29 |
Last Update Posted Date | 2020-02-07 |
Detailed Descriptions
Sequence: | 20735701 |
Description | In a cross-over, randomized controlled trial, 10 healthy young participants (5 men and 5 women) will be recruited to undergo exercise resistance training randomized to habitual diet or habitual diet and supplementation (2 x per training session). For two of the training sessions the investigators will utilize a uni-lateral resistance exercise model to identify the acute effects of exercise and exercise + supplementation on the integrated rate of myofibrillar MPS within subject. This model enhances statistical power and eliminates between-subject differences impacting our outcomes. Throughout the study participants will record their macronutrient dietary intake. In addition, baseline body composition will be assessed with dual-energy x-ray absorptiometry.
Visit 1 (Day -7): Familiarization, strength testing and baseline body composition One week before the exercise trial, the investigators will ask participants to visit McMaster University to undergo a familiarization session with the exercise equipment and to perform 3-5 repetition maximum strength testing. This will allow the investigators to calculate the resistance (weight) participants will lift in their upcoming training sessions. The investigators will also perform a body composition scan using a dual-energy x-ray absorptiometry (DXA), assess participants' height and weight, and administer daily food logs with instructions to assess their habitual diet. Visit 2 (Day 0): D2O administration and resting blood and saliva sampling One week after the familiarization visit, the investigators will ask participants to come to McMaster University in a fasted state and receive a dose of doubly labelled water D2O equal to 0.8mLs/kgBW and every hour for 3 hours after providing a blood and saliva sample. D2O is a safe, and widely used stable isotope, used to effectively measure the rate at which participants' muscle grow. Visits 3 and 7 (Days 1 and 7): Resistance training program and muscle biopsy On these days participants will come to the lab in the morning following their habitual diet routine and will have a resting biopsy, blood and saliva samples taken. Next, participants may be asked to consume the supplement but will be asked to drink a small amount of D2O. Finally, participants will perform a combination resistance style exercise training session and immediately following training may be asked to consume the supplement. Visit 4, 5, 8 & 9 (Days 2, 3, 8, 9): Resistance training program On these days participants will come to the lab in the morning following their habitual diet routine and have a saliva sample taken. Next, participants may be asked to consume the supplement but will be asked to drink a small amount of D2O. Finally, participants will perform a combination resistance style exercise training session and immediately following training participants may be asked to consume the supplement. Visits 6 and 10 (Days 4 and 10): Uni-lateral acute training session and muscle biopsy On these days participants will come to the lab in the morning following their habitual diet routine. First, participants may be asked to consume the supplement immediately before performing a uni-lateral acute resistance training session. Participants will be asked to drink a small amount of D2O but only during Visit 6 (Day 4). Immediately following training, participants may be asked to consume the supplement. One hour following exercise participants will have a muscle biopsy, blood and saliva samples taken. Days 5 and 6 (see attached study timeline): Washout period The investigators will ask that participants drink one aliquot of D2O on day 5 and one aliquot of D2O on day 6. One hour after participants drink the aliquot of D2O the investigators ask that participants take their own saliva sample at home (D2O aliquots and a sampling kit will be provided with instructions). |
Facilities
Sequence: | 200243910 |
Status | Recruiting |
Name | Exercise Metabolism Research Laboratory, McMaster Univeristy |
City | Hamilton |
State | Ontario |
Zip | L8S 4K1 |
Country | Canada |
Facility Contacts
Sequence: | 28127889 |
Facility Id | 200243910 |
Contact Type | primary |
Name | Stuart M Phillips, Ph.D. |
phillis@mcmaster.ca | |
Phone | 905-525-9140 |
Phone Extension | 24465 |
Facility Investigators
Sequence: | 18343517 |
Facility Id | 200243910 |
Role | Principal Investigator |
Name | Stuart M Phillips, Ph.D. |
Conditions
Sequence: | 52207881 | Sequence: | 52207882 |
Name | Dietary Modification | Name | Diet Habit |
Downcase Name | dietary modification | Downcase Name | diet habit |
Id Information
Sequence: | 40186024 |
Id Source | org_study_id |
Id Value | 5706 |
Countries
Sequence: | 42599529 |
Name | Canada |
Removed | False |
Design Groups
Sequence: | 55634478 | Sequence: | 55634479 |
Group Type | Experimental | Group Type | Sham Comparator |
Title | Leucine-enriched protein + exercise | Title | Habitual diet + exercise |
Description | whey protein- hydrolyzed whey protein-micellar casein blend (50:43:7 whey:hydrolyzed-whey:casein), vitamin D, and free leucine | Description | habitual diet only |
Interventions
Sequence: | 52521894 | Sequence: | 52521895 |
Intervention Type | Dietary Supplement | Intervention Type | Behavioral |
Name | Leucine-enriched protein | Name | Habitual diet only |
Description | Supplement contains 16g of protein given twice per exercise session (4 total exercise sessions) | Description | Habitual diet only (no supplementation) for 4 exercise sessions |
Design Outcomes
Sequence: | 177510565 |
Outcome Type | primary |
Measure | Integrated Muscle Protein Synthetic Rate |
Time Frame | 10 days |
Description | oral deuterium consumption: Isotope protocol (See ref., PMID 23821570) |
Sponsors
Sequence: | 48353529 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | McMaster University |
Central Contacts
Sequence: | 12017152 | Sequence: | 12017153 |
Contact Type | primary | Contact Type | backup |
Name | Stuart M Phillips, PhD | Name | Daniel A Traylor, PhD |
Phone | 905-525-9140 | ||
phillis@mcmaster.ca | traylord@mcmaster.ca | ||
Phone Extension | 24465 | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68198963 | Sequence: | 68198964 |
Design Group Id | 55634478 | Design Group Id | 55634479 |
Intervention Id | 52521894 | Intervention Id | 52521895 |
Eligibilities
Sequence: | 30786766 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 29 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Be between the ages of 18-29 years (inclusive) Exclusion Criteria: Smoker |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253989424 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 29 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30532837 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28899130 |
Responsible Party Type | Principal Investigator |
Name | Stuart Phillips |
Title | Professor |
Affiliation | McMaster University |
Study References
Sequence: | 52102848 | Sequence: | 52102849 | Sequence: | 52102850 | Sequence: | 52102851 | Sequence: | 52102852 | Sequence: | 52102853 | Sequence: | 52102854 | Sequence: | 52102855 | Sequence: | 52102856 |
Pmid | 19474134 | Pmid | 19625697 | Pmid | 19056590 | Pmid | 16507602 | Pmid | 25790724 | Pmid | 15570142 | Pmid | 9405716 | Pmid | 23821570 | Pmid | 36126327 |
Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | derived |
Citation | Koopman R, Crombach N, Gijsen AP, Walrand S, Fauquant J, Kies AK, Lemosquet S, Saris WH, Boirie Y, van Loon LJ. Ingestion of a protein hydrolysate is accompanied by an accelerated in vivo digestion and absorption rate when compared with its intact protein. Am J Clin Nutr. 2009 Jul;90(1):106-15. doi: 10.3945/ajcn.2009.27474. Epub 2009 May 27. | Citation | Koopman R, Walrand S, Beelen M, Gijsen AP, Kies AK, Boirie Y, Saris WH, van Loon LJ. Dietary protein digestion and absorption rates and the subsequent postprandial muscle protein synthetic response do not differ between young and elderly men. J Nutr. 2009 Sep;139(9):1707-13. doi: 10.3945/jn.109.109173. Epub 2009 Jul 22. | Citation | Moore DR, Robinson MJ, Fry JL, Tang JE, Glover EI, Wilkinson SB, Prior T, Tarnopolsky MA, Phillips SM. Ingested protein dose response of muscle and albumin protein synthesis after resistance exercise in young men. Am J Clin Nutr. 2009 Jan;89(1):161-8. doi: 10.3945/ajcn.2008.26401. Epub 2008 Dec 3. | Citation | Katsanos CS, Kobayashi H, Sheffield-Moore M, Aarsland A, Wolfe RR. A high proportion of leucine is required for optimal stimulation of the rate of muscle protein synthesis by essential amino acids in the elderly. Am J Physiol Endocrinol Metab. 2006 Aug;291(2):E381-7. doi: 10.1152/ajpendo.00488.2005. Epub 2006 Feb 28. | Citation | Luiking YC, Abrahamse E, Ludwig T, Boirie Y, Verlaan S. Protein type and caloric density of protein supplements modulate postprandial amino acid profile through changes in gastrointestinal behaviour: A randomized trial. Clin Nutr. 2016 Feb;35(1):48-58. doi: 10.1016/j.clnu.2015.02.013. Epub 2015 Mar 5. | Citation | Tipton KD, Elliott TA, Cree MG, Wolf SE, Sanford AP, Wolfe RR. Ingestion of casein and whey proteins result in muscle anabolism after resistance exercise. Med Sci Sports Exerc. 2004 Dec;36(12):2073-81. doi: 10.1249/01.mss.0000147582.99810.c5. | Citation | Boirie Y, Dangin M, Gachon P, Vasson MP, Maubois JL, Beaufrere B. Slow and fast dietary proteins differently modulate postprandial protein accretion. Proc Natl Acad Sci U S A. 1997 Dec 23;94(26):14930-5. doi: 10.1073/pnas.94.26.14930. | Citation | MacDonald AJ, Small AC, Greig CA, Husi H, Ross JA, Stephens NA, Fearon KC, Preston T. A novel oral tracer procedure for measurement of habitual myofibrillar protein synthesis. Rapid Commun Mass Spectrom. 2013 Aug 15;27(15):1769-77. doi: 10.1002/rcm.6622. | Citation | Lim C, Traylor DA, McGlory C, Joanisse S, McKendry J, Grewal T, Mcleod JC, Prior T, Nunes EA, Lees M, Phillips SM. Increased protein intake derived from leucine-enriched protein enhances the integrated myofibrillar protein synthetic response to short-term resistance training in untrained men and women: a 4-day randomized controlled trial. Appl Physiol Nutr Metab. 2022 Nov 1;47(11):1104-1114. doi: 10.1139/apnm-2022-0164. Epub 2022 Sep 20. |
]]>
https://zephyrnet.com/NCT03796884
2019-10-30
https://zephyrnet.com/?p=NCT03796884
NCT03796884https://www.clinicaltrials.gov/study/NCT03796884?tab=tableNANANAThis phase II trial studies the how well linaclotide works in treating patients with stages 0-3 colorectal cancer. Linaclotide is a very small protein that binds to receptors on intestinal cells and makes them secrete water and salt.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-03-22 |
Start Month Year | October 30, 2019 |
Primary Completion Month Year | October 2023 |
Verification Month Year | March 2023 |
Verification Date | 2023-03-31 |
Last Update Posted Date | 2023-03-22 |
Detailed Descriptions
Sequence: | 20657687 |
Description | PRIMARY OBJECTIVES:
I. To determine whether, compared to placebo, linaclotide administered as a single oral daily dose x 7 days, induces a pharmacodynamics (PD) effect on cGMP levels, based on biopsy samples of adenomas or resected colorectal adenocarcinomas. SECONDARY OBJECTIVES: I. To compare Ki-67, guanylin levels and GUCY2C expression in adenomas and cancers versus normal tissue after exposure to linaclotide or placebo. II. To confirm the safety and tolerability of linaclotide in sporadic adenoma and cancer patients. TRANSLATIONAL OBJECTIVE: I. To assess the pharmacodynamic effect of linaclotide on pathway-specific biomarkers relevant to GUCY2C signaling (i.e. VASP phosphorylation), markers of mutant APC-beta-catenin signaling (beta-catenin levels, beta-catenin nuclear localization, axin levels, c-Myc levels, guanylin levels, PCNA expression), based on adenoma/cancer and normal mucosa biopsy samples obtained by endoscopy following linaclotide or placebo exposure. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive linaclotide orally (PO) daily on days 1-7 and undergo standard of care colonoscopy or surgery on day 7. ARM II. Patients receive placebo PO QD on days 1-7 and undergo standard of care colonoscopy or surgery on day 7. After completion of study treatment, patients are followed up at day 14. |
Facilities
Sequence: | 199396417 | Sequence: | 199396418 | Sequence: | 199396419 |
Name | Fox Chase Cancer Center | Name | Sidney Kimmel Cancer Center at Thomas Jefferson University | Name | VA Puget Sound Health Care Sysem |
City | Philadelphia | City | Philadelphia | City | Seattle |
State | Pennsylvania | State | Pennsylvania | State | Washington |
Zip | 19111 | Zip | 19126 | Zip | 98108 |
Country | United States | Country | United States | Country | United States |
Browse Interventions
Sequence: | 95728819 | Sequence: | 95728820 | Sequence: | 95728821 | Sequence: | 95728822 | Sequence: | 95728823 |
Mesh Term | Linaclotide | Mesh Term | Guanylyl Cyclase C Agonists | Mesh Term | Enzyme Activators | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Gastrointestinal Agents |
Downcase Mesh Term | linaclotide | Downcase Mesh Term | guanylyl cyclase c agonists | Downcase Mesh Term | enzyme activators | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | gastrointestinal agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52004720 | Sequence: | 52004721 | Sequence: | 52004722 | Sequence: | 52004723 | Sequence: | 52004724 | Sequence: | 52004725 | Sequence: | 52004726 | Sequence: | 52004727 | Sequence: | 52004728 | Sequence: | 52004729 | Sequence: | 52004730 |
Name | Colorectal Adenoma | Name | Stage 0 Colorectal Cancer AJCC v8 | Name | Stage I Colorectal Cancer AJCC v8 | Name | Stage II Colorectal Cancer AJCC v8 | Name | Stage IIA Colorectal Cancer AJCC v8 | Name | Stage IIB Colorectal Cancer AJCC v8 | Name | Stage IIC Colorectal Cancer AJCC v8 | Name | Stage III Colorectal Cancer AJCC v8 | Name | Stage IIIA Colorectal Cancer AJCC v8 | Name | Stage IIIB Colorectal Cancer AJCC v8 | Name | Stage IIIC Colorectal Cancer AJCC v8 |
Downcase Name | colorectal adenoma | Downcase Name | stage 0 colorectal cancer ajcc v8 | Downcase Name | stage i colorectal cancer ajcc v8 | Downcase Name | stage ii colorectal cancer ajcc v8 | Downcase Name | stage iia colorectal cancer ajcc v8 | Downcase Name | stage iib colorectal cancer ajcc v8 | Downcase Name | stage iic colorectal cancer ajcc v8 | Downcase Name | stage iii colorectal cancer ajcc v8 | Downcase Name | stage iiia colorectal cancer ajcc v8 | Downcase Name | stage iiib colorectal cancer ajcc v8 | Downcase Name | stage iiic colorectal cancer ajcc v8 |
Id Information
Sequence: | 40028736 |
Id Source | org_study_id |
Id Value | 18F.524 |
Countries
Sequence: | 42424204 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55409935 | Sequence: | 55409936 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Arm I (linaclotide) | Title | Arm II (placebo) |
Description | Patients receive linaclotide PO daily on days 1-7 and undergo standard of care colonoscopy or surgery on day 7. | Description | Patients receive placebo PO QD on days 1-7 and undergo standard of care colonoscopy or surgery on day 7. |
Interventions
Sequence: | 52317359 | Sequence: | 52317360 |
Intervention Type | Drug | Intervention Type | Other |
Name | Linaclotide | Name | Placebo |
Description | Given PO | Description | Given PO |
Design Outcomes
Sequence: | 176796960 | Sequence: | 176796961 | Sequence: | 176796962 | Sequence: | 176796963 | Sequence: | 176796964 | Sequence: | 176796965 | Sequence: | 176796966 | Sequence: | 176796967 | Sequence: | 176796968 | Sequence: | 176796969 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Pharmacodynamics effect on cGMP levels | Measure | Incidence of adverse events (AEs) | Measure | Ki-67 expression | Measure | GUCY2C expression | Measure | Guanylin levels | Measure | VASP serine 239 phosphorylation | Measure | Beta-catenin levels | Measure | Beta-catenin nuclear localization | Measure | Axin and c-Myc messenger ribonucleic acid (mRNA) levels | Measure | PCNA expression |
Time Frame | Up to 2 years | Time Frame | From the time of first dose of linaclotide or placebo until resolution, if related to linaclotide, or through 30 days after occurrence | Time Frame | Up to 2 years | Time Frame | Up to 2 years | Time Frame | Up to 2 years | Time Frame | Up to 2 years | Time Frame | Up to 2 years | Time Frame | Up to 2 years | Time Frame | Up to 2 years | Time Frame | Up to 2 years |
Description | Will compare cGMP levels in adenomas between study arms using a two-sample t-test (alpha=.05; two-sided) or Wilcoxon rank sum test. | Description | All participants will be evaluated for toxicity. Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be used to summarize adverse events associated with linaclotide. | Description | Wilcoxon rank sum test will be used to compare Ki-67 expression in adenomas across arms. | Description | Wilcoxon rank sum and Fisher's exact tests will be used to compare GUCY2C expression between study arms. | Description | Wilcoxon rank sum and Fisher's exact tests will be used to compare guanylin levels between study arms. | Description | Assessed by immunoblot analysis. Wilcoxon rank sum and Fisher's exact tests will be used to compare VASP phosphorylation between study arms. | Description | Assessed by immunoblot analysis. Wilcoxon rank sum and Fisher's exact tests will be used to compare beta-catenin accumulation and downstream signaling between study arms. | Description | Assessed by immunofluorescence. Wilcoxon rank sum and Fisher's exact tests will be used to compare beta-catenin accumulation and downstream signaling between study arms | Description | Assessed by quantitative reverse transcriptase-polymerase chain reaction. Wilcoxon rank sum and Fisher's exact tests will be used to compare axin and c-Myc mRNA levels between study arms. | Description | Assessed by immunofluorescence. |
Browse Conditions
Sequence: | 192828166 | Sequence: | 192828167 | Sequence: | 192828168 | Sequence: | 192828169 | Sequence: | 192828170 | Sequence: | 192828171 | Sequence: | 192828172 | Sequence: | 192828173 | Sequence: | 192828174 | Sequence: | 192828175 | Sequence: | 192828176 | Sequence: | 192828177 | Sequence: | 192828178 | Sequence: | 192828179 |
Mesh Term | Colorectal Neoplasms | Mesh Term | Adenoma | Mesh Term | Intestinal Neoplasms | Mesh Term | Gastrointestinal Neoplasms | Mesh Term | Digestive System Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Digestive System Diseases | Mesh Term | Gastrointestinal Diseases | Mesh Term | Colonic Diseases | Mesh Term | Intestinal Diseases | Mesh Term | Rectal Diseases | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type |
Downcase Mesh Term | colorectal neoplasms | Downcase Mesh Term | adenoma | Downcase Mesh Term | intestinal neoplasms | Downcase Mesh Term | gastrointestinal neoplasms | Downcase Mesh Term | digestive system neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | colonic diseases | Downcase Mesh Term | intestinal diseases | Downcase Mesh Term | rectal diseases | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48163873 | Sequence: | 48163874 |
Agency Class | OTHER | Agency Class | FED |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Sidney Kimmel Cancer Center at Thomas Jefferson University | Name | United States Department of Defense |
Overall Officials
Sequence: | 29189972 |
Role | Principal Investigator |
Name | Scott Waldman, MD |
Affiliation | Sidney Kimmel Cancer Center at Thomas Jefferson University |
Design Group Interventions
Sequence: | 67926456 | Sequence: | 67926457 |
Design Group Id | 55409935 | Design Group Id | 55409936 |
Intervention Id | 52317359 | Intervention Id | 52317360 |
Eligibilities
Sequence: | 30667829 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 80 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
History of 1 or more sporadic colorectal adenoma on previous endoscopy (adenoma cohort) or stage 0-3 biopsy proven colorectal cancer (CRC) (colorectal cancer cohort) who are scheduled for a surgical procedure Exclusion Criteria: History of gastroparesis |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254292507 |
Number Of Facilities | 3 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Number Of Other Outcomes To Measure | 5 |
Designs
Sequence: | 30414615 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Investigator Masked | True |
Intervention Other Names
Sequence: | 26583450 | Sequence: | 26583451 | Sequence: | 26583452 | Sequence: | 26583453 | Sequence: | 26583454 | Sequence: | 26583455 | Sequence: | 26583456 |
Intervention Id | 52317359 | Intervention Id | 52317359 | Intervention Id | 52317359 | Intervention Id | 52317359 | Intervention Id | 52317359 | Intervention Id | 52317359 | Intervention Id | 52317359 |
Name | 851199-59-2 | Name | Linzess | Name | [9-L-tyrosine]heat-stable enterotoxin (Escherichia coli)-(6-19)-peptide | Name | L-Tyrosine | Name | L-cysteinyl-L-cysteinyl-L-alpha-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L- asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonylglycyl-L-cysteiny | Name | cyclic (1->6), (2->10), (5->13)-tris(disulfide) | Name | MD-1100 |
Links
Sequence: | 4373240 | Sequence: | 4373241 |
Url | http://www.kimmelcancercenter.org/cancer-center.html | Url | http://hospitals.jefferson.edu/ |
Description | Sidney Kimmel Cancer Center at Thomas Jefferson University | Description | Thomas Jefferson University Hospital |
Responsible Parties
Sequence: | 28781136 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796871
2019-06-19
https://zephyrnet.com/?p=NCT03796871
NCT03796871https://www.clinicaltrials.gov/study/NCT03796871?tab=tableNicolas MEYER, MDnicolas.meyer@chru-strasbourg.fr3 88 11 63 32Skin cancers represent a real public health issue. The diagnosis of pre-cancerous lesions thus is a priority. The diagnosis gold standard is based on the combination of clinical and histopathological examinations. Nevertheless, the clinical examination is not sufficiently effective, meaning that a biopsy has to be done for each suspected lesion. In order to avoid unnecessary biopsy excisions, a new medical device (DERMAPOL) was designed to help dermatologists in diagnosing skin lesions.
This medical device combined with its software is a strong and ergonomic spectro-polarimetric imager instrument. It can realize images of the superficial cutaneous tissues and subcutaneous tissues close to the surface by exploiting polarized light properties.
This first clinical trial aims to demonstrate that this medical device is able to segment effectively healthy and tumor tissues and that it can correlate main semiological elements (identified thanks to the clinical and histopathological examinations) to the physico-optical characteristics obtained on the images of the medical device.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-06 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-08-19 |
Start Month Year | June 19, 2019 |
Primary Completion Month Year | January 14, 2024 |
Verification Month Year | August 2022 |
Verification Date | 2022-08-31 |
Last Update Posted Date | 2022-08-19 |
Facilities
Sequence: | 201197505 |
Status | Recruiting |
Name | Hôpitaux Universitaires de Strasbourg |
City | Strasbourg |
Zip | 67091 |
Country | France |
Facility Contacts
Sequence: | 28267436 |
Facility Id | 201197505 |
Contact Type | primary |
Name | Bernard Cribier, MD |
bernard.cribier@chru-strasbourg.fr | |
Phone | 88 11 61 80 |
Phone Extension | +33 |
Conditions
Sequence: | 52477667 |
Name | Skin Lesion |
Downcase Name | skin lesion |
Id Information
Sequence: | 40378147 |
Id Source | org_study_id |
Id Value | 6798 |
Countries
Sequence: | 42813907 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55933592 |
Group Type | Experimental |
Title | Dermapol |
Description | Use of the experimental medical device |
Interventions
Sequence: | 52787602 |
Intervention Type | Device |
Name | Dermapol |
Description | Use of the experimental medical device before lesion excision : skin lesion lighting (4 wavelengths) for less than 1 minute and image recording |
Design Outcomes
Sequence: | 178528007 | Sequence: | 178528008 | Sequence: | 178528009 | Sequence: | 178528010 | Sequence: | 178528011 | Sequence: | 178528012 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Proportion of lesions with semiological characteristics | Measure | Physico-optical description of the lesions | Measure | Number of different semiological characteristics | Measure | Proportion of semiological characteristics properly identified | Measure | Specificity, sensitivity and predictive values | Measure | Cases proportion for which the same semiological characteristics list was found between the medical device and the combination of clinical and histopathological diagnosis |
Time Frame | Before biopsy | Time Frame | Before biopsy | Time Frame | Before biopsy | Time Frame | Before biopsy | Time Frame | Before biopsy | Time Frame | Before biopsy |
Description | Proportion of lesions for which at least one semiological characteristic (detected by the combination of visual and histopathological examinations) was identified by the medical device thanks to physico-optical properties | Description | Physico-optical description of the cutaneous lesions by the medical device | Description | Number of different semiological characteristics visualized by the medical device and by the combination of clinical and histopathological examinations for each image processing | Description | Proportion of semiological characteristics properly identified by the medical device for all lesions | Description | Specificity, sensitivity, true positive rate, true negative rate, false positive rate, false negative rate of the medical device, for each semiological characteristic identified by the combination of the clinical and histopathological examinations | Description | Proportion of cases with same semiological characteristics list |
Sponsors
Sequence: | 48604136 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University Hospital, Strasbourg, France |
Overall Officials
Sequence: | 29446117 |
Role | Principal Investigator |
Name | Bernard CRIBIER, MD |
Affiliation | Hôpitaux Universitaires de Strasbourg |
Central Contacts
Sequence: | 12087287 |
Contact Type | primary |
Name | Nicolas MEYER, MD |
Phone | 3 88 11 63 32 |
nicolas.meyer@chru-strasbourg.fr | |
Phone Extension | +33 |
Role | Contact |
Design Group Interventions
Sequence: | 68569126 |
Design Group Id | 55933592 |
Intervention Id | 52787602 |
Eligibilities
Sequence: | 30941221 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
adult patient with a skin tumor (benign or cancerous) which has to be excised and analysed according to histopathological examination skin lesion belonging to one of these groups (diagnosed by clinical examination): cutaneous cyst Exclusion Criteria: skin lesion size strictly over than 5 cm |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254279392 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30686831 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Diagnostic |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29053568 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796858
2019-03-22
https://zephyrnet.com/?p=NCT03796858
NCT03796858https://www.clinicaltrials.gov/study/NCT03796858?tab=tableNANANAThe purpose of this study is to evaluate guselkumab efficacy versus placebo in participants with active psoriatic arthritis (PsA) and an inadequate response to Anti-Tumor Necrosis Factor Alpha (TNF-alpha) therapy by assessing the reduction in signs and symptoms of joint disease.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-12-10 |
Start Month Year | March 22, 2019 |
Primary Completion Month Year | November 11, 2020 |
Verification Month Year | November 2021 |
Verification Date | 2021-11-30 |
Last Update Posted Date | 2021-12-10 |
Detailed Descriptions
Sequence: | 20734667 |
Description | Psoriatic arthritis is a multi-faceted disease that impacts the joints, soft tissues, and skin, all of which not only results in functional disability and impaired quality of life, but participants with this disease also have increased mortality. Guselkumab is a monoclonal antibody that binds to human interleukin 23 (IL-23) and inhibits IL-23 specific intracellular signaling and subsequent activation and cytokine production. Investigation of guselkumab in this Phase 3b PsA clinical study is supported by the favorable efficacy and safety results from Phase 2 study of guselkumab in PsA and Phase 2 and Phase 3 studies in psoriasis including the subset of participants with PsA. The primary hypothesis is that guselkumab 100 milligram (mg) at Weeks 0, 4, and every 8 weeks (q8w) thereafter is superior to placebo which will be assessed by the proportion of participants achieving an American College of Rheumatology (ACR 20) response at Week 24. The study includes 2 periods: A 24-week double-blind, placebo-controlled period for the primary analysis of the efficacy and safety of guselkumab, compared with placebo and a 32-week active-treatment and safety follow-up period for additional analysis of the efficacy and safety of guselkumab. Safety will be monitored throughout the study (Up to Week 56). |
Facilities
Sequence: | 200237472 | Sequence: | 200237473 | Sequence: | 200237474 | Sequence: | 200237475 | Sequence: | 200237476 | Sequence: | 200237477 | Sequence: | 200237478 | Sequence: | 200237479 | Sequence: | 200237480 | Sequence: | 200237481 | Sequence: | 200237482 | Sequence: | 200237483 | Sequence: | 200237484 | Sequence: | 200237485 | Sequence: | 200237486 | Sequence: | 200237487 | Sequence: | 200237488 | Sequence: | 200237489 | Sequence: | 200237490 | Sequence: | 200237491 | Sequence: | 200237492 | Sequence: | 200237493 | Sequence: | 200237494 | Sequence: | 200237495 | Sequence: | 200237496 | Sequence: | 200237497 | Sequence: | 200237498 | Sequence: | 200237499 | Sequence: | 200237500 | Sequence: | 200237501 | Sequence: | 200237502 | Sequence: | 200237503 | Sequence: | 200237504 | Sequence: | 200237505 | Sequence: | 200237506 | Sequence: | 200237507 | Sequence: | 200237508 | Sequence: | 200237509 | Sequence: | 200237510 | Sequence: | 200237511 | Sequence: | 200237512 | Sequence: | 200237513 | Sequence: | 200237514 | Sequence: | 200237515 | Sequence: | 200237516 | Sequence: | 200237517 | Sequence: | 200237518 | Sequence: | 200237519 | Sequence: | 200237520 | Sequence: | 200237521 | Sequence: | 200237522 | Sequence: | 200237523 | Sequence: | 200237524 | Sequence: | 200237525 | Sequence: | 200237526 | Sequence: | 200237527 | Sequence: | 200237528 | Sequence: | 200237529 | Sequence: | 200237530 | Sequence: | 200237531 | Sequence: | 200237532 | Sequence: | 200237533 | Sequence: | 200237534 | Sequence: | 200237535 | Sequence: | 200237536 | Sequence: | 200237537 | Sequence: | 200237538 | Sequence: | 200237539 | Sequence: | 200237540 | Sequence: | 200237541 | Sequence: | 200237542 | Sequence: | 200237543 | Sequence: | 200237544 | Sequence: | 200237545 | Sequence: | 200237546 | Sequence: | 200237547 | Sequence: | 200237548 | Sequence: | 200237549 | Sequence: | 200237550 | Sequence: | 200237551 | Sequence: | 200237552 | Sequence: | 200237553 | Sequence: | 200237554 | Sequence: | 200237555 | Sequence: | 200237556 | Sequence: | 200237557 | Sequence: | 200237558 | Sequence: | 200237559 | Sequence: | 200237560 | Sequence: | 200237561 | Sequence: | 200237562 | Sequence: | 200237563 | Sequence: | 200237564 | Sequence: | 200237565 | Sequence: | 200237566 | Sequence: | 200237567 | Sequence: | 200237568 | Sequence: | 200237569 | Sequence: | 200237570 | Sequence: | 200237571 | Sequence: | 200237572 | Sequence: | 200237573 | Sequence: | 200237574 | Sequence: | 200237575 | Sequence: | 200237576 | Sequence: | 200237577 | Sequence: | 200237578 | Sequence: | 200237579 | Sequence: | 200237580 | Sequence: | 200237581 | Sequence: | 200237582 | Sequence: | 200237583 | Sequence: | 200237584 | Sequence: | 200237585 | Sequence: | 200237586 | Sequence: | 200237587 | Sequence: | 200237588 |
Name | CHU Saint Pierre BXL | Name | Reuma Clinic | Name | Universitair Ziekenhuis Gent | Name | UZ Leuven | Name | Diagnostic – Consulting Center II-Pleven | Name | Medical Center Medconsult-Pleven | Name | Multiprofile Hospital for Active Treatment – Plovdiv | Name | Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv | Name | Medical Center 'Teodora' | Name | Diagnostic Consulting Center No 17 | Name | Military Medical Academy | Name | Hopital Pellegrin Tripode – CHU de Bordeaux | Name | CHU Lapeyronie | Name | Centre Hospitalier Regional d'Orleans (CHRO) – Hopital La Source | Name | Hopital Lariboisiere | Name | Hôpital Pitié-Salpétrière | Name | Hopital Cochin | Name | Centre Hospitalier Universitaire de Toulouse – Hopital Purpan | Name | CHU Trousseau – Service de Rhumatologie | Name | Universitätsklinikum Düsseldorf | Name | Hamburger Rheuma Forschungszentrum II | Name | Medizinische Hochschule Hannover | Name | Rheumazentrum Ruhrgebiet | Name | Rheumatologische Schwerpunktpraxis | Name | Krankenhaus St. Josef | Name | 424 Military Hospital of Thessaloniki | Name | Betegapolo Irgalmas Rend – Budai Irgalmasrendi Korhaz | Name | Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz | Name | Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz | Name | MAV Korhaz es Rendelointezet | Name | Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz | Name | Vital Medical Center Orvosi es Fogaszati Kozpont | Name | Barzilai Medical Center | Name | Bnai Zion Medical Center | Name | Carmel Medical Center | Name | Hadassah Medical Center | Name | Sheba Medical Center | Name | Tel Aviv Sourasky Medical Center | Name | Azienda Ospedaliera Universitaria Federico II | Name | Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone | Name | Policlinico Tor Vergata | Name | Complesso Integrato Columbus | Name | Humanitas Hospital | Name | Szpital Uniwersytecki Nr 2 w Bydgoszczy | Name | Centrum Kliniczno Badawcze | Name | Centrum Terapii Wspolczesnej J. M. Jasnorzewska J. M. Jasnorzewska Spolka Komandytowo-Akcyjna | Name | Dermed Centrum Medyczne Sp. z o.o | Name | NZOZ Lecznica MAK-MED. S.C. | Name | Medycyna Kliniczna | Name | Mazowieckie Centrum Reumatologii i Osteoporozy | Name | WroMedica I.Bielicka, A.Strzałkowska s.c. | Name | Hosp. Garcia de Orta | Name | Chbv – Hosp. Infante D. Pedro | Name | Ccab – Hosp. de Braga | Name | Ipr – Inst. Port. de Reumatologia | Name | Chlo – Hosp. Egas Moniz | Name | Chln – Hosp. Santa Maria | Name | Ulsam – Hosp. Conde de Bertiandos | Name | Chelyabinck Regional Clinical Hospital | Name | Kemerovo State Medical University | Name | Medical Centre Maximum Health | Name | Family polyclinic #4 | Name | Krasnodar Clinical Dermatovenerologic Dispensary | Name | Krasnoyarsk State Medical University | Name | Orenburg State Medical Academy | Name | Rostov Regional Clinical Dermatovenerological Dispensary | Name | Ryazan Regional Clinical Dermatovenerological Dispensary | Name | Samara Regional Clinical Hospital Named After V.D.Seredavin | Name | Sararov Regional Clinical Hospital | Name | Smolensk regional hospital on Smolensk railway station | Name | Leningrad region clinical hospital | Name | Tula Regional Clinical Dermatovenerological Dispensary | Name | Republican Clinical Hospital – G.G. Kuvatov | Name | Ulyanovsk Regional Clinical Hospital | Name | Regional Clinical Hospital | Name | Clinical Emergency Hospital n.a. N.V. Solovyev | Name | Clinical Hospital #3 | Name | Hosp. Univ. A Coruña | Name | Hosp. Univ. de Cruces | Name | Hosp. Univ. Germans Trias I Pujol | Name | Hosp. Univ. de Basurto | Name | Hosp. Reina Sofia | Name | Hosp. Univ. Ramon Y Cajal | Name | Hosp. Univ. 12 de Octubre | Name | Hosp. Univ. de Getafe | Name | Hosp. Regional Univ. de Malaga | Name | Hosp. Clinico Univ. de Santiago | Name | Hosp. Virgen Macarena | Name | Hosp. Infanta Luisa | Name | Hosp. Virgen Del Rocio | Name | Hosp. Ntra. Sra. de Valme | Name | Hosp. Do Meixoeiro | Name | Communal Noncommercial Enterprise 'Cherkasy Regional Hospital of Cherkasy Regional Council' | Name | Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital | Name | City Multifield Hospital #18, Mechnikov Institute of Microbiology and Immunology of NAMS | Name | Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital | Name | Khmelnitckiy regional hospital | Name | Kyiv City Clinical Hospital #3, National Medical University | Name | Medical Center 'Consylium Medical' | Name | Kyiv Railway Station Clinical Hospital #2 | Name | SI 'National Scientific Center Institute of Cardiology of M.D. Strazhesko' of NAMS of Ukraine | Name | ME 'Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil' | Name | Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital | Name | Municipal Non-commercial Enterprise 'Ternopil University Hospital' of Ternopil Regional Council | Name | Medical Center LTD Health Clinic Department of Cardiology and Rheumatology | Name | VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council | Name | Municipal institution Central Clinical Hospital #1 Zhytomir | Name | Royal National Hospital for Rheumatic Diseases | Name | Cambridge University Hospitals NHS Foundation Trust | Name | Cannock Chase Hospital | Name | Chapel Allerton Hospital | Name | Barts Health NHS Trust Whipps Cross University Hospital NHS Trust | Name | Guy's and St Thomas' NHS Foundation Trust – Rheumatoid Arthritis (RA) Clinic | Name | North Tyneside General Hospital | Name | Peterborough City Hospital | Name | Haywood Hospital | Name | Torbay Hospital-Devon |
City | Brussels | City | Genk | City | Gent | City | Leuven | City | Pleven | City | Pleven | City | Plovdiv | City | Plovdiv | City | Ruse | City | Sofia | City | Sofia | City | Bordeaux | City | Montpellier, Herault | City | Orleans | City | Paris | City | Paris | City | Paris | City | Toulouse | City | Tours | City | Dusseldorf | City | Hamburg | City | Hannover | City | Herne | City | Rendsburg | City | Wuppertal | City | Thessaloniki | City | Budapest | City | Gyula | City | Nyiregyhaza | City | Szolnok | City | Székesfehérvár | City | Veszprem | City | Ashkelon | City | Hifa | City | Hifa | City | Jerusalem | City | Ramat Gan | City | Tel Aviv | City | Napoli | City | Palermo | City | Roma | City | Rome | City | Rozzano (MI) | City | Bydgoszcz | City | Elblag | City | Lodz | City | Lodz | City | Nadarzyn | City | Warsaw | City | Warszawa | City | Wrocław | City | Almada | City | Aveiro | City | Braga | City | Lisboa | City | Lisboa | City | Lisboa | City | Ponte de Lima | City | Chelyabinsk | City | Kemerovo | City | Kemerovo | City | Korolev | City | Krasnodar | City | Krasnoyarsk | City | Orenburg | City | Rostov | City | Ryazan | City | Samara | City | Saratov | City | Smolensk | City | St-Petersburg | City | Tula | City | Ufa | City | Ulyanovsk | City | Velikiy Novgorod | City | Yaroslavl | City | Yaroslavl | City | A Coruña | City | Barakaldo | City | Barcelona | City | Bilbao | City | Córdoba | City | Madrid | City | Madrid | City | Madrid | City | Málaga | City | Santiago de Compostela | City | Sevilla | City | Sevilla | City | Sevilla | City | Sevilla | City | Vigo | City | Cherkasy | City | Ivano-Frankivsk | City | Kharkiv | City | Kharkiv | City | Khmelnytsky | City | Kyiv | City | Kyiv | City | Kyiv | City | Kyiv | City | Poltava | City | Sumy | City | Ternopil | City | Vinnytsya | City | Vinnytsya | City | Zhytomir | City | Bath | City | Cambridge | City | Cannock | City | Leeds | City | London | City | London | City | Newcastle | City | Peterborough | City | Stoke on Trent | City | Torquay |
Zip | 1000 | Zip | 3600 | Zip | 9000 | Zip | 3000 | Zip | 5800 | Zip | 5800 | Zip | 4003 | Zip | 4004 | Zip | 7003 | Zip | 1505 | Zip | 1606 | Zip | 33076 | Zip | 34295 | Zip | 45067 | Zip | 75010 | Zip | 75013 | Zip | 75014 | Zip | 30159 | Zip | 37044 | Zip | 40225 | Zip | 20095 | Zip | 30625 | Zip | 44649 | Zip | 24768 | Zip | 42105 | Zip | 56429 | Zip | 1023 | Zip | 5700 | Zip | 4400 | Zip | 5000 | Zip | 8000 | Zip | 8200 | Zip | 7830604 | Zip | 31048 | Zip | 34362 | Zip | 91120 | Zip | 5265601 | Zip | 64239 | Zip | 80131 | Zip | 90127 | Zip | 00133 | Zip | 00168 | Zip | 20089 | Zip | 85-168 | Zip | 82-300 | Zip | 90-242 | Zip | 90-265 | Zip | 05-830 | Zip | 00-874 | Zip | 04-030 | Zip | 51-685 | Zip | 2805-267 | Zip | 3814-501 | Zip | 4710-243 | Zip | 1050-034 | Zip | 1349-019 | Zip | 1649-035 | Zip | 4990-041 | Zip | 454076 | Zip | 650000 | Zip | 650066 | Zip | 141060 | Zip | 350020 | Zip | 660022 | Zip | 460000 | Zip | 344007 | Zip | 390046 | Zip | 443095 | Zip | 410053 | Zip | 214025 | Zip | 194291 | Zip | 300053 | Zip | 450005 | Zip | 432063 | Zip | 173008 | Zip | 150003 | Zip | 150007 | Zip | 15006 | Zip | 48902 | Zip | 08916 | Zip | 48013 | Zip | 14004 | Zip | 28034 | Zip | 28041 | Zip | 28905 | Zip | 29009 | Zip | 15706 | Zip | 41009 | Zip | 41010 | Zip | 41013 | Zip | 41014 | Zip | 36312 | Zip | 18009 | Zip | 76018 | Zip | 61029 | Zip | 61058 | Zip | 29000 | Zip | 02125 | Zip | 04050 | Zip | 36011 | Zip | 40031 | Zip | 46002 | Zip | 21009 | Zip | 21018 | Zip | 10002 | Zip | BA1 1RL | Zip | CB2 0QQ | Zip | WS11 5XY | Zip | LS7 4SA | Zip | E11 1NR | Zip | SE1 9RS | Zip | NE29 8NH | Zip | PE3 9GZ | Zip | ST6 7AG | Zip | TQ2 7AA | ||||
Country | Belgium | Country | Belgium | Country | Belgium | Country | Belgium | Country | Bulgaria | Country | Bulgaria | Country | Bulgaria | Country | Bulgaria | Country | Bulgaria | Country | Bulgaria | Country | Bulgaria | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Greece | Country | Hungary | Country | Hungary | Country | Hungary | Country | Hungary | Country | Hungary | Country | Hungary | Country | Israel | Country | Israel | Country | Israel | Country | Israel | Country | Israel | Country | Israel | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Poland | Country | Poland | Country | Poland | Country | Poland | Country | Poland | Country | Poland | Country | Poland | Country | Poland | Country | Portugal | Country | Portugal | Country | Portugal | Country | Portugal | Country | Portugal | Country | Portugal | Country | Portugal | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Ukraine | Country | Ukraine | Country | Ukraine | Country | Ukraine | Country | Ukraine | Country | Ukraine | Country | Ukraine | Country | Ukraine | Country | Ukraine | Country | Ukraine | Country | Ukraine | Country | Ukraine | Country | Ukraine | Country | Ukraine | Country | Ukraine | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom |
Conditions
Sequence: | 52205118 |
Name | Arthritis, Psoriatic |
Downcase Name | arthritis, psoriatic |
Id Information
Sequence: | 40184062 | Sequence: | 40184063 | Sequence: | 40184064 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | CR108573 | Id Value | 2018-003214-41 | Id Value | CNTO1959PSA3003 |
Id Type | EudraCT Number | Id Type | Other Identifier | ||
Id Type Description | Janssen Pharmaceutica N.V., Belgium | ||||
Countries
Sequence: | 42597617 | Sequence: | 42597618 | Sequence: | 42597619 | Sequence: | 42597620 | Sequence: | 42597621 | Sequence: | 42597622 | Sequence: | 42597623 | Sequence: | 42597624 | Sequence: | 42597625 | Sequence: | 42597626 | Sequence: | 42597627 | Sequence: | 42597628 | Sequence: | 42597629 | Sequence: | 42597630 | Sequence: | 42597631 |
Name | Belgium | Name | Bulgaria | Name | France | Name | Germany | Name | Greece | Name | Hungary | Name | Israel | Name | Italy | Name | Poland | Name | Portugal | Name | Russian Federation | Name | Spain | Name | Ukraine | Name | United Kingdom | Name | Austria |
Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | True |
Design Groups
Sequence: | 55631585 | Sequence: | 55631586 |
Group Type | Experimental | Group Type | Experimental |
Title | Group 1: Guselkumab | Title | Group 2: Placebo followed by Guselkumab |
Description | Participants will receive guselkumab 100 milligram (mg) Subcutaneous (SC) injection at Weeks 0, 4, 12, 20, 28, 36, and 44 and placebo SC at Week 24 to maintain the blind. At Week 16, Participants who meet the early escape criteria will receive placebo at Week 16 and guselkumab at Week 20, then guselkumab every 8 weeks (q8w). | Description | Participants will receive placebo SC injection at Weeks 0, 4, 12, and 20, and will crossover to receive guselkumab 100 mg SC injection at Weeks 24, 28, 36, and 44. At Week 16, Participants who meet the early escape criteria will receive guselkumab at Weeks 16 and 20, then guselkumab q8w. |
Interventions
Sequence: | 52519435 | Sequence: | 52519436 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Guselkumab 100 mg | Name | Placebo |
Description | Participants will receive guselkumab 100mg as SC injection. | Description | Participants will receive placebo as SC injection. |
Design Outcomes
Sequence: | 177501890 | Sequence: | 177501891 | Sequence: | 177501892 | Sequence: | 177501893 | Sequence: | 177501894 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24 | Measure | Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 | Measure | Percentage of Participants who Achieve an ACR 50 Response at Week 24 | Measure | Change from Baseline in 36-Item Short form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | Measure | Percentage of Participants who Achieve Psoriatic Area and Severity Index (PASI) 100 Response at Week 24 Among Participants with >=3% body Surface area Psoriatic Involvement and an Investigator's Global Assessment (IGA) Score of >=2 (Mild) at Baseline |
Time Frame | Week 24 | Time Frame | Baseline, Week 24 | Time Frame | Week 24 | Time Frame | Baseline, Week 24 | Time Frame | Week 24 |
Description | The ACR 20 Response is defined as greater than or equal to (>=) 20 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP). | Description | The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. | Description | The ACR 50 Response is defined as greater than or equal to (>=) 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP). | Description | The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the participant's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). The physical component summary measure is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state. | Description | PASI 100 response is defined as 100% improvement in PASI score from baseline (PASI score of 0). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI scoring system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. |
Browse Conditions
Sequence: | 193615948 | Sequence: | 193615949 | Sequence: | 193615950 | Sequence: | 193615951 | Sequence: | 193615952 | Sequence: | 193615953 | Sequence: | 193615954 | Sequence: | 193615955 | Sequence: | 193615956 | Sequence: | 193615957 | Sequence: | 193615958 | Sequence: | 193615959 | Sequence: | 193615960 | Sequence: | 193615961 |
Mesh Term | Arthritis | Mesh Term | Arthritis, Psoriatic | Mesh Term | Necrosis | Mesh Term | Joint Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Pathologic Processes | Mesh Term | Spondylarthropathies | Mesh Term | Spondylarthritis | Mesh Term | Spondylitis | Mesh Term | Spinal Diseases | Mesh Term | Bone Diseases | Mesh Term | Psoriasis | Mesh Term | Skin Diseases, Papulosquamous | Mesh Term | Skin Diseases |
Downcase Mesh Term | arthritis | Downcase Mesh Term | arthritis, psoriatic | Downcase Mesh Term | necrosis | Downcase Mesh Term | joint diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | spondylarthropathies | Downcase Mesh Term | spondylarthritis | Downcase Mesh Term | spondylitis | Downcase Mesh Term | spinal diseases | Downcase Mesh Term | bone diseases | Downcase Mesh Term | psoriasis | Downcase Mesh Term | skin diseases, papulosquamous | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48351009 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Janssen Pharmaceutica N.V., Belgium |
Overall Officials
Sequence: | 29304324 |
Role | Study Director |
Name | Janssen Pharmaceutica N.V., Belgium Clinical Trial |
Affiliation | Janssen Pharmaceutica N.V., Belgium |
Design Group Interventions
Sequence: | 68195653 | Sequence: | 68195654 | Sequence: | 68195655 | Sequence: | 68195656 |
Design Group Id | 55631585 | Design Group Id | 55631586 | Design Group Id | 55631585 | Design Group Id | 55631586 |
Intervention Id | 52519435 | Intervention Id | 52519435 | Intervention Id | 52519436 | Intervention Id | 52519436 |
Eligibilities
Sequence: | 30785196 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening Exclusion Criteria: Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253986427 |
Number Of Facilities | 117 |
Registered In Calendar Year | 2019 |
Actual Duration | 20 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30531275 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Subject Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26691082 |
Intervention Id | 52519435 |
Name | CNTO 1959 |
Links
Sequence: | 4391007 |
Url | https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-003214-41/results |
Description | Link to results on EudraCT registry. |
Responsible Parties
Sequence: | 28897571 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52099568 |
Pmid | 34819273 |
Reference Type | derived |
Citation | Coates LC, Gossec L, Theander E, Bergmans P, Neuhold M, Karyekar CS, Shawi M, Noel W, Schett G, McInnes IB. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS). Ann Rheum Dis. 2022 Mar;81(3):359-369. doi: 10.1136/annrheumdis-2021-220991. Epub 2021 Nov 24. |
]]>
https://zephyrnet.com/NCT03796845
2019-02-01
https://zephyrnet.com/?p=NCT03796845
NCT03796845https://www.clinicaltrials.gov/study/NCT03796845?tab=tableNANANARandomized clinical trial that will include women aged 18 or older, submitted a curative surgery for breast cancer at Hospital do Câncer III (HCIII-INCA). Patients will be allocated into two groups: Intervention (upper limbs no-limited movement with amplitude above 90º for flexion and abduction of shoulder) and Control (upper limbs limited movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal surgical points). Sociodemographic and clinical data will be collected through interviews, questionnaires and electronic and physical records. The outcomes will be incidence of operative wound complications, like edema, joint restraint, winged scapula, pain, axillary web syndrome through the physical examination, performed by the nursing and physiotherapy team throughout the intervention period, ending in the 30-day post-operatory.
<![CDATA[
Studies
Study First Submitted Date | 2018-07-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-04-07 |
Start Month Year | February 1, 2019 |
Primary Completion Month Year | July 1, 2019 |
Verification Month Year | April 2020 |
Verification Date | 2020-04-30 |
Last Update Posted Date | 2020-04-07 |
Detailed Descriptions
Sequence: | 20727204 |
Description | Breast cancer treatment has been accompanying advances in technology, surgeries are more conservative, however postoperative complications are still observed. At early postoperative period, the most common operative wound complications are seroma, infection and necrosis. Shoulder dysfunctions are a frequent complication and difficult women to return to their activities. There is no consensus regarding the onset and type of exercise in postoperative period. Thus, the objective of this study is to compare the active no-limited mobilization with limited mobilization in the immediate post operatory at the incidence of wound complications in women submitted to surgery for the treatment of breast cancer.
It's a randomized clinical trial that will include women aged 18 years or older, submitted a curative surgery for breast cancer at Hospital do Câncer III (HCIII-INCA) located in Rio de Janeiro. All patients admitted for surgical treatment at the institution and during the study period will be evaluated for eligibility criteria. Those considered eligible for the study will be clarified regarding the objectives, treatment groups, adverse effects and non-compulsory participation of the study. Upon acceptance to participate, they will be allocated to the respective intervention groups. Group 1 – upper limbs no-limited movement with amplitude above 90º for flexion and abduction of shoulder; Group 2 – upper limbs limited movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal surgical points. |
Facilities
Sequence: | 200159466 |
Name | Clarice Gomes Chagas Teodozio |
City | Rio de Janeiro |
State | RJ |
Zip | 20230240 |
Country | Brazil |
Conditions
Sequence: | 52185556 |
Name | Breast Neoplasms |
Downcase Name | breast neoplasms |
Id Information
Sequence: | 40169117 |
Id Source | org_study_id |
Id Value | Shoulder exercise cancer |
Countries
Sequence: | 42580703 |
Name | Brazil |
Removed | False |
Design Groups
Sequence: | 55609189 | Sequence: | 55609190 |
Group Type | Experimental | Group Type | Active Comparator |
Title | No-limited movement after surgery | Title | Limited movement after surgery |
Description | Participants should move their arms from the first postoperative day, with unrestricted movement, with an amplitude above 90º for flexion and abduction of shoulder. | Description | Participants should move their arms with restricted movements on the first postoperative day, with maximum amplitude of 90º for flexion and abduction of the shoulder, until withdrawal surgical points. Actual hospital's routine. |
Interventions
Sequence: | 52499490 |
Intervention Type | Other |
Name | No limited movement after surgery |
Description | Participants should move their arms from the first postoperative day, with unrestricted movement, with an amplitude above 90º for flexion and abduction of shoulder. |
Keywords
Sequence: | 79888863 |
Name | Exercise |
Downcase Name | exercise |
Design Outcomes
Sequence: | 177432249 | Sequence: | 177432247 | Sequence: | 177432248 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary |
Measure | Measurement of shoulder's range of motion | Measure | Presence or absence of wound complications. | Measure | Measurement of upper limb functionality |
Time Frame | Thirty days of follow-up | Time Frame | Thirty days of follow-up | Time Frame | Thirty days of follow-up |
Description | Performed routinely by the physiotherapist through physical examination of the range of motion of the shoulder during the first month after the surgical procedure. | Description | Occurrence of wound complications (necrosis, dehiscence, seroma, infection or hematoma) will be obtained by the physical examination, performed routinely by the nursing and physiotherapy during the first month after the surgical procedure. | Description | Performed routinely by physical therapy using the upper limb functionality questionnaire (Disabilities of the arm, shoulder and hand – DASH) during the first month after the surgical procedure. It is a validated, reliable and translated into Portuguese questionnaire. It has 30 items classified from 1 to 5, and aims to grade physical function and symptoms in people with any upper limb dysfunction. The total score ranges from 0 (no dysfunction) to 100 (severe dysfunction). |
Browse Conditions
Sequence: | 193540412 | Sequence: | 193540413 | Sequence: | 193540414 | Sequence: | 193540415 | Sequence: | 193540416 |
Mesh Term | Breast Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Breast Diseases | Mesh Term | Skin Diseases |
Downcase Mesh Term | breast neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | breast diseases | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332387 |
Agency Class | OTHER_GOV |
Lead Or Collaborator | lead |
Name | Instituto Nacional de Cancer, Brazil |
Overall Officials
Sequence: | 29293031 |
Role | Principal Investigator |
Name | Anke Bergmann |
Affiliation | CPQ – INCA |
Design Group Interventions
Sequence: | 68168258 | Sequence: | 68168259 |
Design Group Id | 55609190 | Design Group Id | 55609189 |
Intervention Id | 52499490 | Intervention Id | 52499490 |
Eligibilities
Sequence: | 30773614 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 80 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Women aged 18 and over; Exclusion Criteria: Bilateral breast cancer; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952815 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 5 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30519745 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Patients submitted to surgery for breast cancer will be allocated into two groups: Intervention (upper limbs no-limited movement with amplitude above 90º for flexion and abduction of shoulder) and Control (upper limbs limited movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal surgical points). |
Responsible Parties
Sequence: | 28886046 |
Responsible Party Type | Principal Investigator |
Name | Anke Bergmann |
Title | Principal Investigator |
Affiliation | Instituto Nacional de Cancer, Brazil |
Study References
Sequence: | 52079040 |
Pmid | 32804282 |
Reference Type | derived |
Citation | Teodozio CGC, Marchito LO, Fabro EAN, Macedo FO, de Aguiar SS, Thuler LCS, Bergmann A. Shoulder amplitude movement does not influence postoperative wound complications after breast cancer surgery: a randomized clinical trial. Breast Cancer Res Treat. 2020 Nov;184(1):97-105. doi: 10.1007/s10549-020-05826-9. Epub 2020 Aug 17. |
]]>
https://zephyrnet.com/NCT03796832
2019-01-28
https://zephyrnet.com/?p=NCT03796832
NCT03796832https://www.clinicaltrials.gov/study/NCT03796832?tab=tableNANANAOsteoarthritis (OA) is a chronic degenerative joint disease and leading cause of musculoskeletal pain and disability worldwide. The high rates of knee replacement surgery worldwide emphasize the need for more effective non-surgical interventions to attenuate progressive disability. International scientific and professional societies also propose that therapies need to seek efficacious combinations of modalities with the ultimate aim to achieve longer-term, optimal and synergistic treatment effects.
Exercise therapy, such as strengthening and aerobic exercise, is universally, and strongly, recommended as it demonstrates beneficial effects on clinical symptoms and is considered safe for all patients with knee OA. However, during activities as simple as walking, higher knee joint loads have been demonstrated in people with medial tibiofemoral OA, a common form of knee OA. Increased joint loading as such may elicit aggravated symptoms and accelerated joint structural decline over time. No convincing evidence exists to confirm exercise therapy effectively alters joint loading parameters during walking gait in people with knee OA. Notably, recent studies suggest that wearing appropriate footwear may help offload the joint in people with knee OA, a strategy that is also easily applicable at a wide population level.
The purpose of this clinical study is to compare 9-month treatment consisting of exercise therapy and daily wear of one of two shoe classes (flat flexible shoes or stable supportive shoes), on symptom relief and joint structural damage in people with knee OA. In this study, we will randomly allocate eligible participants in one of two treatment arms. This means there will be an equal amount of participants in each group, and participants nor researchers will be able to choose in which group participants will end up in.Participants in both groups will enroll in a 9 month exercise program and will be provided a pair of one of the two shoe classes to wear daily. To ensure an unbiased appraisal of treatment effects, we will not disclose the study hypotheses to participants during the intervention period.
The results of this study will help determine whether the addition of appropriate footwear to exercise therapy improves symptom relief and/or slows structural disease progression in people with knee OA.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-21 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-01-25 |
Start Month Year | January 28, 2019 |
Primary Completion Month Year | June 1, 2022 |
Verification Month Year | January 2023 |
Verification Date | 2023-01-31 |
Last Update Posted Date | 2023-01-25 |
Facilities
Sequence: | 200660006 |
Name | Ghent University, Department of Rehabilitation Sciences |
City | Ghent |
Zip | 9000 |
Country | Belgium |
Conditions
Sequence: | 52340876 |
Name | Knee Osteoarthritis |
Downcase Name | knee osteoarthritis |
Id Information
Sequence: | 40280095 | Sequence: | 40280096 | Sequence: | 40280097 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | B670201835057 | Id Value | G013318N | Id Value | U1111-1225-9954 |
Id Type | Other Grant/Funding Number | Id Type | Other Identifier | ||
Id Type Description | Fonds voor Wetenschappelijk Onderzoek (FWO) | Id Type Description | WHO | ||
Countries
Sequence: | 42700378 |
Name | Belgium |
Removed | False |
Design Groups
Sequence: | 55782210 | Sequence: | 55782211 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Flat Flexible Shoes+Exercise Therapy | Title | Stable Supportive Shoes+Exercise Therapy |
Description | This arm will wear Flat Flexible Shoes daily for the duration of 9 months combined with supervised facility-based and home-based exercise therapy (months 0-3) and unsupervised home-based exercise therapy (months 4-9). | Description | This arm will wear Stable Supportive Shoes daily for the duration of 9 months combined with supervised facility-based and home-based exercise therapy (months 0-3) and unsupervised home-based exercise therapy (months 4-9). |
Interventions
Sequence: | 52651641 | Sequence: | 52651642 | Sequence: | 52651643 |
Intervention Type | Device | Intervention Type | Device | Intervention Type | Other |
Name | Flat Flexible Shoes | Name | Stable Supportive Shoes | Name | Exercise Therapy |
Description | Off-the-shelf commercially available shoes will be used compliant with previously published criteria: (i) heel height <15 mm, (ii) shoe pitch <10 mm, (iii) absent arch support/motion control, (iv) minimal sole rigidity, (v) weight <=200g (+/-10%). Participants will be instructed to wear the shoes at least 4 hours daily for the duration of the 9-month intervention and to avoid wearing other types of shoes, if possible. | Description | Off-the-shelf commercially available shoes will be used compliant with previously published criteria: (i) heel height >30 mm, (ii) shoe pitch >10 mm, (iii) present arch support/motion control, (iv) sole rigidity, (v) weight >300g (+/-10%). Participants will be instructed to wear the shoes at least 4 hours daily for the duration of the 9-month intervention and to avoid wearing other types of shoes, if possible. | Description | The 3-month supervised exercise program will consist of one group session per week of approximately 30 minutes complemented with home-based exercises 3 times per week. Group sessions will consist of a 10-min warm-up followed by a circuit training of strengthening and/or neuromuscular exercises. Subsequently, during a 6-month unsupervised home exercise program, participants will perform strengthening exercises of the lower limb muscles 3 times weekly. Throughout the 9-month intervention, participants will be encouraged to maintain a daily routine of aerobic exercises, consisting of structured activity bouts of at least 10 minutes at a moderate intensity (grade 5-6 (out of 10, maximum exertion) on a Rate of Perceived Exertion scale), achieving at least 70 minutes of weekly physical activity at 3 months and 150 minutes at 9 months. |
Keywords
Sequence: | 80102933 | Sequence: | 80102934 | Sequence: | 80102935 | Sequence: | 80102936 |
Name | Knee Osteoarthritis | Name | Exercise Therapy | Name | Shoes | Name | Pain |
Downcase Name | knee osteoarthritis | Downcase Name | exercise therapy | Downcase Name | shoes | Downcase Name | pain |
Design Outcomes
Sequence: | 178005703 | Sequence: | 178005704 | Sequence: | 178005705 | Sequence: | 178005706 | Sequence: | 178005707 | Sequence: | 178005708 | Sequence: | 178005709 | Sequence: | 178005710 | Sequence: | 178005711 | Sequence: | 178005712 | Sequence: | 178005713 | Sequence: | 178005714 | Sequence: | 178005715 | Sequence: | 178005716 | Sequence: | 178005717 | Sequence: | 178005718 | Sequence: | 178005719 | Sequence: | 178005720 | Sequence: | 178005721 | Sequence: | 178005722 | Sequence: | 178005723 | Sequence: | 178005724 | Sequence: | 178005725 | Sequence: | 178005726 | Sequence: | 178005727 | Sequence: | 178005728 | Sequence: | 178005729 | Sequence: | 178005730 | Sequence: | 178005731 | Sequence: | 178005732 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Change in severity of knee pain on walking | Measure | Severity of intercondylar synovitis | Measure | Severity of whole knee effusion | Measure | Severity of bone marrow lesions | Measure | Severity of physical dysfunction | Measure | Severity of knee pain overall | Measure | Participant-perceived global change in pain | Measure | Participant-perceived global change in physical function | Measure | Participant-perceived global change overall | Measure | Average Daily Step Count | Measure | Habitual physical activity level | Measure | Health-related quality of life | Measure | Adherence to shoe usage | Measure | Adherence to exercise therapy | Measure | Adverse events, co-interventions including medication use | Measure | Knee joint loading – lower limb kinetics and kinematics | Measure | Markers of local synovial inflammation – synovial hypertrophy and Doppler activity | Measure | Neuropathic pain | Measure | Foot posture | Measure | Location of knee pain | Measure | Numbers of participants dropped out from study | Measure | Peripheral sensitization (thermal) | Measure | Widespread sensitization (thermal) | Measure | Pain sensitivity (local) | Measure | Pain sensitivity (peripheral) | Measure | Peripheral sensitization (mechanical) | Measure | Widespread sensitization (mechanical) | Measure | Dysfunctional endogenous analgesia | Measure | Dysfunctional endogenous analgesia | Measure | Central sensitization |
Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at 13 and 37 weeks | Time Frame | Measured at 13 and 37 weeks | Time Frame | Measured at 13 and 37 weeks | Time Frame | Measured during weeks 1, 12 and 36 | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured by pedometer at week 1, week 12, week 37, and by logbooks at month 1 , month 2, month 3, month 4, month 5, month 6, month 7, month 8, month 9 | Time Frame | Measured at week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12 and month 4, month 5, month 6, month 7, month 8, month 9 | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | From baseline to 9 months | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks | Time Frame | Measured at baseline, 13 and 37 weeks |
Description | Scored on an 11-point numeric rating scale for average knee pain on walking over the past week, with terminal descriptors of "0=no pain" to "10=worst pain imaginable". | Description | Graded using the MRI Osteoarthritis Knee Score hoffa-synovitis sub-score, ranging grade 0 (normal) to grade 3 (severe). | Description | Graded using the MRI Osteoarthritis Knee Score effusion-synovitis sub-score, ranging grade 0 (physiologic amount) to grade 3 (large – evidence of capsular distention). | Description | Graded using the MRI Osteoarthritis Knee Score bone marrow lesion sub-score, grade 0 (none) to grade 3 (>66% of subregional volume). | Description | Measured with the function subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index. This sub-scale gives a range of possible scores from "0=no dysfunction" to "68=maximum dysfunction". | Description | Scored on an 11-point numeric rating scale for average knee pain overall the past week, with terminal descriptors of "0=no pain" to "10=worst pain imaginable". | Description | Scored on a 7-point ordinal scale (with terminal descriptors of "1=much worse" to "7=much better"). Participants who report they are "moderately better" and above will be classified as "improved". | Description | Scored on a 7-point ordinal scale (with terminal descriptors of "1=much worse" to "7=much better"). Participants who report they are "moderately better" and above will be classified as "improved". | Description | Scored on a 7-point ordinal scale (with terminal descriptors of "1=much worse" to "7=much better"). Participants who report they are "moderately better" and above will be classified as "improved". | Description | Measured using a pedometer attached to the hip for 7 subsequent days to assess objective physical activity. | Description | Measured using the Physical Activity Scale for the Elderly with scores ranging 0-400 where higher scores indicate greater physical activity. | Description | Measured using the EuroQoL Quality of Life Scale (EQ-5D) with scores ranging from 0 to 100 (higher scores indication better health-related quality of life). | Description | Measured using a shoe-mounted pedometer on week 1, 12 and 37 for 7 consecutive days and by self-report in logbooks for one week during each month. The number of hours of daily shoe wearing will be recorded for 7 consecutive days and compliance will be rated using an 11-point NRS (with terminal descriptors "0=never worn" to "10=always worn"). | Description | During the supervised 12-week phase, participants will record completed exercise sessions every week in a logbook and will complete weekly 11-point NRS scales rating their overall compliance with the exercise prescription (with terminal descriptors: "0= not at all compliant" to "10=extremely compliant"). Therapists will record participants' attendance. During the 6-month phase, patient-reported adherence will be collected for one week each month. | Description | will be collected monthly using logbooks and will also be quired by questionnaire. | Description | An 8-camera optical motion capture system and a force plate will be used to collect kinematic and ground reaction forces. Participants will perform barefoot walking trials at a self-selected walking speed until seven complete "clean" foot strikes (satisfactory force plate contact defined as initial contact at the heel and toe off occurring on the force plate)) will be recorded from both limbs. At 36 weeks, participants will perform gait analysis under two conditions (in random order): (i) barefoot and (ii) allocated shoe. Major parameters of interest will be: (i) peak knee adduction moment, (ii) knee adduction moment angular impulse, and (iii) peak knee flexion moment. Unblinded scientific personnel and a blinded PhD student will collect the gait data. At 36 weeks the PhD student will be unblinded during the 3D gait analyses (last test of the testing session). Subsequent analyses will be performed by the blinded PhD student. | Description | Will be measured using an ultrasound machine with a 10-18 MHz linear array transducer. The regions examined will be: the suprapatellar recess, the medial and lateral parapatellar recesses and the medial and lateral femorotibial joint space. All anterior scans will be performed in the longitudinal position except for the parapatellar recess (transverse). Posteriorly, The medial aspect of the popliteal space will be assessed both in the longitudinal and transversal position to assess Baker's cyst presence. All US examinations will be carried out by one unblinded investigator with the participant lying supine on an examination table (knee flexed to 30°), except for the Baker's cyst assessment in which the participant is prone (knee fully extended). The same investigator will evaluate all images for capsular distension, synovial Doppler activity, synovial hypertrophy, effusion and presence of Baker's cyst. The investigator will be blinded to participant ID and test date. | Description | Will be assessed using the modified painDETECT questionnaire (mPDQ) a 12-item patient-based, screening questionnaire to determine the presence of neuropathic pain components validated in a range of conditions including OA. | Description | Will be assessed using the Foot Posture Index (FPI), a valid and reliable tool that scores six features of foot posture from – 2 (more supinated) to + 2 (more pronated). | Description | The Photographic Knee Pain Map will be used to determine location of knee pain. The map consists of a photographic representation of the anterior view of a pair of knees on which the participant can mark all painful locations in their study knee. | Description | Participants who will stop participating in the study (either due to loss to follow-up or study withdrawal) will be asked by mail or telephone to provide the reason why they dropped out from the study. These information will be formally recorded throughout the trial by the trial coordinator. | Description | Will be measured assessing heat detection and pain thresholds on the study knee (i.e., most painful knee) by one (always the same) blinded investigator.Heat contact thermal stimuli will be delivered using a computer-controlled (Medoc Pathway Pain & Sensory Evaluation System). | Description | Will be measured assessing heat detection and pain threshold on a remote peripheral site (i.e., extensor carpi radialis longus) by one (always the same) blinded investigator. Heat contact thermal stimuli will be delivered using a computer-controlled (Medoc Pathway Pain & Sensory Evaluation System). | Description | Will be measured by temporal summation (TS) at the study knee (i.e., most painful knee) performed by one (always the same) blinded investigator. Heat contact thermal stimuli will be delivered using a computer-controlled (Medoc Pathway Pain & Sensory Evaluation System). Heat stimuli will be individualized for each subject. Participants will receive10 heat pulses. Participants will be asked to provide a verbal pain rating on a 11-point (0-10) numeric rating scale (NRS) (0 = no pain and 10 = most intense pain imaginable) at 1st; 5th and 10th pulse. TS will be derived according to established protocols. | Description | Will be measured by temporal summation (TS) on a remote peripheral site (i.e., extensor carpi radialis longus) performed by one (always the same person) blinded investigator. Heat contact thermal stimuli will be delivered using a computer-controlled (Medoc Pathway Pain & Sensory Evaluation System). Heat stimuli will be individualized for each subject. Participants will receive10 heat pulses. Participants will be asked to provide a verbal pain rating on a 11-point (0-10) numeric rating scale (NRS) (0 = no pain and 10 = most intense pain imaginable) at 1st; 5th and 10th pulse. TS will be derived according to established protocols. | Description | Pressure pain thresholds (PPTs) will be performed on the study knee (i.e., most painful knee) by eliciting mechanical pressure pain applied perpendicular to the skin using an analogue algometer. PPTs will be performed by one (always the same person) blinded investigator. | Description | Pressure pain thresholds (PPTs) will be performed on a remote peripheral site (i.e., extensor carpi radialis longus) by eliciting mechanical pressure pain applied perpendicular to the skin using an analogue algometer. PPTs will be performed by one (always the same person) blinded investigator. | Description | Will be assessed by conditioned pain modulation (CPM) at the study knee (i.e., most painful knee) by one (always the same person) blinded investigator. CPM will be measured using a test stimulus followed by a conditioning stimulus and re-assessment of the test stimulus during and after the conditioning stimulus. | Description | Will be assessed by conditioned pain modulation (CPM) on a remote peripheral site (i.e., extensor carpi radialis longus) by one (always the same person) blinded investigator. CPM will be measured using a test stimulus followed by a conditioning stimulus and re-assessment of the test stimulus during and after the conditioning stimulus. | Description | Will be assessed using the central sensitisation inventory (CSI). |
Browse Conditions
Sequence: | 194133149 | Sequence: | 194133150 | Sequence: | 194133151 | Sequence: | 194133152 | Sequence: | 194133153 | Sequence: | 194133154 |
Mesh Term | Osteoarthritis | Mesh Term | Osteoarthritis, Knee | Mesh Term | Arthritis | Mesh Term | Joint Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Rheumatic Diseases |
Downcase Mesh Term | osteoarthritis | Downcase Mesh Term | osteoarthritis, knee | Downcase Mesh Term | arthritis | Downcase Mesh Term | joint diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | rheumatic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48477862 | Sequence: | 48477863 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University Ghent | Name | Universiteit Antwerpen |
Overall Officials
Sequence: | 29375462 |
Role | Principal Investigator |
Name | Patrick Calders, PhD |
Affiliation | University Ghent |
Design Group Interventions
Sequence: | 68379361 | Sequence: | 68379362 | Sequence: | 68379363 | Sequence: | 68379364 |
Design Group Id | 55782210 | Design Group Id | 55782211 | Design Group Id | 55782210 | Design Group Id | 55782211 |
Intervention Id | 52651641 | Intervention Id | 52651642 | Intervention Id | 52651643 | Intervention Id | 52651643 |
Eligibilities
Sequence: | 30863617 |
Gender | All |
Minimum Age | 50 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Symptomatic and radiographic diagnosis of knee OA as per the American College of Rheumatology criteria (ie, aged≥50, knee pain on most days and osteophytes) Exclusion Criteria: Current and previous (3 months) participation in exercise therapy |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253939272 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 40 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 50 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 11 |
Number Of Other Outcomes To Measure | 18 |
Designs
Sequence: | 30609438 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Intervention Model Description | This will be a mono-centre randomized controlled trial with a 1:1 allocation into the experimental treatment (exercise therapy and Flat Flexible Shoes) and comparator treatment (exercise therapy and Stable Supportive Shoes). Exercise therapy will consist of supervised facility- and home-based exercises for 3 months (primary time point) and unsupervised home-based exercises for a subsequent 6 months (secondary time point). |
Subject Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28975977 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796819
2019-01-10
https://zephyrnet.com/?p=NCT03796819
NCT03796819https://www.clinicaltrials.gov/study/NCT03796819?tab=tableNANANAThe role of routine lymphadenectomy (LND) in the surgical treatment of intrahepatic cholangiocarcinoma (ICC) remains controversial. The investigators’ multi-institutional retrospective study have showed an increasing adoption of LND among patients undergoing curative resection for ICC during the last decade. The current prospective and randomized study based on a multi-institutional collaboration would investigate whether routine LND would benefit patients in short- and long-term survival remains.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-12-09 |
Start Month Year | January 10, 2019 |
Primary Completion Month Year | August 1, 2021 |
Verification Month Year | August 2019 |
Verification Date | 2019-08-31 |
Last Update Posted Date | 2021-12-09 |
Detailed Descriptions
Sequence: | 20792334 |
Description | Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver cancer and its incidence is increasing worldwide.Resection of the primary ICC tumor site within the liver represents the best curative treatment option. However, the role of lymphadenectomy (LND) at the time of surgery remains controversial with some centers considering it standard while other surgeons perform LND only in select circumstances. The utilization of LND may not only vary among different institutions, but also by geographic region. Specifically, data from East and West centers have noted a variation in the utilization of LND ranging 27%-100%.While several case series from Asia have noted that most centers do not regularly perform LND,other data from the West suggest that LND may be becoming more routine. Despite the lack of consensus among surgeons, the American Joint Committee on Cancer (AJCC) Staging manual recommends that the nodal basin be staged. Disease-specific staging for ICC was first introduced in the 7th edition of the AJCC staging manual published in 2010. The newly updated 8th edition of the AJCC staging system now recommends that 6 lymph nodes be evaluated to stage a patient with ICC.
The previous multi-institutional retrospective study from the investigators have showed an increasing adoption of LND among patients undergoing curative resection for ICC during the last decade. The current prospective and randomized study based on a multi-institutional collaboration would investigate whether routine LND would benefit patients in short- and long-term survival remains. |
Facilities
Sequence: | 200729943 |
Name | The First Affiliated Hospital of Xi'an Jiaotong University |
City | Xi'an |
State | Shaanxi |
Zip | 710061 |
Country | China |
Conditions
Sequence: | 52352798 |
Name | Intrahepatic Cholangiocarcinoma |
Downcase Name | intrahepatic cholangiocarcinoma |
Id Information
Sequence: | 40288732 |
Id Source | org_study_id |
Id Value | XJTU1AFCRC2017SJ-007 |
Countries
Sequence: | 42710616 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55795173 | Sequence: | 55795174 |
Group Type | Experimental | Group Type | No Intervention |
Title | lymphadenectomy | Title | No lymphadenectomy |
Description | This group of patients would undergo routine hepatoduodenal lymphadenectomy combined with ICC resection | Description | This group of patients would not undergo hepatoduodenal lymphadenectomy when preoperative imaging and intraoperative exploration found no lymph node enlargement. |
Interventions
Sequence: | 52663853 |
Intervention Type | Procedure |
Name | lymphadenectomy |
Description | Patients would undergo routine hepatoduodenal lymphadenectomy at the time of ICC resection |
Keywords
Sequence: | 80118428 | Sequence: | 80118429 | Sequence: | 80118430 | Sequence: | 80118431 | Sequence: | 80118432 |
Name | intrahepatic cholangiocarcinoma | Name | surgery | Name | lymphadenectomy | Name | lymph node metastasis | Name | prognosis |
Downcase Name | intrahepatic cholangiocarcinoma | Downcase Name | surgery | Downcase Name | lymphadenectomy | Downcase Name | lymph node metastasis | Downcase Name | prognosis |
Design Outcomes
Sequence: | 178048754 | Sequence: | 178048755 | Sequence: | 178048756 | Sequence: | 178048757 | Sequence: | 178048758 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | 1-year recurrence rate | Measure | 3-year recurrence rate | Measure | Postoperative morbidity | Measure | 1-year overall survival | Measure | 3-year overall survival |
Time Frame | 1 year after surgery (up to 1 year) | Time Frame | 3 years after surgery (up to 3 years) | Time Frame | From the date of surgery to stitches off (up to 1 month) | Time Frame | 1 year after surgery (up to 1 year) | Time Frame | 3 years after surgery (up to 3 years) |
Description | compare the 1-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy | Description | compare the 3-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy | Description | investigate the postoperative morbidity, such as hepatic failure, postoperative bleeding, superficial and deep site infection between lymphadenectomy and no lymphadenectomy groups | Description | compare the 1-year overall survival rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy | Description | compare the 3-year overall survival rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy |
Browse Conditions
Sequence: | 194177450 | Sequence: | 194177451 | Sequence: | 194177452 | Sequence: | 194177453 | Sequence: | 194177454 | Sequence: | 194177455 |
Mesh Term | Cholangiocarcinoma | Mesh Term | Adenocarcinoma | Mesh Term | Carcinoma | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms |
Downcase Mesh Term | cholangiocarcinoma | Downcase Mesh Term | adenocarcinoma | Downcase Mesh Term | carcinoma | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48488245 | Sequence: | 48488246 | Sequence: | 48488247 | Sequence: | 48488248 | Sequence: | 48488249 | Sequence: | 48488250 | Sequence: | 48488251 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | First Affiliated Hospital Xi'an Jiaotong University | Name | Ningxia Medical University | Name | Nanchang University | Name | Binzhou Medical University | Name | Shaanxi Provincial People's Hospital | Name | Shaanxi University of Chinese Medicine | Name | The Third Affiliated Hospital of Beijing University |
Overall Officials
Sequence: | 29381424 | Sequence: | 29381425 |
Role | Study Chair | Role | Principal Investigator |
Name | Yi Lv, MD, PhD | Name | Xu-Feng Zhang, MD,PhD |
Affiliation | First Affiliated Hospital Xi'an Jiaotong University | Affiliation | First Affiliated Hospital Xi'an Jiaotong University |
Design Group Interventions
Sequence: | 68396843 |
Design Group Id | 55795173 |
Intervention Id | 52663853 |
Eligibilities
Sequence: | 30870132 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients diagnosed with intrahepatic cholangiocarcinoma by imaging or biopsy Exclusion Criteria: The primary disease is unresectable with or without distant metastasis |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254027864 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 31 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30615930 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Masking Description | patients would not be told about the lymphadenectomy |
Intervention Model Description | routine hepatoduodenal lymphadenectomy |
Subject Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28982468 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796806
2019-01-14
https://zephyrnet.com/?p=NCT03796806
NCT03796806https://www.clinicaltrials.gov/study/NCT03796806?tab=tableNANANAAssess validity of methods involved in molecular studies of the skin in inflammatory skin disease
Assess feasibility of methods for grafting fresh human skin (normal and diseased with inflammatory skin disease) onto an established xenograft murine model.
<![CDATA[
Studies
Study First Submitted Date | 2018-10-22 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-10-08 |
Start Month Year | January 14, 2019 |
Primary Completion Month Year | January 14, 2019 |
Verification Month Year | October 2021 |
Verification Date | 2021-10-31 |
Last Update Posted Date | 2021-10-08 |
Detailed Descriptions
Sequence: | 20754929 |
Description | The use of fixed tissue specimens for research studies is attractive, because a large number of relevant specimens can be collected quickly from tissue registry. There is a current lack of knowledge regarding to what extent formalin fixation alters the identification of proteins in the skin with inflammatory dermatoses. This information would be important to assess when determining the limitations (or potentially lack thereof) of using fixed specimens in research.
Collaborators have successfully developed a murine model that can accept human skin xenografts. While those investigators have successfully demonstrated transplantation of healthy skin onto mice, it is unknown whether skin affected by inflammatory disease can be transplanted and, if so, whether the inflammatory skin disease remains, whether it spreads to involve host skin, or whether it resolves. Determining feasibility of transplanting inflamed human skin using this model, as well as observing the course of this inflammation, are the next steps in advancing this potentially invaluable research modality. |
Facilities
Sequence: | 200390309 |
Name | Mayo Clinic in Rochester |
City | Rochester |
State | Minnesota |
Zip | 55905 |
Country | United States |
Conditions
Sequence: | 52256617 |
Name | Lichen Planus |
Downcase Name | lichen planus |
Id Information
Sequence: | 40220850 |
Id Source | org_study_id |
Id Value | 18-002404 |
Countries
Sequence: | 42636478 |
Name | United States |
Removed | False |
Keywords
Sequence: | 79989946 | Sequence: | 79989947 | Sequence: | 79989948 |
Name | lichen planus | Name | proteomics | Name | xenograft model for lichen planus |
Downcase Name | lichen planus | Downcase Name | proteomics | Downcase Name | xenograft model for lichen planus |
Design Outcomes
Sequence: | 177692368 | Sequence: | 177692369 | Sequence: | 177692370 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Comparative analysis of proteomes on fresh versus formalin-fixed-paraffin-embedded tissue. | Measure | Viability of human inflammatory skin (lichen planus) graft in a xenograft murine model | Measure | Evaluation of inflammation around human inflammatory skin graft (lichen planus) and elsewhere in a established xenograft murine model |
Time Frame | 8 months | Time Frame | 8 months | Time Frame | 8 months |
Description | Identification and quantification of proteins as obtained by liquid chromatography-mass spectrometry methods using fresh and formalin-fixed-paraffin-embedded tissue. Mass spectrometry data will be matched against a composite protein sequence database using the MyriMatch search engine and IDPicker will filter protein identification at 2% false discovery rate. QuasiTel software will process the spectral count data for the identification of differentially expressed proteins. | Description | Viability of diseased human graft into an established murine xenograft model by visual inspection and microscopic analysis. | Description | Assessment of inflammation around graft and elsewhere in the host by visual inspection and microscopic analysis. |
Browse Conditions
Sequence: | 193812753 | Sequence: | 193812754 | Sequence: | 193812755 | Sequence: | 193812756 |
Mesh Term | Skin Diseases | Mesh Term | Lichen Planus | Mesh Term | Lichenoid Eruptions | Mesh Term | Skin Diseases, Papulosquamous |
Downcase Mesh Term | skin diseases | Downcase Mesh Term | lichen planus | Downcase Mesh Term | lichenoid eruptions | Downcase Mesh Term | skin diseases, papulosquamous |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48399174 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mayo Clinic |
Overall Officials
Sequence: | 29331601 |
Role | Principal Investigator |
Name | Julia S Lehman |
Affiliation | Mayo Clinic |
Eligibilities
Sequence: | 30815029 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Clinic patients with active lichen planus and residing within a 50-mile radius of Mayo Clinic-Rochester. |
Criteria | Inclusion Criteria:
– Adults >18 years with active cutaneous lichen planus with capacity to consent. Exclusion Criteria: Concurrent skin infection |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254076116 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 0 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Designs
Sequence: | 30560992 |
Observational Model | Case-Only |
Time Perspective | Prospective |
Links
Sequence: | 4394826 |
Url | https://www.mayo.edu/research/clinical-trials |
Description | Mayo Clinic Clinical Trials |
Responsible Parties
Sequence: | 28927396 |
Responsible Party Type | Principal Investigator |
Name | Julia S. Lehman |
Title | Professor of Dermatology and Laboratory Medicine and Pathology |
Affiliation | Mayo Clinic |
]]>
https://zephyrnet.com/NCT03796793
2019-03-18
https://zephyrnet.com/?p=NCT03796793
NCT03796793https://www.clinicaltrials.gov/study/NCT03796793?tab=tableAliette Espinosaa.espinosa2@med.miami.edu305-689-3376The goal of this project is to use genomic profiling, candidate genes and proteins to develop guided surgical debridement to improve healing in chronic non-healing venous leg ulcers (VLUs) and to test the efficacy of this approach.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-07-20 |
Start Month Year | March 18, 2019 |
Primary Completion Month Year | December 31, 2024 |
Verification Month Year | July 2023 |
Verification Date | 2023-07-31 |
Last Update Posted Date | 2023-07-20 |
Facilities
Sequence: | 199731494 |
Status | Recruiting |
Name | University of Miami |
City | Miami |
State | Florida |
Zip | 33136 |
Country | United States |
Facility Contacts
Sequence: | 28070782 |
Facility Id | 199731494 |
Contact Type | primary |
Name | Aliette Espinosa |
a.espinosa2@med.miami.edu | |
Phone | 305-689-3376 |
Facility Investigators
Sequence: | 18308461 |
Facility Id | 199731494 |
Role | Principal Investigator |
Name | Marjana Tomic-Canic, PhD |
Conditions
Sequence: | 52091217 |
Name | Venous Leg Ulcer |
Downcase Name | venous leg ulcer |
Id Information
Sequence: | 40095255 | Sequence: | 40095256 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 20180256 | Id Value | R01AR073614 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/R01AR073614 |
Countries
Sequence: | 42497160 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55505820 | Sequence: | 55505821 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Wound Edge Debridement Group | Title | Standard care group |
Description | Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks. | Description | Participants in this group will receive only the standard care of treatment for up to 4 weeks. |
Interventions
Sequence: | 52404550 | Sequence: | 52404551 |
Intervention Type | Procedure | Intervention Type | Other |
Name | Wound Edge Debridement | Name | Standard of Care Treatment |
Description | Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base. | Description | Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly. |
Design Outcomes
Sequence: | 177106128 | Sequence: | 177106129 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Change in the genetic profile after debridement in the intervention group. | Measure | Percent rate of healing |
Time Frame | Baseline and 4 weeks | Time Frame | Up to 4 weeks |
Description | RNA sequencing will be used to determine the number of differentially expressed genes of the intervention group in samples collected pre-debridement to samples collected post-debridement. | Description | Percent rate of healing is measured at every weekly visit and divided by 4 to calculate the average percent wound healing rate in cm2/week. |
Browse Conditions
Sequence: | 193170033 | Sequence: | 193170034 | Sequence: | 193170035 | Sequence: | 193170036 | Sequence: | 193170037 | Sequence: | 193170038 | Sequence: | 193170039 | Sequence: | 193170040 | Sequence: | 193170041 |
Mesh Term | Varicose Ulcer | Mesh Term | Leg Ulcer | Mesh Term | Ulcer | Mesh Term | Pathologic Processes | Mesh Term | Skin Ulcer | Mesh Term | Skin Diseases | Mesh Term | Varicose Veins | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases |
Downcase Mesh Term | varicose ulcer | Downcase Mesh Term | leg ulcer | Downcase Mesh Term | ulcer | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | skin ulcer | Downcase Mesh Term | skin diseases | Downcase Mesh Term | varicose veins | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48245471 | Sequence: | 48245472 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Miami | Name | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
Overall Officials
Sequence: | 29239000 | Sequence: | 29239001 |
Role | Principal Investigator | Role | Principal Investigator |
Name | Marjana Tomic-Canic, PhD | Name | Robert Kirsner, MD/PhD |
Affiliation | University of Miami | Affiliation | University of Miami |
Central Contacts
Sequence: | 11992203 |
Contact Type | primary |
Name | Aliette Espinosa |
Phone | 305-689-3376 |
a.espinosa2@med.miami.edu | |
Role | Contact |
Design Group Interventions
Sequence: | 68042633 | Sequence: | 68042634 | Sequence: | 68042635 |
Design Group Id | 55505820 | Design Group Id | 55505821 | Design Group Id | 55505820 |
Intervention Id | 52404550 | Intervention Id | 52404551 | Intervention Id | 52404551 |
Eligibilities
Sequence: | 30719137 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
>18 years of age Exclusion Criteria: history of diabetes mellitus and a HbA1c > 12% (obtained within past 6 months) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253957626 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30465655 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28832112 |
Responsible Party Type | Principal Investigator |
Name | Robert S. Kirsner |
Title | Professor & Chairman |
Affiliation | University of Miami |
]]>
https://zephyrnet.com/NCT03796780
2019-01-01
https://zephyrnet.com/?p=NCT03796780
NCT03796780https://www.clinicaltrials.gov/study/NCT03796780?tab=tableNANANAConsumption of extra-virgin olive oil has beneficial effects on cardiovascular risk factors. The purpose of this study is to compare the effects of extra-virgin olive oil and refined olive oil, in adjunct to conventional medical treatment, in improving liver enzymes, plasma lipid profile and inflammatory markers in patients with cardiovascular risk factors.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-29 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-12-10 |
Start Month Year | January 1, 2019 |
Primary Completion Month Year | September 1, 2019 |
Verification Month Year | December 2019 |
Verification Date | 2019-12-31 |
Last Update Posted Date | 2019-12-10 |
Detailed Descriptions
Sequence: | 20710018 |
Description | A randomized placebo controlled clinical trial will be conducted in Rajaie Cardiovascular Center in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. The participants are 40 eligible patients, aged 20-75 years. Intervention group will be received 25 mL/d extra-virgin olive oil and control group will be received 25 mL/d refined olive oil for 6 weeks. Fasting blood sample will be taken to measure lipid profile, liver enzymes and inflammatory markers (Interleukine-6 [IL-6] and Interleukine-10 [IL-10] and C-Reactive Protein [CRP]). |
Facilities
Sequence: | 199965406 |
Name | Rajaei Cardiovascular, Medical & Research Center |
City | Tehran |
Country | Iran, Islamic Republic of |
Conditions
Sequence: | 52139084 |
Name | Cardiovascular Risk Factor |
Downcase Name | cardiovascular risk factor |
Id Information
Sequence: | 40135121 |
Id Source | org_study_id |
Id Value | 425 |
Countries
Sequence: | 42542781 |
Name | Iran, Islamic Republic of |
Removed | False |
Design Groups
Sequence: | 55559441 | Sequence: | 55559442 |
Group Type | Active Comparator | Group Type | Placebo Comparator |
Title | Extra-Virgin Olive Oil | Title | Refined Olive Oil |
Description | Daily consumption of 25 mL Extra-Virgin Olive Oil for 6 weeks | Description | Daily consumption of 25 mL Refined Olive Oil for 6 weeks |
Interventions
Sequence: | 52454995 | Sequence: | 52454996 |
Intervention Type | Dietary Supplement | Intervention Type | Dietary Supplement |
Name | Extra-Virgin Olive Oil | Name | Refined Olive Oil |
Description | Daily consumption of 25 mL Extra-Virgin Olive Oil in adjunct to medical treatment for 6 weeks | Description | Daily consumption of 25 mL Refined Olive Oil in adjunct to medical treatment for 6 weeks |
Design Outcomes
Sequence: | 177264123 | Sequence: | 177264124 | Sequence: | 177264125 | Sequence: | 177264126 | Sequence: | 177264127 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Interleukin-6 (IL-6) | Measure | plasma lipid profile | Measure | plasma liver enzymes (SGOT & SGPT) | Measure | Interleukin-10 (IL-10) | Measure | C reactive protein (CRP) |
Time Frame | 6 week | Time Frame | 6 week | Time Frame | 6 week | Time Frame | 6 week | Time Frame | 6 week |
Description | change in plasma level of interleukin-6 (IL-6) in pg/mL from baseline at week-6 | Description | change in plasma level of lipoproteins in mg/dL from baseline at 6 week | Description | change in plasma level of liver enzymes (SGOT & SGPT) in mg/dL from baseline at 6 week | Description | Change in plasma level of interleukin-10 (IL-10) in pg/mL at baseline and week-6 | Description | Change in plasma level of C reactive protein (CRP) in mg/dL from baseline and week-6 |
Sponsors
Sequence: | 48290782 | Sequence: | 48290783 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Javad Nasrollahzadeh | Name | Shahid Beheshti University of Medical Sciences |
Overall Officials
Sequence: | 29268570 |
Role | Study Chair |
Name | Javad Nasrollahzadeh, Ph.D |
Affiliation | Shahid Beheshti University of Medical Sciences |
Design Group Interventions
Sequence: | 68107560 | Sequence: | 68107561 |
Design Group Id | 55559441 | Design Group Id | 55559442 |
Intervention Id | 52454995 | Intervention Id | 52454996 |
Eligibilities
Sequence: | 30747773 |
Gender | All |
Minimum Age | 20 Years |
Maximum Age | 75 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
patients with at least one of the cardiovascular risk factors (hypertension, hyperlipidemia, diabetes mellitus) candidate for angiography Exclusion Criteria: Continuous consumption of any supplement with anti-inflammatory or antioxidant properties such as Omega-3, vitamin E, vitamin C and Selenium in last month |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254122192 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 8 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 20 |
Maximum Age Num | 75 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30494056 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28860336 |
Responsible Party Type | Sponsor-Investigator |
Name | Javad Nasrollahzadeh |
Title | Investigator in Clinical Nutrition |
Affiliation | Shahid Beheshti University |
Study References
Sequence: | 52032800 |
Pmid | 33121297 |
Reference Type | derived |
Citation | Khandouzi N, Zahedmehr A, Nasrollahzadeh J. Effect of polyphenol-rich extra-virgin olive oil on lipid profile and inflammatory biomarkers in patients undergoing coronary angiography: a randomised, controlled, clinical trial. Int J Food Sci Nutr. 2021 Jun;72(4):548-558. doi: 10.1080/09637486.2020.1841123. Epub 2020 Oct 29. |
]]>
https://zephyrnet.com/NCT03796767
2019-09-09
https://zephyrnet.com/?p=NCT03796767
NCT03796767https://www.clinicaltrials.gov/study/NCT03796767?tab=tableKristen JewkesKristen.Jewkes@hci.utah.edu801-587-4776This phase II trial studies how well surgery and radiation therapy work in treating patients with prostate cancer that has come back or spread to other parts of the body. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Surgical procedures, such as oligometastasectomy, may remove tumor cells that have spread to other parts of the body. Surgery and radiation therapy may work better in treating patients with prostate cancer that has come back or spread to other parts of the body.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-01-06 |
Start Month Year | September 9, 2019 |
Primary Completion Month Year | December 1, 2023 |
Verification Month Year | January 2023 |
Verification Date | 2023-01-31 |
Last Update Posted Date | 2023-01-06 |
Detailed Descriptions
Sequence: | 20691053 |
Description | PRIMARY OBJECTIVES:
I. To assess response to treatment of oligometastatic disease. SECONDARY OBJECTIVES: I. To assess additional measurements of response to treatment of oligometastatic disease. II. To assess prostate-specific antigen (PSA) progression free-survival following treatment of oligometastatic disease. III. To assess time to disease recurrence following treatment of oligometastatic disease. IV. To assess time to initiation of antiandrogen therapy (ADT) for metastatic prostate cancer following treatment of oligometastatic disease. V. To assess the rate of undetectable PSA following treatment of oligometastatic disease in subjects who have previously undergone prostatectomy. VI. To assess safety. VII. To assess the impact of study treatment on change in quality of life over three years. |
Facilities
Sequence: | 199713188 |
Status | Recruiting |
Name | Huntsman Cancer Institute/University of Utah |
City | Salt Lake City |
State | Utah |
Zip | 84112 |
Country | United States |
Facility Contacts
Sequence: | 28068632 |
Facility Id | 199713188 |
Contact Type | primary |
Name | Alejandro Sanchez |
Alejandro.Sanchez@hci.utah.edu | |
Phone | 801-587-4385 |
Facility Investigators
Sequence: | 18307648 |
Facility Id | 199713188 |
Role | Principal Investigator |
Name | Alejandro Sanchez |
Conditions
Sequence: | 52089303 | Sequence: | 52089304 | Sequence: | 52089305 | Sequence: | 52089306 | Sequence: | 52089307 | Sequence: | 52089308 |
Name | Recurrent Prostate Carcinoma | Name | Metastatic Malignant Neoplasm in the Bone | Name | Metastatic Malignant Neoplasm in the Lymph Nodes | Name | Oligometastasis | Name | Prostate Adenocarcinoma | Name | PSA Failure |
Downcase Name | recurrent prostate carcinoma | Downcase Name | metastatic malignant neoplasm in the bone | Downcase Name | metastatic malignant neoplasm in the lymph nodes | Downcase Name | oligometastasis | Downcase Name | prostate adenocarcinoma | Downcase Name | psa failure |
Id Information
Sequence: | 40093524 | Sequence: | 40093525 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | HCI115811 | Id Value | NCI-2018-03418 |
Id Type | Registry Identifier | ||
Id Type Description | CTRP (Clinical Trial Reporting Program) | ||
Countries
Sequence: | 42493573 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55503652 | Sequence: | 55503653 | Sequence: | 55503654 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | Arm A (radiation therapy) | Title | Arm B (salvage oligometastasectomy) | Title | Arm C (salvage oligometastasectomy, radiation therapy) |
Description | Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. | Description | Patients with nodal metastases undergo salvage oligometastasectomy. | Description | Patients with nodal metastases undergo salvage oligometastasectomy. Following recovery, patients undergo SBRT or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Within 4 months following completion of salvage therapy (defined as the combination of oligometastasectomy and/or bone radiation) and depending on PSA response as well as previous treatment, patients may receive adjuvant nodal IMRT. |
Interventions
Sequence: | 52402533 | Sequence: | 52402534 | Sequence: | 52402535 | Sequence: | 52402536 | Sequence: | 52402537 | Sequence: | 52402538 |
Intervention Type | Radiation | Intervention Type | Radiation | Intervention Type | Procedure | Intervention Type | Other | Intervention Type | Other | Intervention Type | Radiation |
Name | Hypofractionated Radiation Therapy | Name | Intensity-Modulated Radiation Therapy | Name | Metastasectomy | Name | Quality-of-Life Assessment | Name | Questionnaire Administration | Name | Stereotactic Body Radiation Therapy |
Description | Undergo hypofractionated radiation therapy | Description | Undergo IMRT | Description | Undergo salvage oligometastasectomy | Description | Ancillary studies | Description | Ancillary studies | Description | Undergo SBRT |
Design Outcomes
Sequence: | 177096735 | Sequence: | 177096736 | Sequence: | 177096737 | Sequence: | 177096738 | Sequence: | 177096739 | Sequence: | 177096740 | Sequence: | 177096741 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Prostate-specific antigen (PSA) response rate | Measure | PSA progression-free survival (PFS) | Measure | Time to disease recurrence | Measure | Time to antiandrogen therapy (ADT) | Measure | Rate of undetectable PSA | Measure | Incidence of adverse events | Measure | Assess impact of study treatment on Change in quality of life over 3 years |
Time Frame | At 6 months after completion of treatment | Time Frame | Time elapsed between completion of treatment (salvage + – adjuvant) and the first occurrence of confirmed PSA progression, assessed up to 3 years | Time Frame | Time elapsed between study enrollment and first occurrence of confirmed radiographic disease progression, assessed up to 3 years | Time Frame | Time elapsed between study enrollment and initiation of ADT up to 3 years | Time Frame | Up to 3 years | Time Frame | Up to 3 years | Time Frame | Up to 3 years |
Description | Defined according to Prostate Cancer Working Group (PCWG3) criteria as the proportion of patients achieving a PSA decline >= 50% at 6 months after completion of treatment (salvage + – adjuvant). All study data will use descriptive statistics and will be exploratory only. | Description | Assessed according to PCWG3 criteria. All study data will use descriptive statistics and will be exploratory only. | Description | Time from study enrollment until the date of confirmed radiographic disease progression as defined by RECIST 1.1 and PCWG3. | Description | All study data will use descriptive statistics and will be exploratory only. | Description | Patients previously treated with prostatectomy evaluate the proportion of patients whose PSA remains =< 0.2 ng/mL after 6 and 12 months following completion of treatment (salvage + – adjuvant). All study data will use descriptive statistics and will be exploratory only. | Description | Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All study data will use descriptive statistics and will be exploratory only. | Description | Quality of Life (QOL) questionnaires (FACT-P and Expanded Prostate Cancer Index Composite EPIC-26) administered at screening, response assessment visit, and each follow up visit. |
Browse Conditions
Sequence: | 193161848 | Sequence: | 193161849 | Sequence: | 193161850 | Sequence: | 193161851 | Sequence: | 193161852 |
Mesh Term | Neoplasms | Mesh Term | Neoplasms, Second Primary | Mesh Term | Recurrence | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | neoplasms | Downcase Mesh Term | neoplasms, second primary | Downcase Mesh Term | recurrence | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48243722 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Utah |
Overall Officials
Sequence: | 29237974 |
Role | Principal Investigator |
Name | Alejandro Sanchez |
Affiliation | Huntsman Cancer Institute/ University of Utah |
Central Contacts
Sequence: | 11991441 |
Contact Type | primary |
Name | Kristen Jewkes |
Phone | 801-587-4776 |
Kristen.Jewkes@hci.utah.edu | |
Role | Contact |
Design Group Interventions
Sequence: | 68039776 | Sequence: | 68039777 | Sequence: | 68039778 | Sequence: | 68039779 | Sequence: | 68039780 | Sequence: | 68039781 | Sequence: | 68039782 | Sequence: | 68039783 | Sequence: | 68039784 | Sequence: | 68039785 | Sequence: | 68039786 | Sequence: | 68039787 | Sequence: | 68039788 |
Design Group Id | 55503652 | Design Group Id | 55503654 | Design Group Id | 55503654 | Design Group Id | 55503653 | Design Group Id | 55503654 | Design Group Id | 55503652 | Design Group Id | 55503653 | Design Group Id | 55503654 | Design Group Id | 55503652 | Design Group Id | 55503653 | Design Group Id | 55503654 | Design Group Id | 55503652 | Design Group Id | 55503654 |
Intervention Id | 52402533 | Intervention Id | 52402533 | Intervention Id | 52402534 | Intervention Id | 52402535 | Intervention Id | 52402535 | Intervention Id | 52402536 | Intervention Id | 52402536 | Intervention Id | 52402536 | Intervention Id | 52402537 | Intervention Id | 52402537 | Intervention Id | 52402537 | Intervention Id | 52402538 | Intervention Id | 52402538 |
Eligibilities
Sequence: | 30718003 |
Gender | Male |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Histologically proven adenocarcinoma of the prostate. Recurrent prostate carcinoma after definitive therapy for primary disease defined as: Post-prostatectomy (with/without adjuvant radiotherapy): Patients must have a detectable or rising PSA level that is > 0.05 ng/mL, with a second confirmatory level of > 0.05 ng/mL after a minimum of 1 week. Subjects treated with prior definitive radiotherapy for prostate cancer who have positive molecular imaging (e.g., fluciclovine PET/CT scan or other per PI discretion) suggesting recurrent intraprostatic disease must undergo transrectal ultrasound (TRUS) biopsy less than or equal to one year before study enrollment: If the TRUS biopsy is negative, no additional treatment is required to the prostate in addition to that of scan positive sites. Exclusion Criteria: Known brain or visceral metastases other than lymph nodes as defined by CT, MRI, or othermolecular imaging (e.g., fluciclovine PET/CT or PSMA PET/CT scan or other per PI discretion). Active, uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: Cardiovascular disorders: Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253954834 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30464524 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26627177 | Sequence: | 26627178 | Sequence: | 26627179 | Sequence: | 26627180 | Sequence: | 26627181 | Sequence: | 26627182 | Sequence: | 26627183 | Sequence: | 26627184 | Sequence: | 26627185 |
Intervention Id | 52402533 | Intervention Id | 52402533 | Intervention Id | 52402534 | Intervention Id | 52402534 | Intervention Id | 52402534 | Intervention Id | 52402536 | Intervention Id | 52402538 | Intervention Id | 52402538 | Intervention Id | 52402538 |
Name | Hypofractionated Radiotherapy | Name | hypofractionation | Name | IMRT | Name | Intensity Modulated RT | Name | Intensity-Modulated Radiotherapy | Name | Quality of Life Assessment | Name | SABR | Name | SBRT | Name | Stereotactic Ablative Body Radiation Therapy |
Responsible Parties
Sequence: | 28830978 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796754
2019-01-21
https://zephyrnet.com/?p=NCT03796754
NCT03796754https://www.clinicaltrials.gov/study/NCT03796754?tab=tableNANANAThe aim of this study is a first evaluation of the effectiveness of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) to evaluate potential effects in stress reduction and concomitant psychological parameters.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-09-29 |
Start Month Year | January 21, 2019 |
Primary Completion Month Year | February 15, 2020 |
Verification Month Year | September 2022 |
Verification Date | 2022-09-30 |
Last Update Posted Date | 2022-09-29 |
Facilities
Sequence: | 198397120 |
Name | Charite University |
City | Berlin |
Zip | 14109 |
Country | Germany |
Conditions
Sequence: | 51725090 |
Name | Stress, Psychological |
Downcase Name | stress, psychological |
Id Information
Sequence: | 39804022 |
Id Source | org_study_id |
Id Value | YoBEKA |
Countries
Sequence: | 42203025 |
Name | Germany |
Removed | False |
Design Groups
Sequence: | 55144774 | Sequence: | 55144775 |
Group Type | Active Comparator | Group Type | No Intervention |
Title | YoBEKA Intervention | Title | Control group |
Interventions
Sequence: | 52046656 |
Intervention Type | Behavioral |
Name | YoBEKA |
Description | The teachers and students of the YoBEKA study arm receive a guided YoBEKA practice from an experienced YoBEKA trainer during the regular 4 month intervention period. The YoBEKA program is based on a combination of different, easy to perform exercises appropriate to the school situation, consisting of postures, verses for speech, song and movement, affirmations in movement to promote balance and coordination, and various rest and silence exercises to promote body awareness and relaxation techniques. The teaching is ideologically neutral and without religious background. The participating teachers receive an initial two-hour YoBEKA introductory course. Every 2 weeks there is a one to two-hour training course. The pedagogical specialists are supported once a week by an experienced YoBEKA trainer. The teachers are encouraged to integrate the learned exercises independently and regularly into their everyday school life. |
Design Outcomes
Sequence: | 175926398 | Sequence: | 175926395 | Sequence: | 175926396 | Sequence: | 175926397 | Sequence: | 175926399 | Sequence: | 175926400 | Sequence: | 175926401 | Sequence: | 175926402 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other |
Measure | Teacher anxiety and stress inventory (LASI) | Measure | Questionnaire on the assessment of stress and stress management in childhood and adolescence – Revision (SSKJ 3-8 R) | Measure | Inventory of the quality of life of children and adolescents (KIDSCREEN-27 children) | Measure | Perceived Stress Scale (PSS) | Measure | Screening for somatoform disorders of childhood and adolescence (SOMS-E) | Measure | Inventory of the quality of life of children and adolescents (KIDSCREEN-52 parents) | Measure | Heart rate variability | Measure | Qualitative interviews |
Time Frame | Change Baseline, 4 months, 12 months | Time Frame | Change baseline, 4 months | Time Frame | Change Baseline, 4 months, 12 months | Time Frame | Change Baseline, 4 months, 12 months | Time Frame | Change Baseline, 4 months, 12 months | Time Frame | Change Baseline, 4 months, 12 months | Time Frame | Baseline, 4 months, 12 months | Time Frame | 4 months, 12 months |
Description | Filled out by teachers, assessing LASI 2, range 46-230, higher score meaning a better outcome | Description | Filled out by students, assessing composite score (range 29-94): subscale 1 (stress-vulnerability [range 7-28]) summed with subscale 3 (stress symptoms and well-being [range 22-66]), lower score meaning a better outcome | Description | Filled out by students, assessing full scale, range 27-135, lower score meaning a better outcome | Description | Filled out by teachers, assessing full scale, range 0-40, lower score meaning a better outcome | Description | Filled out by parents, assessing full scale, range 55-110, lower score meaning a better outcome | Description | Filled out by parents, assessing full scale, range 27-135, lower score meaning a better outcome | Description | Assessed with Faros 180 over 24 hours | Description | Semi-structured interviews in focus groups |
Browse Conditions
Sequence: | 191692408 | Sequence: | 191692409 |
Mesh Term | Stress, Psychological | Mesh Term | Behavioral Symptoms |
Downcase Mesh Term | stress, psychological | Downcase Mesh Term | behavioral symptoms |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47905217 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Charite University, Berlin, Germany |
Design Group Interventions
Sequence: | 67604820 |
Design Group Id | 55144774 |
Intervention Id | 52046656 |
Eligibilities
Sequence: | 30505404 |
Gender | All |
Minimum Age | 6 Years |
Maximum Age | 12 Years |
Healthy Volunteers | No |
Criteria | Inclusion criteria:
Students from participating primary schools in Berlin aged 6-12 years Exclusion criteria: Serious chronic or acute diseases |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254050981 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 13 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 6 |
Maximum Age Num | 12 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Number Of Other Outcomes To Measure | 2 |
Designs
Sequence: | 30254489 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28634979 |
Responsible Party Type | Principal Investigator |
Name | Andreas Michalsen |
Title | Principal Investigator |
Affiliation | Charite University, Berlin, Germany |
]]>
https://zephyrnet.com/NCT03796741
2016-03-17
https://zephyrnet.com/?p=NCT03796741
NCT03796741https://www.clinicaltrials.gov/study/NCT03796741?tab=tableNANANAObservational, prospective multicentric, national study, evaluating the diagnostic and therapeutic pathways of patient with cronic coronary artery disease followed in Italian cardiology centers.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-20 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-02-03 |
Start Month Year | March 17, 2016 |
Primary Completion Month Year | February 28, 2018 |
Verification Month Year | December 2018 |
Verification Date | 2018-12-31 |
Last Update Posted Date | 2021-02-03 |
Detailed Descriptions
Sequence: | 20780382 |
Description | Coronary heart disease is still highly prevalent in the world, and chronic stable angina is one of the most common clinical presentations of this disease. The objectives of chronic stable angina treatment include the reduction of symptoms, the inhibition or slowing of the progression of the disease, the prevention of associated cardiovascular events such as myocardial infarction, and the possible improvement of survival.The results of COURAGE Study and of meta-analysis of more recent studies demonstrate that patients in optimized medical therapy (OMT) (aspirin, beta-blocker and statin in association with an ACE-inhibitor and strict control of risk factors). ) the percutaneous coronary revascularization procedure (PCI) did not lead to an improvement in the cardiovascular prognosis. These data led the groups in charge of drafting the guidelines to recommend OMT as an initial treatment of stable angina, reserving the revascularization procedure for those patients with symptoms not adequately controlled by medical therapy.
It is therefore considered appropriate to plan a registry in patients with stable coronary artery disease that has the ability to describe in the heterogeneity of Italian cardiological centers the current characteristics of these patients, their treatment modalities, adherence to the current guidelines both as regards invasive therapy that the optimized medical, the use and the total cost of the resources needed to manage this pathology, the clinical course one year after entering the register. Consecutive patients discharged (after an ordinary or day hospital admission) or managed as outpatient at Cardiology department participating in the project with a diagnosis of stable coronary artery disease will be included in the register. Enrollment will last 3 months in each center, starting with the first enrolled patient, or up to 50 patients enrolled. |
Facilities
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Name | Ospedale San Giovanni Di Dio – Uo Cardiologia E Utic | Name | Istituto Scientifico Inrca – Uo Cardiologia/Utic/Telecardiologia | Name | Ospedale Civile Profili – U.O. Cardiologia | Name | Ospedale Di Jesi Carlo Urbani – U.O. Di Cardiologia | Name | Ospedale Principe Di Piemonte – Uoc Cardiologia Utic | Name | Ospedale Gen.Le Prov.Le C.G. Mazzoni – Sc Cardiologia | Name | Ospedale Madonna Del Soccorso – Uoc Cardiologia Indirizzo Riabilitativo | Name | Ospedale Valdichiana Santa Margherita – Uos Cardiologia E Hdu | Name | Aorn San Giuseppe Moscati – U.O. Cardiologia/Utic 'D. Rotiroti' | Name | Ospedale San Paolo – Cardiologia-Utic | Name | Ospedale Policlinico – U.O. Di Cardiologia Ospedaliera | Name | Ics Maugeri Spa Societa' Benefit – Uo Cardiologia | Name | Ospedale Umberto I – Uosd Di Cardiologia | Name | P.O. Don Tonino Bello – Uosd Cardiologia | Name | Asst Papa Giovanni Xxiii – Cardiologia 1 | Name | Iob – Policlinico San Marco – U.O. Cardiologia | Name | Ospedale Civile – Sc Cardiologia | Name | Ospedale Santa Maria Del Prato – U.O. Di Cardiologia | Name | Azienda Ospedaliera G. Rummo – Cardiologia Interventistica E Utic | Name | Ospedale Perrino – U.O.C. Di Cardiologia | Name | Ospedale Civile Dario Camberlingo – U.O. Di Cardiologia – Utic | Name | Ospedale Civile 'La Memoria' – U.O. Di Cardiologia | Name | Ics Maugeri Spa Societa' Benefit – U.O. Di Cardiologia Riabilitativa | Name | Osp. Andria Canosa – Po Andria – Cardiologia – Utic | Name | Ospedale Monsignor Angelo R. Di Miccoli – Unita' Operativa Di Cardiologia | Name | Presidio Ospedaliero Ss Trinita' – Sc Di Cardiologia | Name | Azienda Ospedaliera G. Brotzu – Struttura Complessa Di Cardiologia | Name | Ospedale A. Cardarelli – U.O. Cardiologia E Utic | Name | Presidio Ospedaliero Moscati – U.O.C. Cardiologia | Name | Az. Ospedaliera S. Anna E S. Sebastiano – Cardiologia E Riabilit. Cardiologica | Name | Az. Ospedaliera S. Anna E S. Sebastiano – U.O. Cardiologia-Utic | Name | Pineta Grande Hospital – U.O. Cardiologia | Name | Ospedale Civile Ave Gratia Plena – U.O. Di Cardiologia E Utic | Name | Ospedale San Giuseppe E Melorio – U.O.C. Cardiologia Utic | Name | Presidio Ospedaliero San Rocco – U.O.C. Cardiologia – Utic | Name | Po Vittorio Emanuele Di Gela – U.O.C Cardiologia – Utic | Name | Ospedale Moriggia Pelascini – Unita' Operativa Di Cardiologia | Name | Ospedale Civile Oglio Po – U.O. Di Cardiologia-Utic | Name | Ospedale Di Cremona – Uo Di Cardiologia | Name | Capt Di Cariati – Ambulatorio Di Cardiologia | Name | Ospedale Annunziata – Uoc Cardiologia | Name | Ospedale Civile Minervini – Medicina Interna | Name | P.O. Garibaldi-Nesima – U.O.C. Di Cardiologia | Name | Ospedale Giovanni Paolo Ii – U.O. Cardiologia E Utic | Name | I.R.C.C.S. Oasi Maria Ss. – U.O. Cardiologia | Name | Ospedale M.Bufalini – U.O. Di Cardiologia-Utic | Name | Ospedale Ss. Annunziata – U.O. Di Cardiologia | Name | Arcispedale Sant'Anna – U.O. Cardiologia – Utic | Name | Ospedale Civile Giuseppe Tatarella – U.O. Di Cardiologia – Utic | Name | Ospedali Riuniti – S.C. Di Cardiologia Univ.-Utic | Name | Ospedale Casa Sollievo Della Sofferenza – Cardiologia – Utic – Riabil Cardiologica | Name | Ospedale Civile Augusto Murri – U.O. Cardiologia | Name | Ospedale Padre Antero Micone – Sc Cardiologia – Utic | Name | Ospedale San Giovanni Di Dio – S.O.C. Cardiologia | Name | Ospedale Civile San Polo – S.O.C. Cardiologia | Name | Ospedale Della Misericordia – U.O. Di Cardiologia | Name | Ospedale Civile – U.O. Cardiologia-Utic | Name | Presidio Ospedaliero – U.O. Cardiologia | Name | Ospedale F. Veneziale – Ssd Cardiologia Emodinamica | Name | Ospedale San Giuseppe Da Copertino – U.O. Di Cardiologia-Utic | Name | Ospedale Santa Caterina Novella – U.O. Di Cardiologia | Name | Casa Di Cura Petrucciani – U.O. Cardiologia – Card. Riabilitativa | Name | Ospedale Vito Fazzi – U.O. Card. Interventistica – Emodinamica | Name | Ospedale Vito Fazzi – U.O. Di Cardiologia | Name | Ospedale Ignazio Veris Delli Ponti – Uoc Cardiologia-Utic | Name | Azienda Osp. Cardinale G. Panico – U.O. Cardiologia – Utic | Name | Ospedale Villamarina – Cardiologia E Utic | Name | Casa Di Cura Citta' Di Aprilia – U.O. Cardiologia | Name | Ospedale Del Dono Svizzero – U.O.C. Di Cardiologia – Utic | Name | Polo Ospedaliero Integrato (C/O Icot) – Uoc Cardiologia Ed Emodinamica Univ. | Name | Nuovo Ospedale Versilia – Sc Cardiologia | Name | Ospedale Carate Brianza – Cardiologia – Carate Brianza/Giussano | Name | Policlinico Di Monza – Uo Cardiol. Clinica E Scompenso Cardiaco | Name | Presidio Osp. Di Civitanova Marche – Sc Cardiologia | Name | P.O. Sant'Agata Di Militello – Uoc Cardiologia | Name | Ospedale Civile – Uo Cardiologia | Name | Ospedale Civile Fornaroli – U.O. Cardiologia | Name | Istituto Clinico Citta' Studi – U.O. Cardiologia | Name | Ospedale San Raffaele – Utic E Subintensiva | Name | Ospedale San Carlo Borromeo – Cardiologia-Ucc | Name | Istituto Clinico Humanitas – Uo Emodinamica Cardiologia Invasiva Ucc | Name | Irccs Policlinico San Donato – U.O. Cardiologia Con Utic | Name | Irccs Policlinico Multimedica – Uo Di Cardiologia | Name | Ospedale Di Vizzolo Predabissi – Uo Cardiologia E Ucc | Name | Ospedale Di Sassuolo – Cardiologia | Name | Ftgm – Stabilimento Di Massa – Uoc Cardiologia Diagn. E Interventistica | Name | Ospedale Apuane – U.O. Cardiologia-Utic | Name | Ospedale San Francesco – Cardiologia – Utic | Name | Casa Di Cura Candela – Uof Cardiologia | Name | Aor Villa Sofia-Cervello P.O. Cervello – U.O. Cardiologia – Cervello | Name | Ospedale Di Camposampiero – U.O.A. Cardiologia | Name | Ospedale Civile Dello Spirito Santo – Utic E Cardiologia Interventistica | Name | Presidio Ospedaliero Citta' Di Castello – U.O. Di Cardiologia | Name | Ospedale Di Pordenone – S.O.C. Cardiologia | Name | Ospedale Di S. Vito Al Tagliamento – S.O.C. Cardiologia | Name | Fondazione Irccs Policlinico San Matteo – Cardiologia | Name | Ics Maugeri Spa Societa' Benefit – U.O. Di Riabilitazione Cardiologica | Name | Istituto Di Cura Citta' Di Pavia – U.O. Cardiologia Ii | Name | Ospedale Civile – Cardiologia | Name | Ospedale S. Giovanni Di Dio – U.O. Cardiologia E Utic | Name | Azienda Ospedaliera San Carlo – S.S.D. Cardiologia Riabilitativa | Name | Ospedale Per Gli Infermi – U.O. Cardiologia – Utic | Name | Ospedale Civile – U.O. Di Cardiologia | Name | Ospedale Civile Santa Maria Delle Croci – U.O. Di Cardiologia | Name | Ospedale Civile – S.O.C. Cardiologia-Utic | Name | Ospedale Tiberio Evoli Riabilitazione – Cardio-Respiratoria | Name | Ospedale Santa Maria Degli Ungheresi – U.O. Di Cardiologia | Name | Ao Bianchi Melacrino Morelli- Po Riuniti – Divisione Di Cardiologia | Name | Ospedale Civile San Sebastiano – Sos Cardiologia Area Nord | Name | Ospedale Civile – Sc Cardiologia Area Nord | Name | Arcispedale Santa Maria Nuova – S.C. Cardiologia | Name | Giovanni Paolo Ii – U.O.C. Cardiologia-Utic | Name | Ospedale Riccardo Guzzardi – U.O.C. Di Cardiologia-Utic | Name | P.O. San Camillo de Lellis – U.O.C. Cardiologia | Name | Ospedali Riuniti Anzio-Nettuno – U.O. Di Cardiologia – Utic | Name | Nuovo Ospedale Dei Castelli – U.O.C. Di Cardiologia E Utic | Name | Ospedale Civile San Paolo – U.O. Cardiologia – Utic | Name | Policlinico Citta' Di Pomezia S. Anna – U.O. Cardiologia-Utic | Name | Campus Biomedico – Cardiologia | Name | P.O. San Filippo Neri – Asl Roma 1 – Uoc Cardiologia E Utic | Name | European Hospital – Uo. Cardiologia Interventistica | Name | Ospedale San Camillo – Cardiologia 2 (Ex Cardio 3) | Name | Ospedale San Camillo – Uoc Cardiologia 1 | Name | Ospedale Sandro Pertini – Uoc Cardiologia | Name | Policlinico Umberto Primo – Cardiologia B – Cardiologia E Angiologia | Name | Policlinico Umberto Primo – Malattie Cardiovascolari A | Name | Aurelia Hospital – U.O.C Cardiologia | Name | Ospedale Madre Giuseppina Vannini – U.O.C. Cardiologia | Name | Ospedale San Pietro Fatebenefratelli – U.O Complessa Di Cardiologia | Name | Ospedale Sant'Andrea Di Roma – U.O.C. Cardiologia | Name | Ospedale Santo Spirito – U.O.C. Di Cardiologia | Name | Ospedale San Giovanni Evangelista – U.O.C. Di Cardiologia – Utic | Name | Ospedale Santa Maria Della Misericordia – U.O.C. Cardiologia | Name | Presidio Osped. S. Maria Della Speranza – U.O. Di Cardiologia | Name | Ospedale Di Roccadaspide – Cardiologia-Utic | Name | Aou S. Giovanni Di Dio-Ruggi D'Aragona – Uoc Cardiologia Preventiva | Name | Ospedale San Luca – U.O. Utic – Cardiologia | Name | Ospedale Dell'Alta Val D'Elsa – Uosd Cardiologia-Utic | Name | Aou Senese Ospedale S. Maria Alle Scotte – U.O.C. Cardiologia Ospedaliera | Name | Ospedale San Bartolomeo – U.O. Cardiologia Clinica-Riabilitativa | Name | Ospedale E. Muscatello – U.O. Di Cardiologia – Utic | Name | Ospedale G. Di Maria – Cardiologia Utic | Name | Ospedale Umberto I – Uoc Cardiologia E Utic | Name | Ospedale Civile M. Giannuzzi – Cardiologia E Utic | Name | Casa Di Cura Villa Verde – Cardiologia | Name | Ospedale Civile G. Mazzini -Cardiologia Utic Ed Emodinamica | Name | Ospedale Santa Chiara – Divisione Di Cardiologia | Name | Por Cirie'- Lanzo Presidio Cirie' – S.C. Cardiologia Cirie'- Ivrea | Name | Ospedale Civile – S.C. Cardiologia Cirie' Ivrea | Name | Maria Pia Hospital – U.O. Cardiologia | Name | Ospedale Ss. Vito E Spirito – U.O.S. Di Cardiologia | Name | Presidio Ospedaliero Paolo Borsellino – U.O.C Cardiologia- Utic | Name | Ospedale S. Maria Della Stella – Sc Di Cardiologia | Name | Ospedali Riuniti – Osp. Maggiore – A.F. Cardiologia E Riabil. Cardiologica | Name | Ospedale Santa Maria Dei Battuti – U.O. Di Cardiologia | Name | Pou Santa Maria Della Misericordia – S.O.C. Cardiologia | Name | Ospedale S. Antonio Abate – U.O. Di Cardiologia | Name | Presidio Ospedaliero Di Saronno – U.O.C. Di Cardiologia | Name | Ospedale Di Circolo A. Bellini – Medicina Generale E Card. Riabilitativa | Name | Ospedale Di Circolo Galmarini – Cardiologia | Name | Ospedale Di Circolo E Fondazione Macchi – Cardiologia I | Name | Ospedale Sant'Andrea – Sc Cardiologia | Name | Ospedale Civile – U.O.C. Cardiologia | Name | Ospedale Civile Di Venezia – U.O. Di Cardiologia | Name | Ospedale Civile – U.O.C. Cardiologia | Name | Centro Polifunzionale Boldrini – Cardiologia Riabilitativa-Cardioaction | Name | Ospedale G. Fracastoro – U.O.C. Di Cardiologia | Name | Ospedale Belcolle – U.O.C. Cardiologia Utic Emodinamica | Name | Clinica Citta' Di Alessandria – Uo Cardiologia | Name | Ospedale Civile Di Boscotrecase – Utic Cardiologia | Name | Ospedale San Giovanni Di Dio – Uo Cardiologia – Utic | Name | Ospedale Generale Di Zona – U.O. Cardiologia – Utic | Name | Clinica Mediterranea – U.O. Di Cardiologia | Name | Aorn Cardarelli – U.O. Cardiologia Con Utic | Name | Aorn Osp. Dei Colli- Po Vincenzo Monaldi – U.O.C. Cardiologia E Utic 'Vanvitelli' | Name | Aorn Osp. Dei Colli- Po Vincenzo Monaldi – U.O.C. Cardiologia | Name | Ospedale San Gennaro – U.O. Cardiologia E Riabilitazione Card. | Name | Ospedale Del Mare – U.O. Cardiologia Con Utic | Name | Aou Maggiore Della Carita' – Cardiologia Ii | Name | Aou Maggiore Della Carita' Scdu Clinica Cardiologica-Cardiologia I | Name | Clinica San Gaudenzio – Uoa Cardiologia | Name | Casa Di Salute Santa Lucia – U.O. Cardiologia | Name | Ics Maugeri Spa Societa' Benefit – Uo Cardiologia Riabilitativa |
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Zip | 92100 | Zip | 60131 | Zip | 60044 | Zip | 60035 | Zip | 60019 | Zip | 63100 | Zip | 63074 | Zip | 52044 | Zip | 83100 | Zip | 70123 | Zip | 70124 | Zip | 70020 | Zip | 70033 | Zip | 70056 | Zip | 24127 | Zip | 24046 | Zip | 32100 | Zip | 32032 | Zip | 82100 | Zip | 72100 | Zip | 72021 | Zip | 25085 | Zip | 25065 | Zip | 76123 | Zip | 76121 | Zip | 09121 | Zip | 09134 | Zip | 86100 | Zip | 81031 | Zip | 81100 | Zip | 81100 | Zip | 81030 | Zip | 81016 | Zip | 81055 | Zip | 81037 | Zip | 93012 | Zip | 22015 | Zip | 26041 | Zip | 26100 | Zip | 87063 | Zip | 87100 | Zip | 87026 | Zip | 95122 | Zip | 88046 | Zip | 94018 | Zip | 47023 | Zip | 44042 | Zip | 44124 | Zip | 71042 | Zip | 71100 | Zip | 71013 | Zip | 63900 | Zip | 16153 | Zip | 34170 | Zip | 34074 | Zip | 58100 | Zip | 18100 | Zip | 18038 | Zip | 86170 | Zip | 73043 | Zip | 73013 | Zip | 73100 | Zip | 73100 | Zip | 73100 | Zip | 73020 | Zip | 73039 | Zip | 57025 | Zip | 04011 | Zip | 04023 | Zip | 04100 | Zip | 55043 | Zip | 20048 | Zip | 20900 | Zip | 62012 | Zip | 98076 | Zip | 20025 | Zip | 20013 | Zip | 20131 | Zip | 20132 | Zip | 20153 | Zip | 20089 | Zip | 20097 | Zip | 20099 | Zip | 20077 | Zip | 41049 | Zip | 54100 | Zip | 54100 | Zip | 08100 | Zip | 90141 | Zip | 90146 | Zip | 35012 | Zip | 65124 | Zip | 06012 | Zip | 33170 | Zip | 33078 | Zip | 27100 | Zip | 27100 | Zip | 27100 | Zip | 27029 | Zip | 85025 | Zip | 85100 | Zip | 48018 | Zip | 48022 | Zip | 48100 | Zip | 89044 | Zip | 89063 | Zip | 89024 | Zip | 89124 | Zip | 42015 | Zip | 42016 | Zip | 42100 | Zip | 97100 | Zip | 97019 | Zip | 02100 | Zip | 00042 | Zip | 00040 | Zip | 00053 | Zip | 00040 | Zip | 00128 | Zip | 00135 | Zip | 00149 | Zip | 00152 | Zip | 00152 | Zip | 00157 | Zip | 00161 | Zip | 00161 | Zip | 00163 | Zip | 00177 | Zip | 00189 | Zip | 00189 | Zip | 00193 | Zip | 00019 | Zip | 45100 | Zip | 84091 | Zip | 84069 | Zip | 84131 | Zip | 84078 | Zip | 53036 | Zip | 53100 | Zip | 19038 | Zip | 96011 | Zip | 96012 | Zip | 96100 | Zip | 74024 | Zip | 74100 | Zip | 64100 | Zip | 38122 | Zip | 10073 | Zip | 10015 | Zip | 10132 | Zip | 91011 | Zip | 91025 | Zip | 05018 | Zip | 34125 | Zip | 31015 | Zip | 33100 | Zip | 21013 | Zip | 21047 | Zip | 21019 | Zip | 21049 | Zip | 21100 | Zip | 13100 | Zip | 30019 | Zip | 30122 | Zip | 36071 | Zip | 36016 | Zip | 37047 | Zip | 01100 | Zip | 15100 | Zip | 80042 | Zip | 80027 | Zip | 80014 | Zip | 80122 | Zip | 80131 | Zip | 80131 | Zip | 80131 | Zip | 80136 | Zip | 80142 | Zip | 28100 | Zip | 28100 | Zip | 28100 | Zip | 80047 | Zip | 28010 |
Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy |
Conditions
Sequence: | 52321457 |
Name | Chronic Ischemic Heart Disease |
Downcase Name | chronic ischemic heart disease |
Id Information
Sequence: | 40266176 |
Id Source | org_study_id |
Id Value | K14 |
Countries
Sequence: | 42685681 |
Name | Italy |
Removed | False |
Interventions
Sequence: | 52632608 |
Intervention Type | Other |
Name | Data collection on Stable Ischemic heart disease |
Description | No intervention only description of management and treatment |
Design Outcomes
Sequence: | 177934596 | Sequence: | 177934592 | Sequence: | 177934593 | Sequence: | 177934594 | Sequence: | 177934595 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Angina recurrence rate | Measure | Number of patients in medical therapy and that underwent revascularization | Measure | Number of patient in optimal medical therapy | Measure | Mortality rate | Measure | All cause hospitalization rate |
Time Frame | 12 months Follow-up | Time Frame | Enrollment | Time Frame | 12 months Follow-up | Time Frame | 12 months Follow-up | Time Frame | 12 months Follow-up |
Description | Rate of patients with angina symtoms | Description | Number of patients in medical therapy and that underwent revascularization | Description | Patient treated according to International Guidelines | Description | Rate of patients died | Description | Rate of patients hospitalized |
Browse Conditions
Sequence: | 194059032 | Sequence: | 194059033 | Sequence: | 194059034 | Sequence: | 194059035 | Sequence: | 194059036 | Sequence: | 194059037 | Sequence: | 194059038 | Sequence: | 194059039 |
Mesh Term | Coronary Artery Disease | Mesh Term | Myocardial Ischemia | Mesh Term | Coronary Disease | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Arteriosclerosis | Mesh Term | Arterial Occlusive Diseases | Mesh Term | Vascular Diseases |
Downcase Mesh Term | coronary artery disease | Downcase Mesh Term | myocardial ischemia | Downcase Mesh Term | coronary disease | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | arteriosclerosis | Downcase Mesh Term | arterial occlusive diseases | Downcase Mesh Term | vascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48460065 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Heart Care Foundation |
Overall Officials
Sequence: | 29365371 |
Role | Study Chair |
Name | Leonardo De Luca, MD |
Affiliation | Heart Care Foundation |
Eligibilities
Sequence: | 30852372 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Consecutive patients discharged (after a hospitalization or DH hospitalization) or managed as outpatients in Cardiology department with diagnoses of stable coronary heart disease. |
Criteria | Inclusion Criteria:
Patients aged >/= 18 Exclusion Criteria: Acute coronary syndrome within 30 days from enrollment |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254272145 |
Number Of Facilities | 183 |
Registered In Calendar Year | 2018 |
Actual Duration | 23 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30598224 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28964714 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52225969 | Sequence: | 52225970 | Sequence: | 52225971 | Sequence: | 52225972 | Sequence: | 52225973 | Sequence: | 52225974 | Sequence: | 52225975 | Sequence: | 52225976 | Sequence: | 52225977 |
Pmid | 30001355 | Pmid | 30039543 | Pmid | 31969932 | Pmid | 32470532 | Pmid | 32559279 | Pmid | 32830646 | Pmid | 33422564 | Pmid | 29124952 | Pmid | 30649303 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | result | Reference Type | result |
Citation | De Luca L, Temporelli PL, Lucci D, Colivicchi F, Calabro P, Riccio C, Amico A, Mascia F, Proia E, Di Lenarda A, Gulizia MM; START Investigators. Characteristics, treatment and quality of life of stable coronary artery disease patients with or without angina: Insights from the START study. PLoS One. 2018 Jul 12;13(7):e0199770. doi: 10.1371/journal.pone.0199770. eCollection 2018. | Citation | De Luca L, Arca M, Temporelli PL, Colivicchi F, Gonzini L, Lucci D, Bosco B, Callerame M, Lettica GV, Di Lenarda A, Gulizia MM; START Investigators. Prevalence and pharmacologic management of familial hypercholesterolemia in an unselected contemporary cohort of patients with stable coronary artery disease. Clin Cardiol. 2018 Aug;41(8):1075-1083. doi: 10.1002/clc.23031. Epub 2018 Aug 20. | Citation | Colivicchi F, Massimo Gulizia M, Arca M, Luigi Temporelli P, Gonzini L, Venturelli V, Morici N, Indolfi C, Gabrielli D, De Luca L. Lipid Lowering Treatment and Eligibility for PCSK9 Inhibition in Post-Myocardial Infarction Patients in Italy: Insights from Two Contemporary Nationwide Registries. Cardiovasc Ther. 2020 Jan 3;2020:3856242. doi: 10.1155/2020/3856242. eCollection 2020. | Citation | De Luca L, Arca M, Temporelli PL, Meessen J, Riccio C, Bonomo P, Colavita AR, Gabrielli D, Gulizia MM, Colivicchi F; START Investigators. Current lipid lowering treatment and attainment of LDL targets recommended by ESC/EAS guidelines in very high-risk patients with established atherosclerotic cardiovascular disease: Insights from the START registry. Int J Cardiol. 2020 Oct 1;316:229-235. doi: 10.1016/j.ijcard.2020.05.055. Epub 2020 May 26. | Citation | De Luca L, Formigli D, Meessen J, Uguccioni M, Cosentino N, Paolillo C, Di Lenarda A, Colivicchi F, Gabrielli D, Gulizia MM, Scherillo M; START Investigators. COMPASS criteria applied to a contemporary cohort of unselected patients with stable coronary artery diseases: insights from the START registry. Eur Heart J Qual Care Clin Outcomes. 2021 Sep 16;7(5):513-520. doi: 10.1093/ehjqcco/qcaa054. | Citation | De Luca L, Uguccioni M, Meessen J, Temporelli PL, Tomai F, De Rosa FM, Passamonti E, Formigli D, Riccio C, Gabrielli D, Colivicchi F, Gulizia MM, Perna GP. External applicability of the ISCHEMIA trial: an analysis of a prospective, nationwide registry of patients with stable coronary artery disease. EuroIntervention. 2020 Dec 18;16(12):e966-e973. doi: 10.4244/EIJ-D-20-00610. | Citation | De Luca L, Temporelli PL, Amico AF, Gonzini L, Uguccioni M, Varani E, Brunetti ND, Colivicchi F, Gabrielli D, Gulizia MM. Impact of history of depression on 1-year outcomes in patients with chronic coronary syndromes: An analysis of a contemporary, prospective, nationwide registry. Int J Cardiol. 2021 May 15;331:273-280. doi: 10.1016/j.ijcard.2020.12.086. Epub 2021 Jan 8. | Citation | De Luca L, Temporelli PL, Lucci D, Gonzini L, Riccio C, Colivicchi F, Geraci G, Formigli D, Maras P, Falcone C, Di Lenarda A, Gulizia MM; START Investigators. Current management and treatment of patients with stable coronary artery diseases presenting to cardiologists in different clinical contexts: A prospective, observational, nationwide study. Eur J Prev Cardiol. 2018 Jan;25(1):43-53. doi: 10.1177/2047487317740663. Epub 2017 Nov 10. | Citation | De Luca L, Temporelli PL, Riccio C, Gonzini L, Marinacci L, Tartaglione SN, Costa P, Scherillo M, Senni M, Colivicchi F, Gulizia MM; START Investigators. Clinical outcomes, pharmacological treatment, and quality of life of patients with stable coronary artery diseases managed by cardiologists: 1-year results of the START study. Eur Heart J Qual Care Clin Outcomes. 2019 Oct 1;5(4):334-342. doi: 10.1093/ehjqcco/qcz002. |
]]>
https://zephyrnet.com/NCT03796728
2018-12-19
https://zephyrnet.com/?p=NCT03796728
NCT03796728https://www.clinicaltrials.gov/study/NCT03796728?tab=tableNANANAThis is an open-label, multi-center, study where eligible participants will undergo treatment with Juvéderm® VOLIFT™ with Lidocaine injected into the lips for lip augmentation.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-17 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-07-28 |
Start Month Year | December 19, 2018 |
Primary Completion Month Year | June 9, 2020 |
Verification Month Year | July 2021 |
Verification Date | 2021-07-31 |
Last Update Posted Date | 2021-07-28 |
Results First Posted Date | 2021-07-28 |
Detailed Descriptions
Sequence: | 20717260 |
Description | This is a prospective, open-label, multi-center, interventional, medical device, post-marketing study. Each participant will act as his/her own control. Eligible participants will undergo treatment with Juvéderm® VOLIFT™ with Lidocaine injected into the lips for lip augmentation. |
Facilities
Sequence: | 200061914 | Sequence: | 200061915 | Sequence: | 200061916 | Sequence: | 200061917 |
Name | Clinica Milenio | Name | Clínica Secret Beauty | Name | Medical and Cosmetic Clinic | Name | MediZen Ltd |
City | Lisbon | City | Lisbon | City | Edinburgh | City | Sutton Coldfield |
Zip | 1600-166 | Zip | 1600-503 | Zip | EH3 6RS | Zip | B74 2UG |
Country | Portugal | Country | Portugal | Country | United Kingdom | Country | United Kingdom |
Browse Interventions
Sequence: | 96032032 | Sequence: | 96032033 | Sequence: | 96032034 | Sequence: | 96032035 | Sequence: | 96032036 | Sequence: | 96032037 | Sequence: | 96032038 | Sequence: | 96032039 | Sequence: | 96032040 | Sequence: | 96032041 | Sequence: | 96032042 | Sequence: | 96032043 |
Mesh Term | Lidocaine | Mesh Term | Anesthetics, Local | Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Anti-Arrhythmia Agents | Mesh Term | Voltage-Gated Sodium Channel Blockers | Mesh Term | Sodium Channel Blockers | Mesh Term | Membrane Transport Modulators | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | lidocaine | Downcase Mesh Term | anesthetics, local | Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | anti-arrhythmia agents | Downcase Mesh Term | voltage-gated sodium channel blockers | Downcase Mesh Term | sodium channel blockers | Downcase Mesh Term | membrane transport modulators | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52158849 |
Name | Lip Augmentation |
Downcase Name | lip augmentation |
Id Information
Sequence: | 40150046 |
Id Source | org_study_id |
Id Value | CMO-MA-FAS-0512 |
Countries
Sequence: | 42559641 | Sequence: | 42559642 |
Name | Portugal | Name | United Kingdom |
Removed | False | Removed | False |
Design Groups
Sequence: | 55580740 |
Group Type | Experimental |
Title | Juvéderm® VOLIFT™ with Lidocaine |
Description | Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL). |
Interventions
Sequence: | 52474438 |
Intervention Type | Device |
Name | Juvéderm® VOLIFT™ with Lidocaine |
Description | Injectable gel that is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel implant (dermal filler). |
Design Outcomes
Sequence: | 177336192 | Sequence: | 177336193 | Sequence: | 177336194 | Sequence: | 177336195 | Sequence: | 177336196 | Sequence: | 177336197 | Sequence: | 177336198 | Sequence: | 177336199 | Sequence: | 177336200 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Percentage of Participants With a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) Compared to Baseline Assessment at Day 30 | Measure | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Measure | Change From Baseline in Participant's Assessment of Overall Satisfaction With Lips as Measured by the FACE-Q Lips Questionnaire | Measure | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Measure | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Measure | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Measure | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Measure | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Measure | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories |
Time Frame | Baseline (Prior to Treatment) to Day 30 | Time Frame | Baseline (Prior to Treatment) to Day 30, Months 3, 6, and 12 | Time Frame | Baseline (Prior to Treatment) to Day 30, Months 3, 6, and 12 | Time Frame | Day 30, Months 3, 6, and 12 | Time Frame | Day 30, Months 3, 6, and 12 | Time Frame | Day 30, Months 3, 6, and 12 | Time Frame | Day 30, Months 3, 6, and 12 | Time Frame | Day 30, Months 3, 6, and 12 | Time Frame | Day 30, Months 3, 6, and 12 |
Description | The LFS2 is an Investigator assessment of overall lip fullness measured by a 5-point scale where: 0=Minimal (Flat or nearly flat contour; minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). The percentage of participants with a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) compared to Baseline are reported. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The FACE-Q™ is a validated 10 question assessment measuring how satisfied the participant is with their lips. Each question is answered on a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat dissatisfied, 3=Somewhat satisfied, and 4= Very Satisfied. The responses to the items were converted to a 100-point Rausch transformed scale score: 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. |
Sponsors
Sequence: | 48308423 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Allergan |
Design Group Interventions
Sequence: | 68134145 |
Design Group Id | 55580740 |
Intervention Id | 52474438 |
Eligibilities
Sequence: | 30758794 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Male or female, 18 years of age or older Exclusion Criteria: Has lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254251198 |
Number Of Facilities | 4 |
Registered In Calendar Year | 2018 |
Actual Duration | 17 |
Were Results Reported | True |
Months To Report Results | 12 |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30505011 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | All participants will sign an informed consent form, and begin at the Screening Visit. Filler treatment (Juvéderm® VOLIFT™ with Lidocaine) will be performed at (Initial Treatment visit) and data will be collected at this visit for all relevant parameters as per the Schedule of Study Procedures, Treatments and Assessments. Fourteen days after the initial treatment, participants will return to the clinic and the Investigator will assess whether a Touch-up treatment is to be performed at this visit. Follow up visits will occur at Day 30 and 3, 6, and 12 months after the last treatment. |
Drop Withdrawals
Sequence: | 28983586 | Sequence: | 28983587 |
Result Group Id | 56087637 | Result Group Id | 56087637 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG000 |
Period | Overall Study | Period | Overall Study |
Reason | Lost to Follow-up | Reason | Reason not Specified |
Count | 8 | Count | 16 |
Milestones
Sequence: | 41000882 | Sequence: | 41000883 | Sequence: | 41000884 |
Result Group Id | 56087637 | Result Group Id | 56087637 | Result Group Id | 56087637 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG000 |
Title | STARTED | Title | COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 60 | Count | 36 | Count | 24 |
Participant Flows
Sequence: | 3920807 |
Outcome Counts
Sequence: | 73990181 | Sequence: | 73990182 | Sequence: | 73990183 | Sequence: | 73990184 | Sequence: | 73990185 | Sequence: | 73990186 | Sequence: | 73990187 | Sequence: | 73990188 | Sequence: | 73990189 |
Outcome Id | 30800490 | Outcome Id | 30800491 | Outcome Id | 30800492 | Outcome Id | 30800493 | Outcome Id | 30800494 | Outcome Id | 30800495 | Outcome Id | 30800496 | Outcome Id | 30800497 | Outcome Id | 30800498 |
Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 59 | Count | 59 | Count | 59 | Count | 59 | Count | 59 | Count | 59 | Count | 59 | Count | 59 | Count | 59 |
Provided Documents
Sequence: | 2578525 | Sequence: | 2578526 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2019-10-10 | Document Date | 2019-10-10 |
Url | https://ClinicalTrials.gov/ProvidedDocs/28/NCT03796728/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/28/NCT03796728/SAP_001.pdf |
Reported Event Totals
Sequence: | 27939439 | Sequence: | 27939440 | Sequence: | 27939441 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 60 | Subjects At Risk | 60 | Subjects At Risk | 60 |
Created At | 2023-08-08 23:06:53.472604 | Created At | 2023-08-08 23:06:53.472604 | Created At | 2023-08-08 23:06:53.472604 |
Updated At | 2023-08-08 23:06:53.472604 | Updated At | 2023-08-08 23:06:53.472604 | Updated At | 2023-08-08 23:06:53.472604 |
Responsible Parties
Sequence: | 28871291 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3851551 |
Pi Employee | No |
Restriction Type | OTHER |
Other Details | A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo. |
Restrictive Agreement | A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo. |
Result Contacts
Sequence: | 3851516 |
Organization | Allergan |
Name | Therapeutic Area, Head |
Phone | 714-246-4500 |
clinicaltrials@allergan.com | |
Outcomes
Sequence: | 30800490 | Sequence: | 30800496 | Sequence: | 30800491 | Sequence: | 30800492 | Sequence: | 30800493 | Sequence: | 30800494 | Sequence: | 30800495 | Sequence: | 30800497 | Sequence: | 30800498 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Percentage of Participants With a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) Compared to Baseline Assessment at Day 30 | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Change From Baseline in Participant's Assessment of Overall Satisfaction With Lips as Measured by the FACE-Q Lips Questionnaire | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories |
Description | The LFS2 is an Investigator assessment of overall lip fullness measured by a 5-point scale where: 0=Minimal (Flat or nearly flat contour; minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). The percentage of participants with a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) compared to Baseline are reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The FACE-Q™ is a validated 10 question assessment measuring how satisfied the participant is with their lips. Each question is answered on a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat dissatisfied, 3=Somewhat satisfied, and 4= Very Satisfied. The responses to the items were converted to a 100-point Rausch transformed scale score: 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. |
Time Frame | Baseline (Prior to Treatment) to Day 30 | Time Frame | Day 30, Months 3, 6, and 12 | Time Frame | Baseline (Prior to Treatment) to Day 30, Months 3, 6, and 12 | Time Frame | Baseline (Prior to Treatment) to Day 30, Months 3, 6, and 12 | Time Frame | Day 30, Months 3, 6, and 12 | Time Frame | Day 30, Months 3, 6, and 12 | Time Frame | Day 30, Months 3, 6, and 12 | Time Frame | Day 30, Months 3, 6, and 12 | Time Frame | Day 30, Months 3, 6, and 12 |
Population | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. | Population | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Population | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with available data for analysis at the given timepoint | Population | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Population | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Population | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Population | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Population | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Population | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. |
Units | percentage of participants | Units | Participants | Units | Participants | Units | score on a scale | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Dispersion Type | Standard Deviation | ||||||||||||||||
Param Type | Number | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Outcome Measurements
Sequence: | 235627458 | Sequence: | 235627459 | Sequence: | 235627460 | Sequence: | 235627461 | Sequence: | 235627462 | Sequence: | 235627463 | Sequence: | 235627464 | Sequence: | 235627465 | Sequence: | 235627466 | Sequence: | 235627467 | Sequence: | 235627468 | Sequence: | 235627469 | Sequence: | 235627470 | Sequence: | 235627471 | Sequence: | 235627472 | Sequence: | 235627473 | Sequence: | 235627474 | Sequence: | 235627475 | Sequence: | 235627476 | Sequence: | 235627477 | Sequence: | 235627478 | Sequence: | 235627479 | Sequence: | 235627480 | Sequence: | 235627481 | Sequence: | 235627482 | Sequence: | 235627483 | Sequence: | 235627484 | Sequence: | 235627485 | Sequence: | 235627486 | Sequence: | 235627487 | Sequence: | 235627488 | Sequence: | 235627489 | Sequence: | 235627490 | Sequence: | 235627491 | Sequence: | 235627492 | Sequence: | 235627493 | Sequence: | 235627494 | Sequence: | 235627495 | Sequence: | 235627496 | Sequence: | 235627497 | Sequence: | 235627498 | Sequence: | 235627499 | Sequence: | 235627500 | Sequence: | 235627501 | Sequence: | 235627502 | Sequence: | 235627503 | Sequence: | 235627504 | Sequence: | 235627505 | Sequence: | 235627506 | Sequence: | 235627507 | Sequence: | 235627508 | Sequence: | 235627509 | Sequence: | 235627510 | Sequence: | 235627511 | Sequence: | 235627512 | Sequence: | 235627513 | Sequence: | 235627514 | Sequence: | 235627515 | Sequence: | 235627516 | Sequence: | 235627517 | Sequence: | 235627518 | Sequence: | 235627519 | Sequence: | 235627520 | Sequence: | 235627521 | Sequence: | 235627522 | Sequence: | 235627523 | Sequence: | 235627524 | Sequence: | 235627530 | Sequence: | 235627525 | Sequence: | 235627526 | Sequence: | 235627527 | Sequence: | 235627528 | Sequence: | 235627529 | Sequence: | 235627531 | Sequence: | 235627532 | Sequence: | 235627533 | Sequence: | 235627534 | Sequence: | 235627535 | Sequence: | 235627536 | Sequence: | 235627537 | Sequence: | 235627538 | Sequence: | 235627539 | Sequence: | 235627540 | Sequence: | 235627541 | Sequence: | 235627542 | Sequence: | 235627543 | Sequence: | 235627544 | Sequence: | 235627545 | Sequence: | 235627567 | Sequence: | 235627546 | Sequence: | 235627547 | Sequence: | 235627548 | Sequence: | 235627549 | Sequence: | 235627550 | Sequence: | 235627551 | Sequence: | 235627552 | Sequence: | 235627568 | Sequence: | 235627553 | Sequence: | 235627554 | Sequence: | 235627555 | Sequence: | 235627556 | Sequence: | 235627557 | Sequence: | 235627558 | Sequence: | 235627559 | Sequence: | 235627560 | Sequence: | 235627561 | Sequence: | 235627562 | Sequence: | 235627563 | Sequence: | 235627564 | Sequence: | 235627565 | Sequence: | 235627566 | Sequence: | 235627569 | Sequence: | 235627570 | Sequence: | 235627571 | Sequence: | 235627572 | Sequence: | 235627573 | Sequence: | 235627574 | Sequence: | 235627575 | Sequence: | 235627576 | Sequence: | 235627577 | Sequence: | 235627578 | Sequence: | 235627579 | Sequence: | 235627580 | Sequence: | 235627581 | Sequence: | 235627582 | Sequence: | 235627583 | Sequence: | 235627584 | Sequence: | 235627585 | Sequence: | 235627586 | Sequence: | 235627587 | Sequence: | 235627588 | Sequence: | 235627589 | Sequence: | 235627590 | Sequence: | 235627591 | Sequence: | 235627592 | Sequence: | 235627593 | Sequence: | 235627594 | Sequence: | 235627595 | Sequence: | 235627596 | Sequence: | 235627597 | Sequence: | 235627598 | Sequence: | 235627599 | Sequence: | 235627600 | Sequence: | 235627601 | Sequence: | 235627602 | Sequence: | 235627603 | Sequence: | 235627604 | Sequence: | 235627605 | Sequence: | 235627606 | Sequence: | 235627607 | Sequence: | 235627608 | Sequence: | 235627609 | Sequence: | 235627610 |
Outcome Id | 30800490 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800491 | Outcome Id | 30800492 | Outcome Id | 30800492 | Outcome Id | 30800492 | Outcome Id | 30800492 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800493 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800494 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800496 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800496 | Outcome Id | 30800495 | Outcome Id | 30800495 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800496 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800497 | Outcome Id | 30800498 | Outcome Id | 30800498 | Outcome Id | 30800498 | Outcome Id | 30800498 | Outcome Id | 30800498 | Outcome Id | 30800498 | Outcome Id | 30800498 | Outcome Id | 30800498 | Outcome Id | 30800498 | Outcome Id | 30800498 | Outcome Id | 30800498 | Outcome Id | 30800498 | Outcome Id | 30800498 | Outcome Id | 30800498 | Outcome Id | 30800498 | Outcome Id | 30800498 |
Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 | Result Group Id | 56087638 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Classification | Change from Baseline to Day 30 | Classification | Change from Baseline to Day 30 | Classification | Change from Baseline to Day 30 | Classification | Change from Baseline to Day 30 | Classification | Change from Baseline to Day 30 | Classification | Change from Baseline to Day 30 | Classification | Change from Baseline to Day 30 | Classification | Change from Baseline to Month 3 | Classification | Change from Baseline to Month 3 | Classification | Change from Baseline to Month 3 | Classification | Change from Baseline to Month 3 | Classification | Change from Baseline to Month 3 | Classification | Change from Baseline to Month 3 | Classification | Change from Baseline to Month 3 | Classification | Change from Baseline to Month 6 | Classification | Change from Baseline to Month 6 | Classification | Change from Baseline to Month 6 | Classification | Change from Baseline to Month 6 | Classification | Change from Baseline to Month 6 | Classification | Change from Baseline to Month 6 | Classification | Change from Baseline to Month 6 | Classification | Change from Baseline to Month 12 | Classification | Change from Baseline to Month 12 | Classification | Change from Baseline to Month 12 | Classification | Change from Baseline to Month 12 | Classification | Change from Baseline to Month 12 | Classification | Change from Baseline to Month 12 | Classification | Change from Baseline to Month 12 | Classification | Change from Baseline to Day 30 | Classification | Change from Baseline to Month 3 | Classification | Change from Baseline to Month 6 | Classification | Change from Baseline to Month 12 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 6 | Classification | Month 6 | Classification | Month 6 | Classification | Month 6 | Classification | Month 6 | Classification | Month 12 | Classification | Month 12 | Classification | Month 12 | Classification | Month 12 | Classification | Month 12 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 6 | Classification | Month 6 | Classification | Month 6 | Classification | Month 6 | Classification | Month 12 | Classification | Month 6 | Classification | Month 12 | Classification | Month 12 | Classification | Month 12 | Classification | Month 12 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 6 | Classification | Month 6 | Classification | Month 6 | Classification | Month 6 | Classification | Month 6 | Classification | Month 6 | Classification | Month 6 | Classification | Month 12 | Classification | Month 12 | Classification | Month 12 | Classification | Month 12 | Classification | Month 6 | Classification | Month 12 | Classification | Month 12 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 6 | Classification | Month 6 | Classification | Month 6 | Classification | Month 12 | Classification | Month 12 | Classification | Month 12 | Classification | Month 12 | Classification | Month 12 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 6 | Classification | Month 6 | Classification | Month 6 | Classification | Month 6 | Classification | Month 6 | Classification | Month 12 | Classification | Month 12 | Classification | Month 12 | Classification | Month 12 | Classification | Month 12 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Day 30 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 3 | Classification | Month 6 | Classification | Month 6 | Classification | Month 6 | Classification | Month 6 | Classification | Month 12 | Classification | Month 12 | Classification | Month 12 | Classification | Month 12 | ||
Category | -3 Point Change | Category | -2 Point Change | Category | -1 Point Change | Category | 0 Point Change (No change) | Category | 1 Point Change | Category | 2 Point Change | Category | 3 Point Change | Category | -3 Point Change | Category | -2 Point Change | Category | -1 Point Change | Category | 0 Point Change (No change) | Category | 1 Point Change | Category | 2 Point Change | Category | 3 Point Change | Category | -3 Point Change | Category | -2 Point Change | Category | -1 Point Change | Category | 0 Point Change (No change) | Category | 1 Point Change | Category | 2 Point Change | Category | 3 Point Change | Category | -3 Point Change | Category | -2 Point Change | Category | -1 Point Change | Category | 0 Point Change (No change) | Category | 1 Point Change | Category | 2 Point Change | Category | 3 Point Change | Category | 2=Much Improved | Category | 1=Improved | Category | 0=No Change | Category | -1=Worse | Category | -2=Much Worse | Category | 2=Much Improved | Category | 1=Improved | Category | 0=No Change | Category | -1=Worse | Category | -2=Much Worse | Category | 2=Much Improved | Category | 1=Improved | Category | 0=No Change | Category | -1=Worse | Category | -2=Much Worse | Category | 2=Much Improved | Category | 1=Improved | Category | 0=No Change | Category | -1=Worse | Category | -2=Much Worse | Category | 2=Much Improved | Category | 1=Improved | Category | 0=No Change | Category | -1=Worse | Category | -2=Much Worse | Category | 2=Much Improved | Category | 1=Improved | Category | 0=No Change | Category | -1=Worse | Category | -2=Much Worse | Category | 2=Much Improved | Category | 1=Improved | Category | 0=No Change | Category | -1=Worse | Category | -2=Much Worse | Category | -2=Much Worse | Category | 2=Much Improved | Category | 1=Improved | Category | 0=No Change | Category | -1=Worse | Category | 0=Not at all | Category | 1 | Category | 2=Somewhat | Category | 3 | Category | 4=Very much | Category | Missing | Category | 0=Not at all | Category | 1 | Category | 2=Somewhat | Category | 3 | Category | 4=Very much | Category | Missing | Category | 0=Not at all | Category | 1 | Category | 2=Somewhat | Category | 2=Somewhat | Category | 3 | Category | 4=Very much | Category | Missing | Category | 0=Not at all | Category | 1 | Category | 2=Somewhat | Category | 3 | Category | 3 | Category | 4=Very much | Category | Missing | Category | 0=Not at all | Category | 1 | Category | 2=Somewhat | Category | 3 | Category | 4=Very much | Category | 0=Not at all | Category | 1 | Category | 2=Somewhat | Category | 3 | Category | 4=Very much | Category | 0=Not at all | Category | 1 | Category | 4=Very much | Category | 0=Not at all | Category | 1 | Category | 2=Somewhat | Category | 3 | Category | 4=Very much | Category | 0=Lumpy/Grainy | Category | 1=Faintly Smooth | Category | 2=Somewhat Smooth | Category | 3=Smooth | Category | 4=Very Smooth | Category | 0=Lumpy/Grainy | Category | 1=Faintly Smooth | Category | 2=Somewhat Smooth | Category | 3=Smooth | Category | 4=Very Smooth | Category | 0=Lumpy/Grainy | Category | 1=Faintly Smooth | Category | 2=Somewhat Smooth | Category | 3=Smooth | Category | 4=Very Smooth | Category | 0=Lumpy/Grainy | Category | 1=Faintly Smooth | Category | 2=Somewhat Smooth | Category | 3=Smooth | Category | 4=Very Smooth | Category | 0=Worse | Category | 1=No Change | Category | 2=Improved | Category | 3=Much Improved | Category | 0=Worse | Category | 1=No Change | Category | 2=Improved | Category | 3=Much Improved | Category | 0=Worse | Category | 1=No Change | Category | 2=Improved | Category | 3=Much Improved | Category | 0=Worse | Category | 1=No Change | Category | 2=Improved | Category | 3=Much Improved | ||||||||||
Title | Percentage of Participants With a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) Compared to Baseline Assessment at Day 30 | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) | Title | Change From Baseline in Participant's Assessment of Overall Satisfaction With Lips as Measured by the FACE-Q Lips Questionnaire | Title | Change From Baseline in Participant's Assessment of Overall Satisfaction With Lips as Measured by the FACE-Q Lips Questionnaire | Title | Change From Baseline in Participant's Assessment of Overall Satisfaction With Lips as Measured by the FACE-Q Lips Questionnaire | Title | Change From Baseline in Participant's Assessment of Overall Satisfaction With Lips as Measured by the FACE-Q Lips Questionnaire | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories | Title | Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories |
Description | The LFS2 is an Investigator assessment of overall lip fullness measured by a 5-point scale where: 0=Minimal (Flat or nearly flat contour; minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). The percentage of participants with a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) compared to Baseline are reported. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint. | Description | The FACE-Q™ is a validated 10 question assessment measuring how satisfied the participant is with their lips. Each question is answered on a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat dissatisfied, 3=Somewhat satisfied, and 4= Very Satisfied. The responses to the items were converted to a 100-point Rausch transformed scale score: 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement. | Description | The FACE-Q™ is a validated 10 question assessment measuring how satisfied the participant is with their lips. Each question is answered on a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat dissatisfied, 3=Somewhat satisfied, and 4= Very Satisfied. The responses to the items were converted to a 100-point Rausch transformed scale score: 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement. | Description | The FACE-Q™ is a validated 10 question assessment measuring how satisfied the participant is with their lips. Each question is answered on a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat dissatisfied, 3=Somewhat satisfied, and 4= Very Satisfied. The responses to the items were converted to a 100-point Rausch transformed scale score: 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement. | Description | The FACE-Q™ is a validated 10 question assessment measuring how satisfied the participant is with their lips. Each question is answered on a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat dissatisfied, 3=Somewhat satisfied, and 4= Very Satisfied. The responses to the items were converted to a 100-point Rausch transformed scale score: 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. | Description | The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported. |
Units | percentage of participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Number | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 93.2 | Param Value | 0 | Param Value | 5 | Param Value | 29 | Param Value | 25 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 4 | Param Value | 27 | Param Value | 21 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 3 | Param Value | 22 | Param Value | 21 | Param Value | 4 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 3 | Param Value | 9 | Param Value | 22 | Param Value | 2 | Param Value | 0 | Param Value | 0 | Param Value | 45.2 | Param Value | 42.7 | Param Value | 38.5 | Param Value | 23.6 | Param Value | 32 | Param Value | 27 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 24 | Param Value | 28 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 12 | Param Value | 39 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 28 | Param Value | 6 | Param Value | 0 | Param Value | 0 | Param Value | 32 | Param Value | 25 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 28 | Param Value | 21 | Param Value | 3 | Param Value | 0 | Param Value | 0 | Param Value | 15 | Param Value | 34 | Param Value | 2 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 6 | Param Value | 25 | Param Value | 5 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 3 | Param Value | 18 | Param Value | 38 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 15 | Param Value | 37 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 2 | Param Value | 20 | Param Value | 30 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 4 | Param Value | 5 | Param Value | 21 | Param Value | 26 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 5 | Param Value | 21 | Param Value | 32 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 17 | Param Value | 34 | Param Value | 0 | Param Value | 0 | Param Value | 28 | Param Value | 0 | Param Value | 0 | Param Value | 4 | Param Value | 4 | Param Value | 28 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 22 | Param Value | 35 | Param Value | 0 | Param Value | 0 | Param Value | 3 | Param Value | 14 | Param Value | 35 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 17 | Param Value | 33 | Param Value | 0 | Param Value | 1 | Param Value | 2 | Param Value | 0 | Param Value | 33 | Param Value | 0 | Param Value | 2 | Param Value | 30 | Param Value | 27 | Param Value | 0 | Param Value | 2 | Param Value | 28 | Param Value | 22 | Param Value | 0 | Param Value | 6 | Param Value | 26 | Param Value | 19 | Param Value | 0 | Param Value | 10 | Param Value | 20 | Param Value | 6 |
Param Value Num | 93.2 | Param Value Num | 0.0 | Param Value Num | 5.0 | Param Value Num | 29.0 | Param Value Num | 25.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 4.0 | Param Value Num | 27.0 | Param Value Num | 21.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 22.0 | Param Value Num | 21.0 | Param Value Num | 4.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 3.0 | Param Value Num | 9.0 | Param Value Num | 22.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 45.2 | Param Value Num | 42.7 | Param Value Num | 38.5 | Param Value Num | 23.6 | Param Value Num | 32.0 | Param Value Num | 27.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 24.0 | Param Value Num | 28.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 12.0 | Param Value Num | 39.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 28.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 32.0 | Param Value Num | 25.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 28.0 | Param Value Num | 21.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 15.0 | Param Value Num | 34.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 6.0 | Param Value Num | 25.0 | Param Value Num | 5.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 3.0 | Param Value Num | 18.0 | Param Value Num | 38.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 15.0 | Param Value Num | 37.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 20.0 | Param Value Num | 30.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 4.0 | Param Value Num | 5.0 | Param Value Num | 21.0 | Param Value Num | 26.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 5.0 | Param Value Num | 21.0 | Param Value Num | 32.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 17.0 | Param Value Num | 34.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 28.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 4.0 | Param Value Num | 4.0 | Param Value Num | 28.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 22.0 | Param Value Num | 35.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 3.0 | Param Value Num | 14.0 | Param Value Num | 35.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 17.0 | Param Value Num | 33.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 33.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 30.0 | Param Value Num | 27.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 28.0 | Param Value Num | 22.0 | Param Value Num | 0.0 | Param Value Num | 6.0 | Param Value Num | 26.0 | Param Value Num | 19.0 | Param Value Num | 0.0 | Param Value Num | 10.0 | Param Value Num | 20.0 | Param Value Num | 6.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 27.16 | Dispersion Value | 30.23 | Dispersion Value | 26.25 | Dispersion Value | 31.78 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 27.16 | Dispersion Value Num | 30.23 | Dispersion Value Num | 26.25 | Dispersion Value Num | 31.78 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline Counts
Sequence: | 11381955 |
Result Group Id | 56087636 |
Ctgov Group Code | BG000 |
Units | Participants |
Scope | overall |
Count | 60 |
Result Groups
Sequence: | 56087636 | Sequence: | 56087637 | Sequence: | 56087638 | Sequence: | 56087639 |
Ctgov Group Code | BG000 | Ctgov Group Code | FG000 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 |
Result Type | Baseline | Result Type | Participant Flow | Result Type | Outcome | Result Type | Reported Event |
Title | Juvéderm® VOLIFT™ With Lidocaine | Title | Juvéderm® VOLIFT™ With Lidocaine | Title | Juvéderm® VOLIFT™ With Lidocaine | Title | Juvéderm® VOLIFT™ With Lidocaine |
Description | Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL). | Description | Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL). | Description | Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL). | Description | Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL). |
Baseline Measurements
Sequence: | 125567295 | Sequence: | 125567296 | Sequence: | 125567297 |
Result Group Id | 56087636 | Result Group Id | 56087636 | Result Group Id | 56087636 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 |
Category | Female | Category | Male | ||
Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male |
Units | years | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 36.8 | Param Value | 59 | Param Value | 1 |
Param Value Num | 36.8 | Param Value Num | 59.0 | Param Value Num | 1.0 |
Dispersion Type | Standard Deviation | ||||
Dispersion Value | 9.25 | ||||
Dispersion Value Num | 9.25 | ||||
Number Analyzed | 60 | Number Analyzed | 60 | Number Analyzed | 60 |
]]>
https://zephyrnet.com/NCT03796715
2018-08-01
https://zephyrnet.com/?p=NCT03796715
NCT03796715https://www.clinicaltrials.gov/study/NCT03796715?tab=tableNANANAPresepsin (soluble CD14 subtype) is a novel marker with growing body of evidence supporting its accuracy and value for the diagnosis of sepsis. Patients with sepsis showed higher Prsepsin levels compared to those with SIRS. In addition the increase in Prsepsin levels correlates well with sepsis severity. Red cell distribution width variations are increased in a variety of medical conditions such as congestive heart failure, acute myocardial infarction, pulmonary embolism, pneumonia, critical illness, and cardiac arrest , and is a predictor of mortality in the general population. we aim to compare between Presepsin (soluble CD14) and RDW as prognostic markers in critically-ill patients with sepsis.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-01 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | August 1, 2018 |
Primary Completion Month Year | November 20, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-08 |
Facilities
Sequence: | 200279701 |
Name | Ain Shams University Hospitals |
City | Cairo |
Zip | 11591 |
Country | Egypt |
Conditions
Sequence: | 52221188 |
Name | Sepsis |
Downcase Name | sepsis |
Id Information
Sequence: | 40195390 |
Id Source | org_study_id |
Id Value | FMASU R76/2018 |
Countries
Sequence: | 42609346 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55649415 | Sequence: | 55649416 |
Title | Red Cell Distribution Width (RDW) | Title | Presepsin (sCD14-ST) |
Description | RDW was assessed as part of complete blood count analysis using SYSMEX XN-550 automated analyzer | Description | Presepsin analysis was done by utilising Elisa technique using kits from (MyBioSource, San Diego, CA 92195-3308 USA) |
Interventions
Sequence: | 52534957 | Sequence: | 52534956 |
Intervention Type | Diagnostic Test | Intervention Type | Diagnostic Test |
Name | Presepsin (sCD14-ST) | Name | Red Cell Distribution Width (RDW) |
Description | : A total of 100 sepsis patients, Presepsin (sCD14-ST) was used as prognostic marker. | Description | A total of 100 sepsis patients, Red Cell Distribution Width (RDW) was used as prognostic marker. |
Keywords
Sequence: | 79941319 | Sequence: | 79941320 | Sequence: | 79941321 |
Name | sepsis | Name | presepsin | Name | red cell distribution width |
Downcase Name | sepsis | Downcase Name | presepsin | Downcase Name | red cell distribution width |
Design Outcomes
Sequence: | 177560092 | Sequence: | 177560093 | Sequence: | 177560094 | Sequence: | 177560095 | Sequence: | 177560096 | Sequence: | 177560097 | Sequence: | 177560098 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Mortality during intensive care unit stay | Measure | Length of ICU stay | Measure | Need for readmission to ICU | Measure | Ventilatory support duration | Measure | Number of participants who need renal replacement therapy | Measure | Number of participants who need inotropic or vasopressor support | Measure | Transfusion requirements (blood and blood products) |
Time Frame | 28 days | Time Frame | assessed up to 3 months | Time Frame | assessed up to 3 months | Time Frame | assessed up to 3 months | Time Frame | assessed up to 3 months | Time Frame | assessed up to 3 months | Time Frame | assessed up to 3 months |
Browse Conditions
Sequence: | 193677223 | Sequence: | 193677224 | Sequence: | 193677225 | Sequence: | 193677226 | Sequence: | 193677227 | Sequence: | 193677228 |
Mesh Term | Sepsis | Mesh Term | Toxemia | Mesh Term | Infections | Mesh Term | Systemic Inflammatory Response Syndrome | Mesh Term | Inflammation | Mesh Term | Pathologic Processes |
Downcase Mesh Term | sepsis | Downcase Mesh Term | toxemia | Downcase Mesh Term | infections | Downcase Mesh Term | systemic inflammatory response syndrome | Downcase Mesh Term | inflammation | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366092 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Ain Shams University |
Overall Officials
Sequence: | 29312749 |
Role | Principal Investigator |
Name | Ahmed Elsayed |
Affiliation | Ain Shams University |
Design Group Interventions
Sequence: | 68216864 | Sequence: | 68216865 |
Design Group Id | 55649415 | Design Group Id | 55649416 |
Intervention Id | 52534956 | Intervention Id | 52534957 |
Eligibilities
Sequence: | 30794507 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Population | Patients admitted to the general ICU with sepsis or septic shock of both sexes between 18 and 65 years of age. |
Criteria | Inclusion Criteria:
Male or female aged 18 65 years. Exclusion Criteria: No informed consent |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254003994 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 3 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30540547 |
Observational Model | Cohort |
Time Perspective | Retrospective |
Responsible Parties
Sequence: | 28906867 |
Responsible Party Type | Principal Investigator |
Name | Ahmed Elsayed |
Title | Principal Investigator |
Affiliation | Ain Shams University |
]]>
https://zephyrnet.com/NCT03796702
2011-11-01
https://zephyrnet.com/?p=NCT03796702
NCT03796702https://www.clinicaltrials.gov/study/NCT03796702?tab=tableNANANAThe study is designed and performed as a prospective randomized controlled single-center study. Patients who underwent rectal resection with preventive ileostomy due to rectal cancer will be included. The study investigates the effect of reversing a temporary ileostomy after 30 vs 90 days.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-30 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-04-26 |
Start Month Year | November 1, 2011 |
Primary Completion Month Year | November 30, 2018 |
Verification Month Year | April 2023 |
Verification Date | 2023-04-30 |
Last Update Posted Date | 2023-04-26 |
Facilities
Sequence: | 199010325 |
Name | National Cancer Institute |
City | Vilnius |
Country | Lithuania |
Conditions
Sequence: | 51898409 |
Name | Ileostomy, Rectal Cancer |
Downcase Name | ileostomy, rectal cancer |
Id Information
Sequence: | 39944504 |
Id Source | org_study_id |
Id Value | 1 |
Countries
Sequence: | 42336779 |
Name | Lithuania |
Removed | False |
Design Groups
Sequence: | 55309329 | Sequence: | 55309330 |
Group Type | Experimental | Group Type | Experimental |
Title | Early closure of preventive ileostomy | Title | Late closure of preventive ileostomy |
Description | A preventive ileostomy is closed 30 days after the primary surgery | Description | A preventive ileostomy is closed 90 days after the primary surgery |
Interventions
Sequence: | 52214167 |
Intervention Type | Procedure |
Name | Deileostomy |
Description | Deileostomy |
Design Outcomes
Sequence: | 176450404 | Sequence: | 176450405 | Sequence: | 176450406 | Sequence: | 176450407 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Postoperative morbidity | Measure | Hospitalization time after ileostomy closure | Measure | 30-days re-admission rate | Measure | Quality of life of patients after ileostomy closure |
Time Frame | 30 days after surgery | Time Frame | 30 days after surgery | Time Frame | 30 days after surgery | Time Frame | at 3, 6, 9 and 12 moths after surgery |
Description | Patients are scored according to the Clavien-Dindo Classification of Surgical Complications. | Description | Hospitalization time | Description | Re-admission rate during 30 days after re-admission | Description | Patients quality of life is assessed with EORTC QLQ-C30 questionnaires |
Browse Conditions
Sequence: | 192389436 | Sequence: | 192389437 | Sequence: | 192389438 | Sequence: | 192389439 | Sequence: | 192389440 | Sequence: | 192389441 | Sequence: | 192389442 | Sequence: | 192389443 | Sequence: | 192389444 | Sequence: | 192389445 | Sequence: | 192389446 |
Mesh Term | Rectal Neoplasms | Mesh Term | Colorectal Neoplasms | Mesh Term | Intestinal Neoplasms | Mesh Term | Gastrointestinal Neoplasms | Mesh Term | Digestive System Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Digestive System Diseases | Mesh Term | Gastrointestinal Diseases | Mesh Term | Intestinal Diseases | Mesh Term | Rectal Diseases |
Downcase Mesh Term | rectal neoplasms | Downcase Mesh Term | colorectal neoplasms | Downcase Mesh Term | intestinal neoplasms | Downcase Mesh Term | gastrointestinal neoplasms | Downcase Mesh Term | digestive system neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | intestinal diseases | Downcase Mesh Term | rectal diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48062877 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Vilnius University |
Design Group Interventions
Sequence: | 67805880 | Sequence: | 67805881 |
Design Group Id | 55309329 | Design Group Id | 55309330 |
Intervention Id | 52214167 | Intervention Id | 52214167 |
Eligibilities
Sequence: | 30603583 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients with temporary ileostomy after rectal resection for rectal cancer Exclusion Criteria: Anastomosis insufficiency detected clinically or radiologically. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253917993 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 86 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30350944 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Caregiver Masked | True |
Responsible Parties
Sequence: | 28724311 |
Responsible Party Type | Principal Investigator |
Name | Rimantas Bausys |
Title | Investigator |
Affiliation | Vilnius University |
]]>
https://zephyrnet.com/NCT03796689
2019-08-15
https://zephyrnet.com/?p=NCT03796689
NCT03796689https://www.clinicaltrials.gov/study/NCT03796689?tab=tableNANANAThe PCORnet Blood Pressure Home Monitoring (BP HOME) Study is a patient-level randomized controlled trial that will compare the effectiveness of home blood pressure monitoring (HPBM) with versus without a linked Smartphone application (“app”) for helping patients with uncontrolled hypertension achieve a reduction in systolic blood pressure. The trial will be conducted within the National Patient-Centered Clinical Research Network (PCORnet), which supports a research network that enables distributed querying of EHR data in a common data model. It will also use the Eureka Research Platform, an online research platform hosted by UCSF that supports eConsent, online surveys, and data collection from devices such as HBPMs. Data from these two data sources will be used together to accomplish the study aims. Given that HBPM is the guideline-recommended standard of care (without specification of Smartphone linkage), the HPBM devices and the app are all commercially available and currently in use, and that clinicians, with input from patients, will maintain full control of how BP is clinically managed, we believe participation in the project poses minimal risk to participants.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-11-16 |
Start Month Year | August 15, 2019 |
Primary Completion Month Year | October 23, 2021 |
Verification Month Year | October 2022 |
Verification Date | 2022-10-31 |
Last Update Posted Date | 2022-11-16 |
Results First Posted Date | 2022-11-16 |
Detailed Descriptions
Sequence: | 20825201 |
Description | We have designed a patient-level randomized controlled trial that will compare the effectiveness of Smartphone-linked versus standard HBPM for helping patients with uncontrolled hypertension achieve a reduction in their Systolic Blood Pressure (SBP), and patient satisfaction with the device. Our original plan was to recruit 2000 patients who would be randomized in a 1:1 ratio to receive a Smartphone-linked or standard HBPM. However, to recruit higher diversity with more African Americans and LatinX patients, we extended the recruitment period.* We will use data from the electronic health record (EHR), an online patient portal, and the home BP monitor (in the Smartphone-linked arm) to collect outcome data for a period of at least 6 months (for the primary outcome), and up to 18 months (for secondary outcomes, depending on enrollment date). The primary BP control outcome will be reduction in SBP, by clinic measurements, at 6 months. The primary patient satisfaction outcome will be the Net Promoter Score derived from self-reported likelihood of recommending the device to a friend, at 6 months.
*edited after completing recruitment |
Facilities
Sequence: | 201065113 | Sequence: | 201065114 | Sequence: | 201065115 | Sequence: | 201065116 |
Name | University of California, San Francisco | Name | University of Florida Health | Name | University Medical Center | Name | Mayo Clinic |
City | San Francisco | City | Gainesville | City | New Orleans | City | Rochester |
State | California | State | Florida | State | Louisiana | State | Minnesota |
Zip | 94143 | Zip | 32610 | Zip | 70112 | Zip | 55902 |
Country | United States | Country | United States | Country | United States | Country | United States |
Conditions
Sequence: | 52437518 |
Name | Hypertension |
Downcase Name | hypertension |
Id Information
Sequence: | 40348493 |
Id Source | org_study_id |
Id Value | 18-254-53 |
Countries
Sequence: | 42781688 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55888499 | Sequence: | 55888500 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Smartphone-linked | Title | Standard |
Interventions
Sequence: | 52747054 | Sequence: | 52747055 |
Intervention Type | Device | Intervention Type | Device |
Name | Smartphone-linked HBPM and associated app | Name | Standard HBPM |
Description | Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app. | Description | Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider. |
Design Outcomes
Sequence: | 178380798 | Sequence: | 178380799 |
Outcome Type | primary | Outcome Type | primary |
Measure | Change in Systolic Blood Pressure (SBP) | Measure | Net Promoter Score |
Time Frame | Baseline and 6 months | Time Frame | 6 months |
Description | Change is defined by the absolute difference between the SBP measured at the most recent outpatient clinical encounter at the time of enrollment, and the SBP measured at the most recent outpatient clinical encounter 6 months after enrollment. If more than 1 measurement is recorded during a single clinical encounter, the lower/lowest will be used. | Description | This score is assessed by asking a single question about likelihood of recommending the device to a friend, with options from 1-10 (10 being extremely likely). As per published methods, persons indicating 9 or 10 are considered "Promoters"; persons indicating 7 or 8 are "Passives"; and persons indicating 1-6 are "Detractors". The score is calculated by taking the percent of Promoters and subtracting the percent of Detractors, yielding a score for each group ranging from -100 to 100, with higher scores indicating a better outcome. |
Browse Conditions
Sequence: | 194501015 | Sequence: | 194501016 | Sequence: | 194501017 |
Mesh Term | Hypertension | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases |
Downcase Mesh Term | hypertension | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48565792 | Sequence: | 48565793 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of California, San Francisco | Name | Patient-Centered Outcomes Research Institute |
Overall Officials
Sequence: | 29423847 |
Role | Principal Investigator |
Name | Mark Pletcher, MD MPH |
Affiliation | University of California, San Francisco |
Design Group Interventions
Sequence: | 68513564 | Sequence: | 68513565 |
Design Group Id | 55888499 | Design Group Id | 55888500 |
Intervention Id | 52747054 | Intervention Id | 52747055 |
Eligibilities
Sequence: | 30917846 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age ≥ 18 years Exclusion Criteria: Has an arm circumference <22 cm or >42 cm |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254185221 |
Number Of Facilities | 4 |
Registered In Calendar Year | 2019 |
Actual Duration | 26 |
Were Results Reported | True |
Months To Report Results | 10 |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Designs
Sequence: | 30663530 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Milestones
Sequence: | 41216177 | Sequence: | 41216178 | Sequence: | 41216179 | Sequence: | 41216180 | Sequence: | 41216181 | Sequence: | 41216182 |
Result Group Id | 56294819 | Result Group Id | 56294820 | Result Group Id | 56294819 | Result Group Id | 56294820 | Result Group Id | 56294819 | Result Group Id | 56294820 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 1051 | Count | 1050 | Count | 1051 | Count | 1050 | Count | 0 | Count | 0 |
Participant Flows
Sequence: | 3937901 |
Recruitment Details | Patients meeting screening criteria were invited to participate by mail, email, phone, patient portal message or in person, and directed to the online study portal for eligibility assessment. The first participant was enrolled on August 15, 2019 and the last participant was enrolled on December 31, 2020. |
Pre Assignment Details | 137 participants who withdrew consent prior to randomization or did not complete their baseline surveys were excluded. |
Outcome Counts
Sequence: | 74388540 | Sequence: | 74388541 | Sequence: | 74388542 | Sequence: | 74388543 |
Outcome Id | 30959881 | Outcome Id | 30959881 | Outcome Id | 30959882 | Outcome Id | 30959882 |
Result Group Id | 56294821 | Result Group Id | 56294822 | Result Group Id | 56294821 | Result Group Id | 56294822 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 1051 | Count | 1050 | Count | 1051 | Count | 1050 |
Provided Documents
Sequence: | 2599103 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2021-04-28 |
Url | https://ClinicalTrials.gov/ProvidedDocs/89/NCT03796689/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 28074286 | Sequence: | 28074287 | Sequence: | 28074288 | Sequence: | 28074289 | Sequence: | 28074290 | Sequence: | 28074291 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 0 | Subjects At Risk | 0 | Subjects At Risk | 0 | Subjects At Risk | 0 | Subjects At Risk | 0 | Subjects At Risk | 0 |
Created At | 2023-08-10 17:40:50.162300 | Created At | 2023-08-10 17:40:50.162300 | Created At | 2023-08-10 17:40:50.162300 | Created At | 2023-08-10 17:40:50.162300 | Created At | 2023-08-10 17:40:50.162300 | Created At | 2023-08-10 17:40:50.162300 |
Updated At | 2023-08-10 17:40:50.162300 | Updated At | 2023-08-10 17:40:50.162300 | Updated At | 2023-08-10 17:40:50.162300 | Updated At | 2023-08-10 17:40:50.162300 | Updated At | 2023-08-10 17:40:50.162300 | Updated At | 2023-08-10 17:40:50.162300 |
Responsible Parties
Sequence: | 29030216 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3868645 |
Pi Employee | Yes |
Result Contacts
Sequence: | 3868610 |
Organization | University of California, San Fransico |
Name | Dr. Mark Pletcher, Professor |
Phone | 415-514-8008 |
mark.pletcher@ucsf.edu | |
Outcomes
Sequence: | 30959881 | Sequence: | 30959882 |
Outcome Type | Primary | Outcome Type | Primary |
Title | Change in Systolic Blood Pressure (SBP) | Title | Net Promoter Score |
Description | Change is defined by the absolute difference between the SBP measured at the most recent outpatient clinical encounter at the time of enrollment, and the SBP measured at the most recent outpatient clinical encounter 6 months after enrollment. If more than 1 measurement is recorded during a single clinical encounter, the lower/lowest will be used. | Description | This score is assessed by asking a single question about likelihood of recommending the device to a friend, with options from 1-10 (10 being extremely likely). As per published methods, persons indicating 9 or 10 are considered "Promoters"; persons indicating 7 or 8 are "Passives"; and persons indicating 1-6 are "Detractors". The score is calculated by taking the percent of Promoters and subtracting the percent of Detractors, yielding a score for each group ranging from -100 to 100, with higher scores indicating a better outcome. |
Time Frame | Baseline and 6 months | Time Frame | 6 months |
Units | mmHg | Units | score on a scale |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 236956870 | Sequence: | 236956871 | Sequence: | 236956872 | Sequence: | 236956873 |
Outcome Id | 30959881 | Outcome Id | 30959881 | Outcome Id | 30959882 | Outcome Id | 30959882 |
Result Group Id | 56294821 | Result Group Id | 56294822 | Result Group Id | 56294821 | Result Group Id | 56294822 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Title | Change in Systolic Blood Pressure (SBP) | Title | Change in Systolic Blood Pressure (SBP) | Title | Net Promoter Score | Title | Net Promoter Score |
Description | Change is defined by the absolute difference between the SBP measured at the most recent outpatient clinical encounter at the time of enrollment, and the SBP measured at the most recent outpatient clinical encounter 6 months after enrollment. If more than 1 measurement is recorded during a single clinical encounter, the lower/lowest will be used. | Description | Change is defined by the absolute difference between the SBP measured at the most recent outpatient clinical encounter at the time of enrollment, and the SBP measured at the most recent outpatient clinical encounter 6 months after enrollment. If more than 1 measurement is recorded during a single clinical encounter, the lower/lowest will be used. | Description | This score is assessed by asking a single question about likelihood of recommending the device to a friend, with options from 1-10 (10 being extremely likely). As per published methods, persons indicating 9 or 10 are considered "Promoters"; persons indicating 7 or 8 are "Passives"; and persons indicating 1-6 are "Detractors". The score is calculated by taking the percent of Promoters and subtracting the percent of Detractors, yielding a score for each group ranging from -100 to 100, with higher scores indicating a better outcome. | Description | This score is assessed by asking a single question about likelihood of recommending the device to a friend, with options from 1-10 (10 being extremely likely). As per published methods, persons indicating 9 or 10 are considered "Promoters"; persons indicating 7 or 8 are "Passives"; and persons indicating 1-6 are "Detractors". The score is calculated by taking the percent of Promoters and subtracting the percent of Detractors, yielding a score for each group ranging from -100 to 100, with higher scores indicating a better outcome. |
Units | mmHg | Units | mmHg | Units | score on a scale | Units | score on a scale |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 10.8 | Param Value | 10.6 | Param Value | 59 | Param Value | 57 |
Param Value Num | 10.8 | Param Value Num | 10.6 | Param Value Num | 59.0 | Param Value Num | 57.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Dispersion Value | 18 | Dispersion Value | 18 | Dispersion Value | 2.81 | Dispersion Value | 4.00 |
Dispersion Value Num | 18.0 | Dispersion Value Num | 18.0 | Dispersion Value Num | 2.81 | Dispersion Value Num | 4.0 |
Study References
Sequence: | 52346828 | Sequence: | 52346829 | Sequence: | 52346830 | Sequence: | 52346831 |
Pmid | 11129362 | Pmid | 24788496 | Pmid | 25345554 | Pmid | 35969408 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | result |
Citation | Adler NE, Epel ES, Castellazzo G, Ickovics JR. Relationship of subjective and objective social status with psychological and physiological functioning: preliminary data in healthy white women. Health Psychol. 2000 Nov;19(6):586-92. doi: 10.1037//0278-6133.19.6.586. | Citation | Hamilton DF, Lane JV, Gaston P, Patton JT, Macdonald DJ, Simpson AH, Howie CR. Assessing treatment outcomes using a single question: the net promoter score. Bone Joint J. 2014 May;96-B(5):622-8. doi: 10.1302/0301-620X.96B5.32434. | Citation | Krol MW, de Boer D, Delnoij DM, Rademakers JJ. The Net Promoter Score–an asset to patient experience surveys? Health Expect. 2015 Dec;18(6):3099-109. doi: 10.1111/hex.12297. Epub 2014 Oct 27. | Citation | Pletcher MJ, Fontil V, Modrow MF, Carton T, Chamberlain AM, Todd J, O'Brien EC, Sheer A, Vittinghoff E, Park S, Orozco J, Lin F, Maeztu C, Wozniak G, Rakotz M, Shay CM, Cooper-DeHoff RM. Effectiveness of Standard vs Enhanced Self-measurement of Blood Pressure Paired With a Connected Smartphone Application: A Randomized Clinical Trial. JAMA Intern Med. 2022 Oct 1;182(10):1025-1034. doi: 10.1001/jamainternmed.2022.3355. Erratum In: JAMA Intern Med. 2023 Mar 1;183(3):278. |
Baseline Counts
Sequence: | 11434962 | Sequence: | 11434963 | Sequence: | 11434964 |
Result Group Id | 56294816 | Result Group Id | 56294817 | Result Group Id | 56294818 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 1051 | Count | 1050 | Count | 2101 |
Result Groups
Sequence: | 56294816 | Sequence: | 56294817 | Sequence: | 56294818 | Sequence: | 56294819 | Sequence: | 56294820 | Sequence: | 56294821 | Sequence: | 56294822 | Sequence: | 56294823 | Sequence: | 56294824 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Smartphone-linked | Title | Standard | Title | Total | Title | Smartphone-linked | Title | Standard | Title | Smartphone-linked | Title | Standard | Title | Smartphone-linked | Title | Standard |
Description | Smartphone-linked HBPM and associated app: Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app. | Description | Standard HBPM: Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider. | Description | Total of all reporting groups | Description | Smartphone-linked HBPM and associated app: Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app. | Description | Standard HBPM: Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider. | Description | Smartphone-linked HBPM and associated app: Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app. | Description | Standard HBPM: Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider. | Description | Smartphone-linked HBPM and associated app: Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app. | Description | Standard HBPM: Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider. |
Baseline Measurements
Sequence: | 126260711 | Sequence: | 126260712 | Sequence: | 126260713 | Sequence: | 126260714 | Sequence: | 126260715 | Sequence: | 126260716 | Sequence: | 126260717 | Sequence: | 126260718 | Sequence: | 126260719 | Sequence: | 126260720 | Sequence: | 126260721 | Sequence: | 126260722 | Sequence: | 126260723 | Sequence: | 126260724 | Sequence: | 126260725 | Sequence: | 126260726 | Sequence: | 126260727 | Sequence: | 126260728 | Sequence: | 126260729 | Sequence: | 126260730 | Sequence: | 126260731 | Sequence: | 126260732 | Sequence: | 126260733 | Sequence: | 126260734 | Sequence: | 126260735 | Sequence: | 126260736 | Sequence: | 126260737 | Sequence: | 126260738 | Sequence: | 126260739 | Sequence: | 126260740 | Sequence: | 126260741 | Sequence: | 126260742 | Sequence: | 126260743 | Sequence: | 126260744 | Sequence: | 126260745 | Sequence: | 126260746 | Sequence: | 126260747 | Sequence: | 126260748 | Sequence: | 126260749 | Sequence: | 126260750 | Sequence: | 126260751 | Sequence: | 126260752 | Sequence: | 126260753 | Sequence: | 126260754 | Sequence: | 126260755 |
Result Group Id | 56294816 | Result Group Id | 56294817 | Result Group Id | 56294818 | Result Group Id | 56294816 | Result Group Id | 56294817 | Result Group Id | 56294818 | Result Group Id | 56294816 | Result Group Id | 56294817 | Result Group Id | 56294818 | Result Group Id | 56294816 | Result Group Id | 56294817 | Result Group Id | 56294818 | Result Group Id | 56294816 | Result Group Id | 56294817 | Result Group Id | 56294818 | Result Group Id | 56294816 | Result Group Id | 56294817 | Result Group Id | 56294818 | Result Group Id | 56294816 | Result Group Id | 56294817 | Result Group Id | 56294818 | Result Group Id | 56294816 | Result Group Id | 56294817 | Result Group Id | 56294818 | Result Group Id | 56294816 | Result Group Id | 56294817 | Result Group Id | 56294818 | Result Group Id | 56294816 | Result Group Id | 56294817 | Result Group Id | 56294818 | Result Group Id | 56294816 | Result Group Id | 56294817 | Result Group Id | 56294818 | Result Group Id | 56294816 | Result Group Id | 56294817 | Result Group Id | 56294818 | Result Group Id | 56294816 | Result Group Id | 56294817 | Result Group Id | 56294818 | Result Group Id | 56294816 | Result Group Id | 56294817 | Result Group Id | 56294818 | Result Group Id | 56294816 | Result Group Id | 56294817 | Result Group Id | 56294818 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Classification | Sex, male | Classification | Sex, male | Classification | Sex, male | Classification | Sex, female | Classification | Sex, female | Classification | Sex, female | Classification | Race/Ethnicity | Classification | Race/Ethnicity | Classification | Race/Ethnicity | Classification | Race/Ethnicity | Classification | Race/Ethnicity | Classification | Race/Ethnicity | Classification | Race/Ethnicity | Classification | Race/Ethnicity | Classification | Race/Ethnicity | Classification | Race/Ethnicity | Classification | Race/Ethnicity | Classification | Race/Ethnicity | Classification | Race/Ethnicity | Classification | Race/Ethnicity | Classification | Race/Ethnicity | Classification | Overall | Classification | Overall | Classification | Overall | Classification | Your healthcare provider | Classification | Your healthcare provider | Classification | Your healthcare provider | Classification | Your BP medications | Classification | Your BP medications | Classification | Your BP medications | ||||||||||||||||||||||||||||||
Category | Non-Hispanic Asian | Category | Non-Hispanic Asian | Category | Non-Hispanic Asian | Category | Non-Hispanic Black | Category | Non-Hispanic Black | Category | Non-Hispanic Black | Category | Non-Hispanic White | Category | Non-Hispanic White | Category | Non-Hispanic White | Category | Hispanic/LatinX, any race | Category | Hispanic/LatinX, any race | Category | Hispanic/LatinX, any race | Category | Non-Hispanic, other/multiple races | Category | Non-Hispanic, other/multiple races | Category | Non-Hispanic, other/multiple races | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex/Gender, Customized | Title | Sex/Gender, Customized | Title | Sex/Gender, Customized | Title | Sex/Gender, Customized | Title | Sex/Gender, Customized | Title | Sex/Gender, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Subjective Social Status | Title | Subjective Social Status | Title | Subjective Social Status | Title | Eligibility systolic BP | Title | Eligibility systolic BP | Title | Eligibility systolic BP | Title | Eligibility diastolic BP | Title | Eligibility diastolic BP | Title | Eligibility diastolic BP | Title | Satisfaction with BP management | Title | Satisfaction with BP management | Title | Satisfaction with BP management | Title | Satisfaction with BP management | Title | Satisfaction with BP management | Title | Satisfaction with BP management | Title | Satisfaction with BP management | Title | Satisfaction with BP management | Title | Satisfaction with BP management | Title | Comfort using technology like a computer or smartphone | Title | Comfort using technology like a computer or smartphone | Title | Comfort using technology like a computer or smartphone |
Description | MacArthur Subjective Social Scale, 1-10 scale (10 = Best off; 1 = Worst off) | Description | MacArthur Subjective Social Scale, 1-10 scale (10 = Best off; 1 = Worst off) | Description | MacArthur Subjective Social Scale, 1-10 scale (10 = Best off; 1 = Worst off) | Description | 1-5 scale (1 = Very Unsatisfied; 5 = Very Satisfied) | Description | 1-5 scale (1 = Very Unsatisfied; 5 = Very Satisfied) | Description | 1-5 scale (1 = Very Unsatisfied; 5 = Very Satisfied) | Description | 1-5 scale (1 = Very Unsatisfied; 5 = Very Satisfied) | Description | 1-5 scale (1 = Very Unsatisfied; 5 = Very Satisfied) | Description | 1-5 scale (1 = Very Unsatisfied; 5 = Very Satisfied) | Description | 1-5 scale (1 = Very Unsatisfied; 5 = Very Satisfied) | Description | 1-5 scale (1 = Very Unsatisfied; 5 = Very Satisfied) | Description | 1-5 scale (1 = Very Unsatisfied; 5 = Very Satisfied) | Description | 1-5 scale (1 = Not at all comfortable; 5 = Very comfortable) | Description | 1-5 scale (1 = Not at all comfortable; 5 = Very comfortable) | Description | 1-5 scale (1 = Not at all comfortable; 5 = Very comfortable) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | mmHg | Units | mmHg | Units | mmHg | Units | mmHg | Units | mmHg | Units | mmHg | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 59 | Param Value | 58 | Param Value | 58 | Param Value | 462 | Param Value | 448 | Param Value | 910 | Param Value | 589 | Param Value | 602 | Param Value | 1191 | Param Value | 6 | Param Value | 22 | Param Value | 28 | Param Value | 239 | Param Value | 226 | Param Value | 465 | Param Value | 676 | Param Value | 666 | Param Value | 1342 | Param Value | 79 | Param Value | 101 | Param Value | 180 | Param Value | 51 | Param Value | 35 | Param Value | 86 | Param Value | 6.2 | Param Value | 6.2 | Param Value | 6.2 | Param Value | 157 | Param Value | 158 | Param Value | 157 | Param Value | 88 | Param Value | 88 | Param Value | 88 | Param Value | 3.8 | Param Value | 3.7 | Param Value | 3.8 | Param Value | 4.3 | Param Value | 4.3 | Param Value | 4.3 | Param Value | 3.7 | Param Value | 3.7 | Param Value | 3.7 | Param Value | 4.1 | Param Value | 4.1 | Param Value | 4.1 |
Param Value Num | 59.0 | Param Value Num | 58.0 | Param Value Num | 58.0 | Param Value Num | 462.0 | Param Value Num | 448.0 | Param Value Num | 910.0 | Param Value Num | 589.0 | Param Value Num | 602.0 | Param Value Num | 1191.0 | Param Value Num | 6.0 | Param Value Num | 22.0 | Param Value Num | 28.0 | Param Value Num | 239.0 | Param Value Num | 226.0 | Param Value Num | 465.0 | Param Value Num | 676.0 | Param Value Num | 666.0 | Param Value Num | 1342.0 | Param Value Num | 79.0 | Param Value Num | 101.0 | Param Value Num | 180.0 | Param Value Num | 51.0 | Param Value Num | 35.0 | Param Value Num | 86.0 | Param Value Num | 6.2 | Param Value Num | 6.2 | Param Value Num | 6.2 | Param Value Num | 157.0 | Param Value Num | 158.0 | Param Value Num | 157.0 | Param Value Num | 88.0 | Param Value Num | 88.0 | Param Value Num | 88.0 | Param Value Num | 3.8 | Param Value Num | 3.7 | Param Value Num | 3.8 | Param Value Num | 4.3 | Param Value Num | 4.3 | Param Value Num | 4.3 | Param Value Num | 3.7 | Param Value Num | 3.7 | Param Value Num | 3.7 | Param Value Num | 4.1 | Param Value Num | 4.1 | Param Value Num | 4.1 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 13 | Dispersion Value | 13 | Dispersion Value | 13 | Dispersion Value | 2.2 | Dispersion Value | 2.2 | Dispersion Value | 2.2 | Dispersion Value | 11 | Dispersion Value | 12 | Dispersion Value | 11 | Dispersion Value | 11 | Dispersion Value | 12 | Dispersion Value | 12 | Dispersion Value | 1.1 | Dispersion Value | 1.2 | Dispersion Value | 1.2 | Dispersion Value | 1.1 | Dispersion Value | 1.0 | Dispersion Value | 1.0 | Dispersion Value | 1.2 | Dispersion Value | 1.2 | Dispersion Value | 1.2 | Dispersion Value | 1.1 | Dispersion Value | 1.1 | Dispersion Value | 1.1 | ||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 13.0 | Dispersion Value Num | 13.0 | Dispersion Value Num | 13.0 | Dispersion Value Num | 2.2 | Dispersion Value Num | 2.2 | Dispersion Value Num | 2.2 | Dispersion Value Num | 11.0 | Dispersion Value Num | 12.0 | Dispersion Value Num | 11.0 | Dispersion Value Num | 11.0 | Dispersion Value Num | 12.0 | Dispersion Value Num | 12.0 | Dispersion Value Num | 1.1 | Dispersion Value Num | 1.2 | Dispersion Value Num | 1.2 | Dispersion Value Num | 1.1 | Dispersion Value Num | 1.0 | Dispersion Value Num | 1.0 | Dispersion Value Num | 1.2 | Dispersion Value Num | 1.2 | Dispersion Value Num | 1.2 | Dispersion Value Num | 1.1 | Dispersion Value Num | 1.1 | Dispersion Value Num | 1.1 | ||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 1051 | Number Analyzed | 1050 | Number Analyzed | 2101 | Number Analyzed | 1051 | Number Analyzed | 1050 | Number Analyzed | 2101 | Number Analyzed | 1051 | Number Analyzed | 1050 | Number Analyzed | 2101 | Number Analyzed | 1051 | Number Analyzed | 1050 | Number Analyzed | 2101 | Number Analyzed | 1051 | Number Analyzed | 1050 | Number Analyzed | 2101 | Number Analyzed | 1051 | Number Analyzed | 1050 | Number Analyzed | 2101 | Number Analyzed | 1051 | Number Analyzed | 1050 | Number Analyzed | 2101 | Number Analyzed | 1051 | Number Analyzed | 1050 | Number Analyzed | 2101 | Number Analyzed | 1051 | Number Analyzed | 1050 | Number Analyzed | 2101 | Number Analyzed | 1051 | Number Analyzed | 1050 | Number Analyzed | 2101 | Number Analyzed | 1051 | Number Analyzed | 1050 | Number Analyzed | 2101 | Number Analyzed | 1051 | Number Analyzed | 1050 | Number Analyzed | 2101 | Number Analyzed | 1051 | Number Analyzed | 1050 | Number Analyzed | 2101 | Number Analyzed | 1051 | Number Analyzed | 1050 | Number Analyzed | 2101 | Number Analyzed | 1051 | Number Analyzed | 1050 | Number Analyzed | 2101 |
]]>
https://zephyrnet.com/NCT03796676
2019-02-18
https://zephyrnet.com/?p=NCT03796676
NCT03796676https://www.clinicaltrials.gov/study/NCT03796676?tab=tableNANANAThis is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to <18 years of age with moderate to severe AD.
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Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-04-13 |
Start Month Year | February 18, 2019 |
Primary Completion Month Year | April 8, 2020 |
Verification Month Year | April 2022 |
Verification Date | 2022-04-30 |
Last Update Posted Date | 2022-04-13 |
Results First Posted Date | 2021-06-04 |
Detailed Descriptions
Sequence: | 20713748 |
Description | This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants will be screened within 28 days prior to the first dose of study intervention to confirm study eligibility. Subjects must have moderate-severe AD involving at least 10% Body Surface Area (BSA); an Investigator Global Assessment (IGA) score of at least 3; an Eczema Area Severity Index (EASI) of at least 16 and Peak Pruritus Numerical Rating Score (NRS) of at least 4 on baseline/Day 1. Eligible subjects will be randomized at the Baseline/Day 1 visit. Approximately 225 participants will be randomized in a 1:1:1 ratio to receive once daily PF 04965842 at 200 mg, 100 mg, or placebo for 12 weeks. Randomization will be stratified by baseline disease severity (moderate [IGA = 3] vs. severe [IGA = 4] AD). The investigational products will be administered QD for 12 weeks. Background therapy (medicated and non-medicated topical therapy) must be applied BID for the duration of the treatment period. The co-primary efficacy endpoints are an IGA score of clear (0) or almost clear (1) with a reduction from baseline of greater than 2 points at Week 12 AND an at least 75% improvement of the EASI score (EASI-75) at week 12. Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment. Scheduled clinic or telephone study visits for all subjects will occur at Screening, Baseline/Day 1, Day 8 (by phone), Day 15, Day 29, Day 43 (by phone), Day 57, Day 85 (End of treatment/Early termination), Day 113 (End of Study). Participants discontinuing early from the study will undergo a 4 week follow up period.
This study includes an immunogenicity sub study integrated into the last 4 weeks of the main study treatment period. At Week 8, up to approximately 90 participants (up to approximately 30 in each treatment arm) who have completed 8 weeks of treatment with study intervention will receive a tetanus, diphtheria and acellular pertussis combination vaccine (Tdap), and collection of blood samples for the evaluation of immunogenicity at Weeks 8 and 12. Participants of this sub study will complete all other protocol specified procedures in the main study. At the end of the 12 week study treatment, qualified participants completing the study will have the option to enter the long term extension (LTE) study B7451015. |
Facilities
Sequence: | 200032995 | Sequence: | 200032996 | Sequence: | 200032997 | Sequence: | 200032998 | Sequence: | 200032999 | Sequence: | 200033000 | Sequence: | 200033001 | Sequence: | 200033002 | Sequence: | 200033003 | Sequence: | 200033004 | Sequence: | 200033005 | Sequence: | 200033006 | Sequence: | 200033007 | Sequence: | 200033008 | Sequence: | 200033009 | Sequence: | 200033010 | Sequence: | 200033011 | Sequence: | 200033012 | Sequence: | 200033013 | Sequence: | 200033014 | Sequence: | 200033015 | Sequence: | 200033016 | Sequence: | 200033017 | Sequence: | 200033018 | Sequence: | 200033019 | Sequence: | 200033020 | Sequence: | 200033021 | Sequence: | 200033022 | Sequence: | 200033023 | Sequence: | 200033024 | Sequence: | 200033025 | Sequence: | 200033026 | Sequence: | 200033027 | Sequence: | 200033028 | Sequence: | 200033029 | Sequence: | 200033030 | Sequence: | 200033031 | Sequence: | 200033032 | Sequence: | 200033033 | Sequence: | 200033034 | Sequence: | 200033035 | Sequence: | 200033036 | Sequence: | 200033037 | Sequence: | 200033038 | Sequence: | 200033039 | Sequence: | 200033040 | Sequence: | 200033041 | Sequence: | 200033042 | Sequence: | 200033043 | Sequence: | 200033044 | Sequence: | 200033045 | Sequence: | 200033046 | Sequence: | 200033047 | Sequence: | 200033048 | Sequence: | 200033049 | Sequence: | 200033050 | Sequence: | 200033051 | Sequence: | 200033052 | Sequence: | 200033053 | Sequence: | 200033120 | Sequence: | 200033054 | Sequence: | 200033055 | Sequence: | 200033056 | Sequence: | 200033057 | Sequence: | 200033058 | Sequence: | 200033059 | Sequence: | 200033060 | Sequence: | 200033061 | Sequence: | 200033062 | Sequence: | 200033063 | Sequence: | 200033064 | Sequence: | 200033065 | Sequence: | 200033066 | Sequence: | 200033067 | Sequence: | 200033121 | Sequence: | 200033068 | Sequence: | 200033069 | Sequence: | 200033070 | Sequence: | 200033071 | Sequence: | 200033072 | Sequence: | 200033073 | Sequence: | 200033074 | Sequence: | 200033075 | Sequence: | 200033076 | Sequence: | 200033077 | Sequence: | 200033078 | Sequence: | 200033079 | Sequence: | 200033080 | Sequence: | 200033081 | Sequence: | 200033082 | Sequence: | 200033083 | Sequence: | 200033084 | Sequence: | 200033085 | Sequence: | 200033086 | Sequence: | 200033087 | Sequence: | 200033088 | Sequence: | 200033089 | Sequence: | 200033090 | Sequence: | 200033091 | Sequence: | 200033092 | Sequence: | 200033093 | Sequence: | 200033094 | Sequence: | 200033095 | Sequence: | 200033096 | Sequence: | 200033097 | Sequence: | 200033098 | Sequence: | 200033099 | Sequence: | 200033100 | Sequence: | 200033101 | Sequence: | 200033102 | Sequence: | 200033103 | Sequence: | 200033104 | Sequence: | 200033105 | Sequence: | 200033106 | Sequence: | 200033107 | Sequence: | 200033108 | Sequence: | 200033109 | Sequence: | 200033110 | Sequence: | 200033111 | Sequence: | 200033112 | Sequence: | 200033113 | Sequence: | 200033114 | Sequence: | 200033115 | Sequence: | 200033116 | Sequence: | 200033117 | Sequence: | 200033118 | Sequence: | 200033119 | Sequence: | 200033122 | Sequence: | 200033123 | Sequence: | 200033124 | Sequence: | 200033125 | Sequence: | 200033126 | Sequence: | 200033127 | Sequence: | 200033128 | Sequence: | 200033129 | Sequence: | 200033130 |
Name | Clinical Research Center of Alabama, LLC | Name | Madera Family Medical Group | Name | Allergy & Asthma Associates of Southern California dba Southern California Research | Name | UC Davis | Name | Moonshine Research Center, Inc. | Name | Homestead Research Institute | Name | Olympian Clinical Research | Name | Clinical Trials Solutions | Name | Global Health Clinical Trials Corp | Name | La Salud Research Clinic, Inc. | Name | Nicklaus Children's Hospital | Name | South Miami Medical & Research Group, Inc. | Name | Ciocca Dermatology, PA | Name | INTERMED Medical Research Center, Inc | Name | Suncoast Research Associates | Name | AdventHealth Orlando | Name | AdventHealth Pediatric Dermatology Orlando | Name | AdventHealth Orlando – Investigational Drug Services | Name | Outpatient Service Center-AdventHealth Orlando | Name | Pediatric Outpatient Procedures and Sedation | Name | NeuroSkeletal Imaging | Name | Accel Research Sites – Pure Skin Dermatology & Aesthetics | Name | Accel Research Sites – Nona Pediatric Center | Name | ForCare Clinical Research | Name | Columbus Regional Research Institute | Name | Meridian Clinical Research, LLC | Name | Midwest Allergy Sinus Asthma, SC | Name | NorthShore University HealthSystem Dermatology Clinical Trials Unit | Name | Dawes Fretzin Clinical Research Group, LLC | Name | The South Bend Clinic Center for Research | Name | Forefront Dermatology S.C. | Name | Institute for Asthma and Allergy | Name | DermAssociates, LLC | Name | Chesapeake Clinical Research, Inc. | Name | Clarkston Skin Research | Name | Wayne State University / Integrative Biosciences Center | Name | Center for Outpatient Health | Name | St. Louis Children's Hospital | Name | St. Louis Children's Hospital | Name | Washington University School of Medicine | Name | Clinical Research Consortium | Name | DermResearch Center of New York, Inc. | Name | Synexus Clinical Research US, Inc. | Name | University of Oklahoma Health Science Center | Name | Synexus Clinical Research US, Inc. | Name | Synexus Clinical Research US, Inc. | Name | Austin Institute for Clinical Research, Inc. | Name | Center for Clinical Studies, LTD.LLP | Name | Virginia Clinical Research, Inc | Name | West Virginia Research Institute | Name | Children's Hospital of Wisconsin Investigational Drug Service | Name | Children's Hospital of Wisconsin Translational Research Unit | Name | Australian Clinical Research Network | Name | The Skin Hospital | Name | The Skin Centre | Name | Sinclair Dermatology | Name | The Royal Children's Hospital | Name | The First Affiliated Hospital of Fujian Medical University, Dermatology Department | Name | The Third Xiangya Hospital of Central South University | Name | Hospital General Universitario de Alicante | Name | Dermatology Hospital of Jiangxi Province | Name | Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin | Name | Huashan Hospital Fudan University | Name | First Affiliated Hospital of Kunming Medical University | Name | Hangzhou Third Hospital | Name | The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept | Name | Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine/Dermatology | Name | Shanghai Dermatology Hospital | Name | Lekarna Na Vaclavskem namesti | Name | Kozni ambulance Kutna Hora, s.r.o | Name | Dermamedica S.R.O. | Name | Oblastni nemocnice Nachod | Name | Lekarna u Stribrneho orla | Name | Lekarna Cisarska | Name | Hospital De La Santa Creu I Sant Pau | Name | Synexus Czech S.R.O. | Name | Mestska poliklinika Praha | Name | Dermatovenerologicka ambulance | Name | Lekarna na Hranicni | Name | Nemocnice Svitavy | Name | Universitaetsklinikum Bonn | Name | Fachklinik Bad Bentheim Thermalsole- und Schwefelbad Bentheim GmbH | Name | Universitaetsklinikum Bonn | Name | MENSINGDERMA research GmbH | Name | Uniklinik Muenster | Name | Clinexpert Kft. | Name | Bugát Pál Kórház, Bőrgyógyászati Szakrendelés | Name | Trial Pharma Kft. | Name | Trial Pharma Kft. | Name | Borsod-Abaúj-Zemplén Megyei Központi Kórház és Gyermek Gasztroenterológia II. emelet | Name | Trial Pharma Kft. | Name | Istituto Clinico Humanitas IRCSS – UOC di Dermatologia | Name | Takagi Dermatological Clinic | Name | Dermatology Shimizu Clinic | Name | Noguchi Dermatology Clinic | Name | Yoshioka Dermatology Clinic | Name | Kume Clinic | Name | Fukuwa Clinic | Name | Hoshikuma Dermatology・Allergy Clinic | Name | Matsuda Tomoko Dermatological Clinic | Name | Aesthetic dermatology clinic of Prof. J. Kisis | Name | Outpatient Clinic Of Ventspils | Name | Hospital Infantil de México Federico Gómez | Name | Hospital de Jesus, I.A.P. | Name | Trials in Medicine S.C. | Name | Clinical Research Institute Saltillo S.A. de C.V. | Name | Unidad de Atención Médica e Investigación en Salud | Name | Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan | Name | Servicios Hospitalarios de Mexico S.A. de C.V. (Hospital Ángeles Chihuahua) | Name | Sociedad de Metabolismo y Corazón S.C. | Name | KLIMED Marek Klimkiewicz | Name | Clinica Dermatoestetica Prywatny Gabinet Dermatologiczny i Alergologiczny | Name | Centrum Medyczne SENSEMED | Name | Centrum Medyczne Pratia Czestochowa | Name | Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna "A-DERM-SERWIS" | Name | Neutrum Lekarze M. Hlebowicz i Partnerzy Spolka Partnerska | Name | MULTIKLINIKA Salute Sp. z o.o. | Name | Centrum Medyczne Angelius Provita | Name | Centrum medyczne PLEJADY | Name | Krakowskie Centrum Medyczne | Name | Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak | Name | Dermedic Jacek Zdybski | Name | Irmed | Name | Synexus Polska Sp. z o.o. Oddzial w Poznaniu | Name | Synexus Polska Sp. z o.o. Oddzial w Warszawie | Name | Synexus Polska Sp. z o.o. Oddzial we Wroclawiu | Name | Hospital Universitario de Gran Canaria Dr. Negrin | Name | Hospital Universitario 12 de Octubre | Name | Hospital Universitario La Paz | Name | Consultas Externas Dermatologia Hospital Universitario Miguel Servet | Name | Hospital Universitario Miguel Servet | Name | Servicio de Radiologia Hospital Universitario Miguel Servet | Name | Chung Shan Medical University Hospital | Name | National Taiwan University Hospital | Name | Taipei Veterans General Hospital | Name | Barnsley Hospital NHS Foundation Trust |
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Browse Interventions
Sequence: | 96015731 | Sequence: | 96015732 | Sequence: | 96015733 | Sequence: | 96015734 |
Mesh Term | Abrocitinib | Mesh Term | Protein Kinase Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | abrocitinib | Downcase Mesh Term | protein kinase inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52149698 |
Name | Atopic Dermatitis |
Downcase Name | atopic dermatitis |
Id Information
Sequence: | 40143078 | Sequence: | 40143079 | Sequence: | 40143080 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | B7451036 | Id Value | JADE TEEN | Id Value | 2018-003804-37 |
Id Type | Other Identifier | Id Type | EudraCT Number | ||
Id Type Description | Alias Study Number | ||||
Countries
Sequence: | 42552456 | Sequence: | 42552457 | Sequence: | 42552458 | Sequence: | 42552459 | Sequence: | 42552460 | Sequence: | 42552461 | Sequence: | 42552462 | Sequence: | 42552463 | Sequence: | 42552464 | Sequence: | 42552465 | Sequence: | 42552466 | Sequence: | 42552467 | Sequence: | 42552468 | Sequence: | 42552469 |
Name | United States | Name | Australia | Name | China | Name | Czechia | Name | Germany | Name | Hungary | Name | Italy | Name | Japan | Name | Latvia | Name | Mexico | Name | Poland | Name | Spain | Name | Taiwan | Name | United Kingdom |
Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False |
Design Groups
Sequence: | 55570381 | Sequence: | 55570382 | Sequence: | 55570383 |
Group Type | Placebo Comparator | Group Type | Experimental | Group Type | Experimental |
Title | Placebo | Title | PF-04965842 100 mg QD | Title | PF-04965842 200 mg QD |
Description | Placebo | Description | active | Description | active |
Interventions
Sequence: | 52465389 | Sequence: | 52465390 | Sequence: | 52465391 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Placebo | Name | PF-04965842 | Name | PF04965842 |
Description | Placebo | Description | 100 mg QD | Description | 200 mg QD |
Keywords
Sequence: | 79837212 |
Name | Atopic Dermatitis, JAK1 inhibitor |
Downcase Name | atopic dermatitis, jak1 inhibitor |
Design Outcomes
Sequence: | 177304434 | Sequence: | 177304435 | Sequence: | 177304436 | Sequence: | 177304437 | Sequence: | 177304438 | Sequence: | 177304439 | Sequence: | 177304440 | Sequence: | 177304441 | Sequence: | 177304442 | Sequence: | 177304443 | Sequence: | 177304444 | Sequence: | 177304445 | Sequence: | 177304446 | Sequence: | 177304447 | Sequence: | 177304448 | Sequence: | 177304449 | Sequence: | 177304450 | Sequence: | 177304451 | Sequence: | 177304452 | Sequence: | 177304453 | Sequence: | 177304454 | Sequence: | 177304455 | Sequence: | 177304456 | Sequence: | 177304457 | Sequence: | 177304458 | Sequence: | 177304459 | Sequence: | 177304460 | Sequence: | 177304461 | Sequence: | 177304462 | Sequence: | 177304463 | Sequence: | 177304464 | Sequence: | 177304465 | Sequence: | 177304469 | Sequence: | 177304466 | Sequence: | 177304467 | Sequence: | 177304468 | Sequence: | 177304470 | Sequence: | 177304471 | Sequence: | 177304472 | Sequence: | 177304473 | Sequence: | 177304474 | Sequence: | 177304475 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12 | Measure | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12 | Measure | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Measure | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12 | Measure | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Measure | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Measure | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Measure | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Measure | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Measure | Percent Change From Baseline in EASI Score | Measure | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Measure | Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus | Measure | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Measure | Change From Baseline in Percentage Body Surface Area (BSA) | Measure | Percent Change From Baseline in Percentage BSA | Measure | Percentage of Participants Achieving Percentage BSA < 5% at Week 12 | Measure | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Measure | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Measure | Change From Baseline in SCORAD Total Score | Measure | Percent Change From Baseline in SCORAD Total Score | Measure | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Measure | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Measure | Number of Days When a Corticosteroid Not Used up to Day 88 | Measure | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Measure | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Measure | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Measure | Change From Baseline in Depression of HADS | Measure | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Measure | Change From Baseline in Dermatitis Family Impact (DFI) at Week 12 | Measure | Change From Baseline in Patient Global Assessment (PtGA) | Measure | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Measure | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Measure | Number of Participants Who Discontinued From the Study Due to TEAEs | Measure | Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12 | Measure | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Measure | Number of Participants With Serious Adverse Events (SAEs) | Measure | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Measure | Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria | Measure | Categorization of Vital Signs Data Meeting Prespecified Criteria | Measure | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Measure | Plasma PF-04965842 Concentration at Week 8 | Measure | Plasma PF-04965842 Concentration at Week 12 |
Time Frame | Baseline to Week 12 | Time Frame | Baseline to Week 12 | Time Frame | Baseline, Weeks 2, 4 and 12 | Time Frame | Baseline to Week 12 | Time Frame | Baseline, Weeks 2, 4 and 8 | Time Frame | Baseline, Weeks 2, 4 and 8 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Time Frame | Baseline to Week 16 | Time Frame | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline to Week 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline to Day 88 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline to Week 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | 16 weeks | Time Frame | Baseline to Week 12 | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 4 weeks post-vaccination with Tdap (Week 12) | Time Frame | 2 hours pre-dose at Week 8 | Time Frame | 2 hours post-dose at Week 12 |
Description | The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep & Usual Activities Questions and Patient Global Impression of Severity & Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms. | Description | The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD. | Description | The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" or "not at all (0)". The score can range from 0 to 30. The higher values represent the worse impact. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine). | Description | An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | Description | The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated. | Description | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | Description | A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to >500 ms or >60 ms change from screening ECG); data are presented below. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. |
Browse Conditions
Sequence: | 193406230 | Sequence: | 193406229 | Sequence: | 193406232 | Sequence: | 193406233 | Sequence: | 193406234 | Sequence: | 193406235 | Sequence: | 193406236 | Sequence: | 193406237 | Sequence: | 193406238 | Sequence: | 193406231 |
Mesh Term | Dermatitis | Mesh Term | Dermatitis, Atopic | Mesh Term | Skin Diseases | Mesh Term | Skin Diseases, Genetic | Mesh Term | Genetic Diseases, Inborn | Mesh Term | Skin Diseases, Eczematous | Mesh Term | Hypersensitivity, Immediate | Mesh Term | Hypersensitivity | Mesh Term | Immune System Diseases | Mesh Term | Eczema |
Downcase Mesh Term | dermatitis | Downcase Mesh Term | dermatitis, atopic | Downcase Mesh Term | skin diseases | Downcase Mesh Term | skin diseases, genetic | Downcase Mesh Term | genetic diseases, inborn | Downcase Mesh Term | skin diseases, eczematous | Downcase Mesh Term | hypersensitivity, immediate | Downcase Mesh Term | hypersensitivity | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | eczema |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list |
Sponsors
Sequence: | 48299884 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Pfizer |
Overall Officials
Sequence: | 29273767 |
Role | Study Director |
Name | Pfizer CT.gov Call Center |
Affiliation | Pfizer |
Design Group Interventions
Sequence: | 68122177 | Sequence: | 68122178 | Sequence: | 68122179 |
Design Group Id | 55570381 | Design Group Id | 55570382 | Design Group Id | 55570383 |
Intervention Id | 52465389 | Intervention Id | 52465390 | Intervention Id | 52465391 |
Eligibilities
Sequence: | 30753371 |
Gender | All |
Minimum Age | 12 Years |
Maximum Age | 17 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Aged between 12 and to 17 with a minimum body weight of 40 kg Exclusion Criteria: Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254165153 |
Number Of Facilities | 136 |
Number Of Nsae Subjects | 239 |
Number Of Sae Subjects | 3 |
Registered In Calendar Year | 2019 |
Actual Duration | 13 |
Were Results Reported | True |
Months To Report Results | 11 |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 12 |
Maximum Age Num | 17 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 40 |
Designs
Sequence: | 30499631 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Drop Withdrawals
Sequence: | 28977257 | Sequence: | 28977258 | Sequence: | 28977259 | Sequence: | 28977260 | Sequence: | 28977261 | Sequence: | 28977262 | Sequence: | 28977263 | Sequence: | 28977264 | Sequence: | 28977265 | Sequence: | 28977266 | Sequence: | 28977267 | Sequence: | 28977268 | Sequence: | 28977269 | Sequence: | 28977270 | Sequence: | 28977271 |
Result Group Id | 56080963 | Result Group Id | 56080964 | Result Group Id | 56080965 | Result Group Id | 56080963 | Result Group Id | 56080964 | Result Group Id | 56080965 | Result Group Id | 56080963 | Result Group Id | 56080964 | Result Group Id | 56080965 | Result Group Id | 56080963 | Result Group Id | 56080964 | Result Group Id | 56080965 | Result Group Id | 56080963 | Result Group Id | 56080964 | Result Group Id | 56080965 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Protocol Violation | Reason | Protocol Violation | Reason | Protocol Violation | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Participant did not complete Week 16 due to COVID-19 impact | Reason | Participant did not complete Week 16 due to COVID-19 impact | Reason | Participant did not complete Week 16 due to COVID-19 impact |
Count | 2 | Count | 1 | Count | 2 | Count | 2 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 1 | Count | 1 | Count | 0 | Count | 1 | Count | 0 | Count | 0 |
Milestones
Sequence: | 40993641 | Sequence: | 40993642 | Sequence: | 40993643 | Sequence: | 40993644 | Sequence: | 40993645 | Sequence: | 40993646 | Sequence: | 40993647 | Sequence: | 40993648 | Sequence: | 40993649 |
Result Group Id | 56080963 | Result Group Id | 56080964 | Result Group Id | 56080965 | Result Group Id | 56080963 | Result Group Id | 56080964 | Result Group Id | 56080965 | Result Group Id | 56080963 | Result Group Id | 56080964 | Result Group Id | 56080965 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 |
Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 96 | Count | 95 | Count | 94 | Count | 90 | Count | 92 | Count | 91 | Count | 6 | Count | 3 | Count | 3 |
Outcome Analyses
Sequence: | 16563356 | Sequence: | 16563357 | Sequence: | 16563358 | Sequence: | 16563359 | Sequence: | 16563360 | Sequence: | 16563361 | Sequence: | 16563362 | Sequence: | 16563363 | Sequence: | 16563364 | Sequence: | 16563365 | Sequence: | 16563366 | Sequence: | 16563367 |
Outcome Id | 30794699 | Outcome Id | 30794699 | Outcome Id | 30794700 | Outcome Id | 30794700 | Outcome Id | 30794701 | Outcome Id | 30794701 | Outcome Id | 30794701 | Outcome Id | 30794701 | Outcome Id | 30794701 | Outcome Id | 30794701 | Outcome Id | 30794702 | Outcome Id | 30794702 |
Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority |
Param Type | Estimate of difference | Param Type | Estimate of difference | Param Type | Estimate of difference | Param Type | Estimate of difference | Param Type | Estimate of difference | Param Type | Estimate of difference | Param Type | Estimate of difference | Param Type | Estimate of difference | Param Type | Estimate of difference | Param Type | Estimate of difference | Param Type | Mean Difference (Net) | Param Type | Mean Difference (Net) |
Param Value | 16.7 | Param Value | 20.6 | Param Value | 26.5 | Param Value | 29.4 | Param Value | 14.7 | Param Value | 26.1 | Param Value | 10.9 | Param Value | 29.4 | Param Value | 22.8 | Param Value | 25.6 | Param Value | -0.5 | Param Value | -0.7 |
P Value Modifier | P Value Modifier | P Value Modifier | P Value Modifier | < | P Value Modifier | P Value Modifier | < | P Value Modifier | P Value Modifier | < | P Value Modifier | P Value Modifier | P Value Modifier | P Value Modifier | |||||||||
P Value | 0.0147 | P Value | 0.003 | P Value | 0.0002 | P Value | 0.0001 | P Value | 0.0119 | P Value | 0.0001 | P Value | 0.0971 | P Value | 0.0001 | P Value | 0.0035 | P Value | 0.0013 | P Value | 0.0664 | P Value | 0.0142 |
Ci N Sides | 2-Sided | Ci N Sides | 2-Sided | Ci N Sides | 2-Sided | Ci N Sides | 2-Sided | Ci N Sides | 2-Sided | Ci N Sides | 2-Sided | Ci N Sides | 2-Sided | Ci N Sides | 2-Sided | Ci N Sides | 2-Sided | Ci N Sides | 2-Sided | Ci N Sides | 2-Sided | ||
Ci Percent | 95.0 | Ci Percent | 95.0 | Ci Percent | 95.0 | Ci Percent | 95.0 | Ci Percent | 95.0 | Ci Percent | 95.0 | Ci Percent | 95.0 | Ci Percent | 95.0 | Ci Percent | 95.0 | Ci Percent | 95.0 | Ci Percent | 95.0 | Ci Percent | 95.0 |
Ci Lower Limit | 3.5 | Ci Lower Limit | 7.3 | Ci Lower Limit | 13.1 | Ci Lower Limit | 16.3 | Ci Lower Limit | 3.5 | Ci Lower Limit | 13.9 | Ci Lower Limit | -1.8 | Ci Lower Limit | 16.0 | Ci Lower Limit | 8.0 | Ci Lower Limit | 10.6 | Ci Lower Limit | -1.1 | Ci Lower Limit | -1.3 |
Ci Upper Limit | 29.9 | Ci Upper Limit | 33.9 | Ci Upper Limit | 39.8 | Ci Upper Limit | 42.5 | Ci Upper Limit | 25.9 | Ci Upper Limit | 38.3 | Ci Upper Limit | 23.6 | Ci Upper Limit | 42.9 | Ci Upper Limit | 37.7 | Ci Upper Limit | 40.6 | Ci Upper Limit | 0.0 | Ci Upper Limit | -0.1 |
Method | Cochran-Mantel-Haenszel | Method | Cochran-Mantel-Haenszel | Method | Cochran-Mantel-Haenszel | Method | Cochran-Mantel-Haenszel | Method | Cochran-Mantel-Haenszel | Method | Cochran-Mantel-Haenszel | Method | Cochran-Mantel-Haenszel | Method | Cochran-Mantel-Haenszel | Method | Cochran-Mantel-Haenszel | Method | Cochran-Mantel-Haenszel | Method | Mixed Models Analysis | Method | Mixed Models Analysis |
Estimate Description | Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo | Estimate Description | Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo | Estimate Description | Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo | Estimate Description | Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo | Estimate Description | Estimate of the difference in percentages of response at Week 2 was calculated by PF-04965842 100 mg minus placebo | Estimate Description | Estimate of the difference in percentages of response at Week 2 was calculated by PF-04965842 200 mg minus placebo | Estimate Description | Estimate of the difference in percentages of response at Week 4 was calculated by PF-04965842 100 mg minus placebo | Estimate Description | Estimate of the difference in percentages of response at Week 4 was calculated by PF-04965842 200 mg minus placebo | Estimate Description | Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo | Estimate Description | Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo | Estimate Description | The least squares mean difference at Week 12 was calculated by PF-04965842 100 mg minus placebo | Estimate Description | The least squares mean difference at Week 12 was calculated by PF-04965842 200 mg minus placebo |
Outcome Analysis Groups
Sequence: | 32123018 | Sequence: | 32123019 | Sequence: | 32123020 | Sequence: | 32123021 | Sequence: | 32123022 | Sequence: | 32123023 | Sequence: | 32123024 | Sequence: | 32123025 | Sequence: | 32123026 | Sequence: | 32123027 | Sequence: | 32123028 | Sequence: | 32123029 | Sequence: | 32123030 | Sequence: | 32123031 | Sequence: | 32123032 | Sequence: | 32123033 | Sequence: | 32123034 | Sequence: | 32123035 | Sequence: | 32123036 | Sequence: | 32123037 | Sequence: | 32123038 | Sequence: | 32123039 | Sequence: | 32123040 | Sequence: | 32123041 |
Outcome Analysis Id | 16563356 | Outcome Analysis Id | 16563356 | Outcome Analysis Id | 16563357 | Outcome Analysis Id | 16563357 | Outcome Analysis Id | 16563358 | Outcome Analysis Id | 16563358 | Outcome Analysis Id | 16563359 | Outcome Analysis Id | 16563359 | Outcome Analysis Id | 16563360 | Outcome Analysis Id | 16563360 | Outcome Analysis Id | 16563361 | Outcome Analysis Id | 16563361 | Outcome Analysis Id | 16563362 | Outcome Analysis Id | 16563362 | Outcome Analysis Id | 16563363 | Outcome Analysis Id | 16563363 | Outcome Analysis Id | 16563364 | Outcome Analysis Id | 16563364 | Outcome Analysis Id | 16563365 | Outcome Analysis Id | 16563365 | Outcome Analysis Id | 16563366 | Outcome Analysis Id | 16563366 | Outcome Analysis Id | 16563367 | Outcome Analysis Id | 16563367 |
Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080966 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080966 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080966 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080966 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080966 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080966 | Result Group Id | 56080968 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG002 |
Links
Sequence: | 4386355 |
Url | https://pmiform.com/clinical-trial-info-request?StudyID=B7451036 |
Description | To obtain contact information for a study center near you, click here. |
Participant Flows
Sequence: | 3920219 |
Pre Assignment Details | A total of 287 adolescent participants were randomized to the study, and 285 adolescent participants received study treatment, including 96 participants in the placebo group, 95 participants in the abrocitinib 100 mg QD group, and 94 participants in the abrocitinib 200 mg QD group. |
Outcome Counts
Sequence: | 73976465 | Sequence: | 73976466 | Sequence: | 73976467 | Sequence: | 73976468 | Sequence: | 73976469 | Sequence: | 73976470 | Sequence: | 73976471 | Sequence: | 73976472 | Sequence: | 73976473 | Sequence: | 73976474 | Sequence: | 73976475 | Sequence: | 73976476 | Sequence: | 73976477 | Sequence: | 73976478 | Sequence: | 73976479 | Sequence: | 73976480 | Sequence: | 73976481 | Sequence: | 73976482 | Sequence: | 73976483 | Sequence: | 73976484 | Sequence: | 73976485 | Sequence: | 73976486 | Sequence: | 73976487 | Sequence: | 73976488 | Sequence: | 73976489 | Sequence: | 73976490 | Sequence: | 73976491 | Sequence: | 73976492 | Sequence: | 73976493 | Sequence: | 73976494 | Sequence: | 73976495 | Sequence: | 73976496 | Sequence: | 73976497 | Sequence: | 73976498 | Sequence: | 73976499 | Sequence: | 73976500 | Sequence: | 73976501 | Sequence: | 73976502 | Sequence: | 73976503 | Sequence: | 73976504 | Sequence: | 73976505 | Sequence: | 73976506 | Sequence: | 73976507 | Sequence: | 73976508 | Sequence: | 73976509 | Sequence: | 73976510 | Sequence: | 73976511 | Sequence: | 73976512 | Sequence: | 73976513 | Sequence: | 73976514 | Sequence: | 73976515 | Sequence: | 73976516 | Sequence: | 73976517 | Sequence: | 73976518 | Sequence: | 73976519 | Sequence: | 73976520 | Sequence: | 73976521 | Sequence: | 73976522 | Sequence: | 73976523 | Sequence: | 73976524 | Sequence: | 73976525 | Sequence: | 73976526 | Sequence: | 73976527 | Sequence: | 73976528 | Sequence: | 73976529 | Sequence: | 73976530 | Sequence: | 73976531 | Sequence: | 73976532 | Sequence: | 73976533 | Sequence: | 73976534 | Sequence: | 73976535 | Sequence: | 73976536 | Sequence: | 73976537 | Sequence: | 73976538 | Sequence: | 73976539 | Sequence: | 73976540 | Sequence: | 73976541 | Sequence: | 73976542 | Sequence: | 73976543 | Sequence: | 73976544 | Sequence: | 73976545 | Sequence: | 73976546 | Sequence: | 73976547 | Sequence: | 73976548 | Sequence: | 73976549 | Sequence: | 73976550 | Sequence: | 73976551 | Sequence: | 73976552 | Sequence: | 73976553 | Sequence: | 73976554 | Sequence: | 73976555 | Sequence: | 73976556 | Sequence: | 73976557 | Sequence: | 73976558 | Sequence: | 73976559 | Sequence: | 73976560 | Sequence: | 73976561 | Sequence: | 73976562 | Sequence: | 73976563 | Sequence: | 73976564 | Sequence: | 73976565 | Sequence: | 73976566 | Sequence: | 73976567 | Sequence: | 73976568 | Sequence: | 73976569 | Sequence: | 73976570 | Sequence: | 73976571 | Sequence: | 73976572 | Sequence: | 73976573 | Sequence: | 73976574 | Sequence: | 73976575 | Sequence: | 73976576 | Sequence: | 73976577 | Sequence: | 73976578 | Sequence: | 73976579 | Sequence: | 73976580 | Sequence: | 73976581 | Sequence: | 73976582 | Sequence: | 73976583 | Sequence: | 73976584 | Sequence: | 73976585 | Sequence: | 73976586 | Sequence: | 73976587 | Sequence: | 73976588 |
Outcome Id | 30794699 | Outcome Id | 30794699 | Outcome Id | 30794699 | Outcome Id | 30794700 | Outcome Id | 30794700 | Outcome Id | 30794700 | Outcome Id | 30794701 | Outcome Id | 30794701 | Outcome Id | 30794701 | Outcome Id | 30794702 | Outcome Id | 30794702 | Outcome Id | 30794702 | Outcome Id | 30794703 | Outcome Id | 30794703 | Outcome Id | 30794703 | Outcome Id | 30794704 | Outcome Id | 30794704 | Outcome Id | 30794704 | Outcome Id | 30794705 | Outcome Id | 30794705 | Outcome Id | 30794705 | Outcome Id | 30794706 | Outcome Id | 30794706 | Outcome Id | 30794706 | Outcome Id | 30794707 | Outcome Id | 30794707 | Outcome Id | 30794707 | Outcome Id | 30794708 | Outcome Id | 30794708 | Outcome Id | 30794708 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794710 | Outcome Id | 30794710 | Outcome Id | 30794710 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794712 | Outcome Id | 30794712 | Outcome Id | 30794712 | Outcome Id | 30794713 | Outcome Id | 30794713 | Outcome Id | 30794713 | Outcome Id | 30794714 | Outcome Id | 30794714 | Outcome Id | 30794714 | Outcome Id | 30794715 | Outcome Id | 30794715 | Outcome Id | 30794715 | Outcome Id | 30794716 | Outcome Id | 30794716 | Outcome Id | 30794716 | Outcome Id | 30794717 | Outcome Id | 30794717 | Outcome Id | 30794717 | Outcome Id | 30794718 | Outcome Id | 30794718 | Outcome Id | 30794718 | Outcome Id | 30794719 | Outcome Id | 30794719 | Outcome Id | 30794719 | Outcome Id | 30794720 | Outcome Id | 30794720 | Outcome Id | 30794720 | Outcome Id | 30794721 | Outcome Id | 30794721 | Outcome Id | 30794721 | Outcome Id | 30794722 | Outcome Id | 30794722 | Outcome Id | 30794722 | Outcome Id | 30794723 | Outcome Id | 30794723 | Outcome Id | 30794723 | Outcome Id | 30794724 | Outcome Id | 30794724 | Outcome Id | 30794724 | Outcome Id | 30794725 | Outcome Id | 30794725 | Outcome Id | 30794725 | Outcome Id | 30794726 | Outcome Id | 30794726 | Outcome Id | 30794726 | Outcome Id | 30794727 | Outcome Id | 30794727 | Outcome Id | 30794727 | Outcome Id | 30794728 | Outcome Id | 30794728 | Outcome Id | 30794728 | Outcome Id | 30794729 | Outcome Id | 30794729 | Outcome Id | 30794729 | Outcome Id | 30794730 | Outcome Id | 30794730 | Outcome Id | 30794730 | Outcome Id | 30794731 | Outcome Id | 30794731 | Outcome Id | 30794731 | Outcome Id | 30794732 | Outcome Id | 30794732 | Outcome Id | 30794732 | Outcome Id | 30794733 | Outcome Id | 30794733 | Outcome Id | 30794733 | Outcome Id | 30794734 | Outcome Id | 30794734 | Outcome Id | 30794734 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794736 | Outcome Id | 30794736 | Outcome Id | 30794736 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794739 | Outcome Id | 30794739 | Outcome Id | 30794740 | Outcome Id | 30794740 |
Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080969 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080970 | Result Group Id | 56080971 | Result Group Id | 56080970 | Result Group Id | 56080971 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 94 | Count | 89 | Count | 93 | Count | 94 | Count | 89 | Count | 93 | Count | 95 | Count | 92 | Count | 88 | Count | 95 | Count | 95 | Count | 93 | Count | 96 | Count | 92 | Count | 94 | Count | 96 | Count | 92 | Count | 94 | Count | 96 | Count | 92 | Count | 94 | Count | 96 | Count | 92 | Count | 94 | Count | 96 | Count | 92 | Count | 94 | Count | 96 | Count | 92 | Count | 94 | Count | 84 | Count | 83 | Count | 82 | Count | 96 | Count | 93 | Count | 90 | Count | 84 | Count | 83 | Count | 82 | Count | 96 | Count | 95 | Count | 94 | Count | 96 | Count | 95 | Count | 94 | Count | 94 | Count | 89 | Count | 93 | Count | 96 | Count | 93 | Count | 93 | Count | 96 | Count | 93 | Count | 93 | Count | 96 | Count | 95 | Count | 93 | Count | 96 | Count | 95 | Count | 93 | Count | 96 | Count | 95 | Count | 93 | Count | 96 | Count | 95 | Count | 93 | Count | 83 | Count | 89 | Count | 82 | Count | 96 | Count | 95 | Count | 94 | Count | 95 | Count | 92 | Count | 94 | Count | 96 | Count | 95 | Count | 94 | Count | 96 | Count | 95 | Count | 94 | Count | 95 | Count | 95 | Count | 94 | Count | 92 | Count | 95 | Count | 93 | Count | 96 | Count | 95 | Count | 94 | Count | 96 | Count | 93 | Count | 94 | Count | 96 | Count | 95 | Count | 94 | Count | 96 | Count | 95 | Count | 94 | Count | 96 | Count | 95 | Count | 94 | Count | 96 | Count | 95 | Count | 94 | Count | 96 | Count | 95 | Count | 94 | Count | 96 | Count | 95 | Count | 93 | Count | 96 | Count | 95 | Count | 93 | Count | 96 | Count | 95 | Count | 93 | Count | 10 | Count | 8 | Count | 4 | Count | 72 | Count | 62 | Count | 59 | Count | 50 |
Provided Documents
Sequence: | 2577899 | Sequence: | 2577900 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2019-04-26 | Document Date | 2020-04-16 |
Url | https://ClinicalTrials.gov/ProvidedDocs/76/NCT03796676/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/76/NCT03796676/SAP_001.pdf |
Reported Event Totals
Sequence: | 27935158 | Sequence: | 27935159 | Sequence: | 27935160 | Sequence: | 27935161 | Sequence: | 27935162 | Sequence: | 27935163 | Sequence: | 27935164 | Sequence: | 27935165 | Sequence: | 27935166 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 2 | Subjects Affected | 42 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 40 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 50 | Subjects Affected | 0 |
Subjects At Risk | 96 | Subjects At Risk | 96 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 95 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 94 | Subjects At Risk | 94 |
Created At | 2023-08-08 21:51:35.721759 | Created At | 2023-08-08 21:51:35.721759 | Created At | 2023-08-08 21:51:35.721759 | Created At | 2023-08-08 21:51:35.721759 | Created At | 2023-08-08 21:51:35.721759 | Created At | 2023-08-08 21:51:35.721759 | Created At | 2023-08-08 21:51:35.721759 | Created At | 2023-08-08 21:51:35.721759 | Created At | 2023-08-08 21:51:35.721759 |
Updated At | 2023-08-08 21:51:35.721759 | Updated At | 2023-08-08 21:51:35.721759 | Updated At | 2023-08-08 21:51:35.721759 | Updated At | 2023-08-08 21:51:35.721759 | Updated At | 2023-08-08 21:51:35.721759 | Updated At | 2023-08-08 21:51:35.721759 | Updated At | 2023-08-08 21:51:35.721759 | Updated At | 2023-08-08 21:51:35.721759 | Updated At | 2023-08-08 21:51:35.721759 |
Reported Events
Sequence: | 528051228 | Sequence: | 528051229 | Sequence: | 528051230 | Sequence: | 528051231 | Sequence: | 528051232 | Sequence: | 528051233 | Sequence: | 528051234 | Sequence: | 528051235 | Sequence: | 528051236 | Sequence: | 528051237 | Sequence: | 528051238 | Sequence: | 528051239 | Sequence: | 528051240 | Sequence: | 528051241 | Sequence: | 528051242 | Sequence: | 528051243 | Sequence: | 528051244 | Sequence: | 528051245 | Sequence: | 528051246 | Sequence: | 528051247 | Sequence: | 528051248 | Sequence: | 528051249 | Sequence: | 528051250 | Sequence: | 528051251 | Sequence: | 528051252 | Sequence: | 528051253 | Sequence: | 528051254 | Sequence: | 528051255 | Sequence: | 528051256 | Sequence: | 528051257 | Sequence: | 528051258 | Sequence: | 528051259 | Sequence: | 528051260 | Sequence: | 528051261 | Sequence: | 528051262 | Sequence: | 528051263 | Sequence: | 528051264 | Sequence: | 528051265 | Sequence: | 528051266 | Sequence: | 528051267 | Sequence: | 528051268 | Sequence: | 528051269 | Sequence: | 528051270 | Sequence: | 528051271 | Sequence: | 528051272 | Sequence: | 528051273 | Sequence: | 528051274 | Sequence: | 528051275 | Sequence: | 528051276 | Sequence: | 528051277 | Sequence: | 528051278 | Sequence: | 528051279 | Sequence: | 528051280 | Sequence: | 528051281 | Sequence: | 528051282 | Sequence: | 528051283 | Sequence: | 528051284 | Sequence: | 528051285 | Sequence: | 528051286 | Sequence: | 528051287 | Sequence: | 528051288 | Sequence: | 528051289 | Sequence: | 528051290 | Sequence: | 528051291 | Sequence: | 528051292 | Sequence: | 528051293 | Sequence: | 528051294 | Sequence: | 528051295 | Sequence: | 528051296 | Sequence: | 528051297 | Sequence: | 528051298 | Sequence: | 528051299 | Sequence: | 528051300 | Sequence: | 528051301 | Sequence: | 528051302 | Sequence: | 528051303 | Sequence: | 528051304 | Sequence: | 528051305 | Sequence: | 528051306 | Sequence: | 528051307 | Sequence: | 528051308 | Sequence: | 528051309 | Sequence: | 528051310 | Sequence: | 528051311 | Sequence: | 528051312 | Sequence: | 528051313 | Sequence: | 528051314 | Sequence: | 528051315 | Sequence: | 528051316 | Sequence: | 528051317 | Sequence: | 528051318 | Sequence: | 528051319 | Sequence: | 528051320 | Sequence: | 528051321 | Sequence: | 528051322 | Sequence: | 528051323 | Sequence: | 528051324 | Sequence: | 528051325 | Sequence: | 528051326 | Sequence: | 528051327 | Sequence: | 528051328 | Sequence: | 528051329 | Sequence: | 528051330 | Sequence: | 528051331 | Sequence: | 528051332 | Sequence: | 528051333 | Sequence: | 528051334 | Sequence: | 528051335 |
Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 | Result Group Id | 56080972 | Result Group Id | 56080973 | Result Group Id | 56080974 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 |
Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks |
Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 3 | Subjects Affected | 1 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 7 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 4 | Subjects Affected | 4 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 6 | Subjects Affected | 2 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 3 | Subjects Affected | 5 | Subjects Affected | 2 | Subjects Affected | 2 | Subjects Affected | 1 | Subjects Affected | 2 | Subjects Affected | 4 | Subjects Affected | 1 | Subjects Affected | 3 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 7 | Subjects Affected | 5 | Subjects Affected | 8 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 2 | Subjects Affected | 2 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 2 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 2 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 4 | Subjects Affected | 2 | Subjects Affected | 9 | Subjects Affected | 8 | Subjects Affected | 8 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 2 | Subjects Affected | 3 | Subjects Affected | 5 | Subjects Affected | 3 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 3 | Subjects Affected | 10 | Subjects Affected | 9 | Subjects Affected | 10 | Subjects Affected | 4 | Subjects Affected | 3 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 4 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 1 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 7 | Subjects Affected | 17 | Subjects Affected | 0 | Subjects Affected | 4 | Subjects Affected | 5 |
Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 | Subjects At Risk | 96 | Subjects At Risk | 95 | Subjects At Risk | 94 |
Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. |
Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 2 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 3 | Event Count | 1 | Event Count | 2 | Event Count | 0 | Event Count | 1 | Event Count | 7 | Event Count | 2 | Event Count | 0 | Event Count | 2 | Event Count | 0 | Event Count | 0 | Event Count | 5 | Event Count | 4 | Event Count | 2 | Event Count | 0 | Event Count | 9 | Event Count | 2 | Event Count | 1 | Event Count | 3 | Event Count | 2 | Event Count | 3 | Event Count | 5 | Event Count | 2 | Event Count | 2 | Event Count | 2 | Event Count | 2 | Event Count | 6 | Event Count | 1 | Event Count | 4 | Event Count | 1 | Event Count | 0 | Event Count | 8 | Event Count | 7 | Event Count | 12 | Event Count | 2 | Event Count | 0 | Event Count | 2 | Event Count | 0 | Event Count | 1 | Event Count | 2 | Event Count | 2 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 3 | Event Count | 2 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 2 | Event Count | 2 | Event Count | 0 | Event Count | 2 | Event Count | 0 | Event Count | 1 | Event Count | 4 | Event Count | 2 | Event Count | 11 | Event Count | 10 | Event Count | 9 | Event Count | 0 | Event Count | 2 | Event Count | 2 | Event Count | 3 | Event Count | 5 | Event Count | 3 | Event Count | 2 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 3 | Event Count | 12 | Event Count | 11 | Event Count | 14 | Event Count | 4 | Event Count | 3 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 5 | Event Count | 0 | Event Count | 2 | Event Count | 1 | Event Count | 2 | Event Count | 0 | Event Count | 0 | Event Count | 2 | Event Count | 7 | Event Count | 27 | Event Count | 0 | Event Count | 4 | Event Count | 7 |
Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders |
Adverse Event Term | Anxiety | Adverse Event Term | Anxiety | Adverse Event Term | Anxiety | Adverse Event Term | Angioedema | Adverse Event Term | Angioedema | Adverse Event Term | Angioedema | Adverse Event Term | Dermatitis stopic | Adverse Event Term | Dermatitis stopic | Adverse Event Term | Dermatitis stopic | Adverse Event Term | Eosinophilia | Adverse Event Term | Eosinophilia | Adverse Event Term | Eosinophilia | Adverse Event Term | Abdominal Pain | Adverse Event Term | Abdominal Pain | Adverse Event Term | Abdominal Pain | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Folliculitis | Adverse Event Term | Folliculitis | Adverse Event Term | Folliculitis | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Blood creatine phosphokinase increased | Adverse Event Term | Blood creatine phosphokinase increased | Adverse Event Term | Blood creatine phosphokinase increased | Adverse Event Term | Dizziness | Adverse Event Term | Dizziness | Adverse Event Term | Dizziness | Adverse Event Term | Asthma | Adverse Event Term | Asthma | Adverse Event Term | Asthma | Adverse Event Term | Acne | Adverse Event Term | Acne | Adverse Event Term | Acne | Adverse Event Term | Dermatitis atopic | Adverse Event Term | Dermatitis atopic | Adverse Event Term | Dermatitis atopic | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Rhinorrhoea | Adverse Event Term | Rhinorrhoea | Adverse Event Term | Rhinorrhoea | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Somnolence | Adverse Event Term | Somnolence | Adverse Event Term | Somnolence | Adverse Event Term | Blood lactate dehydrogenase increased | Adverse Event Term | Blood lactate dehydrogenase increased | Adverse Event Term | Blood lactate dehydrogenase increased | Adverse Event Term | Blood uric acid increased | Adverse Event Term | Blood uric acid increased | Adverse Event Term | Blood uric acid increased | Adverse Event Term | Haemoglobin decreased | Adverse Event Term | Haemoglobin decreased | Adverse Event Term | Haemoglobin decreased | Adverse Event Term | Protein urine | Adverse Event Term | Protein urine | Adverse Event Term | Protein urine | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Hordeolum | Adverse Event Term | Hordeolum | Adverse Event Term | Hordeolum | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Oral herpes | Adverse Event Term | Oral herpes | Adverse Event Term | Oral herpes | Adverse Event Term | Pharyngitis | Adverse Event Term | Pharyngitis | Adverse Event Term | Pharyngitis | Adverse Event Term | Pharyngitis streptococcal | Adverse Event Term | Pharyngitis streptococcal | Adverse Event Term | Pharyngitis streptococcal | Adverse Event Term | Sinusitis | Adverse Event Term | Sinusitis | Adverse Event Term | Sinusitis | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Abdominal pain upper | Adverse Event Term | Abdominal pain upper | Adverse Event Term | Abdominal pain upper | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Lip swelling | Adverse Event Term | Lip swelling | Adverse Event Term | Lip swelling | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting |
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Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 | Vocab | MedDRA v23.0 |
Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment |
Responsible Parties
Sequence: | 28865908 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3850963 |
Pi Employee | No |
Restriction Type | OTHER |
Other Details | Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results. |
Restrictive Agreement | Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results. |
Result Contacts
Sequence: | 3850928 |
Organization | Pfizer, Inc. |
Name | Pfizer ClinicalTrials.gov Call Center |
Phone | 1-800-718-1021 |
ClinicalTrials.gov_Inquiries@pfizer.com | |
Outcomes
Sequence: | 30794699 | Sequence: | 30794700 | Sequence: | 30794701 | Sequence: | 30794702 | Sequence: | 30794703 | Sequence: | 30794704 | Sequence: | 30794705 | Sequence: | 30794706 | Sequence: | 30794707 | Sequence: | 30794708 | Sequence: | 30794709 | Sequence: | 30794710 | Sequence: | 30794711 | Sequence: | 30794712 | Sequence: | 30794713 | Sequence: | 30794734 | Sequence: | 30794714 | Sequence: | 30794715 | Sequence: | 30794716 | Sequence: | 30794717 | Sequence: | 30794718 | Sequence: | 30794719 | Sequence: | 30794720 | Sequence: | 30794721 | Sequence: | 30794722 | Sequence: | 30794723 | Sequence: | 30794724 | Sequence: | 30794725 | Sequence: | 30794726 | Sequence: | 30794727 | Sequence: | 30794728 | Sequence: | 30794729 | Sequence: | 30794730 | Sequence: | 30794731 | Sequence: | 30794732 | Sequence: | 30794733 | Sequence: | 30794735 | Sequence: | 30794736 | Sequence: | 30794737 | Sequence: | 30794738 | Sequence: | 30794739 | Sequence: | 30794740 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12 | Title | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Title | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12 | Title | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Title | Percent Change From Baseline in EASI Score | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Change From Baseline in Percentage Body Surface Area (BSA) | Title | Percent Change From Baseline in Percentage BSA | Title | Number of Participants Who Discontinued From the Study Due to TEAEs | Title | Percentage of Participants Achieving Percentage BSA < 5% at Week 12 | Title | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Title | Change From Baseline in SCORAD Total Score | Title | Percent Change From Baseline in SCORAD Total Score | Title | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Title | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Title | Number of Days When a Corticosteroid Not Used up to Day 88 | Title | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Title | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Title | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Title | Change From Baseline in Depression of HADS | Title | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Title | Change From Baseline in Dermatitis Family Impact (DFI) at Week 12 | Title | Change From Baseline in Patient Global Assessment (PtGA) | Title | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Title | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Title | Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12 | Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Title | Number of Participants With Serious Adverse Events (SAEs) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Plasma PF-04965842 Concentration at Week 8 | Title | Plasma PF-04965842 Concentration at Week 12 |
Description | The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep & Usual Activities Questions and Patient Global Impression of Severity & Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms. | Description | The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD. | Description | The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" or "not at all (0)". The score can range from 0 to 30. The higher values represent the worse impact. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine). | Description | The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated. | Description | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | Description | A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to >500 ms or >60 ms change from screening ECG); data are presented below. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | ||||||
Time Frame | Baseline to Week 12 | Time Frame | Baseline to Week 12 | Time Frame | Baseline, Weeks 2, 4 and 12 | Time Frame | Baseline to Week 12 | Time Frame | Baseline, Weeks 2, 4 and 8 | Time Frame | Baseline, Weeks 2, 4 and 8 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Time Frame | Baseline to Week 16 | Time Frame | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | 16 weeks | Time Frame | Baseline to Week 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline to Day 88 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline to Week 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline, Weeks 2, 4, 8 and 12 | Time Frame | Baseline to Week 12 | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 16 weeks | Time Frame | 4 weeks post-vaccination with Tdap (Week 12) | Time Frame | 2 hours pre-dose at Week 8 | Time Frame | 2 hours post-dose at Week 12 |
Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The Full Analysis Set (FAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants in the FAS with a baseline numeric rating score for severity of pruritus >=4 were included in the analysis. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The Full Analysis Set (FAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The analysis population included all participants in the FAS who had used corticosteroid during treatment period. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants with at least one observation of the given laboratory test. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. | Population | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. | Population | The immunogenicity sub-study analysis set included all participants who had completed 8 weeks of treatment and received Tdap vaccination. Number of Participants Analyzed refers to the number of participants evaluable in the analysis set at the specified visit. | Population | The PK analysis included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Samples from site 1173 were excluded from the analysis. | Population | The PK analysis included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Samples from site 1173 were excluded from the analysis. |
Units | Percentage of participants | Units | Percentage of participants | Units | Percentage of participants | Units | Units on a scale | Units | Percentage of participants | Units | Percentage of participants | Units | Percentage of participants | Units | Percentage of participants | Units | Percentage of participants | Units | Percent change | Units | Percentage of participants | Units | Days | Units | Percent change | Units | Units on a scale | Units | Percent change | Units | Participants | Units | Percentage of participants | Units | Percentage of participants | Units | Percentage of participants | Units | Units on a scale | Units | Percent change | Units | Units on a scale | Units | Percent change | Units | Days | Units | Units on a scale | Units | Percentage of participants | Units | Units on a scale | Units | Units on a scale | Units | Units on a scale | Units | Units on a scale | Units | Units on a scale | Units | Percentage of participants | Units | Units on a scale | Units | Units on a scale | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Ratio | Units | ng/mL | Units | ng/mL |
Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||
Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Least Squares Mean | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Least Squares Mean | Param Type | Number | Param Type | Median | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Number | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Number | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Geometric Mean | Param Type | Mean | Param Type | Mean |
Outcome Measurements
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Sequence: | 235578276 | Sequence: | 235578277 | Sequence: | 235578278 | Sequence: | 235578279 | Sequence: | 235578280 | Sequence: | 235578281 | Sequence: | 235578282 | Sequence: | 235578283 | Sequence: | 235578284 | Sequence: | 235578285 | Sequence: | 235578286 | Sequence: | 235578287 | Sequence: | 235578288 | Sequence: | 235578289 | Sequence: | 235578290 | Sequence: | 235578291 | Sequence: | 235578292 | Sequence: | 235578293 | Sequence: | 235578860 | Sequence: | 235578294 | Sequence: | 235578295 | Sequence: | 235578296 | Sequence: | 235578297 | Sequence: | 235578298 | Sequence: | 235578299 | Sequence: | 235578300 | Sequence: | 235578301 | Sequence: | 235578302 | Sequence: | 235578303 | Sequence: | 235578341 | Sequence: | 235578304 | Sequence: | 235578305 | Sequence: | 235578306 | Sequence: | 235578307 | Sequence: | 235578308 | Sequence: | 235578309 | Sequence: | 235578310 | Sequence: | 235578311 | Sequence: | 235578312 | Sequence: | 235578313 | Sequence: | 235578314 | Sequence: | 235578315 | Sequence: | 235578316 | Sequence: | 235578317 | Sequence: | 235578318 | Sequence: | 235578319 | Sequence: | 235578320 | Sequence: | 235578321 | Sequence: | 235578322 | Sequence: | 235578323 | Sequence: | 235578324 | Sequence: | 235578325 | Sequence: | 235578326 | Sequence: | 235578327 | Sequence: | 235578328 | Sequence: | 235578329 | Sequence: | 235578330 | Sequence: | 235578331 | Sequence: | 235578332 | Sequence: | 235578333 | Sequence: | 235578334 | Sequence: | 235578342 | Sequence: | 235578343 | Sequence: | 235578335 | Sequence: | 235578336 | Sequence: | 235578337 | Sequence: | 235578338 | Sequence: | 235578339 | Sequence: | 235578344 | Sequence: | 235578345 | Sequence: | 235578346 | Sequence: | 235578347 | Sequence: | 235578348 | Sequence: | 235578349 | Sequence: | 235578350 | Sequence: | 235578351 | Sequence: | 235578352 | Sequence: | 235578353 | Sequence: | 235578354 | Sequence: | 235578355 | Sequence: | 235578356 | Sequence: | 235578357 | Sequence: | 235578358 | Sequence: | 235578359 | Sequence: | 235578360 | Sequence: | 235578361 | Sequence: | 235578362 | Sequence: | 235578363 | Sequence: | 235578364 | Sequence: | 235578365 | Sequence: | 235578366 | Sequence: | 235578367 | Sequence: | 235578368 | Sequence: | 235578369 | Sequence: | 235578370 | Sequence: | 235578371 | Sequence: | 235578372 | Sequence: | 235578373 | Sequence: | 235578374 | Sequence: | 235578375 | Sequence: | 235578376 | Sequence: | 235578377 | Sequence: | 235578378 | Sequence: | 235578379 | Sequence: | 235578380 | Sequence: | 235578381 | Sequence: | 235578387 | Sequence: | 235578382 | Sequence: | 235578383 | Sequence: | 235578384 | Sequence: | 235578385 | Sequence: | 235578386 | Sequence: | 235578388 | Sequence: | 235578389 | Sequence: | 235578390 | Sequence: | 235578391 | Sequence: | 235578392 | Sequence: | 235578393 | Sequence: | 235578394 | Sequence: | 235578395 | Sequence: | 235578396 | Sequence: | 235578397 | Sequence: | 235578398 | Sequence: | 235578399 | Sequence: | 235578400 | Sequence: | 235578401 | Sequence: | 235578402 | Sequence: | 235578403 | Sequence: | 235578404 | Sequence: | 235578405 | Sequence: | 235578406 | Sequence: | 235578407 | Sequence: | 235578408 | Sequence: | 235578409 | Sequence: | 235578410 | Sequence: | 235578411 | Sequence: | 235578412 | Sequence: | 235578413 | Sequence: | 235578414 | Sequence: | 235578415 | Sequence: | 235578416 | Sequence: | 235578417 | Sequence: | 235578418 | Sequence: | 235578419 | Sequence: | 235578420 | Sequence: | 235578421 | Sequence: | 235578422 | Sequence: | 235578423 | Sequence: | 235578424 | Sequence: | 235578425 | Sequence: | 235578523 | Sequence: | 235578426 | Sequence: | 235578427 | Sequence: | 235578428 | Sequence: | 235578429 | Sequence: | 235578430 | Sequence: | 235578431 | Sequence: | 235578432 | Sequence: | 235578433 | Sequence: | 235578434 | Sequence: | 235578435 | Sequence: | 235578436 | Sequence: | 235578437 | Sequence: | 235578438 | Sequence: | 235578439 | Sequence: | 235578440 | Sequence: | 235578441 | Sequence: | 235578442 | Sequence: | 235578443 | Sequence: | 235578444 | Sequence: | 235578445 | Sequence: | 235578446 | Sequence: | 235578447 | Sequence: | 235578448 | Sequence: | 235578449 | Sequence: | 235578450 | Sequence: | 235578451 | Sequence: | 235578452 | Sequence: | 235578453 | Sequence: | 235578454 | Sequence: | 235578455 | Sequence: | 235578456 | Sequence: | 235578457 | Sequence: | 235578458 | Sequence: | 235578595 | Sequence: | 235578459 | Sequence: | 235578460 | Sequence: | 235578461 | Sequence: | 235578462 | Sequence: | 235578463 | Sequence: | 235578464 | Sequence: | 235578465 | Sequence: | 235578466 | Sequence: | 235578467 | Sequence: | 235578468 | Sequence: | 235578469 | Sequence: | 235578470 | Sequence: | 235578471 | Sequence: | 235578472 | Sequence: | 235578473 | Sequence: | 235578474 | Sequence: | 235578475 | Sequence: | 235578476 | Sequence: | 235578477 | Sequence: | 235578478 | Sequence: | 235578479 | Sequence: | 235578480 | Sequence: | 235578481 | Sequence: | 235578596 | Sequence: | 235578482 | Sequence: | 235578483 | Sequence: | 235578484 | Sequence: | 235578485 | Sequence: | 235578486 | Sequence: | 235578487 | Sequence: | 235578488 | Sequence: | 235578489 | Sequence: | 235578490 | Sequence: | 235578491 | Sequence: | 235578492 | Sequence: | 235578493 | Sequence: | 235578494 | Sequence: | 235578495 | Sequence: | 235578496 | Sequence: | 235578497 | Sequence: | 235578498 | Sequence: | 235578499 | Sequence: | 235578500 | Sequence: | 235578501 | Sequence: | 235578502 | Sequence: | 235578503 | Sequence: | 235578504 | Sequence: | 235578505 | Sequence: | 235578506 | Sequence: | 235578507 | Sequence: | 235578508 | Sequence: | 235578509 | Sequence: | 235578510 | Sequence: | 235578511 | Sequence: | 235578512 | Sequence: | 235578513 | Sequence: | 235578514 | Sequence: | 235578522 | Sequence: | 235578515 | Sequence: | 235578516 | Sequence: | 235578517 | Sequence: | 235578518 | Sequence: | 235578519 | Sequence: | 235578520 | Sequence: | 235578521 | Sequence: | 235578524 | Sequence: | 235578525 | Sequence: | 235578526 | Sequence: | 235578527 | Sequence: | 235578528 | Sequence: | 235578529 | Sequence: | 235578530 | Sequence: | 235578531 | Sequence: | 235578538 | Sequence: | 235578532 | Sequence: | 235578533 | Sequence: | 235578534 | Sequence: | 235578535 | Sequence: | 235578536 | Sequence: | 235578537 | Sequence: | 235578539 | Sequence: | 235578540 | Sequence: | 235578541 | Sequence: | 235578542 | Sequence: | 235578543 | Sequence: | 235578544 | Sequence: | 235578545 | Sequence: | 235578597 | Sequence: | 235578598 | Sequence: | 235578546 | Sequence: | 235578547 | Sequence: | 235578548 | Sequence: | 235578549 | Sequence: | 235578550 | Sequence: | 235578551 | Sequence: | 235578552 | Sequence: | 235578553 | Sequence: | 235578554 | Sequence: | 235578555 | Sequence: | 235578556 | Sequence: | 235578599 | Sequence: | 235578557 | Sequence: | 235578558 | Sequence: | 235578559 | Sequence: | 235578560 | Sequence: | 235578561 | Sequence: | 235578562 | Sequence: | 235578563 | Sequence: | 235578564 | Sequence: | 235578565 | Sequence: | 235578566 | Sequence: | 235578567 | Sequence: | 235578568 | Sequence: | 235578569 | Sequence: | 235578570 | Sequence: | 235578571 | Sequence: | 235578600 | Sequence: | 235578572 | Sequence: | 235578573 | Sequence: | 235578574 | Sequence: | 235578575 | Sequence: | 235578576 | Sequence: | 235578577 | Sequence: | 235578578 | Sequence: | 235578579 | Sequence: | 235578580 | Sequence: | 235578581 | Sequence: | 235578582 | Sequence: | 235578583 | Sequence: | 235578584 | Sequence: | 235578585 | Sequence: | 235578586 | Sequence: | 235578587 | Sequence: | 235578588 | Sequence: | 235578589 | Sequence: | 235578590 | Sequence: | 235578591 | Sequence: | 235578592 | Sequence: | 235578593 | Sequence: | 235578594 | Sequence: | 235578601 | Sequence: | 235578602 | Sequence: | 235578603 | Sequence: | 235578604 | Sequence: | 235578605 | Sequence: | 235578606 | Sequence: | 235578607 | Sequence: | 235578608 | Sequence: | 235578609 | Sequence: | 235578610 | Sequence: | 235578611 | Sequence: | 235578612 | Sequence: | 235578613 | Sequence: | 235578614 | Sequence: | 235578615 | Sequence: | 235578616 | Sequence: | 235578617 | Sequence: | 235578618 | Sequence: | 235578619 | Sequence: | 235578620 | Sequence: | 235578621 | Sequence: | 235578622 | Sequence: | 235578623 | Sequence: | 235578624 | Sequence: | 235578625 | Sequence: | 235578626 | Sequence: | 235578627 | Sequence: | 235578628 | Sequence: | 235578629 | Sequence: | 235578630 | Sequence: | 235578631 | Sequence: | 235578632 | Sequence: | 235578633 | Sequence: | 235578634 | Sequence: | 235578635 | Sequence: | 235578636 | Sequence: | 235578637 | Sequence: | 235578638 | Sequence: | 235578639 | Sequence: | 235578640 | Sequence: | 235578641 | Sequence: | 235578642 | Sequence: | 235578643 | Sequence: | 235578644 | Sequence: | 235578645 | Sequence: | 235578646 | Sequence: | 235578647 | Sequence: | 235578648 | Sequence: | 235578649 | Sequence: | 235578650 | Sequence: | 235578651 | Sequence: | 235578652 | Sequence: | 235578653 | Sequence: | 235578654 | Sequence: | 235578655 | Sequence: | 235578656 | Sequence: | 235578657 | Sequence: | 235578658 | Sequence: | 235578659 | Sequence: | 235578660 | Sequence: | 235578661 | Sequence: | 235578662 | Sequence: | 235578663 | Sequence: | 235578664 | Sequence: | 235578665 | Sequence: | 235578666 | Sequence: | 235578667 | Sequence: | 235578668 | Sequence: | 235578669 | Sequence: | 235578670 | Sequence: | 235578671 | Sequence: | 235578672 | Sequence: | 235578673 | Sequence: | 235578674 | Sequence: | 235578675 | Sequence: | 235578676 | Sequence: | 235578677 | Sequence: | 235578678 | Sequence: | 235578679 | Sequence: | 235578680 | Sequence: | 235578681 | Sequence: | 235578682 | Sequence: | 235578683 | Sequence: | 235578684 | Sequence: | 235578685 | Sequence: | 235578686 | Sequence: | 235578687 | Sequence: | 235578688 | Sequence: | 235578689 | Sequence: | 235578690 | Sequence: | 235578691 | Sequence: | 235578692 | Sequence: | 235578693 | Sequence: | 235578694 | Sequence: | 235578695 | Sequence: | 235578696 | Sequence: | 235578697 | Sequence: | 235578698 | Sequence: | 235578699 | Sequence: | 235578700 | Sequence: | 235578701 | Sequence: | 235578702 | Sequence: | 235578703 | Sequence: | 235578704 | Sequence: | 235578705 | Sequence: | 235578706 | Sequence: | 235578707 | Sequence: | 235578708 | Sequence: | 235578709 | Sequence: | 235578710 | Sequence: | 235578711 | Sequence: | 235578712 | Sequence: | 235578713 | Sequence: | 235578714 | Sequence: | 235578715 | Sequence: | 235578716 | Sequence: | 235578717 | Sequence: | 235578718 | Sequence: | 235578719 | Sequence: | 235578720 | Sequence: | 235578721 | Sequence: | 235578722 | Sequence: | 235578723 | Sequence: | 235578724 | Sequence: | 235578725 | Sequence: | 235578726 | Sequence: | 235578727 | Sequence: | 235578728 | Sequence: | 235578729 | Sequence: | 235578730 | Sequence: | 235578731 | Sequence: | 235578741 | Sequence: | 235578732 | Sequence: | 235578733 | Sequence: | 235578734 | Sequence: | 235578735 | Sequence: | 235578736 | Sequence: | 235578737 | Sequence: | 235578738 | Sequence: | 235578739 | Sequence: | 235578740 | Sequence: | 235578742 | Sequence: | 235578743 | Sequence: | 235578744 | Sequence: | 235578745 | Sequence: | 235578746 | Sequence: | 235578747 | Sequence: | 235578748 | Sequence: | 235578749 | Sequence: | 235578750 | Sequence: | 235578751 | Sequence: | 235578752 | Sequence: | 235578753 | Sequence: | 235578754 | Sequence: | 235578755 | Sequence: | 235578756 | Sequence: | 235578773 | Sequence: | 235578757 | Sequence: | 235578758 | Sequence: | 235578759 | Sequence: | 235578760 | Sequence: | 235578761 | Sequence: | 235578762 | Sequence: | 235578763 | Sequence: | 235578764 | Sequence: | 235578765 | Sequence: | 235578766 | Sequence: | 235578767 | Sequence: | 235578768 | Sequence: | 235578769 | Sequence: | 235578770 | Sequence: | 235578771 | Sequence: | 235578772 | Sequence: | 235578774 | Sequence: | 235578775 | Sequence: | 235578776 | Sequence: | 235578777 | Sequence: | 235578778 | Sequence: | 235578779 | Sequence: | 235578780 | Sequence: | 235578781 | Sequence: | 235578782 | Sequence: | 235578783 | Sequence: | 235578784 | Sequence: | 235578785 | Sequence: | 235578786 | Sequence: | 235578787 | Sequence: | 235578788 | Sequence: | 235578789 | Sequence: | 235578790 | Sequence: | 235578791 | Sequence: | 235578792 | Sequence: | 235578793 | Sequence: | 235578794 | Sequence: | 235578795 | Sequence: | 235578796 | Sequence: | 235578797 | Sequence: | 235578798 | Sequence: | 235578799 | Sequence: | 235578800 | Sequence: | 235578801 | Sequence: | 235578802 | Sequence: | 235578803 | Sequence: | 235578804 | Sequence: | 235578805 | Sequence: | 235578806 | Sequence: | 235578807 | Sequence: | 235578808 | Sequence: | 235578809 | Sequence: | 235578810 | Sequence: | 235578811 | Sequence: | 235578812 | Sequence: | 235578813 | Sequence: | 235578814 | Sequence: | 235578815 | Sequence: | 235578816 | Sequence: | 235578817 | Sequence: | 235578818 | Sequence: | 235578819 | Sequence: | 235578820 | Sequence: | 235578821 | Sequence: | 235578822 | Sequence: | 235578823 | Sequence: | 235578824 | Sequence: | 235578825 | Sequence: | 235578826 | Sequence: | 235578827 | Sequence: | 235578828 | Sequence: | 235578854 | Sequence: | 235578829 | Sequence: | 235578830 | Sequence: | 235578855 | Sequence: | 235578831 | Sequence: | 235578832 | Sequence: | 235578833 | Sequence: | 235578834 | Sequence: | 235578835 | Sequence: | 235578836 | Sequence: | 235578837 | Sequence: | 235578838 | Sequence: | 235578839 | Sequence: | 235578840 | Sequence: | 235578841 | Sequence: | 235578842 | Sequence: | 235578843 | Sequence: | 235578844 | Sequence: | 235578845 | Sequence: | 235578846 | Sequence: | 235578847 | Sequence: | 235578848 | Sequence: | 235578849 | Sequence: | 235578850 | Sequence: | 235578851 | Sequence: | 235578852 | Sequence: | 235578853 | Sequence: | 235578861 | Sequence: | 235578862 | Sequence: | 235578863 | Sequence: | 235578864 | Sequence: | 235578865 | Sequence: | 235578866 | Sequence: | 235578867 | Sequence: | 235578868 | Sequence: | 235578869 | Sequence: | 235578870 | Sequence: | 235578884 | Sequence: | 235578885 | Sequence: | 235578871 | Sequence: | 235578872 | Sequence: | 235578873 | Sequence: | 235578874 | Sequence: | 235578875 | Sequence: | 235578876 | Sequence: | 235578877 | Sequence: | 235578878 | Sequence: | 235578879 | Sequence: | 235578880 | Sequence: | 235578881 | Sequence: | 235578882 | Sequence: | 235578883 |
Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794699 | Outcome Id | 30794699 | Outcome Id | 30794699 | Outcome Id | 30794700 | Outcome Id | 30794700 | Outcome Id | 30794700 | Outcome Id | 30794701 | Outcome Id | 30794701 | Outcome Id | 30794701 | Outcome Id | 30794701 | Outcome Id | 30794701 | Outcome Id | 30794701 | Outcome Id | 30794701 | Outcome Id | 30794701 | Outcome Id | 30794701 | Outcome Id | 30794702 | Outcome Id | 30794702 | Outcome Id | 30794702 | Outcome Id | 30794703 | Outcome Id | 30794703 | Outcome Id | 30794703 | Outcome Id | 30794703 | Outcome Id | 30794703 | Outcome Id | 30794703 | Outcome Id | 30794703 | Outcome Id | 30794703 | Outcome Id | 30794703 | Outcome Id | 30794704 | Outcome Id | 30794711 | Outcome Id | 30794704 | Outcome Id | 30794704 | Outcome Id | 30794704 | Outcome Id | 30794704 | Outcome Id | 30794704 | Outcome Id | 30794704 | Outcome Id | 30794704 | Outcome Id | 30794704 | Outcome Id | 30794705 | Outcome Id | 30794705 | Outcome Id | 30794705 | Outcome Id | 30794705 | Outcome Id | 30794705 | Outcome Id | 30794705 | Outcome Id | 30794705 | Outcome Id | 30794705 | Outcome Id | 30794705 | Outcome Id | 30794705 | Outcome Id | 30794705 | Outcome Id | 30794705 | Outcome Id | 30794706 | Outcome Id | 30794706 | Outcome Id | 30794706 | Outcome Id | 30794706 | Outcome Id | 30794706 | Outcome Id | 30794706 | Outcome Id | 30794706 | Outcome Id | 30794706 | Outcome Id | 30794706 | Outcome Id | 30794706 | Outcome Id | 30794706 | Outcome Id | 30794706 | Outcome Id | 30794707 | Outcome Id | 30794707 | Outcome Id | 30794707 | Outcome Id | 30794707 | Outcome Id | 30794707 | Outcome Id | 30794707 | Outcome Id | 30794707 | Outcome Id | 30794707 | Outcome Id | 30794707 | Outcome Id | 30794707 | Outcome Id | 30794707 | Outcome Id | 30794707 | Outcome Id | 30794708 | Outcome Id | 30794708 | Outcome Id | 30794708 | Outcome Id | 30794708 | Outcome Id | 30794708 | Outcome Id | 30794708 | Outcome Id | 30794708 | Outcome Id | 30794708 | Outcome Id | 30794708 | Outcome Id | 30794708 | Outcome Id | 30794708 | Outcome Id | 30794708 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794737 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794711 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794709 | Outcome Id | 30794710 | Outcome Id | 30794710 | Outcome Id | 30794710 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794711 | Outcome Id | 30794712 | Outcome Id | 30794712 | Outcome Id | 30794712 | Outcome Id | 30794712 | Outcome Id | 30794712 | Outcome Id | 30794712 | Outcome Id | 30794712 | Outcome Id | 30794712 | Outcome Id | 30794712 | Outcome Id | 30794712 | Outcome Id | 30794712 | Outcome Id | 30794712 | Outcome Id | 30794713 | Outcome Id | 30794713 | Outcome Id | 30794713 | Outcome Id | 30794713 | Outcome Id | 30794713 | Outcome Id | 30794713 | Outcome Id | 30794713 | Outcome Id | 30794713 | Outcome Id | 30794713 | Outcome Id | 30794713 | Outcome Id | 30794713 | Outcome Id | 30794713 | Outcome Id | 30794714 | Outcome Id | 30794714 | Outcome Id | 30794714 | Outcome Id | 30794715 | Outcome Id | 30794715 | Outcome Id | 30794715 | Outcome Id | 30794715 | Outcome Id | 30794715 | Outcome Id | 30794715 | Outcome Id | 30794715 | Outcome Id | 30794715 | Outcome Id | 30794715 | Outcome Id | 30794715 | Outcome Id | 30794715 | Outcome Id | 30794715 | Outcome Id | 30794716 | Outcome Id | 30794716 | Outcome Id | 30794716 | Outcome Id | 30794716 | Outcome Id | 30794716 | Outcome Id | 30794716 | Outcome Id | 30794716 | Outcome Id | 30794716 | Outcome Id | 30794716 | Outcome Id | 30794716 | Outcome Id | 30794716 | Outcome Id | 30794716 | Outcome Id | 30794717 | Outcome Id | 30794717 | Outcome Id | 30794717 | Outcome Id | 30794717 | Outcome Id | 30794717 | Outcome Id | 30794717 | Outcome Id | 30794726 | Outcome Id | 30794717 | Outcome Id | 30794717 | Outcome Id | 30794717 | Outcome Id | 30794717 | Outcome Id | 30794717 | Outcome Id | 30794717 | Outcome Id | 30794718 | Outcome Id | 30794718 | Outcome Id | 30794718 | Outcome Id | 30794718 | Outcome Id | 30794718 | Outcome Id | 30794718 | Outcome Id | 30794718 | Outcome Id | 30794718 | Outcome Id | 30794718 | Outcome Id | 30794718 | Outcome Id | 30794718 | Outcome Id | 30794718 | Outcome Id | 30794719 | Outcome Id | 30794719 | Outcome Id | 30794719 | Outcome Id | 30794719 | Outcome Id | 30794719 | Outcome Id | 30794719 | Outcome Id | 30794719 | Outcome Id | 30794719 | Outcome Id | 30794719 | Outcome Id | 30794719 | Outcome Id | 30794719 | Outcome Id | 30794719 | Outcome Id | 30794720 | Outcome Id | 30794720 | Outcome Id | 30794720 | Outcome Id | 30794735 | Outcome Id | 30794720 | Outcome Id | 30794720 | Outcome Id | 30794720 | Outcome Id | 30794720 | Outcome Id | 30794720 | Outcome Id | 30794720 | Outcome Id | 30794720 | Outcome Id | 30794720 | Outcome Id | 30794720 | Outcome Id | 30794721 | Outcome Id | 30794721 | Outcome Id | 30794721 | Outcome Id | 30794722 | Outcome Id | 30794722 | Outcome Id | 30794722 | Outcome Id | 30794722 | Outcome Id | 30794722 | Outcome Id | 30794722 | Outcome Id | 30794722 | Outcome Id | 30794722 | Outcome Id | 30794722 | Outcome Id | 30794722 | Outcome Id | 30794722 | Outcome Id | 30794735 | Outcome Id | 30794722 | Outcome Id | 30794723 | Outcome Id | 30794723 | Outcome Id | 30794723 | Outcome Id | 30794723 | Outcome Id | 30794723 | Outcome Id | 30794723 | Outcome Id | 30794723 | Outcome Id | 30794723 | Outcome Id | 30794723 | Outcome Id | 30794723 | Outcome Id | 30794723 | Outcome Id | 30794723 | Outcome Id | 30794724 | Outcome Id | 30794724 | Outcome Id | 30794724 | Outcome Id | 30794724 | Outcome Id | 30794724 | Outcome Id | 30794724 | Outcome Id | 30794724 | Outcome Id | 30794724 | Outcome Id | 30794724 | Outcome Id | 30794724 | Outcome Id | 30794724 | Outcome Id | 30794724 | Outcome Id | 30794725 | Outcome Id | 30794725 | Outcome Id | 30794725 | Outcome Id | 30794725 | Outcome Id | 30794725 | Outcome Id | 30794725 | Outcome Id | 30794725 | Outcome Id | 30794725 | Outcome Id | 30794726 | Outcome Id | 30794725 | Outcome Id | 30794725 | Outcome Id | 30794725 | Outcome Id | 30794725 | Outcome Id | 30794726 | Outcome Id | 30794726 | Outcome Id | 30794726 | Outcome Id | 30794726 | Outcome Id | 30794726 | Outcome Id | 30794726 | Outcome Id | 30794726 | Outcome Id | 30794726 | Outcome Id | 30794726 | Outcome Id | 30794726 | Outcome Id | 30794727 | Outcome Id | 30794728 | Outcome Id | 30794727 | Outcome Id | 30794727 | Outcome Id | 30794728 | Outcome Id | 30794728 | Outcome Id | 30794728 | Outcome Id | 30794728 | Outcome Id | 30794728 | Outcome Id | 30794728 | Outcome Id | 30794728 | Outcome Id | 30794728 | Outcome Id | 30794728 | Outcome Id | 30794728 | Outcome Id | 30794728 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794729 | Outcome Id | 30794729 | Outcome Id | 30794729 | Outcome Id | 30794729 | Outcome Id | 30794729 | Outcome Id | 30794729 | Outcome Id | 30794729 | Outcome Id | 30794729 | Outcome Id | 30794729 | Outcome Id | 30794729 | Outcome Id | 30794729 | Outcome Id | 30794735 | Outcome Id | 30794729 | Outcome Id | 30794730 | Outcome Id | 30794730 | Outcome Id | 30794730 | Outcome Id | 30794730 | Outcome Id | 30794730 | Outcome Id | 30794730 | Outcome Id | 30794730 | Outcome Id | 30794730 | Outcome Id | 30794730 | Outcome Id | 30794730 | Outcome Id | 30794730 | Outcome Id | 30794730 | Outcome Id | 30794731 | Outcome Id | 30794731 | Outcome Id | 30794735 | Outcome Id | 30794731 | Outcome Id | 30794732 | Outcome Id | 30794732 | Outcome Id | 30794732 | Outcome Id | 30794732 | Outcome Id | 30794732 | Outcome Id | 30794732 | Outcome Id | 30794733 | Outcome Id | 30794733 | Outcome Id | 30794733 | Outcome Id | 30794733 | Outcome Id | 30794733 | Outcome Id | 30794733 | Outcome Id | 30794734 | Outcome Id | 30794734 | Outcome Id | 30794734 | Outcome Id | 30794734 | Outcome Id | 30794734 | Outcome Id | 30794734 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 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Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 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Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794737 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794737 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794735 | Outcome Id | 30794736 | Outcome Id | 30794736 | Outcome Id | 30794736 | Outcome Id | 30794736 | Outcome Id | 30794736 | Outcome Id | 30794736 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794737 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794740 | Outcome Id | 30794740 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794738 | Outcome Id | 30794739 | Outcome Id | 30794739 |
Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080967 | Result Group 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Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080968 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080968 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080970 | Result Group Id | 56080971 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080966 | Result Group Id | 56080967 | Result Group Id | 56080968 | Result Group Id | 56080970 | Result Group Id | 56080971 |
Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | 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Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Classification | Systolic Blood Pressure Value <90mmHg | Classification | Systolic Blood Pressure Value <90mmHg | Classification | Systolic Blood Pressure Increase From Baseline >=30mmHg | Classification | Systolic Blood Pressure Increase From Baseline >=30mmHg | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 2 | Classification | Day 6 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Day 2 | Classification | Day 2 | Classification | Day 2 | Classification | Day 3 | Classification | Day 3 | Classification | Day 3 | Classification | Day 4 | Classification | Day 4 | Classification | Day 4 | Classification | Day 5 | Classification | Day 5 | Classification | Day 5 | Classification | Systolic Blood Pressure Increase From Baseline >=30mmHg | Classification | Day 6 | Classification | Day 6 | Classification | Day 6 | Classification | Day 7 | Classification | Day 7 | Classification | Day 7 | Classification | Day 8 | Classification | Day 8 | Classification | Day 8 | Classification | Day 9 | Classification | Day 6 | Classification | Day 9 | Classification | Day 9 | Classification | Day 10 | Classification | Day 10 | Classification | Day 10 | Classification | Day 11 | Classification | Day 11 | Classification | Day 11 | Classification | Day 12 | Classification | Day 12 | Classification | Day 12 | Classification | Day 13 | Classification | Day 13 | Classification | Day 13 | Classification | Day 14 | Classification | Day 14 | Classification | Day 14 | Classification | Day 15 | Classification | Day 15 | Classification | Day 15 | Classification | Day 2 | Classification | Day 2 | Classification | Day 2 | Classification | Day 3 | Classification | Day 3 | Classification | Day 3 | Classification | Day 4 | Classification | Day 4 | Classification | Day 7 | Classification | Day 7 | Classification | Day 4 | Classification | Day 5 | Classification | Day 5 | Classification | Day 5 | Classification | Day 6 | Classification | Day 7 | Classification | Day 8 | Classification | Day 8 | Classification | Day 8 | Classification | Day 9 | Classification | Day 9 | Classification | Day 9 | Classification | Day 10 | Classification | Day 10 | Classification | Day 10 | Classification | Day 11 | Classification | Day 11 | Classification | Day 11 | Classification | Day 12 | Classification | Day 12 | Classification | Day 12 | Classification | Day 13 | Classification | Day 13 | Classification | Day 13 | Classification | Day 14 | Classification | Day 14 | Classification | Day 14 | Classification | Day 15 | Classification | Day 15 | Classification | Day 15 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 2 | Classification | Week 8 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Hematocrit (%) <0.8*LLN | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Hematocrit (%) <0.8*LLN | Classification | Week 12 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 4 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 4 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Erythrocytes (10^6/mm^3) <0.8*LLN | Classification | Erythrocytes (10^6/mm^3) <0.8*LLN | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Erythrocytes (10^6/mm^3) <0.8*LLN | Classification | Week 12 | Classification | Week 2 | Classification | Week 2 | Classification | Week 2 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Reticulocytes (10^3/mm^3) <0.5*LLN | Classification | All-causality TEAEs | Classification | All-causality TEAEs | Classification | All-causality TEAEs | Classification | Treatment-related TEAEs | Classification | Treatment-related TEAEs | Classification | Treatment-related TEAEs | Classification | All-causality SAEs | Classification | All-causality SAEs | Classification | All-causality SAEs | Classification | Treatment-related SAEs | Classification | Treatment-related SAEs | Classification | Treatment-related SAEs | Classification | All-causality TEAEs | Classification | All-causality TEAEs | Classification | All-causality TEAEs | Classification | Treatment-related TEAEs | Classification | Treatment-related TEAEs | Classification | Treatment-related TEAEs | Classification | Hemoglobin (g/dL) <0.8*LLN | Classification | Hemoglobin (g/dL) <0.8*LLN | Classification | Hemoglobin (g/dL) <0.8*LLN | Classification | Hematocrit (%) <0.8*LLN | Classification | Reticulocytes (10^3/mm^3) <0.5*LLN | Classification | Reticulocytes (10^3/mm^3) <0.5*LLN | Classification | Reticulocytes (10^3/mm^3) >1.5*ULN | Classification | Reticulocytes (10^3/mm^3) >1.5*ULN | Classification | Reticulocytes (10^3/mm^3) >1.5*ULN | Classification | Ery. Mean Corpuscular Volume (10^-15L) <0.9*LLN | Classification | Ery. Mean Corpuscular Volume (10^-15L) <0.9*LLN | Classification | Ery. Mean Corpuscular Volume (10^-15L) <0.9*LLN | Classification | Ery. Mean Corpuscular Volume (10^-15L) >1.1*ULN | Classification | Ery. Mean Corpuscular Volume (10^-15L) >1.1*ULN | Classification | Ery. Mean Corpuscular Volume (10^-15L) >1.1*ULN | Classification | Ery. Mean Corpuscular Hemoglobin (pg/cell) <0.9*LLN | Classification | Ery. Mean Corpuscular Hemoglobin (pg/cell) <0.9*LLN | Classification | Ery. Mean Corpuscular Hemoglobin (pg/cell) <0.9*LLN | Classification | Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN | Classification | Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN | Classification | Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN | Classification | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | Classification | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | Classification | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | Classification | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | Classification | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | Classification | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | Classification | Platelets (10^3/mm^3) <0.5*LLN | Classification | Platelets (10^3/mm^3) <0.5*LLN | Classification | Platelets (10^3/mm^3) <0.5*LLN | Classification | Platelets (10^3/mm^3) >1.75*ULN | Classification | Platelets (10^3/mm^3) >1.75*ULN | Classification | Platelets (10^3/mm^3) >1.75*ULN | Classification | Reticulocytes/Erythrocytes (%) <0.5*LLN | Classification | Reticulocytes/Erythrocytes (%) <0.5*LLN | Classification | Reticulocytes/Erythrocytes (%) <0.5*LLN | Classification | Reticulocytes/Erythrocytes (%) >1.5*ULN | Classification | Reticulocytes/Erythrocytes (%) >1.5*ULN | Classification | Reticulocytes/Erythrocytes (%) >1.5*ULN | Classification | Leukocytes (10^3/mm^3) <0.6*LLN | Classification | Leukocytes (10^3/mm^3) <0.6*LLN | Classification | Leukocytes (10^3/mm^3) <0.6*LLN | Classification | Leukocytes (10^3/mm^3) >1.5*ULN | Classification | Leukocytes (10^3/mm^3) >1.5*ULN | Classification | Leukocytes (10^3/mm^3) >1.5*ULN | Classification | Lymphocytes (10^3/mm^3) <0.8*LLN | Classification | Lymphocytes (10^3/mm^3) <0.8*LLN | Classification | Lymphocytes (10^3/mm^3) <0.8*LLN | Classification | Lymphocytes (10^3/mm^3) >1.2*ULN | Classification | Lymphocytes (10^3/mm^3) >1.2*ULN | Classification | Lymphocytes (10^3/mm^3) >1.2*ULN | Classification | Lymphocytes/Leukocytes (%) <0.8*LLN | Classification | Lymphocytes/Leukocytes (%) <0.8*LLN | Classification | Lymphocytes/Leukocytes (%) <0.8*LLN | Classification | Lymphocytes/Leukocytes (%) >1.2*ULN | Classification | Lymphocytes/Leukocytes (%) >1.2*ULN | Classification | Lymphocytes/Leukocytes (%) >1.2*ULN | Classification | Neutrophils (10^3/mm^3) <0.8*LLN | Classification | Neutrophils (10^3/mm^3) <0.8*LLN | Classification | Neutrophils (10^3/mm^3) <0.8*LLN | Classification | Neutrophils (10^3/mm^3) >1.2*ULN | Classification | Neutrophils (10^3/mm^3) >1.2*ULN | Classification | Neutrophils (10^3/mm^3) >1.2*ULN | Classification | Neutrophils/Leukocytes (%) <0.8*LLN | Classification | Neutrophils/Leukocytes (%) <0.8*LLN | Classification | Neutrophils/Leukocytes (%) <0.8*LLN | Classification | Neutrophils/Leukocytes (%) >1.2*ULN | Classification | Neutrophils/Leukocytes (%) >1.2*ULN | Classification | Neutrophils/Leukocytes (%) >1.2*ULN | Classification | Basophils (10^3/mm^3) >1.2*ULN | Classification | Basophils (10^3/mm^3) >1.2*ULN | Classification | Basophils (10^3/mm^3) >1.2*ULN | Classification | Basophils/Leukocytes (%) >1.2*ULN | Classification | Basophils/Leukocytes (%) >1.2*ULN | Classification | Basophils/Leukocytes (%) >1.2*ULN | Classification | Eosinophils (10^3/mm^3) >1.2*ULN | Classification | Eosinophils (10^3/mm^3) >1.2*ULN | Classification | Eosinophils (10^3/mm^3) >1.2*ULN | Classification | Eosinophils/Leukocytes (%) >1.2*ULN | Classification | Eosinophils/Leukocytes (%) >1.2*ULN | Classification | Eosinophils/Leukocytes (%) >1.2*ULN | Classification | Monocytes (10^3/mm^3) >1.2*ULN | Classification | Monocytes (10^3/mm^3) >1.2*ULN | Classification | Monocytes (10^3/mm^3) >1.2*ULN | Classification | Monocytes/Leukocytes (%) >1.2*ULN | Classification | Monocytes/Leukocytes (%) >1.2*ULN | Classification | Monocytes/Leukocytes (%) >1.2*ULN | Classification | Activated Partial Thromboplastin Time (sec) >1.1*ULN | Classification | Activated Partial Thromboplastin Time (sec) >1.1*ULN | Classification | Activated Partial Thromboplastin Time (sec) >1.1*ULN | Classification | Prothrombin Time (sec) >1.1*ULN | Classification | Prothrombin Time (sec) >1.1*ULN | Classification | Prothrombin Time (sec) >1.1*ULN | Classification | Prothrombin Intl.Normalized Ratio >1.1*ULN | Classification | Prothrombin Intl.Normalized Ratio >1.1*ULN | Classification | Prothrombin Intl.Normalized Ratio >1.1*ULN | Classification | Bilirubin (mg/dL) >1.5*ULN | Classification | Bilirubin (mg/dL) >1.5*ULN | Classification | Bilirubin (mg/dL) >1.5*ULN | Classification | Direct Bilirubin (mg/dL) >1.5*ULN | Classification | Direct Bilirubin (mg/dL) >1.5*ULN | Classification | Direct Bilirubin (mg/dL) >1.5*ULN | Classification | Indirect Bilirubin (mg/dL) >1.5*ULN | Classification | Indirect Bilirubin (mg/dL) >1.5*ULN | Classification | Indirect Bilirubin (mg/dL) >1.5*ULN | Classification | Aspartate Aminotransferase (U/L) >3.0*ULN | Classification | Aspartate Aminotransferase (U/L) >3.0*ULN | Classification | Aspartate Aminotransferase (U/L) >3.0*ULN | Classification | Alanine Aminotransferase (U/L) >3.0*ULN | Classification | Alanine Aminotransferase (U/L) >3.0*ULN | Classification | Alanine Aminotransferase (U/L) >3.0*ULN | Classification | Gamma Glutamyl Transferase (U/L) >3.0*ULN | Classification | Gamma Glutamyl Transferase (U/L) >3.0*ULN | Classification | Gamma Glutamyl Transferase (U/L) >3.0*ULN | Classification | Lactate Dehydrogenase (U/L) >3.0*ULN | Classification | Lactate Dehydrogenase (U/L) >3.0*ULN | Classification | Lactate Dehydrogenase (U/L) >3.0*ULN | Classification | Alkaline Phosphatase (U/L) >3.0*ULN | Classification | Alkaline Phosphatase (U/L) >3.0*ULN | Classification | Alkaline Phosphatase (U/L) >3.0*ULN | Classification | Protein (g/dL) <0.8*LLN | Classification | Protein (g/dL) <0.8*LLN | Classification | Protein (g/dL) <0.8*LLN | Classification | Protein (g/dL) >1.2*ULN | Classification | Protein (g/dL) >1.2*ULN | Classification | Protein (g/dL) >1.2*ULN | Classification | Albumin (g/dL) <0.8*LLN | Classification | Albumin (g/dL) <0.8*LLN | Classification | Albumin (g/dL) <0.8*LLN | Classification | Albumin (g/dL) >1.2*ULN | Classification | Albumin (g/dL) >1.2*ULN | Classification | Albumin (g/dL) >1.2*ULN | Classification | Urea Nitrogen (mg/dL) >1.3*ULN | Classification | Urea Nitrogen (mg/dL) >1.3*ULN | Classification | Urea Nitrogen (mg/dL) >1.3*ULN | Classification | Triglycerides (mg/dL) >1.3*ULN | Classification | Creatinine (mg/dL) >1.3*ULN | Classification | Creatinine (mg/dL) >1.3*ULN | Classification | Creatinine (mg/dL) >1.3*ULN | Classification | Urate (mg/dL) >1.2*ULN | Classification | Urate (mg/dL) >1.2*ULN | Classification | Urate (mg/dL) >1.2*ULN | Classification | LDL Cholesterol (mg/dL) >1.2*ULN | Classification | LDL Cholesterol (mg/dL) >1.2*ULN | Classification | LDL Cholesterol (mg/dL) >1.2*ULN | Classification | Triglycerides (mg/dL) >1.3*ULN | Classification | Triglycerides (mg/dL) >1.3*ULN | Classification | Sodium (mEq/L) <0.95*LLN | Classification | Sodium (mEq/L) <0.95*LLN | Classification | Sodium (mEq/L) <0.95*LLN | Classification | Sodium (mEq/L) >1.05*ULN | Classification | Sodium (mEq/L) >1.05*ULN | Classification | Sodium (mEq/L) >1.05*ULN | Classification | Potassium (mEq/L) <0.9*LLN | Classification | Potassium (mEq/L) <0.9*LLN | Classification | Potassium (mEq/L) <0.9*LLN | Classification | Potassium (mEq/L) >1.1*ULN | Classification | Potassium (mEq/L) >1.1*ULN | Classification | Potassium (mEq/L) >1.1*ULN | Classification | Chloride (mEq/L) <0.9*LLN | Classification | Bicarbonate (mEq/L) >1.1*ULN | Classification | Chloride (mEq/L) <0.9*LLN | Classification | Chloride (mEq/L) <0.9*LLN | Classification | Chloride (mEq/L) >1.1*ULN | Classification | Chloride (mEq/L) >1.1*ULN | Classification | Chloride (mEq/L) >1.1*ULN | Classification | Calcium (mg/dL) <0.9*LLN | Classification | Calcium (mg/dL) <0.9*LLN | Classification | Calcium (mg/dL) <0.9*LLN | Classification | Calcium (mg/dL) >1.1*ULN | Classification | Calcium (mg/dL) >1.1*ULN | Classification | Calcium (mg/dL) >1.1*ULN | Classification | Bicarbonate (mEq/L) <0.9*LLN | Classification | Bicarbonate (mEq/L) <0.9*LLN | Classification | Bicarbonate (mEq/L) <0.9*LLN | Classification | Bicarbonate (mEq/L) >1.1*ULN | Classification | Bicarbonate (mEq/L) >1.1*ULN | Classification | Glucose (mg/dL) <0.6*LLN | Classification | Glucose (mg/dL) <0.6*LLN | Classification | Glucose (mg/dL) <0.6*LLN | Classification | Glucose (mg/dL) >1.5*ULN | Classification | Glucose (mg/dL) >1.5*ULN | Classification | Glucose (mg/dL) >1.5*ULN | Classification | Creatine Kinase (U/L) >2.0*ULN | Classification | Creatine Kinase (U/L) >2.0*ULN | Classification | Creatine Kinase (U/L) >2.0*ULN | Classification | Cholesterol (mg/dL)>1.3*ULN | Classification | Cholesterol (mg/dL)>1.3*ULN | Classification | Cholesterol (mg/dL)>1.3*ULN | Classification | HDL Cholesterol (mg/dL) <0.8*LLN | Classification | HDL Cholesterol (mg/dL) <0.8*LLN | Classification | HDL Cholesterol (mg/dL) <0.8*LLN | Classification | Urine Specific Gravity (scalar) <1.003 | Classification | Urine Specific Gravity (scalar) <1.003 | Classification | Urine Specific Gravity (scalar) <1.003 | Classification | Urine Specific Gravity (scalar) >1.030 | Classification | Urine Specific Gravity (scalar) >1.030 | Classification | Urine Specific Gravity (scalar) >1.030 | Classification | Urine pH (Scalar) <4.5 | Classification | Urine pH (Scalar) <4.5 | Classification | Urine pH (Scalar) <4.5 | Classification | Urine pH (Scalar) >8 | Classification | Urine pH (Scalar) >8 | Classification | Urine pH (Scalar) >8 | Classification | Urine Glucose >=1 | Classification | Urine Glucose >=1 | Classification | Urine Glucose >=1 | Classification | Urine Ketones >=1 | Classification | Urine Ketones >=1 | Classification | Urine Ketones >=1 | Classification | Urine Protein >=1 | Classification | Urine Protein >=1 | Classification | Urine Protein >=1 | Classification | Urine Hemoglobin >=1 | Classification | Urine Hemoglobin >=1 | Classification | Urine Hemoglobin >=1 | Classification | Urine Nitrite >=1 | Classification | Urine Nitrite >=1 | Classification | Urine Nitrite >=1 | Classification | Urine Leukocyte Esterase >=1 | Classification | Urine Leukocyte Esterase >=1 | Classification | Urine Leukocyte Esterase >=1 | Classification | Urine Erythrocytes (/HPF) >=20 | Classification | Urine Erythrocytes (/HPF) >=20 | Classification | Urine Erythrocytes (/HPF) >=20 | Classification | Urine Leukocytes (/HPF) >=20 | Classification | Urine Leukocytes (/HPF) >=20 | Classification | Urine Leukocytes (/HPF) >=20 | Classification | Urine Granular Casts (/LPF) >1 | Classification | Urine Granular Casts (/LPF) >1 | Classification | Urine Granular Casts (/LPF) >1 | Classification | Urine Hyaline Casts (/LPF) >1 | Classification | Pulse Rate Value >120 bpm | Classification | Urine Hyaline Casts (/LPF) >1 | Classification | Urine Hyaline Casts (/LPF) >1 | Classification | Systolic Blood Pressure Value <90mmHg | Classification | Urine Bacteria >20 | Classification | Urine Bacteria >20 | Classification | Urine Bacteria >20 | Classification | QTcF Interval, Single Beat (msec) Value >500 | Classification | QTcF Interval, Single Beat (msec) Value >500 | Classification | QTcF Interval, Single Beat (msec) Value >500 | Classification | QTcF Interval, Single Beat (msec) Change From Screening >60 | Classification | QTcF Interval, Single Beat (msec) Change From Screening >60 | Classification | QTcF Interval, Single Beat (msec) Change From Screening >60 | Classification | Diastolic Blood Pressure Value <50mmHg | Classification | Diastolic Blood Pressure Value <50mmHg | Classification | Diastolic Blood Pressure Value <50mmHg | Classification | Diastolic Blood Pressure Increase From Baseline >= 20mmHg | Classification | Diastolic Blood Pressure Increase From Baseline >= 20mmHg | Classification | Diastolic Blood Pressure Increase From Baseline >= 20mmHg | Classification | Diastolic Blood Pressure Decrease From Baseline >= 20mmHg | Classification | Diastolic Blood Pressure Decrease From Baseline >= 20mmHg | Classification | Diastolic Blood Pressure Decrease From Baseline >= 20mmHg | Classification | Pulse Rate Value <40 bpm | Classification | Pulse Rate Value <40 bpm | Classification | Pulse Rate Value <40 bpm | Classification | Pulse Rate Value >120 bpm | Classification | Pulse Rate Value >120 bpm | Classification | Systolic Blood Pressure Decrease From Baseline >=30mmHg | Classification | Systolic Blood Pressure Decrease From Baseline >=30mmHg | Classification | Systolic Blood Pressure Decrease From Baseline >=30mmHg | Classification | Diphtheria IgG Antibody | Classification | Diphtheria IgG Antibody | Classification | Diphtheria IgG Antibody | Classification | Filamentous Hemagglutinin IgG | Classification | Filamentous Hemagglutinin IgG | Classification | Filamentous Hemagglutinin IgG | Classification | Fimbriae 2/3 IgG | Classification | Fimbriae 2/3 IgG | Classification | Fimbriae 2/3 IgG | Classification | Pertactin IgG | Classification | Pertactin IgG | Classification | Pertactin IgG | Classification | Pertussis Toxin IgG | Classification | Pertussis Toxin IgG | Classification | Pertussis Toxin IgG | Classification | Tetanus Toxoid IGG AB | Classification | Tetanus Toxoid IGG AB | Classification | Tetanus Toxoid IGG AB |
Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12 | Title | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12 | Title | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12 | Title | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12 | Title | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12 | Title | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 | Title | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12 | Title | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12 | Title | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12 | Title | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 | Title | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Title | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline | Title | Percent Change From Baseline in EASI Score | Title | Percent Change From Baseline in EASI Score | Title | Percent Change From Baseline in EASI Score | Title | Percent Change From Baseline in EASI Score | Title | Percent Change From Baseline in EASI Score | Title | Percent Change From Baseline in EASI Score | Title | Percent Change From Baseline in EASI Score | Title | Percent Change From Baseline in EASI Score | Title | Percent Change From Baseline in EASI Score | Title | Percent Change From Baseline in EASI Score | Title | Percent Change From Baseline in EASI Score | Title | Percent Change From Baseline in EASI Score | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 | Title | Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus | Title | Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus | Title | Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Percent Change From Baseline in PP-NRS for Severity of Pruritus | Title | Change From Baseline in Percentage Body Surface Area (BSA) | Title | Change From Baseline in Percentage Body Surface Area (BSA) | Title | Change From Baseline in Percentage Body Surface Area (BSA) | Title | Change From Baseline in Percentage Body Surface Area (BSA) | Title | Change From Baseline in Percentage Body Surface Area (BSA) | Title | Change From Baseline in Percentage Body Surface Area (BSA) | Title | Change From Baseline in Percentage Body Surface Area (BSA) | Title | Change From Baseline in Percentage Body Surface Area (BSA) | Title | Change From Baseline in Percentage Body Surface Area (BSA) | Title | Change From Baseline in Percentage Body Surface Area (BSA) | Title | Change From Baseline in Percentage Body Surface Area (BSA) | Title | Change From Baseline in Percentage Body Surface Area (BSA) | Title | Percent Change From Baseline in Percentage BSA | Title | Percent Change From Baseline in Percentage BSA | Title | Percent Change From Baseline in Percentage BSA | Title | Percent Change From Baseline in Percentage BSA | Title | Percent Change From Baseline in Percentage BSA | Title | Percent Change From Baseline in Percentage BSA | Title | Percent Change From Baseline in Percentage BSA | Title | Percent Change From Baseline in Percentage BSA | Title | Percent Change From Baseline in Percentage BSA | Title | Percent Change From Baseline in Percentage BSA | Title | Percent Change From Baseline in Percentage BSA | Title | Percent Change From Baseline in Percentage BSA | Title | Percentage of Participants Achieving Percentage BSA < 5% at Week 12 | Title | Percentage of Participants Achieving Percentage BSA < 5% at Week 12 | Title | Percentage of Participants Achieving Percentage BSA < 5% at Week 12 | Title | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline | Title | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Title | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Title | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Title | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Title | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Title | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Title | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Title | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Title | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Title | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Title | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Title | Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline | Title | Change From Baseline in SCORAD Total Score | Title | Change From Baseline in SCORAD Total Score | Title | Change From Baseline in SCORAD Total Score | Title | Change From Baseline in SCORAD Total Score | Title | Change From Baseline in SCORAD Total Score | Title | Change From Baseline in SCORAD Total Score | Title | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Title | Change From Baseline in SCORAD Total Score | Title | Change From Baseline in SCORAD Total Score | Title | Change From Baseline in SCORAD Total Score | Title | Change From Baseline in SCORAD Total Score | Title | Change From Baseline in SCORAD Total Score | Title | Change From Baseline in SCORAD Total Score | Title | Percent Change From Baseline in SCORAD Total Score | Title | Percent Change From Baseline in SCORAD Total Score | Title | Percent Change From Baseline in SCORAD Total Score | Title | Percent Change From Baseline in SCORAD Total Score | Title | Percent Change From Baseline in SCORAD Total Score | Title | Percent Change From Baseline in SCORAD Total Score | Title | Percent Change From Baseline in SCORAD Total Score | Title | Percent Change From Baseline in SCORAD Total Score | Title | Percent Change From Baseline in SCORAD Total Score | Title | Percent Change From Baseline in SCORAD Total Score | Title | Percent Change From Baseline in SCORAD Total Score | Title | Percent Change From Baseline in SCORAD Total Score | Title | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Title | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Title | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Title | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Title | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Title | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Title | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Title | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Title | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Title | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Title | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Title | Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss | Title | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Title | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Title | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Title | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Title | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Title | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Title | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Title | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Title | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Title | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Title | Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss | Title | Number of Days When a Corticosteroid Not Used up to Day 88 | Title | Number of Days When a Corticosteroid Not Used up to Day 88 | Title | Number of Days When a Corticosteroid Not Used up to Day 88 | Title | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Title | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Title | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Title | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Title | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Title | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Title | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Title | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Title | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Title | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Title | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Change From Baseline in Children's Dermatology Life Quality Index (DLQI) | Title | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Title | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Title | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Title | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Title | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Title | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Title | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Title | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Title | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Title | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Title | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Title | Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI | Title | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Title | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Title | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Title | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Title | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Title | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Title | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Title | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Title | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Title | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Title | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Title | Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) | Title | Change From Baseline in Depression of HADS | Title | Change From Baseline in Depression of HADS | Title | Change From Baseline in Depression of HADS | Title | Change From Baseline in Depression of HADS | Title | Change From Baseline in Depression of HADS | Title | Change From Baseline in Depression of HADS | Title | Change From Baseline in Depression of HADS | Title | Change From Baseline in Depression of HADS | Title | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Title | Change From Baseline in Depression of HADS | Title | Change From Baseline in Depression of HADS | Title | Change From Baseline in Depression of HADS | Title | Change From Baseline in Depression of HADS | Title | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Title | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Title | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Title | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Title | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Title | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Title | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Title | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Title | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Title | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | Title | Change From Baseline in Dermatitis Family Impact (DFI) at Week 12 | Title | Change From Baseline in Patient Global Assessment (PtGA) | Title | Change From Baseline in Dermatitis Family Impact (DFI) at Week 12 | Title | Change From Baseline in Dermatitis Family Impact (DFI) at Week 12 | Title | Change From Baseline in Patient Global Assessment (PtGA) | Title | Change From Baseline in Patient Global Assessment (PtGA) | Title | Change From Baseline in Patient Global Assessment (PtGA) | Title | Change From Baseline in Patient Global Assessment (PtGA) | Title | Change From Baseline in Patient Global Assessment (PtGA) | Title | Change From Baseline in Patient Global Assessment (PtGA) | Title | Change From Baseline in Patient Global Assessment (PtGA) | Title | Change From Baseline in Patient Global Assessment (PtGA) | Title | Change From Baseline in Patient Global Assessment (PtGA) | Title | Change From Baseline in Patient Global Assessment (PtGA) | Title | Change From Baseline in Patient Global Assessment (PtGA) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Title | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Title | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Title | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Title | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Title | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Title | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Title | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Title | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Title | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Title | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA | Title | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Title | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Title | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Title | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Title | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Title | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Title | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Title | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Title | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Title | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Title | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Title | Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score | Title | Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12 | Title | Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12 | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12 | Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Title | Number of Participants With Serious Adverse Events (SAEs) | Title | Number of Participants With Serious Adverse Events (SAEs) | Title | Number of Participants With Serious Adverse Events (SAEs) | Title | Number of Participants With Serious Adverse Events (SAEs) | Title | Number of Participants With Serious Adverse Events (SAEs) | Title | Number of Participants With Serious Adverse Events (SAEs) | Title | Number of Participants Who Discontinued From the Study Due to TEAEs | Title | Number of Participants Who Discontinued From the Study Due to TEAEs | Title | Number of Participants Who Discontinued From the Study Due to TEAEs | Title | Number of Participants Who Discontinued From the Study Due to TEAEs | Title | Number of Participants Who Discontinued From the Study Due to TEAEs | Title | Number of Participants Who Discontinued From the Study Due to TEAEs | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Title | Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria | Title | Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria | Title | Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria | Title | Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria | Title | Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria | Title | Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Categorization of Vital Signs Data Meeting Prespecified Criteria | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Plasma PF-04965842 Concentration at Week 12 | Title | Plasma PF-04965842 Concentration at Week 12 | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination | Title | Plasma PF-04965842 Concentration at Week 8 | Title | Plasma PF-04965842 Concentration at Week 8 |
Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | Description | The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | Description | The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep & Usual Activities Questions and Patient Global Impression of Severity & Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms. | Description | The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep & Usual Activities Questions and Patient Global Impression of Severity & Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms. | Description | The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep & Usual Activities Questions and Patient Global Impression of Severity & Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms. | Description | The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | Description | The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | Description | The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | Description | The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | Description | The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | Description | The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | Description | The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | Description | The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | Description | The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. | Description | The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD. | Description | The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD. | Description | The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD. | Description | The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD. | Description | The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD. | Description | The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD. | Description | The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD. | Description | The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD. | Description | The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD. | Description | The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD. | Description | The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" or "not at all (0)". The score can range from 0 to 30. The higher values represent the worse impact. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" or "not at all (0)". The score can range from 0 to 30. The higher values represent the worse impact. | Description | The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" or "not at all (0)". The score can range from 0 to 30. The higher values represent the worse impact. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. | Description | The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine). | Description | The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine). | Description | The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine). | Description | The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine). | Description | The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine). | Description | The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine). | Description | The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine). | Description | The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine). | Description | The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine). | Description | The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine). | Description | The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine). | Description | The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine). | Description | The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated. | Description | The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated. | Description | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | Description | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | Description | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | Description | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | Description | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | Description | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | Description | A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator. | Description | A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator. | Description | A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator. | Description | A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator. | Description | A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator. | Description | A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator. | Description | An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | Description | An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | Description | An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | Description | An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | Description | An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | Description | An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal. | Description | A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to >500 ms or >60 ms change from screening ECG); data are presented below. | Description | A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to >500 ms or >60 ms change from screening ECG); data are presented below. | Description | A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to >500 ms or >60 ms change from screening ECG); data are presented below. | Description | A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to >500 ms or >60 ms change from screening ECG); data are presented below. | Description | A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to >500 ms or >60 ms change from screening ECG); data are presented below. | Description | A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to >500 ms or >60 ms change from screening ECG); data are presented below. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. | Description | The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution. |
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Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Mean | Param Type | Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Mean | Param Type | Mean |
Param Value | 7 | Param Value | 4 | Param Value | 2 | Param Value | 1 | Param Value | 24.5 | Param Value | 41.6 | Param Value | 46.2 | Param Value | 41.5 | Param Value | 68.5 | Param Value | 72.0 | Param Value | 12.6 | Param Value | 27.2 | Param Value | 38.6 | Param Value | 20.7 | Param Value | 31.5 | Param Value | 50.0 | Param Value | 29.8 | Param Value | 52.6 | Param Value | 55.4 | Param Value | -2.0 | Param Value | -2.5 | Param Value | -2.7 | Param Value | 1.1 | Param Value | 6.5 | Param Value | 12.8 | Param Value | 3.1 | Param Value | 19.6 | Param Value | 38.3 | Param Value | 16.0 | Param Value | 30.8 | Param Value | 48.9 | Param Value | 4.4 | Param Value | -18.5 | Param Value | 19.6 | Param Value | 25.5 | Param Value | 14.6 | Param Value | 41.3 | Param Value | 63.8 | Param Value | 33.3 | Param Value | 60.4 | Param Value | 68.5 | Param Value | 24.2 | Param Value | 55.4 | Param Value | 64.9 | Param Value | 51.0 | Param Value | 75.0 | Param Value | 81.9 | Param Value | 65.6 | Param Value | 85.7 | Param Value | 82.6 | Param Value | 69.1 | Param Value | 87.6 | Param Value | 87.1 | Param Value | 0 | Param Value | 8.7 | Param Value | 10.6 | Param Value | 2.1 | Param Value | 17.4 | Param Value | 30.9 | Param Value | 14.0 | Param Value | 29.7 | Param Value | 40.2 | Param Value | 18.1 | Param Value | 41.6 | Param Value | 49.5 | Param Value | 0 | Param Value | 1.1 | Param Value | 0 | Param Value | 0 | Param Value | 2.2 | Param Value | 5.3 | Param Value | 0 | Param Value | 3.3 | Param Value | 9.8 | Param Value | 2.1 | Param Value | 2.2 | Param Value | 8.6 | Param Value | -27.6 | Param Value | -51.5 | Param Value | -54.5 | Param Value | -41.7 | Param Value | -66.1 | Param Value | -74.3 | Param Value | -57.6 | Param Value | -72.6 | Param Value | -77.8 | Param Value | -63.7 | Param Value | -77.3 | Param Value | -80.6 | Param Value | 1.2 | Param Value | 2.8 | Param Value | 3.9 | Param Value | 0 | Param Value | 5.1 | Param Value | 7.7 | Param Value | 4.9 | Param Value | 11.5 | Param Value | 14.3 | Param Value | 6.9 | Param Value | 12.2 | Param Value | 18.5 | Param Value | 2 | Param Value | 8.8 | Param Value | 16.0 | Param Value | 21.3 | Param Value | 10.1 | Param Value | 16.0 | Param Value | 21.3 | Param Value | 4.0 | Param Value | 17.3 | Param Value | 25.0 | Param Value | 6.0 | Param Value | -18.7 | Param Value | 16.0 | Param Value | 25.0 | Param Value | 8.3 | Param Value | 15.6 | Param Value | 28.8 | Param Value | 7.6 | Param Value | 20.8 | Param Value | 27.0 | Param Value | 10.8 | Param Value | 22.2 | Param Value | 23.6 | Param Value | 10.0 | Param Value | 26.3 | Param Value | 31.2 | Param Value | 9.5 | Param Value | 24.7 | Param Value | 32.4 | Param Value | 14.3 | Param Value | 27.7 | Param Value | 37.8 | Param Value | 90.0 | Param Value | 70.0 | Param Value | 29.0 | Param Value | -0.9 | Param Value | -9.5 | Param Value | -5.4 | Param Value | -1.1 | Param Value | -11.3 | Param Value | -10.2 | Param Value | -5.0 | Param Value | -14.6 | Param Value | -12.3 | Param Value | -20.0 | Param Value | -14.7 | Param Value | -9.5 | Param Value | -16.1 | Param Value | -17.6 | Param Value | -8.7 | Param Value | -18.8 | Param Value | -10.6 | Param Value | -21.6 | Param Value | -22.7 | Param Value | -9.9 | Param Value | -20.9 | Param Value | -21.7 | Param Value | -10.8 | Param Value | -26.1 | Param Value | -28.0 | Param Value | -10.7 | Param Value | -26.5 | Param Value | -26.3 | Param Value | -11.0 | Param Value | -27.0 | Param Value | -28.9 | Param Value | -14.1 | Param Value | -25.2 | Param Value | -32.5 | Param Value | -12.0 | Param Value | -29.4 | Param Value | -35.3 | Param Value | -15.8 | Param Value | -30.7 | Param Value | -33.4 | Param Value | -10.9 | Param Value | -21.0 | Param Value | -20.7 | Param Value | -15.1 | Param Value | -27.7 | Param Value | -32.6 | Param Value | -21.8 | Param Value | -32.6 | Param Value | -34.1 | Param Value | -24.2 | Param Value | -34.4 | Param Value | -35.2 | Param Value | -20.6 | Param Value | -46.0 | Param Value | -40.4 | Param Value | -42.2 | Param Value | -29.0 | Param Value | -55.4 | Param Value | -66.0 | Param Value | -65.7 | Param Value | -69.5 | Param Value | -53.4 | Param Value | -71.4 | Param Value | -72.6 | Param Value | 24.5 | Param Value | 38.2 | Param Value | 36.6 | Param Value | 8.6 | Param Value | 22.6 | Param Value | 29.0 | Param Value | 24.0 | Param Value | 44.1 | Param Value | 64.1 | Param Value | 34.0 | Param Value | 65.6 | Param Value | 75.0 | Param Value | 37.6 | Param Value | 75.6 | Param Value | 73.9 | Param Value | 0 | Param Value | 5.4 | Param Value | 7.5 | Param Value | 0 | Param Value | 11.8 | Param Value | 21.7 | Param Value | 8.5 | Param Value | 17.2 | Param Value | 33.7 | Param Value | 12.9 | Param Value | 36.7 | Param Value | 34.8 | Param Value | -12.3 | Param Value | -24.6 | Param Value | -25.8 | Param Value | -20.2 | Param Value | -32.4 | Param Value | -38.0 | Param Value | -9.5 | Param Value | -26.6 | Param Value | -37.3 | Param Value | -41.5 | Param Value | -30.2 | Param Value | -40.9 | Param Value | -42.9 | Param Value | -18.7 | Param Value | -36.1 | Param Value | -38.7 | Param Value | -30.0 | Param Value | -47.4 | Param Value | -56.9 | Param Value | -39.9 | Param Value | -54.0 | Param Value | -62.0 | Param Value | -44.4 | Param Value | -59.2 | Param Value | -64.3 | Param Value | -0.9 | Param Value | -2.1 | Param Value | -2.6 | Param Value | -1.8 | Param Value | -2.9 | Param Value | -3.4 | Param Value | -2.2 | Param Value | -3.3 | Param Value | -3.7 | Param Value | -2.7 | Param Value | -3.5 | Param Value | -3.9 | Param Value | 2.6 | Param Value | 65.1 | Param Value | -36.5 | Param Value | 0 | Param Value | -20.0 | Param Value | -35.2 | Param Value | -53.4 | Param Value | -24.7 | Param Value | -44.2 | Param Value | -30.6 | Param Value | -39.5 | Param Value | -49.8 | Param Value | -35.2 | Param Value | 6.8 | Param Value | 10.9 | Param Value | 15.1 | Param Value | -4.2 | Param Value | -6.1 | Param Value | -6.3 | Param Value | -5.4 | Param Value | -7.3 | Param Value | -7.6 | Param Value | -6.1 | Param Value | -8.1 | Param Value | -8.2 | Param Value | -6.3 | Param Value | -8.6 | Param Value | 0 | Param Value | -8.7 | Param Value | 61.5 | Param Value | 73.6 | Param Value | 71.3 | Param Value | 73.7 | Param Value | 82.4 | Param Value | 73.4 | Param Value | 71.0 | Param Value | 85.9 | Param Value | 79.6 | Param Value | 67.7 | Param Value | 80.9 | Param Value | 78.5 | Param Value | -1.2 | Param Value | -1.6 | Param Value | -1.3 | Param Value | -1.5 | Param Value | -1.6 | Param Value | -1.9 | Param Value | -1.7 | Param Value | -2.1 | Param Value | -2.2 | Param Value | -2.1 | Param Value | -2.0 | Param Value | -2.4 | Param Value | -0.8 | Param Value | -1.2 | Param Value | -0.8 | Param Value | -0.8 | Param Value | -1.3 | Param Value | -1.3 | Param Value | -1.1 | Param Value | -1.4 | Param Value | -4.8 | Param Value | -1.2 | Param Value | -1.0 | Param Value | -1.4 | Param Value | -1.2 | Param Value | -3.4 | Param Value | -6.9 | Param Value | -8.2 | Param Value | -10.6 | Param Value | -5.4 | Param Value | -10.0 | Param Value | -10.6 | Param Value | -6.9 | Param Value | -11.1 | Param Value | -10.9 | Param Value | -5.2 | Param Value | -0.9 | Param Value | -6.7 | Param Value | -7.3 | Param Value | -0.4 | Param Value | -0.7 | Param Value | -1.0 | Param Value | -0.7 | Param Value | -1.2 | Param Value | -0.8 | Param Value | -1.2 | Param Value | -1.4 | Param Value | -0.9 | Param Value | -1.4 | Param Value | -1.6 | Param Value | 0 | Param Value | 0 | Param Value | 1.1 | Param Value | 5.4 | Param Value | 5.3 | Param Value | 4.2 | Param Value | 14.1 | Param Value | 20.2 | Param Value | 6.4 | Param Value | 22.6 | Param Value | 26.9 | Param Value | 10.6 | Param Value | 30.0 | Param Value | 0 | Param Value | 36.6 | Param Value | 7.140 | Param Value | 11.241 | Param Value | 12.141 | Param Value | 8.784 | Param Value | 13.222 | Param Value | 14.677 | Param Value | 8.415 | Param Value | 14.502 | Param Value | 14.653 | Param Value | 9.944 | Param Value | 14.226 | Param Value | 15.756 | Param Value | 2.5 | Param Value | 4.5 | Param Value | 0 | Param Value | 4.3 | Param Value | 50 | Param Value | 54 | Param Value | 59 | Param Value | 16 | Param Value | 20 | Param Value | 31 | Param Value | 2 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 1 | Param Value | 2 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 6 | Param Value | 4 | Param Value | 6 | Param Value | 1 | Param Value | 1 | Param Value | 4 | Param Value | 1 | Param Value | 2 | Param Value | 1 | Param Value | 6 | Param Value | 5 | Param Value | 3 | Param Value | 5 | Param Value | 3 | Param Value | 7 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 3 | Param Value | 0 | Param Value | 0 | Param Value | 35 | Param Value | 24 | Param Value | 27 | Param Value | 63 | Param Value | 55 | Param Value | 39 | Param Value | 61 | Param Value | 62 | Param Value | 47 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 7 | Param Value | 11 | Param Value | 6 | Param Value | 2 | Param Value | 4 | Param Value | 4 | Param Value | 4 | Param Value | 6 | Param Value | 8 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 4 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 2 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 3 | Param Value | 0 | Param Value | 3 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 2 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 3 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 17 | Param Value | 3 | Param Value | 2 | Param Value | 0 | Param Value | 2 | Param Value | 4 | Param Value | 1 | Param Value | 2 | Param Value | 2 | Param Value | 3 | Param Value | 11 | Param Value | 13 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 3 | Param Value | 5 | Param Value | 7 | Param Value | 12 | Param Value | 2 | Param Value | 2 | Param Value | 2 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 8 | Param Value | 0 | Param Value | 1 | Param Value | 4 | Param Value | 5 | Param Value | 0 | Param Value | 20 | Param Value | 19 | Param Value | 15 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 7 | Param Value | 14 | Param Value | 17 | Param Value | 8 | Param Value | 7 | Param Value | 5 | Param Value | 0 | Param Value | 2 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 4 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 3 | Param Value | 1 | Param Value | 9 | Param Value | 3 | Param Value | 6 | Param Value | 6 | Param Value | 3 | Param Value | 4 | Param Value | 8 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 1 | Param Value | 2 | Param Value | 14.00 | Param Value | 6.51 | Param Value | 34.61 | Param Value | 15.19 | Param Value | 11.48 | Param Value | 22.77 | Param Value | 1.93 | Param Value | 486.6 | Param Value | 1271 | Param Value | 1.11 | Param Value | 1.47 | Param Value | 54.03 | Param Value | 15.60 | Param Value | 60.18 | Param Value | 6.94 | Param Value | 10.17 | Param Value | 33.16 | Param Value | 8.36 | Param Value | 16.26 | Param Value | 48.41 | Param Value | 7.882 | Param Value | 32.33 |
Param Value Num | 7.0 | Param Value Num | 4.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 24.5 | Param Value Num | 41.6 | Param Value Num | 46.2 | Param Value Num | 41.5 | Param Value Num | 68.5 | Param Value Num | 72.0 | Param Value Num | 12.6 | Param Value Num | 27.2 | Param Value Num | 38.6 | Param Value Num | 20.7 | Param Value Num | 31.5 | Param Value Num | 50.0 | Param Value Num | 29.8 | Param Value Num | 52.6 | Param Value Num | 55.4 | Param Value Num | -2.0 | Param Value Num | -2.5 | Param Value Num | -2.7 | Param Value Num | 1.1 | Param Value Num | 6.5 | Param Value Num | 12.8 | Param Value Num | 3.1 | Param Value Num | 19.6 | Param Value Num | 38.3 | Param Value Num | 16.0 | Param Value Num | 30.8 | Param Value Num | 48.9 | Param Value Num | 4.4 | Param Value Num | -18.5 | Param Value Num | 19.6 | Param Value Num | 25.5 | Param Value Num | 14.6 | Param Value Num | 41.3 | Param Value Num | 63.8 | Param Value Num | 33.3 | Param Value Num | 60.4 | Param Value Num | 68.5 | Param Value Num | 24.2 | Param Value Num | 55.4 | Param Value Num | 64.9 | Param Value Num | 51.0 | Param Value Num | 75.0 | Param Value Num | 81.9 | Param Value Num | 65.6 | Param Value Num | 85.7 | Param Value Num | 82.6 | Param Value Num | 69.1 | Param Value Num | 87.6 | Param Value Num | 87.1 | Param Value Num | 0.0 | Param Value Num | 8.7 | Param Value Num | 10.6 | Param Value Num | 2.1 | Param Value Num | 17.4 | Param Value Num | 30.9 | Param Value Num | 14.0 | Param Value Num | 29.7 | Param Value Num | 40.2 | Param Value Num | 18.1 | Param Value Num | 41.6 | Param Value Num | 49.5 | Param Value Num | 0.0 | Param Value Num | 1.1 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.2 | Param Value Num | 5.3 | Param Value Num | 0.0 | Param Value Num | 3.3 | Param Value Num | 9.8 | Param Value Num | 2.1 | Param Value Num | 2.2 | Param Value Num | 8.6 | Param Value Num | -27.6 | Param Value Num | -51.5 | Param Value Num | -54.5 | Param Value Num | -41.7 | Param Value Num | -66.1 | Param Value Num | -74.3 | Param Value Num | -57.6 | Param Value Num | -72.6 | Param Value Num | -77.8 | Param Value Num | -63.7 | Param Value Num | -77.3 | Param Value Num | -80.6 | Param Value Num | 1.2 | Param Value Num | 2.8 | Param Value Num | 3.9 | Param Value Num | 0.0 | Param Value Num | 5.1 | Param Value Num | 7.7 | Param Value Num | 4.9 | Param Value Num | 11.5 | Param Value Num | 14.3 | Param Value Num | 6.9 | Param Value Num | 12.2 | Param Value Num | 18.5 | Param Value Num | 2.0 | Param Value Num | 8.8 | Param Value Num | 16.0 | Param Value Num | 21.3 | Param Value Num | 10.1 | Param Value Num | 16.0 | Param Value Num | 21.3 | Param Value Num | 4.0 | Param Value Num | 17.3 | Param Value Num | 25.0 | Param Value Num | 6.0 | Param Value Num | -18.7 | Param Value Num | 16.0 | Param Value Num | 25.0 | Param Value Num | 8.3 | Param Value Num | 15.6 | Param Value Num | 28.8 | Param Value Num | 7.6 | Param Value Num | 20.8 | Param Value Num | 27.0 | Param Value Num | 10.8 | Param Value Num | 22.2 | Param Value Num | 23.6 | Param Value Num | 10.0 | Param Value Num | 26.3 | Param Value Num | 31.2 | Param Value Num | 9.5 | Param Value Num | 24.7 | Param Value Num | 32.4 | Param Value Num | 14.3 | Param Value Num | 27.7 | Param Value Num | 37.8 | Param Value Num | 90.0 | Param Value Num | 70.0 | Param Value Num | 29.0 | Param Value Num | -0.9 | Param Value Num | -9.5 | Param Value Num | -5.4 | Param Value Num | -1.1 | Param Value Num | -11.3 | Param Value Num | -10.2 | Param Value Num | -5.0 | Param Value Num | -14.6 | Param Value Num | -12.3 | Param Value Num | -20.0 | Param Value Num | -14.7 | Param Value Num | -9.5 | Param Value Num | -16.1 | Param Value Num | -17.6 | Param Value Num | -8.7 | Param Value Num | -18.8 | Param Value Num | -10.6 | Param Value Num | -21.6 | Param Value Num | -22.7 | Param Value Num | -9.9 | Param Value Num | -20.9 | Param Value Num | -21.7 | Param Value Num | -10.8 | Param Value Num | -26.1 | Param Value Num | -28.0 | Param Value Num | -10.7 | Param Value Num | -26.5 | Param Value Num | -26.3 | Param Value Num | -11.0 | Param Value Num | -27.0 | Param Value Num | -28.9 | Param Value Num | -14.1 | Param Value Num | -25.2 | Param Value Num | -32.5 | Param Value Num | -12.0 | Param Value Num | -29.4 | Param Value Num | -35.3 | Param Value Num | -15.8 | Param Value Num | -30.7 | Param Value Num | -33.4 | Param Value Num | -10.9 | Param Value Num | -21.0 | Param Value Num | -20.7 | Param Value Num | -15.1 | Param Value Num | -27.7 | Param Value Num | -32.6 | Param Value Num | -21.8 | Param Value Num | -32.6 | Param Value Num | -34.1 | Param Value Num | -24.2 | Param Value Num | -34.4 | Param Value Num | -35.2 | Param Value Num | -20.6 | Param Value Num | -46.0 | Param Value Num | -40.4 | Param Value Num | -42.2 | Param Value Num | -29.0 | Param Value Num | -55.4 | Param Value Num | -66.0 | Param Value Num | -65.7 | Param Value Num | -69.5 | Param Value Num | -53.4 | Param Value Num | -71.4 | Param Value Num | -72.6 | Param Value Num | 24.5 | Param Value Num | 38.2 | Param Value Num | 36.6 | Param Value Num | 8.6 | Param Value Num | 22.6 | Param Value Num | 29.0 | Param Value Num | 24.0 | Param Value Num | 44.1 | Param Value Num | 64.1 | Param Value Num | 34.0 | Param Value Num | 65.6 | Param Value Num | 75.0 | Param Value Num | 37.6 | Param Value Num | 75.6 | Param Value Num | 73.9 | Param Value Num | 0.0 | Param Value Num | 5.4 | Param Value Num | 7.5 | Param Value Num | 0.0 | Param Value Num | 11.8 | Param Value Num | 21.7 | Param Value Num | 8.5 | Param Value Num | 17.2 | Param Value Num | 33.7 | Param Value Num | 12.9 | Param Value Num | 36.7 | Param Value Num | 34.8 | Param Value Num | -12.3 | Param Value Num | -24.6 | Param Value Num | -25.8 | Param Value Num | -20.2 | Param Value Num | -32.4 | Param Value Num | -38.0 | Param Value Num | -9.5 | Param Value Num | -26.6 | Param Value Num | -37.3 | Param Value Num | -41.5 | Param Value Num | -30.2 | Param Value Num | -40.9 | Param Value Num | -42.9 | Param Value Num | -18.7 | Param Value Num | -36.1 | Param Value Num | -38.7 | Param Value Num | -30.0 | Param Value Num | -47.4 | Param Value Num | -56.9 | Param Value Num | -39.9 | Param Value Num | -54.0 | Param Value Num | -62.0 | Param Value Num | -44.4 | Param Value Num | -59.2 | Param Value Num | -64.3 | Param Value Num | -0.9 | Param Value Num | -2.1 | Param Value Num | -2.6 | Param Value Num | -1.8 | Param Value Num | -2.9 | Param Value Num | -3.4 | Param Value Num | -2.2 | Param Value Num | -3.3 | Param Value Num | -3.7 | Param Value Num | -2.7 | Param Value Num | -3.5 | Param Value Num | -3.9 | Param Value Num | 2.6 | Param Value Num | 65.1 | Param Value Num | -36.5 | Param Value Num | 0.0 | Param Value Num | -20.0 | Param Value Num | -35.2 | Param Value Num | -53.4 | Param Value Num | -24.7 | Param Value Num | -44.2 | Param Value Num | -30.6 | Param Value Num | -39.5 | Param Value Num | -49.8 | Param Value Num | -35.2 | Param Value Num | 6.8 | Param Value Num | 10.9 | Param Value Num | 15.1 | Param Value Num | -4.2 | Param Value Num | -6.1 | Param Value Num | -6.3 | Param Value Num | -5.4 | Param Value Num | -7.3 | Param Value Num | -7.6 | Param Value Num | -6.1 | Param Value Num | -8.1 | Param Value Num | -8.2 | Param Value Num | -6.3 | Param Value Num | -8.6 | Param Value Num | 0.0 | Param Value Num | -8.7 | Param Value Num | 61.5 | Param Value Num | 73.6 | Param Value Num | 71.3 | Param Value Num | 73.7 | Param Value Num | 82.4 | Param Value Num | 73.4 | Param Value Num | 71.0 | Param Value Num | 85.9 | Param Value Num | 79.6 | Param Value Num | 67.7 | Param Value Num | 80.9 | Param Value Num | 78.5 | Param Value Num | -1.2 | Param Value Num | -1.6 | Param Value Num | -1.3 | Param Value Num | -1.5 | Param Value Num | -1.6 | Param Value Num | -1.9 | Param Value Num | -1.7 | Param Value Num | -2.1 | Param Value Num | -2.2 | Param Value Num | -2.1 | Param Value Num | -2.0 | Param Value Num | -2.4 | Param Value Num | -0.8 | Param Value Num | -1.2 | Param Value Num | -0.8 | Param Value Num | -0.8 | Param Value Num | -1.3 | Param Value Num | -1.3 | Param Value Num | -1.1 | Param Value Num | -1.4 | Param Value Num | -4.8 | Param Value Num | -1.2 | Param Value Num | -1.0 | Param Value Num | -1.4 | Param Value Num | -1.2 | Param Value Num | -3.4 | Param Value Num | -6.9 | Param Value Num | -8.2 | Param Value Num | -10.6 | Param Value Num | -5.4 | Param Value Num | -10.0 | Param Value Num | -10.6 | Param Value Num | -6.9 | Param Value Num | -11.1 | Param Value Num | -10.9 | Param Value Num | -5.2 | Param Value Num | -0.9 | Param Value Num | -6.7 | Param Value Num | -7.3 | Param Value Num | -0.4 | Param Value Num | -0.7 | Param Value Num | -1.0 | Param Value Num | -0.7 | Param Value Num | -1.2 | Param Value Num | -0.8 | Param Value Num | -1.2 | Param Value Num | -1.4 | Param Value Num | -0.9 | Param Value Num | -1.4 | Param Value Num | -1.6 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.1 | Param Value Num | 5.4 | Param Value Num | 5.3 | Param Value Num | 4.2 | Param Value Num | 14.1 | Param Value Num | 20.2 | Param Value Num | 6.4 | Param Value Num | 22.6 | Param Value Num | 26.9 | Param Value Num | 10.6 | Param Value Num | 30.0 | Param Value Num | 0.0 | Param Value Num | 36.6 | Param Value Num | 7.14 | Param Value Num | 11.241 | Param Value Num | 12.141 | Param Value Num | 8.784 | Param Value Num | 13.222 | Param Value Num | 14.677 | Param Value Num | 8.415 | Param Value Num | 14.502 | Param Value Num | 14.653 | Param Value Num | 9.944 | Param Value Num | 14.226 | Param Value Num | 15.756 | Param Value Num | 2.5 | Param Value Num | 4.5 | Param Value Num | 0.0 | Param Value Num | 4.3 | Param Value Num | 50.0 | Param Value Num | 54.0 | Param Value Num | 59.0 | Param Value Num | 16.0 | Param Value Num | 20.0 | Param Value Num | 31.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 6.0 | Param Value Num | 4.0 | Param Value Num | 6.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 4.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 6.0 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 7.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 35.0 | Param Value Num | 24.0 | Param Value Num | 27.0 | Param Value Num | 63.0 | Param Value Num | 55.0 | Param Value Num | 39.0 | Param Value Num | 61.0 | Param Value Num | 62.0 | Param Value Num | 47.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 7.0 | Param Value Num | 11.0 | Param Value Num | 6.0 | Param Value Num | 2.0 | Param Value Num | 4.0 | Param Value Num | 4.0 | Param Value Num | 4.0 | Param Value Num | 6.0 | Param Value Num | 8.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 4.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 3.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 17.0 | Param Value Num | 3.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 4.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 3.0 | Param Value Num | 11.0 | Param Value Num | 13.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 3.0 | Param Value Num | 5.0 | Param Value Num | 7.0 | Param Value Num | 12.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 8.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 4.0 | Param Value Num | 5.0 | Param Value Num | 0.0 | Param Value Num | 20.0 | Param Value Num | 19.0 | Param Value Num | 15.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 7.0 | Param Value Num | 14.0 | Param Value Num | 17.0 | Param Value Num | 8.0 | Param Value Num | 7.0 | Param Value Num | 5.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 4.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 3.0 | Param Value Num | 1.0 | Param Value Num | 9.0 | Param Value Num | 3.0 | Param Value Num | 6.0 | Param Value Num | 6.0 | Param Value Num | 3.0 | Param Value Num | 4.0 | Param Value Num | 8.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 14.0 | Param Value Num | 6.51 | Param Value Num | 34.61 | Param Value Num | 15.19 | Param Value Num | 11.48 | Param Value Num | 22.77 | Param Value Num | 1.93 | Param Value Num | 486.6 | Param Value Num | 1271.0 | Param Value Num | 1.11 | Param Value Num | 1.47 | Param Value Num | 54.03 | Param Value Num | 15.6 | Param Value Num | 60.18 | Param Value Num | 6.94 | Param Value Num | 10.17 | Param Value Num | 33.16 | Param Value Num | 8.36 | Param Value Num | 16.26 | Param Value Num | 48.41 | Param Value Num | 7.882 | Param Value Num | 32.33 |
Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 403.69 | Dispersion Value | 1000.4 | Dispersion Value | 26.350 | Dispersion Value | 76.506 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 403.69 | Dispersion Value Num | 1000.4 | Dispersion Value Num | 26.35 | Dispersion Value Num | 76.506 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Lower Limit | 15.8 | Dispersion Lower Limit | 31.3 | Dispersion Lower Limit | 36.1 | Dispersion Lower Limit | 31.5 | Dispersion Lower Limit | 58.9 | Dispersion Lower Limit | 62.9 | Dispersion Lower Limit | 6.0 | Dispersion Lower Limit | 18.1 | Dispersion Lower Limit | 28.5 | Dispersion Lower Limit | 12.4 | Dispersion Lower Limit | 21.8 | Dispersion Lower Limit | 39.3 | Dispersion Lower Limit | 20.0 | Dispersion Lower Limit | 41.4 | Dispersion Lower Limit | 44.1 | Dispersion Lower Limit | -2.4 | Dispersion Lower Limit | -2.9 | Dispersion Lower Limit | -3.1 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 1.5 | Dispersion Lower Limit | 6.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 11.5 | Dispersion Lower Limit | 28.5 | Dispersion Lower Limit | 8.6 | Dispersion Lower Limit | 21.3 | Dispersion Lower Limit | 38.7 | Dispersion Lower Limit | 0.2 | Dispersion Lower Limit | -25.0 | Dispersion Lower Limit | 11.5 | Dispersion Lower Limit | 16.7 | Dispersion Lower Limit | 7.5 | Dispersion Lower Limit | 31.2 | Dispersion Lower Limit | 54.1 | Dispersion Lower Limit | 23.8 | Dispersion Lower Limit | 50.4 | Dispersion Lower Limit | 59.0 | Dispersion Lower Limit | 15.4 | Dispersion Lower Limit | 45.3 | Dispersion Lower Limit | 55.2 | Dispersion Lower Limit | 41.0 | Dispersion Lower Limit | 66.2 | Dispersion Lower Limit | 74.1 | Dispersion Lower Limit | 55.9 | Dispersion Lower Limit | 78.5 | Dispersion Lower Limit | 74.9 | Dispersion Lower Limit | 59.8 | Dispersion Lower Limit | 80.8 | Dispersion Lower Limit | 80.3 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 2.9 | Dispersion Lower Limit | 4.4 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 9.6 | Dispersion Lower Limit | 21.5 | Dispersion Lower Limit | 6.9 | Dispersion Lower Limit | 20.3 | Dispersion Lower Limit | 30.2 | Dispersion Lower Limit | 10.3 | Dispersion Lower Limit | 31.3 | Dispersion Lower Limit | 39.3 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.8 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 3.7 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 2.9 | Dispersion Lower Limit | -34.0 | Dispersion Lower Limit | -57.9 | Dispersion Lower Limit | -61.0 | Dispersion Lower Limit | -48.3 | Dispersion Lower Limit | -72.7 | Dispersion Lower Limit | -81.0 | Dispersion Lower Limit | -63.4 | Dispersion Lower Limit | -78.4 | Dispersion Lower Limit | -83.7 | Dispersion Lower Limit | -69.5 | Dispersion Lower Limit | -83.1 | Dispersion Lower Limit | -86.5 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.2 | Dispersion Lower Limit | 1.8 | Dispersion Lower Limit | 0.2 | Dispersion Lower Limit | 4.4 | Dispersion Lower Limit | 6.5 | Dispersion Lower Limit | 1.1 | Dispersion Lower Limit | 5.1 | Dispersion Lower Limit | 10.1 | Dispersion Lower Limit | 2.6 | Dispersion Lower Limit | 8.1 | Dispersion Lower Limit | 12.3 | Dispersion Lower Limit | 3.5 | Dispersion Lower Limit | 8.1 | Dispersion Lower Limit | 12.3 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 8.8 | Dispersion Lower Limit | 15.3 | Dispersion Lower Limit | 0.9 | Dispersion Lower Limit | -25.3 | Dispersion Lower Limit | 7.7 | Dispersion Lower Limit | 15.5 | Dispersion Lower Limit | 2.4 | Dispersion Lower Limit | 7.5 | Dispersion Lower Limit | 18.8 | Dispersion Lower Limit | 1.8 | Dispersion Lower Limit | 11.7 | Dispersion Lower Limit | 16.9 | Dispersion Lower Limit | 3.7 | Dispersion Lower Limit | 12.6 | Dispersion Lower Limit | 13.8 | Dispersion Lower Limit | 3.4 | Dispersion Lower Limit | 16.6 | Dispersion Lower Limit | 20.8 | Dispersion Lower Limit | 3.2 | Dispersion Lower Limit | 15.3 | Dispersion Lower Limit | 21.8 | Dispersion Lower Limit | 6.8 | Dispersion Lower Limit | 18.1 | Dispersion Lower Limit | 27.3 | Dispersion Lower Limit | 62.0 | Dispersion Lower Limit | 30.0 | Dispersion Lower Limit | 15.0 | Dispersion Lower Limit | -5.5 | Dispersion Lower Limit | -14.2 | Dispersion Lower Limit | -10.0 | Dispersion Lower Limit | -6.0 | Dispersion Lower Limit | -16.2 | Dispersion Lower Limit | -15.2 | Dispersion Lower Limit | -10.6 | Dispersion Lower Limit | -20.2 | Dispersion Lower Limit | -19.4 | Dispersion Lower Limit | -27.1 | Dispersion Lower Limit | -20.3 | Dispersion Lower Limit | -15.8 | Dispersion Lower Limit | -22.3 | Dispersion Lower Limit | -23.9 | Dispersion Lower Limit | -15.2 | Dispersion Lower Limit | -26.0 | Dispersion Lower Limit | -17.9 | Dispersion Lower Limit | -28.9 | Dispersion Lower Limit | -30.2 | Dispersion Lower Limit | -17.6 | Dispersion Lower Limit | -28.7 | Dispersion Lower Limit | -29.5 | Dispersion Lower Limit | -17.8 | Dispersion Lower Limit | -33.1 | Dispersion Lower Limit | -35.1 | Dispersion Lower Limit | -17.7 | Dispersion Lower Limit | -33.5 | Dispersion Lower Limit | -33.5 | Dispersion Lower Limit | -18.0 | Dispersion Lower Limit | -34.0 | Dispersion Lower Limit | -36.1 | Dispersion Lower Limit | -20.4 | Dispersion Lower Limit | -31.5 | Dispersion Lower Limit | -39.0 | Dispersion Lower Limit | -18.1 | Dispersion Lower Limit | -35.5 | Dispersion Lower Limit | -41.6 | Dispersion Lower Limit | -22.7 | Dispersion Lower Limit | -37.7 | Dispersion Lower Limit | -40.5 | Dispersion Lower Limit | -14.0 | Dispersion Lower Limit | -24.1 | Dispersion Lower Limit | -23.8 | Dispersion Lower Limit | -18.4 | Dispersion Lower Limit | -31.0 | Dispersion Lower Limit | -36.0 | Dispersion Lower Limit | -25.3 | Dispersion Lower Limit | -36.1 | Dispersion Lower Limit | -37.7 | Dispersion Lower Limit | -27.8 | Dispersion Lower Limit | -38.0 | Dispersion Lower Limit | -38.8 | Dispersion Lower Limit | -26.7 | Dispersion Lower Limit | -52.6 | Dispersion Lower Limit | -46.5 | Dispersion Lower Limit | -48.3 | Dispersion Lower Limit | -36.3 | Dispersion Lower Limit | -62.7 | Dispersion Lower Limit | -73.4 | Dispersion Lower Limit | -72.4 | Dispersion Lower Limit | -76.3 | Dispersion Lower Limit | -60.1 | Dispersion Lower Limit | -78.2 | Dispersion Lower Limit | -79.3 | Dispersion Lower Limit | 15.8 | Dispersion Lower Limit | 28.1 | Dispersion Lower Limit | 26.8 | Dispersion Lower Limit | 2.9 | Dispersion Lower Limit | 14.1 | Dispersion Lower Limit | 19.8 | Dispersion Lower Limit | 15.4 | Dispersion Lower Limit | 34.0 | Dispersion Lower Limit | 54.3 | Dispersion Lower Limit | 24.5 | Dispersion Lower Limit | 55.9 | Dispersion Lower Limit | 66.2 | Dispersion Lower Limit | 27.8 | Dispersion Lower Limit | 66.7 | Dispersion Lower Limit | 64.9 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.8 | Dispersion Lower Limit | 2.2 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 5.3 | Dispersion Lower Limit | 13.3 | Dispersion Lower Limit | 2.9 | Dispersion Lower Limit | 9.5 | Dispersion Lower Limit | 24.0 | Dispersion Lower Limit | 6.1 | Dispersion Lower Limit | 26.7 | Dispersion Lower Limit | 25.1 | Dispersion Lower Limit | -15.4 | Dispersion Lower Limit | -27.7 | Dispersion Lower Limit | -28.9 | Dispersion Lower Limit | -23.3 | Dispersion Lower Limit | -35.5 | Dispersion Lower Limit | -41.2 | Dispersion Lower Limit | -10.7 | Dispersion Lower Limit | -30.0 | Dispersion Lower Limit | -40.7 | Dispersion Lower Limit | -45.0 | Dispersion Lower Limit | -33.9 | Dispersion Lower Limit | -44.7 | Dispersion Lower Limit | -46.7 | Dispersion Lower Limit | -23.1 | Dispersion Lower Limit | -40.6 | Dispersion Lower Limit | -43.2 | Dispersion Lower Limit | -34.5 | Dispersion Lower Limit | -52.0 | Dispersion Lower Limit | -61.6 | Dispersion Lower Limit | -44.9 | Dispersion Lower Limit | -59.0 | Dispersion Lower Limit | -67.2 | Dispersion Lower Limit | -50.1 | Dispersion Lower Limit | -64.9 | Dispersion Lower Limit | -70.1 | Dispersion Lower Limit | -1.4 | Dispersion Lower Limit | -2.6 | Dispersion Lower Limit | -3.1 | Dispersion Lower Limit | -2.3 | Dispersion Lower Limit | -3.3 | Dispersion Lower Limit | -3.9 | Dispersion Lower Limit | -2.7 | Dispersion Lower Limit | -3.8 | Dispersion Lower Limit | -4.2 | Dispersion Lower Limit | -3.2 | Dispersion Lower Limit | -3.9 | Dispersion Lower Limit | -4.4 | Dispersion Lower Limit | -101.2 | Dispersion Lower Limit | -39.2 | Dispersion Lower Limit | -140.7 | Dispersion Lower Limit | -35.2 | Dispersion Lower Limit | -50.7 | Dispersion Lower Limit | -69.1 | Dispersion Lower Limit | -60.1 | Dispersion Lower Limit | -79.9 | Dispersion Lower Limit | -66.7 | Dispersion Lower Limit | -77.7 | Dispersion Lower Limit | -88.3 | Dispersion Lower Limit | -74.1 | Dispersion Lower Limit | 2.0 | Dispersion Lower Limit | 6.2 | Dispersion Lower Limit | 10.2 | Dispersion Lower Limit | -5.1 | Dispersion Lower Limit | -7.1 | Dispersion Lower Limit | -7.2 | Dispersion Lower Limit | -6.3 | Dispersion Lower Limit | -8.2 | Dispersion Lower Limit | -8.6 | Dispersion Lower Limit | -7.0 | Dispersion Lower Limit | -9.1 | Dispersion Lower Limit | -9.2 | Dispersion Lower Limit | -7.4 | Dispersion Lower Limit | -9.6 | Dispersion Lower Limit | -9.7 | Dispersion Lower Limit | 51.5 | Dispersion Lower Limit | 64.6 | Dispersion Lower Limit | 62.1 | Dispersion Lower Limit | 64.8 | Dispersion Lower Limit | 74.6 | Dispersion Lower Limit | 64.5 | Dispersion Lower Limit | 61.7 | Dispersion Lower Limit | 78.8 | Dispersion Lower Limit | 71.4 | Dispersion Lower Limit | 58.2 | Dispersion Lower Limit | 72.7 | Dispersion Lower Limit | 70.1 | Dispersion Lower Limit | -1.7 | Dispersion Lower Limit | -2.1 | Dispersion Lower Limit | -1.8 | Dispersion Lower Limit | -2.1 | Dispersion Lower Limit | -2.2 | Dispersion Lower Limit | -2.5 | Dispersion Lower Limit | -2.3 | Dispersion Lower Limit | -2.7 | Dispersion Lower Limit | -2.8 | Dispersion Lower Limit | -2.7 | Dispersion Lower Limit | -2.6 | Dispersion Lower Limit | -3.0 | Dispersion Lower Limit | -1.3 | Dispersion Lower Limit | -1.7 | Dispersion Lower Limit | -1.3 | Dispersion Lower Limit | -1.3 | Dispersion Lower Limit | -1.8 | Dispersion Lower Limit | -1.8 | Dispersion Lower Limit | -1.6 | Dispersion Lower Limit | -1.9 | Dispersion Lower Limit | -6.0 | Dispersion Lower Limit | -1.7 | Dispersion Lower Limit | -1.5 | Dispersion Lower Limit | -1.9 | Dispersion Lower Limit | -1.7 | Dispersion Lower Limit | -4.7 | Dispersion Lower Limit | -8.2 | Dispersion Lower Limit | -9.5 | Dispersion Lower Limit | -11.9 | Dispersion Lower Limit | -6.7 | Dispersion Lower Limit | -11.4 | Dispersion Lower Limit | -12.0 | Dispersion Lower Limit | -8.3 | Dispersion Lower Limit | -12.5 | Dispersion Lower Limit | -12.2 | Dispersion Lower Limit | -6.5 | Dispersion Lower Limit | -1.1 | Dispersion Lower Limit | -7.9 | Dispersion Lower Limit | -8.6 | Dispersion Lower Limit | -0.6 | Dispersion Lower Limit | -0.9 | Dispersion Lower Limit | -1.1 | Dispersion Lower Limit | -0.8 | Dispersion Lower Limit | -1.4 | Dispersion Lower Limit | -1.0 | Dispersion Lower Limit | -1.3 | Dispersion Lower Limit | -1.6 | Dispersion Lower Limit | -1.1 | Dispersion Lower Limit | -1.6 | Dispersion Lower Limit | -1.8 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.8 | Dispersion Lower Limit | 0.8 | Dispersion Lower Limit | 0.2 | Dispersion Lower Limit | 7.0 | Dispersion Lower Limit | 12.1 | Dispersion Lower Limit | 1.4 | Dispersion Lower Limit | 14.1 | Dispersion Lower Limit | 17.9 | Dispersion Lower Limit | 4.4 | Dispersion Lower Limit | 20.5 | Dispersion Lower Limit | 26.8 | Dispersion Lower Limit | 3.787 | Dispersion Lower Limit | 7.882 | Dispersion Lower Limit | 8.763 | Dispersion Lower Limit | 5.625 | Dispersion Lower Limit | 10.02 | Dispersion Lower Limit | 11.438 | Dispersion Lower Limit | 4.888 | Dispersion Lower Limit | 10.977 | Dispersion Lower Limit | 11.076 | Dispersion Lower Limit | 6.373 | Dispersion Lower Limit | 10.624 | Dispersion Lower Limit | 12.153 | Dispersion Lower Limit | 1.1 | Dispersion Lower Limit | 3.0 | Dispersion Lower Limit | 2.9 | Dispersion Lower Limit | 6.32 | Dispersion Lower Limit | 2.31 | Dispersion Lower Limit | 6.96 | Dispersion Lower Limit | 4.89 | Dispersion Lower Limit | 2.65 | Dispersion Lower Limit | 7.26 | Dispersion Lower Limit | 0.79 | Dispersion Lower Limit | 0.85 | Dispersion Lower Limit | 0.61 | Dispersion Lower Limit | 14.67 | Dispersion Lower Limit | 5.77 | Dispersion Lower Limit | 12.79 | Dispersion Lower Limit | 1.95 | Dispersion Lower Limit | 4.71 | Dispersion Lower Limit | 5.04 | Dispersion Lower Limit | 1.62 | Dispersion Lower Limit | 3.52 | Dispersion Lower Limit | 9.01 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Upper Limit | 33.2 | Dispersion Upper Limit | 51.8 | Dispersion Upper Limit | 56.4 | Dispersion Upper Limit | 51.4 | Dispersion Upper Limit | 78.2 | Dispersion Upper Limit | 81.2 | Dispersion Upper Limit | 19.3 | Dispersion Upper Limit | 36.3 | Dispersion Upper Limit | 48.8 | Dispersion Upper Limit | 28.9 | Dispersion Upper Limit | 41.1 | Dispersion Upper Limit | 60.7 | Dispersion Upper Limit | 39.5 | Dispersion Upper Limit | 63.9 | Dispersion Upper Limit | 66.7 | Dispersion Upper Limit | -1.6 | Dispersion Upper Limit | -2.1 | Dispersion Upper Limit | -2.3 | Dispersion Upper Limit | 3.2 | Dispersion Upper Limit | 11.6 | Dispersion Upper Limit | 19.5 | Dispersion Upper Limit | 6.6 | Dispersion Upper Limit | 27.7 | Dispersion Upper Limit | 48.1 | Dispersion Upper Limit | 23.4 | Dispersion Upper Limit | 40.3 | Dispersion Upper Limit | 59.1 | Dispersion Upper Limit | 8.6 | Dispersion Upper Limit | -12.1 | Dispersion Upper Limit | 27.7 | Dispersion Upper Limit | 34.3 | Dispersion Upper Limit | 21.6 | Dispersion Upper Limit | 51.4 | Dispersion Upper Limit | 73.5 | Dispersion Upper Limit | 42.9 | Dispersion Upper Limit | 70.5 | Dispersion Upper Limit | 78.0 | Dispersion Upper Limit | 33.0 | Dispersion Upper Limit | 65.6 | Dispersion Upper Limit | 74.5 | Dispersion Upper Limit | 61.0 | Dispersion Upper Limit | 83.8 | Dispersion Upper Limit | 89.7 | Dispersion Upper Limit | 75.2 | Dispersion Upper Limit | 92.9 | Dispersion Upper Limit | 90.4 | Dispersion Upper Limit | 78.5 | Dispersion Upper Limit | 94.5 | Dispersion Upper Limit | 93.9 | Dispersion Upper Limit | 4.0 | Dispersion Upper Limit | 14.5 | Dispersion Upper Limit | 16.9 | Dispersion Upper Limit | 4.9 | Dispersion Upper Limit | 25.1 | Dispersion Upper Limit | 40.2 | Dispersion Upper Limit | 21.0 | Dispersion Upper Limit | 39.1 | Dispersion Upper Limit | 50.2 | Dispersion Upper Limit | 25.9 | Dispersion Upper Limit | 51.8 | Dispersion Upper Limit | 59.6 | Dispersion Upper Limit | 4.0 | Dispersion Upper Limit | 3.2 | Dispersion Upper Limit | 3.8 | Dispersion Upper Limit | 3.8 | Dispersion Upper Limit | 5.2 | Dispersion Upper Limit | 9.9 | Dispersion Upper Limit | 3.9 | Dispersion Upper Limit | 7.0 | Dispersion Upper Limit | 15.9 | Dispersion Upper Limit | 5.0 | Dispersion Upper Limit | 5.3 | Dispersion Upper Limit | 14.3 | Dispersion Upper Limit | -21.2 | Dispersion Upper Limit | -45.1 | Dispersion Upper Limit | -48.0 | Dispersion Upper Limit | -35.1 | Dispersion Upper Limit | -59.4 | Dispersion Upper Limit | -67.5 | Dispersion Upper Limit | -51.8 | Dispersion Upper Limit | -66.8 | Dispersion Upper Limit | -71.9 | Dispersion Upper Limit | -57.9 | Dispersion Upper Limit | -71.5 | Dispersion Upper Limit | -74.8 | Dispersion Upper Limit | 3.6 | Dispersion Upper Limit | 6.7 | Dispersion Upper Limit | 8.2 | Dispersion Upper Limit | 4.6 | Dispersion Upper Limit | 9.9 | Dispersion Upper Limit | 13.6 | Dispersion Upper Limit | 9.7 | Dispersion Upper Limit | 18.6 | Dispersion Upper Limit | 22.1 | Dispersion Upper Limit | 12.8 | Dispersion Upper Limit | 19.3 | Dispersion Upper Limit | 27.0 | Dispersion Upper Limit | 14.9 | Dispersion Upper Limit | 24.0 | Dispersion Upper Limit | 30.2 | Dispersion Upper Limit | 16.8 | Dispersion Upper Limit | 24.0 | Dispersion Upper Limit | 30.2 | Dispersion Upper Limit | 8.4 | Dispersion Upper Limit | 25.9 | Dispersion Upper Limit | 34.7 | Dispersion Upper Limit | 11.1 | Dispersion Upper Limit | -12.1 | Dispersion Upper Limit | 24.3 | Dispersion Upper Limit | 34.5 | Dispersion Upper Limit | 14.2 | Dispersion Upper Limit | 23.7 | Dispersion Upper Limit | 38.7 | Dispersion Upper Limit | 13.4 | Dispersion Upper Limit | 29.8 | Dispersion Upper Limit | 37.1 | Dispersion Upper Limit | 17.9 | Dispersion Upper Limit | 31.8 | Dispersion Upper Limit | 33.4 | Dispersion Upper Limit | 16.6 | Dispersion Upper Limit | 35.9 | Dispersion Upper Limit | 41.5 | Dispersion Upper Limit | 15.8 | Dispersion Upper Limit | 34.1 | Dispersion Upper Limit | 43.1 | Dispersion Upper Limit | 21.8 | Dispersion Upper Limit | 37.3 | Dispersion Upper Limit | 48.3 | Dispersion Upper Limit | 85.0 | Dispersion Upper Limit | 61.0 | Dispersion Upper Limit | 3.6 | Dispersion Upper Limit | -4.8 | Dispersion Upper Limit | -0.7 | Dispersion Upper Limit | 3.8 | Dispersion Upper Limit | -6.4 | Dispersion Upper Limit | -5.2 | Dispersion Upper Limit | 0.5 | Dispersion Upper Limit | -9.1 | Dispersion Upper Limit | -5.2 | Dispersion Upper Limit | -12.9 | Dispersion Upper Limit | -9.1 | Dispersion Upper Limit | -3.2 | Dispersion Upper Limit | -9.9 | Dispersion Upper Limit | -11.3 | Dispersion Upper Limit | -2.2 | Dispersion Upper Limit | -11.6 | Dispersion Upper Limit | -3.3 | Dispersion Upper Limit | -14.2 | Dispersion Upper Limit | -15.3 | Dispersion Upper Limit | -2.3 | Dispersion Upper Limit | -13.2 | Dispersion Upper Limit | -13.9 | Dispersion Upper Limit | -3.8 | Dispersion Upper Limit | -19.0 | Dispersion Upper Limit | -20.8 | Dispersion Upper Limit | -3.7 | Dispersion Upper Limit | -19.4 | Dispersion Upper Limit | -19.1 | Dispersion Upper Limit | -4.0 | Dispersion Upper Limit | -20.0 | Dispersion Upper Limit | -21.8 | Dispersion Upper Limit | -7.8 | Dispersion Upper Limit | -18.8 | Dispersion Upper Limit | -26.0 | Dispersion Upper Limit | -5.8 | Dispersion Upper Limit | -23.2 | Dispersion Upper Limit | -29.0 | Dispersion Upper Limit | -8.8 | Dispersion Upper Limit | -23.7 | Dispersion Upper Limit | -26.3 | Dispersion Upper Limit | -7.8 | Dispersion Upper Limit | -17.9 | Dispersion Upper Limit | -17.6 | Dispersion Upper Limit | -11.7 | Dispersion Upper Limit | -24.3 | Dispersion Upper Limit | -29.1 | Dispersion Upper Limit | -18.3 | Dispersion Upper Limit | -29.1 | Dispersion Upper Limit | -30.6 | Dispersion Upper Limit | -20.7 | Dispersion Upper Limit | -30.8 | Dispersion Upper Limit | -31.6 | Dispersion Upper Limit | -14.5 | Dispersion Upper Limit | -39.3 | Dispersion Upper Limit | -34.3 | Dispersion Upper Limit | -36.1 | Dispersion Upper Limit | -21.8 | Dispersion Upper Limit | -48.1 | Dispersion Upper Limit | -58.6 | Dispersion Upper Limit | -59.1 | Dispersion Upper Limit | -62.8 | Dispersion Upper Limit | -46.7 | Dispersion Upper Limit | -64.7 | Dispersion Upper Limit | -65.8 | Dispersion Upper Limit | 33.2 | Dispersion Upper Limit | 48.3 | Dispersion Upper Limit | 46.3 | Dispersion Upper Limit | 14.3 | Dispersion Upper Limit | 31.1 | Dispersion Upper Limit | 38.3 | Dispersion Upper Limit | 32.5 | Dispersion Upper Limit | 54.2 | Dispersion Upper Limit | 73.9 | Dispersion Upper Limit | 43.6 | Dispersion Upper Limit | 75.2 | Dispersion Upper Limit | 83.8 | Dispersion Upper Limit | 47.5 | Dispersion Upper Limit | 84.4 | Dispersion Upper Limit | 82.9 | Dispersion Upper Limit | 3.9 | Dispersion Upper Limit | 10.0 | Dispersion Upper Limit | 12.9 | Dispersion Upper Limit | 3.8 | Dispersion Upper Limit | 18.4 | Dispersion Upper Limit | 30.2 | Dispersion Upper Limit | 14.2 | Dispersion Upper Limit | 24.9 | Dispersion Upper Limit | 43.4 | Dispersion Upper Limit | 19.7 | Dispersion Upper Limit | 46.6 | Dispersion Upper Limit | 44.5 | Dispersion Upper Limit | -9.2 | Dispersion Upper Limit | -21.6 | Dispersion Upper Limit | -22.7 | Dispersion Upper Limit | -17.0 | Dispersion Upper Limit | -29.2 | Dispersion Upper Limit | -34.8 | Dispersion Upper Limit | -8.3 | Dispersion Upper Limit | -23.2 | Dispersion Upper Limit | -33.9 | Dispersion Upper Limit | -38.0 | Dispersion Upper Limit | -26.4 | Dispersion Upper Limit | -37.2 | Dispersion Upper Limit | -39.1 | Dispersion Upper Limit | -14.2 | Dispersion Upper Limit | -31.7 | Dispersion Upper Limit | -34.2 | Dispersion Upper Limit | -25.5 | Dispersion Upper Limit | -42.9 | Dispersion Upper Limit | -52.3 | Dispersion Upper Limit | -34.8 | Dispersion Upper Limit | -48.9 | Dispersion Upper Limit | -56.9 | Dispersion Upper Limit | -38.8 | Dispersion Upper Limit | -53.6 | Dispersion Upper Limit | -58.6 | Dispersion Upper Limit | -0.4 | Dispersion Upper Limit | -1.6 | Dispersion Upper Limit | -2.1 | Dispersion Upper Limit | -1.3 | Dispersion Upper Limit | -2.4 | Dispersion Upper Limit | -2.9 | Dispersion Upper Limit | -1.7 | Dispersion Upper Limit | -2.9 | Dispersion Upper Limit | -3.2 | Dispersion Upper Limit | -2.2 | Dispersion Upper Limit | -3.0 | Dispersion Upper Limit | -3.4 | Dispersion Upper Limit | 106.3 | Dispersion Upper Limit | 169.4 | Dispersion Upper Limit | 67.8 | Dispersion Upper Limit | -4.9 | Dispersion Upper Limit | -19.8 | Dispersion Upper Limit | -37.8 | Dispersion Upper Limit | 10.8 | Dispersion Upper Limit | -8.5 | Dispersion Upper Limit | 5.5 | Dispersion Upper Limit | -1.3 | Dispersion Upper Limit | -11.3 | Dispersion Upper Limit | 3.7 | Dispersion Upper Limit | 11.6 | Dispersion Upper Limit | 15.5 | Dispersion Upper Limit | 19.9 | Dispersion Upper Limit | -3.3 | Dispersion Upper Limit | -5.2 | Dispersion Upper Limit | -5.3 | Dispersion Upper Limit | -4.5 | Dispersion Upper Limit | -6.4 | Dispersion Upper Limit | -6.7 | Dispersion Upper Limit | -5.1 | Dispersion Upper Limit | -7.1 | Dispersion Upper Limit | -7.2 | Dispersion Upper Limit | -5.3 | Dispersion Upper Limit | -7.5 | Dispersion Upper Limit | -7.6 | Dispersion Upper Limit | 71.5 | Dispersion Upper Limit | 82.7 | Dispersion Upper Limit | 80.4 | Dispersion Upper Limit | 82.5 | Dispersion Upper Limit | 90.2 | Dispersion Upper Limit | 82.3 | Dispersion Upper Limit | 80.2 | Dispersion Upper Limit | 93.0 | Dispersion Upper Limit | 87.8 | Dispersion Upper Limit | 77.2 | Dispersion Upper Limit | 89.1 | Dispersion Upper Limit | 86.8 | Dispersion Upper Limit | -0.7 | Dispersion Upper Limit | -1.1 | Dispersion Upper Limit | -0.8 | Dispersion Upper Limit | -1.0 | Dispersion Upper Limit | -1.1 | Dispersion Upper Limit | -1.3 | Dispersion Upper Limit | -1.1 | Dispersion Upper Limit | -1.5 | Dispersion Upper Limit | -1.5 | Dispersion Upper Limit | -1.5 | Dispersion Upper Limit | -1.4 | Dispersion Upper Limit | -1.8 | Dispersion Upper Limit | -0.3 | Dispersion Upper Limit | -0.8 | Dispersion Upper Limit | -0.3 | Dispersion Upper Limit | -0.3 | Dispersion Upper Limit | -0.8 | Dispersion Upper Limit | -0.8 | Dispersion Upper Limit | -0.6 | Dispersion Upper Limit | -0.9 | Dispersion Upper Limit | -3.6 | Dispersion Upper Limit | -0.7 | Dispersion Upper Limit | -0.5 | Dispersion Upper Limit | -0.8 | Dispersion Upper Limit | -0.6 | Dispersion Upper Limit | -2.1 | Dispersion Upper Limit | -5.6 | Dispersion Upper Limit | -6.9 | Dispersion Upper Limit | -9.4 | Dispersion Upper Limit | -4.0 | Dispersion Upper Limit | -8.7 | Dispersion Upper Limit | -9.3 | Dispersion Upper Limit | -5.6 | Dispersion Upper Limit | -9.7 | Dispersion Upper Limit | -9.5 | Dispersion Upper Limit | -3.9 | Dispersion Upper Limit | -0.8 | Dispersion Upper Limit | -5.4 | Dispersion Upper Limit | -6.0 | Dispersion Upper Limit | -0.3 | Dispersion Upper Limit | -0.6 | Dispersion Upper Limit | -0.8 | Dispersion Upper Limit | -0.5 | Dispersion Upper Limit | -1.1 | Dispersion Upper Limit | -0.6 | Dispersion Upper Limit | -1.0 | Dispersion Upper Limit | -1.2 | Dispersion Upper Limit | -0.7 | Dispersion Upper Limit | -1.2 | Dispersion Upper Limit | -1.4 | Dispersion Upper Limit | 3.2 | Dispersion Upper Limit | 10.1 | Dispersion Upper Limit | 9.9 | Dispersion Upper Limit | 8.2 | Dispersion Upper Limit | 21.2 | Dispersion Upper Limit | 28.3 | Dispersion Upper Limit | 11.3 | Dispersion Upper Limit | 31.1 | Dispersion Upper Limit | 35.9 | Dispersion Upper Limit | 16.9 | Dispersion Upper Limit | 39.5 | Dispersion Upper Limit | 46.3 | Dispersion Upper Limit | 10.492 | Dispersion Upper Limit | 14.601 | Dispersion Upper Limit | 15.52 | Dispersion Upper Limit | 11.943 | Dispersion Upper Limit | 16.423 | Dispersion Upper Limit | 17.917 | Dispersion Upper Limit | 11.941 | Dispersion Upper Limit | 18.028 | Dispersion Upper Limit | 18.231 | Dispersion Upper Limit | 13.515 | Dispersion Upper Limit | 17.828 | Dispersion Upper Limit | 19.36 | Dispersion Upper Limit | 3.9 | Dispersion Upper Limit | 5.9 | Dispersion Upper Limit | 5.7 | Dispersion Upper Limit | 30.99 | Dispersion Upper Limit | 18.34 | Dispersion Upper Limit | 172.06 | Dispersion Upper Limit | 47.16 | Dispersion Upper Limit | 49.69 | Dispersion Upper Limit | 71.45 | Dispersion Upper Limit | 4.73 | Dispersion Upper Limit | 1.46 | Dispersion Upper Limit | 3.5 | Dispersion Upper Limit | 199.03 | Dispersion Upper Limit | 42.14 | Dispersion Upper Limit | 283.08 | Dispersion Upper Limit | 24.71 | Dispersion Upper Limit | 21.94 | Dispersion Upper Limit | 218.38 | Dispersion Upper Limit | 43.18 | Dispersion Upper Limit | 75.11 | Dispersion Upper Limit | 260.09 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Explanation Of Na | The upper limit was not evaluable as too few events were observed. |
Study References
Sequence: | 52042300 | Sequence: | 52042301 |
Pmid | 34743361 | Pmid | 34406366 |
Reference Type | derived | Reference Type | derived |
Citation | Cork MJ, McMichael A, Teng J, Valdez H, Rojo R, Chan G, Zhang F, Myers DE, DiBonaventura M. Impact of oral abrocitinib on signs, symptoms and quality of life among adolescents with moderate-to-severe atopic dermatitis: an analysis of patient-reported outcomes. J Eur Acad Dermatol Venereol. 2022 Mar;36(3):422-433. doi: 10.1111/jdv.17792. Epub 2021 Dec 4. | Citation | Eichenfield LF, Flohr C, Sidbury R, Siegfried E, Szalai Z, Galus R, Yao Z, Takahashi H, Barbarot S, Feeney C, Zhang F, DiBonaventura M, Rojo R, Valdez H, Chan G. Efficacy and Safety of Abrocitinib in Combination With Topical Therapy in Adolescents With Moderate-to-Severe Atopic Dermatitis: The JADE TEEN Randomized Clinical Trial. JAMA Dermatol. 2021 Oct 1;157(10):1165-1173. doi: 10.1001/jamadermatol.2021.2830. Erratum In: JAMA Dermatol. 2021 Oct 1;157(10):1246. |
Baseline Counts
Sequence: | 11380189 | Sequence: | 11380190 | Sequence: | 11380191 | Sequence: | 11380192 |
Result Group Id | 56080959 | Result Group Id | 56080960 | Result Group Id | 56080961 | Result Group Id | 56080962 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 |
Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall | Scope | overall |
Count | 96 | Count | 95 | Count | 94 | Count | 285 |
Result Groups
Sequence: | 56080959 | Sequence: | 56080960 | Sequence: | 56080961 | Sequence: | 56080962 | Sequence: | 56080963 | Sequence: | 56080964 | Sequence: | 56080965 | Sequence: | 56080966 | Sequence: | 56080967 | Sequence: | 56080968 | Sequence: | 56080969 | Sequence: | 56080970 | Sequence: | 56080971 | Sequence: | 56080972 | Sequence: | 56080973 | Sequence: | 56080974 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event |
Title | Placebo | Title | PF-04965842 100mg QD | Title | PF-04965842 200mg QD | Title | Total | Title | Placebo | Title | PF-04965842 100mg QD | Title | PF-04965842 200mg QD | Title | Placebo | Title | PF-04965842 100mg QD | Title | PF-04965842 200mg QD | Title | Placebo | Title | PF-04965842 100mg QD | Title | PF-04965842 200mg QD | Title | Placebo | Title | PF-04965842 100mg QD | Title | PF-04965842 200mg QD |
Description | Participants received two PF-04965842-matching placebo tablets QD | Description | Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD | Description | Participants received two PF-04965842 100 mg tablets QD | Description | Total of all reporting groups | Description | Participants received two PF-04965842-matching placebo tablets QD | Description | Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD | Description | Participants received two PF-04965842 100 mg tablets QD | Description | Participants received two PF-04965842-matching placebo tablets QD | Description | Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD | Description | Participants received two PF-04965842 100 mg tablets QD | Description | Participants received PF-04965842-matching placebo tablets QD | Description | Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD | Description | Participants received two PF-04965842 100 mg tablets QD | Description | Participants received two PF-04965842-matching placebo tablets QD | Description | Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD | Description | Participants received two PF-04965842 100 mg tablets QD |
Baseline Measurements
Sequence: | 125545452 | Sequence: | 125545453 | Sequence: | 125545454 | Sequence: | 125545455 | Sequence: | 125545456 | Sequence: | 125545457 | Sequence: | 125545458 | Sequence: | 125545459 | Sequence: | 125545460 | Sequence: | 125545461 | Sequence: | 125545462 | Sequence: | 125545463 | Sequence: | 125545464 | Sequence: | 125545465 | Sequence: | 125545466 | Sequence: | 125545467 | Sequence: | 125545468 | Sequence: | 125545469 | Sequence: | 125545470 | Sequence: | 125545471 | Sequence: | 125545472 | Sequence: | 125545473 | Sequence: | 125545474 | Sequence: | 125545475 | Sequence: | 125545476 | Sequence: | 125545477 | Sequence: | 125545478 | Sequence: | 125545479 | Sequence: | 125545480 | Sequence: | 125545481 | Sequence: | 125545482 | Sequence: | 125545483 | Sequence: | 125545484 | Sequence: | 125545485 | Sequence: | 125545486 | Sequence: | 125545487 | Sequence: | 125545488 | Sequence: | 125545489 | Sequence: | 125545490 | Sequence: | 125545491 | Sequence: | 125545492 | Sequence: | 125545493 | Sequence: | 125545494 | Sequence: | 125545495 | Sequence: | 125545496 | Sequence: | 125545497 | Sequence: | 125545498 | Sequence: | 125545499 | Sequence: | 125545500 | Sequence: | 125545501 | Sequence: | 125545502 | Sequence: | 125545503 |
Result Group Id | 56080959 | Result Group Id | 56080960 | Result Group Id | 56080961 | Result Group Id | 56080962 | Result Group Id | 56080959 | Result Group Id | 56080960 | Result Group Id | 56080961 | Result Group Id | 56080962 | Result Group Id | 56080959 | Result Group Id | 56080960 | Result Group Id | 56080961 | Result Group Id | 56080962 | Result Group Id | 56080959 | Result Group Id | 56080960 | Result Group Id | 56080961 | Result Group Id | 56080962 | Result Group Id | 56080959 | Result Group Id | 56080960 | Result Group Id | 56080961 | Result Group Id | 56080962 | Result Group Id | 56080959 | Result Group Id | 56080960 | Result Group Id | 56080961 | Result Group Id | 56080962 | Result Group Id | 56080959 | Result Group Id | 56080960 | Result Group Id | 56080961 | Result Group Id | 56080962 | Result Group Id | 56080959 | Result Group Id | 56080960 | Result Group Id | 56080961 | Result Group Id | 56080962 | Result Group Id | 56080959 | Result Group Id | 56080960 | Result Group Id | 56080961 | Result Group Id | 56080962 | Result Group Id | 56080959 | Result Group Id | 56080960 | Result Group Id | 56080961 | Result Group Id | 56080962 | Result Group Id | 56080959 | Result Group Id | 56080960 | Result Group Id | 56080961 | Result Group Id | 56080962 | Result Group Id | 56080959 | Result Group Id | 56080960 | Result Group Id | 56080961 | Result Group Id | 56080962 | Result Group Id | 56080959 | Result Group Id | 56080960 | Result Group Id | 56080961 | Result Group Id | 56080962 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 |
Category | Female | Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | Male | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | White | Category | White | Category | White | Category | White | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Multiracial | Category | Multiracial | Category | Multiracial | Category | Multiracial | Category | Not reported | Category | Not reported | Category | Not reported | Category | Not reported | ||||||||
Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized |
Units | Years | Units | Years | Units | Years | Units | Years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 14.8 | Param Value | 15.1 | Param Value | 14.7 | Param Value | 14.9 | Param Value | 52 | Param Value | 50 | Param Value | 38 | Param Value | 140 | Param Value | 44 | Param Value | 45 | Param Value | 56 | Param Value | 145 | Param Value | 25 | Param Value | 26 | Param Value | 25 | Param Value | 76 | Param Value | 65 | Param Value | 63 | Param Value | 69 | Param Value | 197 | Param Value | 6 | Param Value | 6 | Param Value | 0 | Param Value | 12 | Param Value | 56 | Param Value | 52 | Param Value | 52 | Param Value | 160 | Param Value | 3 | Param Value | 9 | Param Value | 5 | Param Value | 17 | Param Value | 32 | Param Value | 31 | Param Value | 31 | Param Value | 94 | Param Value | 1 | Param Value | 3 | Param Value | 4 | Param Value | 8 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 2 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 2 | Param Value | 2 | Param Value | 0 | Param Value | 0 | Param Value | 2 |
Param Value Num | 14.8 | Param Value Num | 15.1 | Param Value Num | 14.7 | Param Value Num | 14.9 | Param Value Num | 52.0 | Param Value Num | 50.0 | Param Value Num | 38.0 | Param Value Num | 140.0 | Param Value Num | 44.0 | Param Value Num | 45.0 | Param Value Num | 56.0 | Param Value Num | 145.0 | Param Value Num | 25.0 | Param Value Num | 26.0 | Param Value Num | 25.0 | Param Value Num | 76.0 | Param Value Num | 65.0 | Param Value Num | 63.0 | Param Value Num | 69.0 | Param Value Num | 197.0 | Param Value Num | 6.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 12.0 | Param Value Num | 56.0 | Param Value Num | 52.0 | Param Value Num | 52.0 | Param Value Num | 160.0 | Param Value Num | 3.0 | Param Value Num | 9.0 | Param Value Num | 5.0 | Param Value Num | 17.0 | Param Value Num | 32.0 | Param Value Num | 31.0 | Param Value Num | 31.0 | Param Value Num | 94.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 4.0 | Param Value Num | 8.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 1.7 | Dispersion Value | 1.8 | Dispersion Value | 1.8 | Dispersion Value | 1.7 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 1.7 | Dispersion Value Num | 1.8 | Dispersion Value Num | 1.8 | Dispersion Value Num | 1.7 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 96 | Number Analyzed | 95 | Number Analyzed | 94 | Number Analyzed | 285 | Number Analyzed | 96 | Number Analyzed | 95 | Number Analyzed | 94 | Number Analyzed | 285 | Number Analyzed | 96 | Number Analyzed | 95 | Number Analyzed | 94 | Number Analyzed | 285 | Number Analyzed | 96 | Number Analyzed | 95 | Number Analyzed | 94 | Number Analyzed | 285 | Number Analyzed | 96 | Number Analyzed | 95 | Number Analyzed | 94 | Number Analyzed | 285 | Number Analyzed | 96 | Number Analyzed | 95 | Number Analyzed | 94 | Number Analyzed | 285 | Number Analyzed | 96 | Number Analyzed | 95 | Number Analyzed | 94 | Number Analyzed | 285 | Number Analyzed | 96 | Number Analyzed | 95 | Number Analyzed | 94 | Number Analyzed | 285 | Number Analyzed | 96 | Number Analyzed | 95 | Number Analyzed | 94 | Number Analyzed | 285 | Number Analyzed | 96 | Number Analyzed | 95 | Number Analyzed | 94 | Number Analyzed | 285 | Number Analyzed | 96 | Number Analyzed | 95 | Number Analyzed | 94 | Number Analyzed | 285 | Number Analyzed | 96 | Number Analyzed | 95 | Number Analyzed | 94 | Number Analyzed | 285 | Number Analyzed | 96 | Number Analyzed | 95 | Number Analyzed | 94 | Number Analyzed | 285 |
]]>
https://zephyrnet.com/NCT03796663
2018-12-18
https://zephyrnet.com/?p=NCT03796663
NCT03796663https://www.clinicaltrials.gov/study/NCT03796663?tab=tableNANANAThe Mindful Parenting and Parent Training Study will be investigating the combination of Bögels and Restifo’s (2014) Mindful Parenting Program and Chorpita and Weisz’s (2009) Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH) Program, specifically the BPT module. The Mindful Parenting Program is an adaptation for parents of the Mindfulness-Based Cognitive Therapy, and the Mindfulness-Based Stress Reduction program; the program will consist of 7-weekly 2.5-hour parent group sessions. Following the completion of the Mindful Parenting group sessions, half of the participants will be randomly selected to receive individually-implemented MATCH BPT sessions, which will consist of 8-12 weekly (depending on how long it takes for individual parents and their assigned trainer to get through the material), 1.5-hour sessions. The other half of families will have the opportunity to also receive the MATCH BPT program following the completion of data collection.
Both evaluation and treatment services will be offered at no cost to study participants. Parents, children, and teachers will also be offered monetary incentive to thank them for their time and effort completing study related assessments throughout the course of the study to determine if the combination of the Mindful Parenting Program with BPT improves functioning in children with disruptive behavioral problems, as well as the parent-child relationship and the parent’s acquisition and enactment of the skills they learn in BPT.
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Studies
Study First Submitted Date | 2018-12-19 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-11-02 |
Start Month Year | December 18, 2018 |
Primary Completion Month Year | October 31, 2020 |
Verification Month Year | June 2021 |
Verification Date | 2021-06-30 |
Last Update Posted Date | 2022-11-02 |
Facilities
Sequence: | 199402660 |
Name | New York University – Kimball Hall |
City | New York |
State | New York |
Zip | 10003 |
Country | United States |
Conditions
Sequence: | 52006265 | Sequence: | 52006266 | Sequence: | 52006267 | Sequence: | 52006268 | Sequence: | 52006269 |
Name | Disruptive Behavior | Name | Attention Deficit Hyperactivity Disorder | Name | Oppositional Defiant Disorder | Name | Conduct Disorder | Name | Disruptive Behavior Disorder |
Downcase Name | disruptive behavior | Downcase Name | attention deficit hyperactivity disorder | Downcase Name | oppositional defiant disorder | Downcase Name | conduct disorder | Downcase Name | disruptive behavior disorder |
Id Information
Sequence: | 40029866 |
Id Source | org_study_id |
Id Value | IRB-FY2019-2401 |
Countries
Sequence: | 42425576 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55411555 | Sequence: | 55411556 |
Group Type | Active Comparator | Group Type | Experimental |
Title | Mindful Parenting Only | Title | Mindful Parenting and BPT Combined |
Description | Participants in this arm will receive only the Mindful Parenting Program at the start of the study. Bögels and Restifo's (2014) Mindful Parenting Program is an adaptation for parents of MBCT, and MBSR; the program will consist of 7-weekly 2.5-hour parent group sessions. In the program, parents learn to apply the skills of mindfulness to themselves and to their experience of parenting their children.
Following the completion of the Mindful Parenting Sessions, participants in this arm will be asked continue to participate in data collection for the post-intervention assessment time point (i.e. 8 weeks after the completion of the Mindful Parenting group sessions) and for the 2-month follow up assessment time point (i.e. 16 weeks after the completion of the Mindful Parenting group sessions). After they have completed both assessments, they will be offered the opportunity to participate in the MATCH BPT program if they so choose (no data will be collected). |
Description | Participants in this arm will receive the Mindful Parenting Program at the start of the study, which will consist of 7-weekly 2.5-hour parent group sessions. In the program, parents learn to apply the skills of mindfulness to themselves and to their experience of parenting their children.
Following the completion of the Mindful Parenting Sessions, participants in this arm will receive receive individually-implemented MATCH BPT sessions, which will consist of 8-12 weekly (depending on how long it takes for individual parents and their assigned trainer to get through the material), 1 hour sessions. The MATCH manual is comprised of 33 modules (i.e. coping, giving effective instructions, learning to relax, etc.). For the purpose of this study we will be utilizing the section on BPT, which consists of 12 modules with corresponding handouts and worksheets. |
Interventions
Sequence: | 52318839 | Sequence: | 52318840 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Mindful Parenting Program | Name | MATCH BPT Program |
Description | The Mindful Parenting Program consists of 7, 2.5 hour weekly group sessions. In the program, parents learn to apply the skills of mindfulness to themselves and to their experience of parenting their children. Parents are introduced to formal meditation practices, including the bodyscan; choiceless awareness; mindful walking; and yoga. They are also introduced to mindfulness of everyday activities from the beginning of the sessions, with an added focus on day-to-day parenting and family activities. Additionally, short self-compassion practices occur throughout the weekly sessions, culminating in the teaching of formal loving-kindness meditation.
Additionally, the program encourages parents to engage in "home practice", where parents can experience and practice many of the new skills they are learning. This includes both formal, longer meditation practices, as well as shorter practices, which can occur throughout the day, such as mindfulness of daily routines. |
Description | The MATCH BPT Program consists of 8-12 weekly (depending on how long it takes for individual parents and their assigned trainer to get through the material), 60 minute individually-implemented sessions.The sessions will consist of the coach obtaining and reviewing weekly assignments completed by the parent, followed by activities and discussions that focus on a particular parenting skill (i.e. praise, active ignoring, giving effective instructions). The discussions will emphasize benefits and possible problems that the parent may encounter throughout the week while implementing the new skill. The coach will assign to the parent a practice assignment to further encourage use of the concept. |
Keywords
Sequence: | 79605259 | Sequence: | 79605260 | Sequence: | 79605261 | Sequence: | 79605262 | Sequence: | 79605263 | Sequence: | 79605264 | Sequence: | 79605265 |
Name | Disruptive Behavioral Problems | Name | ADHD | Name | Oppositional Defiant Disorder | Name | Conduct Disorder | Name | Mindfulness | Name | Mindful Parenting | Name | Behavioral Parent Training |
Downcase Name | disruptive behavioral problems | Downcase Name | adhd | Downcase Name | oppositional defiant disorder | Downcase Name | conduct disorder | Downcase Name | mindfulness | Downcase Name | mindful parenting | Downcase Name | behavioral parent training |
Design Outcomes
Sequence: | 176802415 | Sequence: | 176802416 | Sequence: | 176802417 | Sequence: | 176802418 | Sequence: | 176802419 | Sequence: | 176802420 | Sequence: | 176802421 | Sequence: | 176802422 | Sequence: | 176802423 | Sequence: | 176802424 | Sequence: | 176802425 | Sequence: | 176802426 | Sequence: | 176802427 | Sequence: | 176802428 | Sequence: | 176802429 | Sequence: | 176802430 | Sequence: | 176802431 | Sequence: | 176802432 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Behavioral Assessment System for Children – 3 (BASC-3) | Measure | Brief Problem Checklist-Parent (BPC-P) | Measure | Impairment Rating Scale – Parent/Teacher Version (IRS) | Measure | Columbia Impairment Scale (CIS) | Measure | Mindfulness In Parenting Questionnaire (MIPQ) | Measure | Five-Facet Mindfulness Questionnaire (FFMQ) | Measure | Parent-Child Interaction Questionnaire-Revised-Parent and Child Version (PACHIQ-R) | Measure | Parenting Scale (PS) | Measure | Parent Behavior Inventory (PBI) – Supportive/Engaged Subscale | Measure | Family and Peer Process Code (FPP) and Five Observational Lab Tasks | Measure | IOWA Conners Rating Scale | Measure | Parent Emotion Regulation Inventory-2 (PERI-2) | Measure | Knowledge of Parenting Strategies Scale (KoPSS) | Measure | Emotion Regulation Questionnaire (ERQ) | Measure | Berkeley Expressivity Questionnaire (BEQ) | Measure | Positive and Negative Affect Scale (PANAS) | Measure | Parenting Stress Index-Short Form (PSI-SF) | Measure | Fragile Families Aggravation in Parenting Scale |
Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. | Time Frame | Seven months from start of intervention. |
Description | A well-standardized, multidimensional approach to evaluating the behavior of children. For this measure we will be looking at several subscales, including Hyperactivity, Agression, Conduct Problems, Externalizing Problems, Attention Problems, Anger Control, and Emotional Self-Control. For each subscale, a T-score is obtained using norms; T-scores range from 20 to 120, with higher T-Scores indicating a worse outcome/greater impairment. | Description | A measure designed to periodically assess the clinical progress of a child over the course of psychological treatment, specifically measuring the severity of internalizing and externalizing problems found in children. The scale scores of the BPC are based on the raw sum of item responses, each of which ranges from 0 to 2. Thus, scores on the six-item Internalizing and Externalizing scales each range from 0 to 12, and scores on the Total Problems scale range from 0 to 24, with higher scores indicating increased problem levels. | Description | A multidimensional measure that assesses functioning across domains. Specifically, the IRS qualifies and quantifies impairment present in a child's life, both in school and non-school settings. No total or subscale scores are calculated, each item of this measure is considered individually. | Description | Measures 4 major areas of functioning: interpersonal relations, broad psychopathological domains, functioning in job or schoolwork, and use of leisure time. Items are scored on a 5-point Likert-type scale ranging from 0 ("no problem") to 4 ("a very big problem"). "Not applicable/do not know" is scored as a 5. Sum scores can range from 0 to 52, with higher scores indicating greater impairment. | Description | Assesses two factors of mindfulness in parenting: Being in the moment with the child and mindful discipline. For all 28 items, parents rate themselves for each item using the following scale: 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = almost always. Standard Scores are obtained for each subscale by summing up the items that make up that subscale and then using a conversion table. | Description | A widely used scale to assess the tendency to be mindful in daily life.The FFMQ is a 39-item self-report measure that evaluates five facets of the tendency to be mindful in daily life and consists of the five subscales of Observing (scores range from 8 to 40), Describing (scores range from 8 to 40), Acting with Awareness (scores range from 8 to 40), Nonreactivity (scores range from 7 to 35), and Nonjudging (scores range from 8 to 40). The scale uses a five-point Likert scale for all items, where 1 = never or very rarely true and 5 = very often or always true. For all subscales a higher score is indicative of a greater tendency to be mindful in that particular facet. The two subscales are Mindful Discipline and Being in the Moment with the Child; for both scales, Standard scores between 90 and 110 fall within the average range, with higher scores indicating greater levels of mindful parenting. | Description | Assesses how parents view their relationship with their children (and how children view their relationship with their parents). There are 25 items split into two parts, part 1 with items 1 through 14 and part 2 with items 15 through 25 in the PACHIQ-R questionnaire. The Total Score ranges from 25 to 125. A high Total Score is indicative for a positive relationship. | Description | Self-report measure of dysfunctional parenting in discipline situations. The measure consists of 30 items, and each item receives a 1-7 score. The Total Score is calculated by averaging the responses on all 30 items and ranges from 1 to 7. There are 4 subscales – Laxness, Overreactivity, Verbosity, and Other – the scores for which are also calculated by averaging the responses on the items that make up each subscale. The score for each subscale ranges from 1 to 7. For each score, lower numbers indicate a higher probability of using effective discipline strategies and higher numbers indicate a higher probability of using ineffective discipline strategies. | Description | Measure of parenting behavior that contains two independent scales, Supportive/Engaged and Hostile/Coercive. We will only be looking at the Supportive/Engaged Subscale, which measures levels of supportive/engagement parenting behavior. For this subscale, parents rate themselves for each item using the following scale: 0 = not at all true, 1 = a little true, 2 = somewhat true, 3= moderately true, 4 = quite a bit true, 5 = very true. To obtain To obtain the Subscale score, the responses to each item are summed together; the score can range from 0 to 50. A higher score is indicative of parents engaging in more supportive or engaged parenting behaviors. | Description | Parenting practices will be assessed using data derived from 35 min of videotaped parent-child interaction. These interactions will sample five different tasks. Trained observers blind to intervention assignment will then code the tapes of the family interaction using the FPP and will make global ratings. | Description | The first half of the measure is designed to assess inattentive-impulsive-overactive behaviors while the second half captures behaviors related to oppositional-defiant activity. All 10 items of the measure are scored using a four point Likert scale with the following anchors: not at all (0); just a little (1); pretty much (2); and very much (3). The first five items on the IOWA are designed to measure inattentive-impulsive-overactive (IO Subscale) behaviors and the second five items are designed to measure oppositional-defiant (OD Subscale) behaviors. For both scales, higher scores indicate greater impairment and the scores can range from 0 to 15. | Description | Measures parent emotions and their ability to regulate their emotions during interactions with their child. This measure consists of items, on which parents rate themselves for each item using a Likert scale of 1 (I never do this) to 7 (I very often do this). We will be looking at two subscales – Reappraisal and Suppression; the scores for both subscales are calculated by taking the average of the responses on the items for each subscale, and so each of the subscales scores can range from 1 to 7. For the Reappraisal scale, a higher score indicates a more frequent use of reappraisal as an emotional regulation strategy, and for the Suppression Subscale a higher score indicates a more frequent use of suppression as an emotion regulation strategy. | Description | A measure of parents' knowledge of effective parenting strategies.This measure consists of 33 items, and we will be looking at the total number of correct answers obtained by the participant. As such, the score can range from 0 to 33, with a higher score indicate a greater knowledge of parenting strategies. | Description | Assesses individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression. The ERQ is a 10-item scale on which parents rate each item using a Likert scale of 1 (Strongly disagree) to 7 (strongly agree). There are two subscales, Reappraisal (ranges from 1 to 42) and Suppression (ranges from 4 to 28). For the Reappraisal scale higher scores indicate a more frequent use of reappraisal as an emotional regulation strategy, and for the Suppression Subscale higher scores mean a more frequent use of suppression as an emotion regulation strategy. | Description | A measure of parent emotional expression in discipline specific situations; it will be modified to reflect parents' emotional expression when faced with child misbehavior. We will be looking at the Total Score (which ranges from 16 to 112), as well as several subscale scores: Negative Expressivity (ranges from 6 to 42), Positive Expressivity (ranges from 4 to 28), and Impulse Strength (ranges from 6 to 42). For all scales a higher score means a greater amount of emotional expressivity is displayed by the individual. | Description | A measure of parent's emotional experience in discipline specific situations. The measure consists of 20 items, on which parents rate themselves for each item using the following scale: 1 = very slightly or not at all, 2 = a little, 3 = moderately, 4 = quite a bit, and 5 = very much. To calculate the Positive Affect Subscale Score, the scores on the ten items that make up the subscale are summed together. Scores can range from 10-50, with higher scores representing higher levels of positive affect. To calculate the Negative Affect Subscale Score, the scores on the 10 items that make up that subscale are summed together. Scores can range from 10-50, with lower scores representing lower levels of negative affect. | Description | Measures the level of stress in the parent-child relationship and is appropriate for use with children aged 1 month to 12 years. It consists of 36 statements, each rated on a 1 to 5 scale (i.e., strongly disagree, disagree, not sure, agree, and strongly agree), which produces a Total Stress score that ranges from 36 to 180, with a higher score indicating greater levels of parenting stress. | Description | The scale measures the amount of parenting stress brought on by changes in employment, income or other factors in the parent's life. This questionnaire consists of 4 items on a Likert Scale. Parents rate themselves for each item using the following scale on a: 1 = Strongly agree, 2 = Somewhat agree, 3 = Somewhat disagree, and 4 = Strongly disagree. A Total Score is calculated by using the sum of all items divided by the top value of the Likert scale (i.e. 4); as such the Total Score ranges from 1 to 4, with a higher score indicating greater levels of stress. |
Browse Conditions
Sequence: | 192834404 | Sequence: | 192834405 | Sequence: | 192834406 | Sequence: | 192834407 | Sequence: | 192834408 | Sequence: | 192834409 | Sequence: | 192834410 |
Mesh Term | Attention Deficit Disorder with Hyperactivity | Mesh Term | Mental Disorders | Mesh Term | Problem Behavior | Mesh Term | Conduct Disorder | Mesh Term | Attention Deficit and Disruptive Behavior Disorders | Mesh Term | Neurodevelopmental Disorders | Mesh Term | Behavioral Symptoms |
Downcase Mesh Term | attention deficit disorder with hyperactivity | Downcase Mesh Term | mental disorders | Downcase Mesh Term | problem behavior | Downcase Mesh Term | conduct disorder | Downcase Mesh Term | attention deficit and disruptive behavior disorders | Downcase Mesh Term | neurodevelopmental disorders | Downcase Mesh Term | behavioral symptoms |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48165305 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | New York University |
Design Group Interventions
Sequence: | 67928404 | Sequence: | 67928405 | Sequence: | 67928406 |
Design Group Id | 55411555 | Design Group Id | 55411556 | Design Group Id | 55411556 |
Intervention Id | 52318839 | Intervention Id | 52318839 | Intervention Id | 52318840 |
Eligibilities
Sequence: | 30668703 |
Gender | All |
Minimum Age | 6 Years |
Maximum Age | 11 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
the child participant must be between the ages of 6 and 11 years old at baseline/time of pretreatment data collection; 2015), as assessed during the intake assessment for the study; 3) both the parent and child participants must be fluent English speakers, and; 4) the parent participant(s) must be available to attend weekly treatment sessions and assessments for up to 26 weeks at New York University – Kimball Hall. Exclusion Criteria: There is evidence of significant developmental delay or psychosis that impacts the child's ability to fully engage in the intervention; |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254293606 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 22 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 6 |
Maximum Age Num | 11 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 11 |
Number Of Secondary Outcomes To Measure | 7 |
Designs
Sequence: | 30415483 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | All participants will receive the Mindful Parenting program at the start of their involvement in the study. Following the completion of the Mindful Parenting group sessions, half of the participants will be randomly selected to receive individually-implemented MATCH BPT sessions. The other half of families will have the opportunity to also receive the MATCH BPT program following the completion of data collection. |
Links
Sequence: | 4373368 |
Url | https://steinhardt.nyu.edu/appsych/faceslab/ |
Description | FACES Lab – Study Website |
Responsible Parties
Sequence: | 28782002 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796650
2019-07-17
https://zephyrnet.com/?p=NCT03796650
NCT03796650https://www.clinicaltrials.gov/study/NCT03796650?tab=tableFrederik Emil Juul, MDf.e.juul@medisin.uio.no+4797512966In this randomized controlled trial the investigators want to compare the effect of one-time rectal instillation of fecal microbiota transplantation, compared to a ten-day antibiotic course for the treatment of primary Clostridium difficile infection (CDI). The investigators hypothetsize that the instillation of feces from a healthy donor will be non-inferior to vancomycin in inducing a durable cure.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-04-29 |
Start Month Year | July 17, 2019 |
Primary Completion Month Year | January 31, 2024 |
Verification Month Year | April 2022 |
Verification Date | 2022-04-30 |
Last Update Posted Date | 2022-04-29 |
Detailed Descriptions
Sequence: | 20753260 |
Description | Up to one third of patients with clostridium difficile infection treated with antibiotics experience recurrent or relapsing symptoms within a few weeks. Even with subsequent antibiotic treatment, multiple recurrences/relapses are frequent. Fecal microbiota transplantation (FMT) has been shown to be significantly more effective in curing recurrent CDI than repeated antibiotic treatment. In current guidelines, FMT is proposed as a treatment option after multiple recurrences/relapses of CDI. The rationale to reserve transplantation of donor feces for recurrent and difficult cases of CDI is a possible risk of pathogen transmittance and the process of finding a donor and screen for communicable disease.
The effect of FMT for recurrent CDI, however, suggests that this therapy may be more effective than antibiotics in inducing a durable cure also for primary CDI. If the therapeutic effect of FMT proves to be equal (non-inferior) or more effective than antibiotics, FMT may be the preferable treatment option due to favourable ecological impact compared to antibiotics. In an era with increasing concerns about overuse of antibiotics and emergence of antibiotic resistant bacteria, it is important to investigate therapeutic alternatives that may reduce the need for antibiotics. This trial is a phase III multicentre, randomized controlled, open-label non-inferiority parallel group trial with two arms (FMT and antibiotics), and is a continuation of the phase II trial IMT for Primary Clostridium Difficile Infection (NCT02301000). In the current trial, patients with Clostridium difficile infection and no previous CDI within 12 months prior to inclusion will be randomized 1:1 to FMT or 10 days of guideline-recommended antibiotic therapy (vancomycin 125 mg four times a day). Patients are recruited in Norwegian hospitals. The investigators plan to use frozen microbiota, because supply is easier to organize, compared to fresh fecal samples. Patients in the FMT treatment group will receive one rectal dose of FMT, originating from screened, healthy donors. Patients who are not cured by the first dose is offered a protocol defined additional FMT treatment. In the case of clinical deterioration, appropriate measures will be undertaken according to current guidelines. Patient treatment outcomes are evaluated after 14, 60 and 365 days from inclusion and treatment initiation. An interim analysis is planned after inclusion of the first 94 patients (corresponding to 50% of the planned number of patients). |
Facilities
Sequence: | 200371639 | Sequence: | 200371640 | Sequence: | 200371641 | Sequence: | 200371642 | Sequence: | 200371643 | Sequence: | 200371644 | Sequence: | 200371645 | Sequence: | 200371646 | Sequence: | 200371647 | Sequence: | 200371648 | Sequence: | 200371649 | Sequence: | 200371650 | Sequence: | 200371651 | Sequence: | 200371652 | Sequence: | 200371653 | Sequence: | 200371654 | Sequence: | 200371655 | Sequence: | 200371656 |
Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Not yet recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting |
Name | Vestre Viken HF, Bærum Hospital | Name | Haukeland universitetssykehus | Name | Nordlandssykehuset | Name | Sykehuset Østfold Kalnes | Name | UNN Harstad | Name | Sørlandet Hospital HF | Name | Sykehuset Levanger | Name | Sykehuset Innlandet HF | Name | Akershus University Hospital | Name | Diakonhjemmet Hospital | Name | Lovisenberg sykehus | Name | Oslo University Hospital Rikshospitalet | Name | Oslo University Hospital Ullevål | Name | Telemark Hospital HF | Name | Stavanger University Hospital | Name | UNN Tromsø | Name | Sykehuset i Vestfold | Name | Ålesund Sjukehus |
City | Sandvika | City | Bergen | City | Bodø | City | Grålum | City | Harstad | City | Kristiansand | City | Levanger | City | Lillehammer | City | Lørenskog | City | Oslo | City | Oslo | City | Oslo | City | Oslo | City | Skien | City | Stavanger | City | Tromsø | City | Tønsberg | City | Ålesund |
State | Gjettum | ||||||||||||||||||||||||||||||||||
Zip | 1346 | Zip | 8092 | Zip | 1478 | Zip | 0319 | ||||||||||||||||||||||||||||
Country | Norway | Country | Norway | Country | Norway | Country | Norway | Country | Norway | Country | Norway | Country | Norway | Country | Norway | Country | Norway | Country | Norway | Country | Norway | Country | Norway | Country | Norway | Country | Norway | Country | Norway | Country | Norway | Country | Norway | Country | Norway |
Facility Contacts
Sequence: | 28144249 | Sequence: | 28144250 | Sequence: | 28144251 | Sequence: | 28144252 | Sequence: | 28144253 | Sequence: | 28144254 | Sequence: | 28144255 | Sequence: | 28144256 | Sequence: | 28144257 | Sequence: | 28144258 | Sequence: | 28144259 | Sequence: | 28144260 | Sequence: | 28144261 | Sequence: | 28144262 | Sequence: | 28144263 | Sequence: | 28144264 | Sequence: | 28144265 | Sequence: | 28144266 | Sequence: | 28144267 |
Facility Id | 200371639 | Facility Id | 200371640 | Facility Id | 200371641 | Facility Id | 200371642 | Facility Id | 200371643 | Facility Id | 200371644 | Facility Id | 200371645 | Facility Id | 200371646 | Facility Id | 200371647 | Facility Id | 200371648 | Facility Id | 200371649 | Facility Id | 200371650 | Facility Id | 200371650 | Facility Id | 200371651 | Facility Id | 200371652 | Facility Id | 200371653 | Facility Id | 200371654 | Facility Id | 200371655 | Facility Id | 200371656 |
Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary |
Name | Øystein Rose, MD | Name | Trygve Hausken, MD, PhD | Name | Eirik H Ofstad, MD, PhD | Name | Jon Birger Haug, MD, PhD | Name | Peter H. Johnsen, MD | Name | Håvard Wiig, MD | Name | Eivind Ness-Jensen, MD, PhD | Name | Ragnhild Eiken, MD | Name | Jan Erik Berdal, MD, PhD | Name | Raziye B. Cetinkaya, MD, PhD | Name | Jørgen Valeur, MD, PhD | Name | Frederik Emil Juul, MD | Name | Siv Elisabeth Isaksen | Name | Kristian Tonby, MD, PhD | Name | Pavel Gudkov, MD | Name | Trond J Cooper, MD | Name | Rasmus Goll, MD, PhD | Name | Awet Abraham, MD | Name | Dag Arne Lihaug Hoff, MD, PhD |
f.e.juul@medisin.uio.no | |||||||||||||||||||||||||||||||||||||
Facility Investigators
Sequence: | 18352428 | Sequence: | 18352429 | Sequence: | 18352430 |
Facility Id | 200371644 | Facility Id | 200371650 | Facility Id | 200371651 |
Role | Sub-Investigator | Role | Principal Investigator | Role | Sub-Investigator |
Name | Rita Helleren, MD | Name | Kjetil Garborg, MD, PhD | Name | Frederik Emil Juul, MD |
Browse Interventions
Sequence: | 96181110 | Sequence: | 96181111 | Sequence: | 96181112 |
Mesh Term | Vancomycin | Mesh Term | Anti-Bacterial Agents | Mesh Term | Anti-Infective Agents |
Downcase Mesh Term | vancomycin | Downcase Mesh Term | anti-bacterial agents | Downcase Mesh Term | anti-infective agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52251963 |
Name | Clostridium Difficile Infection |
Downcase Name | clostridium difficile infection |
Id Information
Sequence: | 40217539 |
Id Source | org_study_id |
Id Value | COLONIZE |
Countries
Sequence: | 42632499 |
Name | Norway |
Removed | False |
Design Groups
Sequence: | 55683735 | Sequence: | 55683736 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Fecal microbiota transplantation | Title | Antibiotic treatment |
Description | Fecal microbiota from healthy, screened stool donors at the University Hospital of North Norway. Patients will receive one FMT enema immediately after enrolment. | Description | Patients randomized to the control group will receive a ten-day course of oral vancomycin four times a day. This is according to international guidelines for primary C. difficile treatment. |
Interventions
Sequence: | 52564848 | Sequence: | 52564849 |
Intervention Type | Other | Intervention Type | Drug |
Name | Fecal microbiota transplantation | Name | Vancomycin |
Description | 50 g donor feces suspended in saline with added glycerol, administered by a enema kit. | Description | Peroral vancomycin 125 mg q.i.d. for ten days. |
Keywords
Sequence: | 79983168 | Sequence: | 79983169 | Sequence: | 79983170 | Sequence: | 79983171 | Sequence: | 79983172 | Sequence: | 79983173 |
Name | Clostridium difficile | Name | Intestinal microbiota therapy | Name | Fecal microbiota transplantation | Name | Investigator-initiated | Name | Antibiotics | Name | Diarrhea |
Downcase Name | clostridium difficile | Downcase Name | intestinal microbiota therapy | Downcase Name | fecal microbiota transplantation | Downcase Name | investigator-initiated | Downcase Name | antibiotics | Downcase Name | diarrhea |
Design Outcomes
Sequence: | 177674994 | Sequence: | 177674995 | Sequence: | 177674996 | Sequence: | 177674997 | Sequence: | 177674998 | Sequence: | 177674999 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other |
Measure | Patients with durable cure | Measure | Patients with durable cure with additional treatment. | Measure | Treatment adverse events | Measure | Patients with long-time cure | Measure | Health-economic evaluation | Measure | Fecal composition and treatment outcome |
Time Frame | 60 days | Time Frame | 60 days | Time Frame | 60 and 365 days | Time Frame | 365 days | Time Frame | 365 days | Time Frame | 60 days |
Description | Proportion of patients with primary clinical cure at day 14 after treatment start and no recurrent C. difficile infection during 60 days after treatment start, with the assigned treatment alone. | Description | Proportion of patients with primary clinical cure at day 14 after treatment start and no recurrent C. difficile infection during 60 days after treatment start, with or without the need of additional treatment (FMT, metronidazole or vancomycin). | Description | Proportion of patients with adverse events. | Description | Proportion of patients with primary clinical cure at day 14 after treatment start and no recurrent C. difficile infection during 60 days after treatment start, and without recurrent C. difficile infection within 365 days after treatment start. | Description | Health-economic analysis of the two compared treatment modalities | Description | Correlation in fecal composition changes before versus after treatment, and treatment outcome (such as bacterial diversity and fecal short chain fatty acids).
Subgroup analyses will be performed for sex, age, co-morbidities, and FMT donor. |
Browse Conditions
Sequence: | 193795775 | Sequence: | 193795776 | Sequence: | 193795777 | Sequence: | 193795778 | Sequence: | 193795779 | Sequence: | 193795780 | Sequence: | 193795781 | Sequence: | 193795782 |
Mesh Term | Infections | Mesh Term | Communicable Diseases | Mesh Term | Clostridium Infections | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes | Mesh Term | Gram-Positive Bacterial Infections | Mesh Term | Bacterial Infections | Mesh Term | Bacterial Infections and Mycoses |
Downcase Mesh Term | infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | clostridium infections | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | gram-positive bacterial infections | Downcase Mesh Term | bacterial infections | Downcase Mesh Term | bacterial infections and mycoses |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48395117 | Sequence: | 48395118 | Sequence: | 48395119 | Sequence: | 48395120 | Sequence: | 48395121 | Sequence: | 48395122 | Sequence: | 48395123 | Sequence: | 48395124 | Sequence: | 48395125 | Sequence: | 48395126 | Sequence: | 48395127 | Sequence: | 48395128 | Sequence: | 48395129 | Sequence: | 48395130 | Sequence: | 48395131 | Sequence: | 48395132 | Sequence: | 48395133 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER_GOV | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER_GOV | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER_GOV |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Oslo University Hospital | Name | South-Eastern Norway Regional Health Authority | Name | University Hospital of North Norway | Name | Haukeland University Hospital | Name | Helse Nord-Trøndelag HF | Name | Vestre Viken Hospital Trust | Name | The Hospital of Vestfold | Name | Sykehuset Telemark | Name | Alesund Hospital | Name | University Hospital, Akershus | Name | Lovisenberg Diakonale Hospital | Name | Sorlandet Hospital HF | Name | Ostfold Hospital Trust | Name | Diakonhjemmet Hospital | Name | Nordlandssykehuset HF | Name | Sykehuset Innlandet HF | Name | Helse Stavanger HF |
Overall Officials
Sequence: | 29329311 |
Role | Study Chair |
Name | Michael Bretthauer, MD, PhD |
Affiliation | Oslo Universitetssykehus HF, Rikshospitalet |
Central Contacts
Sequence: | 12027622 | Sequence: | 12027623 |
Contact Type | primary | Contact Type | backup |
Name | Kjetil Garborg, MD, PhD | Name | Frederik Emil Juul, MD |
Phone | +4741578975 | Phone | +4797512966 |
k.k.garborg@medisin.uio.no | f.e.juul@medisin.uio.no | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68258096 | Sequence: | 68258097 |
Design Group Id | 55683735 | Design Group Id | 55683736 |
Intervention Id | 52564848 | Intervention Id | 52564849 |
Eligibilities
Sequence: | 30812489 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients, ≥18 years with primary C. difficile infection, defined by the following three criteria: Diarrhea as defined by the WHO (≥3 loose stools per day), and Exclusion Criteria: Known presence of other stool pathogens known to cause diarrhea. Serious immunodeficiency, defined as one of the following: Ongoing or recent chemotherapy and current or expected neutropenia with neutrophil count of < 500/μL. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254054915 |
Number Of Facilities | 18 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30558462 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Masking Description | An open-label, partly assessor blinded trial. |
Intervention Model Description | Randomized clinical trial with two parallel treatment arms with a 1:1 allocation. |
Intervention Other Names
Sequence: | 26710768 | Sequence: | 26710769 | Sequence: | 26710770 |
Intervention Id | 52564848 | Intervention Id | 52564848 | Intervention Id | 52564848 |
Name | FMT | Name | IMT | Name | Bacteriotherapy |
Links
Sequence: | 4394397 |
Url | https://www.med.uio.no/helsam/english/research/groups/clinical-effectiveness/index.html |
Description | Investigating research group' home page |
Responsible Parties
Sequence: | 28924854 |
Responsible Party Type | Principal Investigator |
Name | Kjetil Garborg |
Title | Joint Principal Investigator |
Affiliation | Oslo University Hospital |
Study References
Sequence: | 52151266 | Sequence: | 52151267 | Sequence: | 52151268 | Sequence: | 52151269 | Sequence: | 52151270 |
Pmid | 29562266 | Pmid | 29860912 | Pmid | 25875259 | Pmid | 23718168 | Pmid | 23511459 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | McDonald LC, Gerding DN, Johnson S, Bakken JS, Carroll KC, Coffin SE, Dubberke ER, Garey KW, Gould CV, Kelly C, Loo V, Shaklee Sammons J, Sandora TJ, Wilcox MH. Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018 Mar 19;66(7):987-994. doi: 10.1093/cid/ciy149. | Citation | Juul FE, Garborg K, Bretthauer M, Skudal H, Oines MN, Wiig H, Rose O, Seip B, Lamont JT, Midtvedt T, Valeur J, Kalager M, Holme O, Helsingen L, Loberg M, Adami HO. Fecal Microbiota Transplantation for Primary Clostridium difficile Infection. N Engl J Med. 2018 Jun 28;378(26):2535-2536. doi: 10.1056/NEJMc1803103. Epub 2018 Jun 2. No abstract available. | Citation | Leffler DA, Lamont JT. Clostridium difficile infection. N Engl J Med. 2015 Apr 16;372(16):1539-48. doi: 10.1056/NEJMra1403772. No abstract available. | Citation | van Nood E, Dijkgraaf MG, Keller JJ. Duodenal infusion of feces for recurrent Clostridium difficile. N Engl J Med. 2013 May 30;368(22):2145. doi: 10.1056/NEJMc1303919. No abstract available. | Citation | Kassam Z, Lee CH, Yuan Y, Hunt RH. Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis. Am J Gastroenterol. 2013 Apr;108(4):500-8. doi: 10.1038/ajg.2013.59. Epub 2013 Mar 19. |
]]>
https://zephyrnet.com/NCT03796637
2019-04-11
https://zephyrnet.com/?p=NCT03796637
NCT03796637https://www.clinicaltrials.gov/study/NCT03796637?tab=tableNANANAThis study is designed to generate additional data on the effect of ataluren for producing dystrophin protein in nonsense mutation nmDMD participants. This study will evaluate dystrophin levels from participants with nmDMD who currently have been receiving ataluren for ≥9 months.
The study will have a single visit (Visit 1).
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-04-05 |
Start Month Year | April 11, 2019 |
Primary Completion Month Year | June 3, 2019 |
Verification Month Year | February 2022 |
Verification Date | 2022-02-28 |
Last Update Posted Date | 2022-04-05 |
Results First Posted Date | 2022-04-05 |
Facilities
Sequence: | 200680833 |
Name | University of California, Los Angeles (UCLA) |
City | Los Angeles |
State | California |
Zip | 90025 |
Country | United States |
Conditions
Sequence: | 52346405 |
Name | Duchenne Muscular Dystrophy |
Downcase Name | duchenne muscular dystrophy |
Id Information
Sequence: | 40284235 | Sequence: | 40284236 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | PTC124-GD-046-DMD | Id Value | 2019-001691-11 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42705278 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55788746 |
Group Type | Experimental |
Title | nmDMD Participants |
Description | Participants who have been receiving ataluren, will be dosed daily 10 milligrams per kilogram (mg/kg) in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening, for >=9 months from ongoing PTC-sponsored nmDMD clinical trials. |
Interventions
Sequence: | 52657530 |
Intervention Type | Drug |
Name | Ataluren |
Description | Ataluren will be administered as per the dose and schedule specified in the arm. |
Design Outcomes
Sequence: | 178026343 | Sequence: | 178026342 |
Outcome Type | secondary | Outcome Type | primary |
Measure | Dystrophin Protein Levels as Determined by Immunohistochemistry | Measure | Mean Dystrophin Levels as Measured by Electrochemiluminescence (ECL) |
Time Frame | Day 1 of biopsy | Time Frame | Day 1 of biopsy |
Description | Dystrophin levels by IHC mean membrane stain density are reported by muscle group (gastrocnemius, tibialis anterior, and across muscle locations). | Description | The mean dystrophin protein levels were measured by ECL. Dystrophin levels are reported by muscle group (gastrocnemius, tibialis anterior, and across muscle locations). Results below the limit of quantitation were imputed as half of lower limit of quantitation (LLOQ). LLOQ = 0.5 micrograms (μg)/milliliter (mL) |
Browse Conditions
Sequence: | 194154819 | Sequence: | 194154820 | Sequence: | 194154821 | Sequence: | 194154822 | Sequence: | 194154823 | Sequence: | 194154824 | Sequence: | 194154825 | Sequence: | 194154826 | Sequence: | 194154827 |
Mesh Term | Muscular Dystrophies | Mesh Term | Muscular Dystrophy, Duchenne | Mesh Term | Muscular Disorders, Atrophic | Mesh Term | Muscular Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Neuromuscular Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Genetic Diseases, Inborn | Mesh Term | Genetic Diseases, X-Linked |
Downcase Mesh Term | muscular dystrophies | Downcase Mesh Term | muscular dystrophy, duchenne | Downcase Mesh Term | muscular disorders, atrophic | Downcase Mesh Term | muscular diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | neuromuscular diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | genetic diseases, inborn | Downcase Mesh Term | genetic diseases, x-linked |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48483100 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | PTC Therapeutics |
Overall Officials
Sequence: | 29378433 |
Role | Study Director |
Name | Francesco Bibbiani, MD |
Affiliation | PTC Therapeutics, Inc. |
Design Group Interventions
Sequence: | 68387515 |
Design Group Id | 55788746 |
Intervention Id | 52657530 |
Eligibilities
Sequence: | 30866923 |
Gender | Male |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Evidence of signed and dated informed consent/assent document(s) indicating that the participant (and/or his parent/legal guardian) has been informed of all pertinent aspects of the trial. Exclusion Criteria: Known contra-indication to muscle biopsy (such as bleeding or clotting disorders). |
Gender Based | True |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 253996071 |
Number Of Facilities | 1 |
Number Of Nsae Subjects | 3 |
Registered In Calendar Year | 2019 |
Actual Duration | 1 |
Were Results Reported | True |
Months To Report Results | 33 |
Has Us Facility | True |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30612737 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26757218 |
Intervention Id | 52657530 |
Name | PTC124 |
Milestones
Sequence: | 41116521 | Sequence: | 41116522 | Sequence: | 41116523 |
Result Group Id | 56195085 | Result Group Id | 56195085 | Result Group Id | 56195085 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG000 |
Title | STARTED | Title | COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 6 | Count | 6 | Count | 0 |
Participant Flows
Sequence: | 3929694 |
Outcome Counts
Sequence: | 74203077 | Sequence: | 74203078 |
Outcome Id | 30886617 | Outcome Id | 30886618 |
Result Group Id | 56195086 | Result Group Id | 56195086 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants |
Count | 6 | Count | 6 |
Provided Documents
Sequence: | 2592612 | Sequence: | 2592613 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2019-03-20 | Document Date | 2020-02-12 |
Url | https://ClinicalTrials.gov/ProvidedDocs/37/NCT03796637/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/37/NCT03796637/SAP_001.pdf |
Reported Event Totals
Sequence: | 28009294 | Sequence: | 28009295 | Sequence: | 28009296 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 |
Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 |
Created At | 2023-08-10 03:28:17.253571 | Created At | 2023-08-10 03:28:17.253571 | Created At | 2023-08-10 03:28:17.253571 |
Updated At | 2023-08-10 03:28:17.253571 | Updated At | 2023-08-10 03:28:17.253571 | Updated At | 2023-08-10 03:28:17.253571 |
Reported Events
Sequence: | 529562395 | Sequence: | 529562396 |
Result Group Id | 56195087 | Result Group Id | 56195087 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Time Frame | Baseline (Day 1) up to Week 1 | Time Frame | Baseline (Day 1) up to Week 1 |
Event Type | other | Event Type | other |
Subjects Affected | 1 | Subjects Affected | 2 |
Subjects At Risk | 6 | Subjects At Risk | 6 |
Description | Safety population included all participants who received at least 1 dose of ataluren. | Description | Safety population included all participants who received at least 1 dose of ataluren. |
Organ System | General disorders | Organ System | Injury, poisoning and procedural complications |
Adverse Event Term | Puncture site discharge | Adverse Event Term | Procedural pain |
Frequency Threshold | 5 | Frequency Threshold | 5 |
Vocab | MedDRA 22.1 | Vocab | MedDRA 22.1 |
Assessment | Systematic Assessment | Assessment | Systematic Assessment |
Responsible Parties
Sequence: | 28979271 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3860438 |
Pi Employee | No |
Restriction Type | OTHER |
Other Details | The Sponsor can review results and/or communications prior to public release and can embargo communications regarding trial results for a period that is up to 180 days from the time submitted to the sponsor for review. The sponsor may consult with the PI to require changes to the communication or extend the embargo. |
Restrictive Agreement | The Sponsor can review results and/or communications prior to public release and can embargo communications regarding trial results for a period that is up to 180 days from the time submitted to the sponsor for review. The sponsor may consult with the PI to require changes to the communication or extend the embargo. |
Result Contacts
Sequence: | 3860403 |
Organization | PTC Therapeutics, Inc. |
Name | Medical Information |
Phone | 1-866-562-4620 |
medinfo@ptcbio.com | |
Outcomes
Sequence: | 30886617 | Sequence: | 30886618 |
Outcome Type | Primary | Outcome Type | Secondary |
Title | Mean Dystrophin Levels as Measured by Electrochemiluminescence (ECL) | Title | Dystrophin Protein Levels as Determined by Immunohistochemistry |
Description | The mean dystrophin protein levels were measured by ECL. Dystrophin levels are reported by muscle group (gastrocnemius, tibialis anterior, and across muscle locations). Results below the limit of quantitation were imputed as half of lower limit of quantitation (LLOQ). LLOQ = 0.5 micrograms (μg)/milliliter (mL) | Description | Dystrophin levels by IHC mean membrane stain density are reported by muscle group (gastrocnemius, tibialis anterior, and across muscle locations). |
Time Frame | Day 1 of biopsy | Time Frame | Day 1 of biopsy |
Population | ITT population included all enrolled participants with a valid assessment of dystrophin level, as measured by ECL. | Population | ITT population included all enrolled participants with a valid assessment of dystrophin level, as measured by ECL. |
Units | nanograms (ng)/mg | Units | ng/mg |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 236337704 | Sequence: | 236337705 | Sequence: | 236337700 | Sequence: | 236337701 | Sequence: | 236337702 | Sequence: | 236337703 |
Outcome Id | 30886618 | Outcome Id | 30886618 | Outcome Id | 30886617 | Outcome Id | 30886617 | Outcome Id | 30886617 | Outcome Id | 30886618 |
Result Group Id | 56195086 | Result Group Id | 56195086 | Result Group Id | 56195086 | Result Group Id | 56195086 | Result Group Id | 56195086 | Result Group Id | 56195086 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Classification | Tibialis Anterior | Classification | Across Muscle Locations | Classification | Gastrocnemius | Classification | Tibialis Anterior | Classification | Across Muscle Locations | Classification | Gastrocnemius |
Title | Dystrophin Protein Levels as Determined by Immunohistochemistry | Title | Dystrophin Protein Levels as Determined by Immunohistochemistry | Title | Mean Dystrophin Levels as Measured by Electrochemiluminescence (ECL) | Title | Mean Dystrophin Levels as Measured by Electrochemiluminescence (ECL) | Title | Mean Dystrophin Levels as Measured by Electrochemiluminescence (ECL) | Title | Dystrophin Protein Levels as Determined by Immunohistochemistry |
Description | Dystrophin levels by IHC mean membrane stain density are reported by muscle group (gastrocnemius, tibialis anterior, and across muscle locations). | Description | Dystrophin levels by IHC mean membrane stain density are reported by muscle group (gastrocnemius, tibialis anterior, and across muscle locations). | Description | The mean dystrophin protein levels were measured by ECL. Dystrophin levels are reported by muscle group (gastrocnemius, tibialis anterior, and across muscle locations). Results below the limit of quantitation were imputed as half of lower limit of quantitation (LLOQ). LLOQ = 0.5 micrograms (μg)/milliliter (mL) | Description | The mean dystrophin protein levels were measured by ECL. Dystrophin levels are reported by muscle group (gastrocnemius, tibialis anterior, and across muscle locations). Results below the limit of quantitation were imputed as half of lower limit of quantitation (LLOQ). LLOQ = 0.5 micrograms (μg)/milliliter (mL) | Description | The mean dystrophin protein levels were measured by ECL. Dystrophin levels are reported by muscle group (gastrocnemius, tibialis anterior, and across muscle locations). Results below the limit of quantitation were imputed as half of lower limit of quantitation (LLOQ). LLOQ = 0.5 micrograms (μg)/milliliter (mL) | Description | Dystrophin levels by IHC mean membrane stain density are reported by muscle group (gastrocnemius, tibialis anterior, and across muscle locations). |
Units | ng/mg | Units | ng/mg | Units | nanograms (ng)/mg | Units | nanograms (ng)/mg | Units | nanograms (ng)/mg | Units | ng/mg |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 0.26578 | Param Value | 0.30483 | Param Value | 0.0844 | Param Value | 0.1002 | Param Value | 0.1054 | Param Value | 0.28817 |
Param Value Num | 0.26578 | Param Value Num | 0.30483 | Param Value Num | 0.0844 | Param Value Num | 0.1002 | Param Value Num | 0.1054 | Param Value Num | 0.28817 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Dispersion Value | 0.226510 | Dispersion Value | 0.218600 | Dispersion Value | 0.05874 | Dispersion Value | 0.08060 | Dispersion Value | 0.08300 | Dispersion Value | 0.220547 |
Dispersion Value Num | 0.22651 | Dispersion Value Num | 0.2186 | Dispersion Value Num | 0.05874 | Dispersion Value Num | 0.0806 | Dispersion Value Num | 0.083 | Dispersion Value Num | 0.220547 |
Baseline Counts
Sequence: | 11409504 |
Result Group Id | 56195084 |
Ctgov Group Code | BG000 |
Units | Participants |
Scope | overall |
Count | 6 |
Result Groups
Sequence: | 56195084 | Sequence: | 56195085 | Sequence: | 56195086 | Sequence: | 56195087 |
Ctgov Group Code | BG000 | Ctgov Group Code | FG000 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 |
Result Type | Baseline | Result Type | Participant Flow | Result Type | Outcome | Result Type | Reported Event |
Title | Ataluren | Title | Ataluren | Title | Ataluren | Title | Ataluren |
Description | Participants who had been receiving ataluren, were dosed daily 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening, for ≥9 months from ongoing PTC-sponsored nmDMD clinical trials. | Description | Participants who had been receiving ataluren, were dosed daily 10 milligrams (mg)/kilogram (kg) in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening, for ≥9 months from ongoing PTC-sponsored nmDMD clinical trials. | Description | Participants who had been receiving ataluren, were dosed daily 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening, for ≥9 months from ongoing PTC-sponsored nmDMD clinical trials. | Description | Participants who had been receiving ataluren, were dosed daily 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening, for ≥9 months from ongoing PTC-sponsored nmDMD clinical trials. |
Baseline Measurements
Sequence: | 125951106 | Sequence: | 125951107 | Sequence: | 125951108 | Sequence: | 125951109 | Sequence: | 125951110 | Sequence: | 125951111 | Sequence: | 125951112 | Sequence: | 125951113 | Sequence: | 125951114 | Sequence: | 125951115 | Sequence: | 125951116 | Sequence: | 125951117 | Sequence: | 125951118 |
Result Group Id | 56195084 | Result Group Id | 56195084 | Result Group Id | 56195084 | Result Group Id | 56195084 | Result Group Id | 56195084 | Result Group Id | 56195084 | Result Group Id | 56195084 | Result Group Id | 56195084 | Result Group Id | 56195084 | Result Group Id | 56195084 | Result Group Id | 56195084 | Result Group Id | 56195084 | Result Group Id | 56195084 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 |
Category | Female | Category | Male | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Unknown or Not Reported | Category | American Indian or Alaska Native | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | White | Category | More than one race | Category | Unknown or Not Reported | ||
Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) |
Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 10.2 | Param Value | 0 | Param Value | 6 | Param Value | 0 | Param Value | 6 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 6 | Param Value | 0 | Param Value | 0 |
Param Value Num | 10.2 | Param Value Num | 0.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 0.0 |
Dispersion Type | Standard Deviation | ||||||||||||||||||||||||
Dispersion Value | 2.04 | ||||||||||||||||||||||||
Dispersion Value Num | 2.04 | ||||||||||||||||||||||||
Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 |
]]>
https://zephyrnet.com/NCT03796624
2019-02-12
https://zephyrnet.com/?p=NCT03796624
NCT03796624https://www.clinicaltrials.gov/study/NCT03796624?tab=tableNANANAProspective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3. and PODEYE intraocular lenses.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-07-09 |
Start Month Year | February 12, 2019 |
Primary Completion Month Year | June 17, 2021 |
Verification Month Year | July 2021 |
Verification Date | 2021-07-31 |
Last Update Posted Date | 2021-07-09 |
Detailed Descriptions
Sequence: | 20709966 |
Description | This clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have implantation of monofocal intraocular lens Micropure 1.2.3. (PhysIOL, Liège, Belgium) in one eye and implantation of monofocal intraocular lens PODEYE (PhysIOL, Liège, Belgium) in the contralateral eye of the same patient.
The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with Micropure 1.2.3. and PODEYE The devices under investigation (Micropure 1.2.3. and PODEYE) are a monofocal glistening-free hydrophobic acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. The optical properties of the lenses are very comparable. The main difference is the mechanical design of the haptics, that is not expected to have an influence on the clinical outcomes. The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development. In total 76 patients will be recruited for this clinical study and receive the implantation of Micropure 1.2.3. and POPDEYE intraocular lenses. Subjects participating in the trial will attend study visits over a period of 12 months. |
Facilities
Sequence: | 199964473 |
Name | GEMINI Eye Clinic |
City | Zlin |
Zip | 76001 |
Country | Czechia |
Conditions
Sequence: | 52138947 | Sequence: | 52138948 |
Name | Cataract | Name | Lens Opacities |
Downcase Name | cataract | Downcase Name | lens opacities |
Id Information
Sequence: | 40135016 |
Id Source | org_study_id |
Id Value | PHY1803 |
Countries
Sequence: | 42542637 |
Name | Czechia |
Removed | False |
Design Groups
Sequence: | 55559283 | Sequence: | 55559284 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Investigational Device Micropure 1.2.3. | Title | Comparator PODEYE |
Description | Implantation of monofocal intraocular lens (IOL) "Micropure 1.2.3." in one of the eyes of the study subject | Description | Implantation of monofocal intraocular lens (IOL) "PODEYE" in the contralateral eye of the study subject |
Interventions
Sequence: | 52454847 | Sequence: | 52454848 |
Intervention Type | Device | Intervention Type | Device |
Name | Micropure 1.2.3. | Name | PODEYE |
Description | Implantation of intraocular lens (IOL). Name: "MicroPure 1.2.3." It is a monofocal intraocular lens consisting of hydrophobic acrylic material. One IOL per patient will be implanted | Description | Implantation of intraocular lens (IOL). Name: "PODEYE" It is a monofocal intraocular lens consisting of hydrophobic acrylic material. The IOL will be implanted in the contralateral eye of the same patient already implanted with Micropure 1.2.3. |
Keywords
Sequence: | 79822735 | Sequence: | 79822736 | Sequence: | 79822737 |
Name | Intraocular lens | Name | Monofocal | Name | Hydrophobic |
Downcase Name | intraocular lens | Downcase Name | monofocal | Downcase Name | hydrophobic |
Design Outcomes
Sequence: | 177263363 | Sequence: | 177263364 | Sequence: | 177263365 | Sequence: | 177263366 | Sequence: | 177263367 | Sequence: | 177263368 | Sequence: | 177263369 | Sequence: | 177263370 | Sequence: | 177263371 | Sequence: | 177263372 | Sequence: | 177263373 | Sequence: | 177263374 | Sequence: | 177263377 | Sequence: | 177263375 | Sequence: | 177263376 | Sequence: | 177263378 | Sequence: | 177263379 | Sequence: | 177263380 | Sequence: | 177263381 | Sequence: | 177263382 | Sequence: | 177263383 | Sequence: | 177263384 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | monocular Corrected Distance Visual Acuity (CDVA) | Measure | Manifested refraction | Measure | Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions | Measure | Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions | Measure | Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions | Measure | Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions | Measure | Monocular Contrast Sensitivity under photopic light conditions | Measure | Monocular Contrast Sensitivity under mesopic light conditions | Measure | Slitlamp examination – Corneal status | Measure | Slitlamp examination – Fundus | Measure | Slitlamp examination – Signs of inflammation | Measure | Slitlamp examination – Pupillary block | Measure | Slitlamp examination – IOL decentration | Measure | Slitlamp examination – Retinal detachment | Measure | Slitlamp examination – Status of anterior and posterior capsule | Measure | Slitlamp examination IOL tilt | Measure | Slitlamp examination – IOL discoloration | Measure | Slitlamp examination – IOL opacity | Measure | Intraocular pressure (IOP) measurement | Measure | Questionnaire on IOL implantation | Measure | Keratometry | Measure | Biometry |
Time Frame | 6 months postoperative | Time Frame | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | Time Frame | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | Time Frame | preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | Time Frame | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | Time Frame | preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | Time Frame | 6 months postoperative | Time Frame | 6 months postoperative | Time Frame | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | Time Frame | preoperative, 12 months postoperative | Time Frame | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | Time Frame | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | Time Frame | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | Time Frame | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | Time Frame | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | Time Frame | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | Time Frame | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | Time Frame | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | Time Frame | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | Time Frame | peroperative | Time Frame | preoperative | Time Frame | preoperative |
Description | Statistically non-inferior visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions compared to eyes implanted with the comparator PODEYE at the 6 months follow up visit. | Description | The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to ISO 11979-7:2018. | Description | UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is performed under photopic light conditions | Description | UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is performed under mesopic light conditions | Description | CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is performed under photopic light conditions | Description | CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is performed under mesopic light conditions | Description | Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision) | Description | Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision) | Description | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Corneal status. |
Description | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Fundus. |
Description | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Signs of inflammation. |
Description | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Pupillary block. |
Description | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL decentration. |
Description | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Retinal detachment. |
Description | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Status of anterior and posterior capsule. |
Description | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL tilt. |
Description | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL discoloration. |
Description | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL opacity. |
Description | The IOP will be measured with non-contact tonometer as part of the routine follow up examinations | Description | A questionnaire will be handed out to the surgeon right after the surgery to document the ease of use and possible issues during IOL implantation. These data will be used to compare the outcomes to different surgery techniques or injectors. The questionnaire is not validated and the outcomes serve only for the sponsor to receive feedback if one or the other IOL is easier to implant. | Description | Keratometric measurements are performed to calculate the required IOL power | Description | Biometry measurements are performed to calculate the required IOL power |
Browse Conditions
Sequence: | 193366322 | Sequence: | 193366323 | Sequence: | 193366324 |
Mesh Term | Cataract | Mesh Term | Lens Diseases | Mesh Term | Eye Diseases |
Downcase Mesh Term | cataract | Downcase Mesh Term | lens diseases | Downcase Mesh Term | eye diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290663 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Beaver-Visitec International, Inc. |
Overall Officials
Sequence: | 29268504 |
Role | Principal Investigator |
Name | Pavel Stodůlka, MD, PhD |
Affiliation | Gemini Eye Clinic |
Design Group Interventions
Sequence: | 68107374 | Sequence: | 68107375 |
Design Group Id | 55559283 | Design Group Id | 55559284 |
Intervention Id | 52454847 | Intervention Id | 52454848 |
Eligibilities
Sequence: | 30747690 |
Gender | All |
Minimum Age | 45 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Cataractous eyes with no comorbidity Exclusion Criteria: Age of patient < 45 years; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121751 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 28 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 45 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 17 |
Number Of Other Outcomes To Measure | 4 |
Designs
Sequence: | 30493973 |
Allocation | Randomized |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28860253 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796611
2020-12-31
https://zephyrnet.com/?p=NCT03796611
NCT03796611https://www.clinicaltrials.gov/study/NCT03796611?tab=tableHélène ZEPHIR, MD, PhDhelene.zephir@chru-lille.fr3 20 44 68 46Recent works highlight the B cells involvement in multiple sclerosis (MS) pathology but their role remains poorly understood. It was previously described that activated memory B cells called 4BL due to the increased expression of 4-1BBL, an activation marker, induce pro-inflammatory response by activating T CD8+ lymphocytes. Those 4BL cells are also described in systemic inflammation in 80 years old people explaining the poor efficiency of vaccination in that sub population. Those 4BL cells can also induce anti-tumoral T cell response.
The hypothesize is that 4BL may induce a pathogenic inflammatory response in MS.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-09-16 |
Start Month Year | December 2020 |
Primary Completion Month Year | October 2022 |
Verification Month Year | September 2020 |
Verification Date | 2020-09-30 |
Last Update Posted Date | 2020-09-16 |
Detailed Descriptions
Sequence: | 20762972 |
Description | the aim to compare the proportion of peripheral (blood) 4 BL cells but also 4-BL cells in cerebro spinal fluid (CSF) in MS compared to healthy controls and to other inflammatory neurological disease but also non inflammatory neurological disease.
For all groups of patients and controls it will collect blood and CSF only once (at diagnosis time for patients). Blood collect from healthy controls will come from transfusion volunteers and we won't have CSF from them. For patients from the MS group, the blood collect will be sequential at diagnosis, 3, 6, 12 and 24 months after during the follow up. In the blood and CSF we will evaluate: percentage of 4 BL cells. 4 BL cells are found using cytometric parameters |
Conditions
Sequence: | 52277551 |
Name | Multiple Sclerosis |
Downcase Name | multiple sclerosis |
Id Information
Sequence: | 40235528 | Sequence: | 40235529 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 2016_04 | Id Value | 2017-A00835-48 |
Id Type | Other Identifier | ||
Id Type Description | ID-RCB number, ANSM | ||
Design Groups
Sequence: | 55711690 | Sequence: | 55711691 | Sequence: | 55711692 | Sequence: | 55711693 |
Title | multiple sclerosis patient | Title | other neurological inflammatory disease | Title | neurological non inflammatory disease | Title | healthy controls |
Description | MS is defined according to McDonald criteria 2017. MS patients included have a disease duration of less than 1 year | Description | autoimmune encephalitis, myasthenia gravis, chronic inflammatory demyelinating polyradiculitis | Description | benign intracranial hypertension, degenerative disorder | Description | transfusion volunteers from transfusion center |
Keywords
Sequence: | 80019112 | Sequence: | 80019113 |
Name | immunology | Name | B cells |
Downcase Name | immunology | Downcase Name | b cells |
Design Outcomes
Sequence: | 177770952 | Sequence: | 177770953 | Sequence: | 177770954 | Sequence: | 177770955 | Sequence: | 177770956 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other |
Measure | the percentage of 4 BL cells in blood between MS patients and healthy controls | Measure | the percentage of 4 BL cells in blood between MS patients and patients with inflammatory and non inflammatory neurological disease | Measure | the percentage of 4 BL cells in CSF between MS patients and patients with inflammatory and non inflammatory neurological disease | Measure | to analyse over time the evolution of 4BL percentages in blood in MS patients | Measure | biological bank with mononuclear cells from all the groups fo that study |
Time Frame | Baseline: one session | Time Frame | Baseline: one session | Time Frame | Baseline: one session | Time Frame | 5 blood collection at baseline, 3, 6, 12, and 24 months after baseline | Time Frame | through study completion, an average of 2 years |
Description | 4 BL are defined using cytometric parameters | Description | 4 BL are defined using cytometric parameters | Description | 4 BL are defined using cytometric parameters | Description | 4 BL are defined using cytometric parameters | Description | to constitute at Baseline a biological bank with mononuclear cells from all the groups fo that study |
Browse Conditions
Sequence: | 193893202 | Sequence: | 193893203 | Sequence: | 193893204 | Sequence: | 193893205 | Sequence: | 193893206 | Sequence: | 193893207 | Sequence: | 193893208 | Sequence: | 193893209 | Sequence: | 193893210 |
Mesh Term | Multiple Sclerosis | Mesh Term | Sclerosis | Mesh Term | Pathologic Processes | Mesh Term | Demyelinating Autoimmune Diseases, CNS | Mesh Term | Autoimmune Diseases of the Nervous System | Mesh Term | Nervous System Diseases | Mesh Term | Demyelinating Diseases | Mesh Term | Autoimmune Diseases | Mesh Term | Immune System Diseases |
Downcase Mesh Term | multiple sclerosis | Downcase Mesh Term | sclerosis | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | demyelinating autoimmune diseases, cns | Downcase Mesh Term | autoimmune diseases of the nervous system | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | demyelinating diseases | Downcase Mesh Term | autoimmune diseases | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48418732 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University Hospital, Lille |
Overall Officials
Sequence: | 29342669 |
Role | Principal Investigator |
Name | Hélène ZEPHIR, MD, PhD |
Affiliation | University Hospital, Lille |
Central Contacts
Sequence: | 12034511 |
Contact Type | primary |
Name | Hélène ZEPHIR, MD, PhD |
Phone | 3 20 44 68 46 |
helene.zephir@chru-lille.fr | |
Phone Extension | +33 |
Role | Contact |
Eligibilities
Sequence: | 30827088 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | MS patients and controls: healthy controls and patients having non-MS neurological inflammatory disease and patients having other non inflammatory neurological disease. |
Criteria | Inclusion Criteria for MS group:
MS defined by McDonald 2017 criteria with a disease duration of less than 1 year Inclusion Criteria for controls with inflammatory of non inflammatory neurological disease: patients who signed consent to the study Inclusion criteria for healthy controls: control who signed consent at transfusion center for their blood collect to be used for study Exclusion Criteria: pregnancy or breast-feeding |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254123869 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30573018 |
Observational Model | Case-Control |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28939440 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796598
2019-07-29
https://zephyrnet.com/?p=NCT03796598
NCT03796598https://www.clinicaltrials.gov/study/NCT03796598?tab=tableEdith A Gavis, RNedith.gavis@va.gov(804) 675-5584Patients with end stage of liver disease or cirrhosis can develop confusion due to high ammonia and inflammation. This confusion is brought upon by changes in the bacteria in the bowels and may not respond to current standard of care treatments. Repeated episodes of confusion can make it difficult for patients to function and may result in multiple admissions to the hospital and burden on the family. The investigators have studied using a healthy person’s stool to replace the bowel bacteria, called fecal microbial transplant, in small studies with good results. In this trial the investigators propose to perform these procedures using an upper and lower route in Veterans who suffer from this condition and follow them for safety and hospitalizations over 6 months. The investigators will compare this to placebo treatments and hope that this intervention can improve the health and daily functioning of affected patients.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-02-27 |
Start Month Year | July 29, 2019 |
Primary Completion Month Year | June 24, 2024 |
Verification Month Year | February 2023 |
Verification Date | 2023-02-28 |
Last Update Posted Date | 2023-02-27 |
Detailed Descriptions
Sequence: | 20698245 |
Description | Indication: Cirrhosis and hepatic encephalopathy
Study Objectives: To evaluate the safety and tolerability of fecal transplant in patients with cirrhosis and hepatic encephalopathy Rationale and Supporting Evidence: Hepatic encephalopathy affects 30-45% of patients with cirrhosis and adversely affects survival in these patients. The mainstay of treatment for hepatic encephalopathy (HE) has long been the manipulation of the gut flora through antibiotics, prebiotics or probiotics. The current first and second line therapies for HE in the US are lactulose and rifaximin respectively that uniquely act within the confines of the gut lumen with encouraging clinical results. However, there is a subset of patients with HE that continues to recur despite being on both treatments. This patient group is at a higher risk of poor outcomes because HE has now been removed from liver transplant priority and multiple episodes of HE can result in cumulative brain injury which may be irreversible. Therefore, the prevention of recurrent HE is an important therapeutic goal. The investigators' group and other reports have shown that patients with HE and cirrhosis are more likely to have overgrowth of potentially pathogenic bacterial taxa such as Enterobacteriaceae and reduction of autochthonous species such as Lachnospiraceae and Ruminococcaceae in the stool and the colonic mucosa. This has been linked to poor performance on cognitive tests that are a hallmark of HE and with increased systemic inflammation in these patients. Therefore, a gut-based therapeutic option that can potentially improve the recurrence rate and the overall prognosis is needed. Fecal transplant has been shown to be effective in conditions with predominant gut-bacterial overgrowth or alteration such as recurrent Clostridium difficile and inflammatory bowel disease. Safe protocols have been developed across the world and studies are being performed in the US under FDA-monitored INDs. Limitations to performing fecal transplant include identifying and screening appropriate donors, which is time consuming and costly, with the cost typically falling to the patient or donor as the required screening is generally not covered by insurance. The investigators' preliminary data suggest that a one-time administration of an FMT-enema using a rationally-selected donor is safe in patients with cirrhosis and recurrent HE. However, given the small bowel overgrowth and the predominantly small bowel location for bacterial translocation in cirrhosis, which is out of the reach of an enema, an upper GI route for FMT needs to be explored. In the investigators' published experience, a single enema from a rationally-derived donor was associated with significantly lower total and HE-related hospitalizations compared to patients who were randomized to standard of care, with a stable long-term course over >1 year. The investigators' data show that FMT was associated with favorable changes in fecal bile acid (BA) profile with a decrease in proportions of fecal secondary BAs, conjugated BAs and increase in sulfated BAs, indicating a healthier milieu. The investigators also have preliminary data defining the safety of oral FMT capsules in patients with cirrhosis and HE in a current trial led by us. The use of combined oral and rectal routes of FMT, which can potentially alleviate both small bowel and colonic translocation are likely to be better than either alone. Overall aim: To determine the effect of dual oral and rectal administration of FMT from a rational donor on clinical outcomes (hospitalizations, brain function, quality of life) and host-microbiota interactions (microbial composition and bile acid composition with systemic and intestinal inflammation), compared to single route of administration and placebo, along with a second oral capsular FMT vs placebo administration in cirrhotic patients with HE using a randomized, phase II clinical trial. Design overview: Four groups of outpatients with cirrhosis will be randomized using random sequence generator into placebo and FMT groups and followed for 6 months under an FDA IND double-blind clinical trial. |
Facilities
Sequence: | 199800418 |
Status | Recruiting |
Name | Hunter Holmes McGuire VA Medical Center, Richmond, VA |
City | Richmond |
State | Virginia |
Zip | 23249 |
Country | United States |
Facility Contacts
Sequence: | 28076463 | Sequence: | 28076464 |
Facility Id | 199800418 | Facility Id | 199800418 |
Contact Type | primary | Contact Type | backup |
Name | Edith A Gavis, RN | Name | Jasmohan S Bajaj, MD MS |
edith.gavis@va.gov | Jasmohan.Bajaj@va.gov | ||
Phone | 804-675-5584 | Phone | (804) 675-5802 |
Facility Investigators
Sequence: | 18312189 |
Facility Id | 199800418 |
Role | Principal Investigator |
Name | Jasmohan S. Bajaj, MD MS |
Conditions
Sequence: | 52107620 | Sequence: | 52107621 |
Name | Cirrhosis | Name | Hepatic Encephalopathy |
Downcase Name | cirrhosis | Downcase Name | hepatic encephalopathy |
Id Information
Sequence: | 40109200 | Sequence: | 40109201 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | GAST-001-18S | Id Value | CX001076 |
Id Type | Other Grant/Funding Number | ||
Id Type Description | Office of Research and Development, VA | ||
Countries
Sequence: | 42511976 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55524286 | Sequence: | 55524287 | Sequence: | 55524288 | Sequence: | 55524289 |
Group Type | Placebo Comparator | Group Type | Active Comparator | Group Type | Active Comparator | Group Type | Experimental |
Title | Placebo | Title | Group 3: Oral placebo and rectal FMT | Title | Group 2: Oral FMT and rectal placebo | Title | Group 1: Dual Oral and rectal FMT |
Description | Oral and rectal placebo at visit 2 Oral placebo at day 30 | Description | Oral placebo and rectal FMT at visit 2 Oral placebo at day 30 | Description | Oral FMT and rectal placebo at visit 2 Oral FMT at day 30 | Description | Dual Oral and rectal FMT at visit 2 Oral FMT at day 30 |
Interventions
Sequence: | 52421910 | Sequence: | 52421911 | Sequence: | 52421912 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Other |
Name | Fecal Microbial transplant Capsules | Name | Fecal Microbial Transplant Enema | Name | Placebo |
Description | Oral capsules of FMT | Description | FMT enema | Description | Placebo |
Keywords
Sequence: | 79768005 | Sequence: | 79768006 | Sequence: | 79768007 |
Name | fecal microbial transplant | Name | cirrhosis | Name | hepatic encephalopathy |
Downcase Name | fecal microbial transplant | Downcase Name | cirrhosis | Downcase Name | hepatic encephalopathy |
Design Outcomes
Sequence: | 177157102 | Sequence: | 177157103 | Sequence: | 177157104 | Sequence: | 177157105 | Sequence: | 177157106 | Sequence: | 177157107 | Sequence: | 177157108 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Serious adverse events related to FMT | Measure | Adverse events related to FMT | Measure | Change in microbial diversity in stool | Measure | Sickness Impact Profile change | Measure | EncephalApp performance change | Measure | Psychometric hepatic encephalopathy score (PHES) change | Measure | Change in microbial diversity in saliva |
Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 30 days and 6 months | Time Frame | 30 days, 60 days and 6 months | Time Frame | 30 days, 60 days and 6 months | Time Frame | 6 months |
Description | Number of serious adverse events between groups related to FMT | Description | Number of adverse events that do not fit the criteria of serious adverse events between groups related to FMT | Description | Shannon diversity index compared to baseline and engraftment related to the donor at baseline, within 30 days and then monthly till 6 months. Ranges usually from 0-10 | Description | Quality of life assessment change defined by Sickness Impact Profile total score at 30 days and 6 months between groups. This is a percentage result ranges usually from 0-100 | Description | Cognitive assessment change using the OffTime+OnTime in seconds between groups at 30 days, 60 days and 6 months | Description | Cognitive assessment change using the total PHES score between groups at 30 days, 60 days and 6 months. This ranges from -15 to +5 | Description | Shannon diversity index compared to baseline at 30 days and then monthly till 6 months. Ranges usually from 0-10 |
Browse Conditions
Sequence: | 193238222 | Sequence: | 193238223 | Sequence: | 193238224 | Sequence: | 193238225 | Sequence: | 193238226 | Sequence: | 193238227 | Sequence: | 193238228 | Sequence: | 193238229 | Sequence: | 193238230 | Sequence: | 193238231 | Sequence: | 193238232 | Sequence: | 193238233 | Sequence: | 193238234 |
Mesh Term | Liver Cirrhosis | Mesh Term | Hepatic Encephalopathy | Mesh Term | Brain Diseases | Mesh Term | Fibrosis | Mesh Term | Pathologic Processes | Mesh Term | Liver Diseases | Mesh Term | Digestive System Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Liver Failure | Mesh Term | Hepatic Insufficiency | Mesh Term | Brain Diseases, Metabolic | Mesh Term | Metabolic Diseases |
Downcase Mesh Term | liver cirrhosis | Downcase Mesh Term | hepatic encephalopathy | Downcase Mesh Term | brain diseases | Downcase Mesh Term | fibrosis | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | liver diseases | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | liver failure | Downcase Mesh Term | hepatic insufficiency | Downcase Mesh Term | brain diseases, metabolic | Downcase Mesh Term | metabolic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48261299 |
Agency Class | FED |
Lead Or Collaborator | lead |
Name | VA Office of Research and Development |
Overall Officials
Sequence: | 29249227 |
Role | Principal Investigator |
Name | Jasmohan S. Bajaj, MD MS |
Affiliation | Hunter Holmes McGuire VA Medical Center, Richmond, VA |
Central Contacts
Sequence: | 11994963 | Sequence: | 11994964 |
Contact Type | primary | Contact Type | backup |
Name | Jasmohan S Bajaj, MD MS | Name | Edith A Gavis, RN |
Phone | (804) 675-5802 | Phone | (804) 675-5584 |
Jasmohan.Bajaj@va.gov | edith.gavis@va.gov | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68064678 | Sequence: | 68064679 | Sequence: | 68064680 | Sequence: | 68064681 | Sequence: | 68064682 | Sequence: | 68064683 |
Design Group Id | 55524289 | Design Group Id | 55524288 | Design Group Id | 55524289 | Design Group Id | 55524287 | Design Group Id | 55524287 | Design Group Id | 55524286 |
Intervention Id | 52421910 | Intervention Id | 52421910 | Intervention Id | 52421911 | Intervention Id | 52421911 | Intervention Id | 52421912 | Intervention Id | 52421912 |
Eligibilities
Sequence: | 30729206 |
Gender | All |
Minimum Age | 21 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Cirrhosis diagnosed by either of the following in a patient with chronic liver disease Liver Biopsy Exclusion Criteria: MELD score >22 Patients who are immuno-compromised due to the following reasons: HIV infection (any CD4 count) Current or recent (<3 mos) treatment with any immunosuppressant medications [including but not limited to monoclonal antibodies to B and T cells, anti-TNF agents, glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine), calcineurin inhibitors (tacrolimus, cyclosporine), mycophenolate mofetil]. Subjects who are otherwise immunocompetent and have discontinued any immunosuppressant medications 3 or more months prior to enrollment may be eligible to enroll Patients with a history of chronic intrinsic GI diseases such as inflammatory bowel disease ulcerative colitis, Crohn's disease or microscopic colitis eosinophilic gastroenteritis or celiac disease Other Exclusion Criteria: Enema-related Platelet count<25,000 Safety-related: Dysphagia |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253985567 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 21 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30475615 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Quadruple |
Intervention Model Description | Subjects will be divided into 4 groups via randomization
Group 1: Dual oral and rectal FMT, Group 2: Oral FMT and rectal placebo, Group 3: Oral placebo and rectal FMT and Group 4: Oral and rectal placebo |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28842026 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796585
2019-01-10
https://zephyrnet.com/?p=NCT03796585
NCT03796585https://www.clinicaltrials.gov/study/NCT03796585?tab=tableNANANAThe purpose of this study is to identify barriers to utilization of immunization registries within a pharmacy context and tailor the information into a novel immunization registry training program.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-10-30 |
Start Month Year | January 10, 2019 |
Primary Completion Month Year | September 15, 2019 |
Verification Month Year | October 2019 |
Verification Date | 2019-10-31 |
Last Update Posted Date | 2019-10-30 |
Detailed Descriptions
Sequence: | 20735705 |
Description | The purpose of this study is to identify barriers to utilization of immunization registries within a pharmacy context and tailor the information learned about barriers into a novel immunization registry training program with strategies specific to individual subsets of pharmacies, independent pharmacies in rural areas. Doing so will help achieve the long-term goal which is to increase the use of immunization registries in community pharmacies in Alabama.
The specific aims are to identify barriers and best practices of immunization registry implementation, The impact of the training program on registry participation rates will be assessed using a randomized controlled trial design comparing Alabama community pharmacies' registry data as well as intention to participate. |
Facilities
Sequence: | 200243938 |
Name | Auburn University |
City | Auburn |
State | Alabama |
Zip | 36849 |
Country | United States |
Conditions
Sequence: | 52207888 |
Name | Immunization |
Downcase Name | immunization |
Id Information
Sequence: | 40186029 |
Id Source | org_study_id |
Id Value | 1R36HS026093-01A1 |
Id Type | U.S. AHRQ Grant/Contract |
Id Link | https://reporter.nih.gov/quickSearch/1R36HS026093-01A1 |
Countries
Sequence: | 42599533 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55634488 | Sequence: | 55634489 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Intervention | Title | Control |
Description | Pharmacists assigned to this group will receive an immunization registry training program and informational flyer. | Description | Pharmacists assigned to this group will receive an informational flyer. They will not receive training. |
Interventions
Sequence: | 52521905 | Sequence: | 52521904 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Informational flyer | Name | Immunization Registry Training |
Description | Informational flyer with ImmPRINT contact information | Description | Education highlighting practical strategies to improve pharmacies' willingness to adopt the immunization registry and improve their ability to integrate the immunization registry into their pharmacy workflow. |
Design Outcomes
Sequence: | 177510609 | Sequence: | 177510610 | Sequence: | 177510611 | Sequence: | 177510612 | Sequence: | 177510613 | Sequence: | 177510614 | Sequence: | 177510615 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Number of pharmacies enrolled in the Alabama Immunization Registry | Measure | Level of Immunization Registry Participation | Measure | Change in awareness | Measure | Change in knowledge | Measure | Change in attitudes | Measure | Change in intention to enroll in immunization registry | Measure | Change in Implementation Factors |
Time Frame | 3 months | Time Frame | 3 months | Time Frame | 1 month and 3 months | Time Frame | 1 month and 3 months | Time Frame | 1 month and 3 months | Time Frame | 1 month and 3 months | Time Frame | 3 months |
Description | The change in the number of participant pharmacies enrolled in the Alabama immunization registry from baseline to 3 months. | Description | Proportion of self-reported doses administered that are verified in the immunization registry. | Description | The change in participant awareness of immunization registries from baseline to 3 months assessed by online questionnaire at baseline, one month, and three months. Awareness will be measured using three true or false items. Each item will be scored, 0 for an incorrect answer and 1 for a correct answer. Awareness index is the sum of the 3 items and could range from 0-3 with higher values representing greater awareness. | Description | The extent to which participant is familiar with and understands immunization registries will be assessed via online questionnaire at baseline, one month, and three months. Eight true or false and multiple answer items will be used to measure knowledge. Each item will be scored, 0 for an incorrect answer and 1 for a correct answer. Knowledge is the sum of the 8 items and could range from 0-8 with higher values representing greater knowledge. | Description | Participant's perceptions toward attributes of the immunization registry assessed via online questionnaire at baseline, one month, and three months. A scale including 25 Likert-type items will be used to measure attitudes. Each Likert-type item will be scored, ranging from 0 for strongly disagree to 6 for strongly agree. Mean scores will be calculated for the 25 items in the scale so that attitudes score range from 0 to 6 with higher values indicating greater positive attitudes. | Description | Participant's likelihood to enroll their pharmacy in the immunization registry assessed via online questionnaire at baseline and one month. A scale including 3 Likert-type items will be used to measure intention. Each Likert-type item will be scored, ranging from 0 for strongly disagree to 6 for strongly agree. Mean scores will be calculated for the three items in the scale so that intention score ranges from 0 to 6 with higher values indicating greater intention. | Description | Implementation factors informed by the Consolidated Framework for Implementation Research (CFIR) including innovation characteristics, characteristics of individuals, inner setting, outer setting, and process will be assessed via online questionnaire at baseline and three months. A scale including 42 Likert-type items will be used to measure Implementation Factors. Each Likert-type item will be scored, ranging from 0 for strongly disagree to 6 for strongly agree. Mean scores will be calculated so that the implementation factors score ranges from 0 to 6 with higher values indicating greater positive influence of CFIR implementation factors. |
Sponsors
Sequence: | 48353536 | Sequence: | 48353537 |
Agency Class | OTHER | Agency Class | FED |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Auburn University | Name | Agency for Healthcare Research and Quality (AHRQ) |
Design Group Interventions
Sequence: | 68198973 | Sequence: | 68198974 | Sequence: | 68198975 |
Design Group Id | 55634488 | Design Group Id | 55634489 | Design Group Id | 55634488 |
Intervention Id | 52521904 | Intervention Id | 52521905 | Intervention Id | 52521905 |
Eligibilities
Sequence: | 30786771 |
Gender | All |
Minimum Age | 19 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
not currently enrolled in ImmPRINT Exclusion Criteria: – |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989429 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 8 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 19 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30532842 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Health Services Research |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28899135 |
Responsible Party Type | Principal Investigator |
Name | Tessa Hastings |
Title | Principal Investigator |
Affiliation | Auburn University |
Study References
Sequence: | 52102857 |
Pmid | 35292212 |
Reference Type | derived |
Citation | Hastings TJ, Ha D, Fox BI, Qian J, Lakin J, Westrick SC. Increasing use of immunization information systems for routine vaccinations in independent community pharmacies: A randomized controlled trial. J Am Pharm Assoc (2003). 2022 Jul-Aug;62(4):1270-1279.e2. doi: 10.1016/j.japh.2022.02.010. Epub 2022 Feb 19. |
]]>
https://zephyrnet.com/NCT03796572
2019-09-16
https://zephyrnet.com/?p=NCT03796572
NCT03796572https://www.clinicaltrials.gov/study/NCT03796572?tab=tableSierra M Pinal, BSspinal@mednet.ucla.edu2137421057The purpose of this study is to investigate the post-operative pain control in pediatric patients with closed lateral condyle fractures who undergo open reduction and percutaneous pinning. Patients will be randomized into one of two groups. Group 1 will receive an infraclavicular nerve block to the affected extremity by a fellowship trained pediatric anesthesiologist prior to surgery. Group 2 will undergo the Orthopaedic Institute of Children’s (OIC) standard preoperative protocol. Post-operative pain management will be the same for both groups per standard protocol. Pain level will be assessed post-operatively using the Wong-Baker FACES scale and parents will be asked to fill out a questionnaire regarding their satisfaction with the surgery and pain control. Parents will also fill out a medication log until the patient no longer requires pain medication. All patients in both groups will receive standard oxycodone solution prescriptions post-operatively as per typical protocol. The duration of participation in the study is approximately 1 week and requires 2 visits (time of recruitment at surgery and 1st post-op visit). This study is being conducted in hopes of developing comprehensive pain management protocols to reduce opioid consumption after surgical fixations of displaced lateral condyle fractures if the study can show that patients are more satisfied and require less opioid medication when receiving preoperative regional anesthesia.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-04-27 |
Start Month Year | September 16, 2019 |
Primary Completion Month Year | January 7, 2024 |
Verification Month Year | April 2021 |
Verification Date | 2021-04-30 |
Last Update Posted Date | 2021-04-27 |
Detailed Descriptions
Sequence: | 20721560 |
Description | This is a double-blinded, randomized controlled trial evaluating the analgesic efficacy of infraclavicular regional blocks for postoperative pain control in patients following open reduction and percutaneous pinning for isolated closed lateral condyle fractures. Each patient will be evaluated initially at OIC's pediatric urgent care center and placed in a long arm splint with instructions to elevate the affected arm. Patients will not be discharged with any prescriptions for narcotic pain medication and will be instructed to take weight-based doses of acetaminophen and/or ibuprofen for pain control as needed.
All patients age 4-12 with isolated closed Weiss classification type II and III (>2mm displacement) lateral condyle fractures requiring fixation (e.g. satisfactory reduction not achieved with closed reduction and casting) will be approached for participation in the study. Demographic data (age, gender, weight, height, ethnicity, primary language spoken at home, insurance type) will be obtained through chart review on each included patient. The exclusion criteria include open fractures, fractures with concomitant vascular or neurologic deficit, pathologic fractures, those presenting with concomitant injuries, swelling requiring post-operative hospitalization for monitoring, any known history of allergies to ropivacaine or oxycodone, and patients with developmental delay that would preclude participation in the visual analog Faces Pain Scale-Revised. Informed consent will be obtained from all parents who wish to participate in the study, and assent will be obtained from patients when possible. If parents refuse participation in the study, the reason for refusal will be documented, and their child's care and post-operative protocol will be consistent with typical protocol at OIC. All surgeries will be performed at the outpatient surgery center at OIC. Prior to surgery each patient will be randomized into one of two treatment groups. The group selected to undergo regional anesthesia will receive a single-stick ultrasound-guided infraclavicular nerve block to the affected extremity by a fellowship-trained pediatric anesthesiologist in the operating room using standard sterile technique. For each block ropivacaine 0.5% will be administered up to a max of 0.5 mL/kg until appropriate US-guided spread is achieved. Block duration and volume of ropivacaine used will be recorded, as will any immediate complications encountered (e.g. failed block). Participants randomized to the no regional anesthesia group will not receive any additional anesthetic prior to surgery and will undergo OIC's standard preoperative protocol. All patients in both groups will receive general anesthesia per standard protocol. All patients will undergo open reduction and percutaneous pinning using 2-3 pins placed laterally by two pediatric orthopedic surgeons (Dr. Mauricio Silva and Dr. Rachel Thompson). Participants will all be placed in posterior long arm splints thereafter and made non-weight bearing in that extremity. The patients will be transferred to OIC's post-anesthesia care unit (PACU), where morphine IV 0.1mg/kg will be utilized as needed before discharge home. Nursing staff will record the amount of pain medication provided in the PACU, as well as the pre-discharge pain scores, as is typical post-operative protocol. Prior to discharge a prescription for oxycodone solution 0.1 mg/kg PO q4-6 hours as needed will be given to all participants in both groups with instructions on medication administration and how to fill out the home medication log as per typical OIC post-operative protocol. Post-operatively, the parents of each participant will be asked to use the Faces Pain Scale-Revised (FPS-R) to rate the child's level of pain at 24 hours and 48 hours after surgery. A research team member will call each participant's guardian at 24 and 48 hours post-operatively to collect these responses. Parents will further be asked to complete the modified Total Quality Pain Management Instrument (TQPM) regarding their level of satisfaction with surgery and post-operative pain control. Parents will be asked to report any side effects (e.g. nausea, vomiting, lethargy, constipation) associated with the medications. Parents will also be asked about any side effects (e.g. swelling, redness, hematoma, prolonged block) from the regional anesthesia. A take-home medication log will be utilized by the parents to record the type and amount of mediation given to each participant and to record any associated side effects. |
Facilities
Sequence: | 200107763 |
Status | Recruiting |
Name | Orthopaedic Institute for Children |
City | Los Angeles |
State | California |
Zip | 90007 |
Country | United States |
Facility Contacts
Sequence: | 28106370 | Sequence: | 28106371 |
Facility Id | 200107763 | Facility Id | 200107763 |
Contact Type | primary | Contact Type | backup |
Name | Mauricio Silva, MD | Name | Samantha C Bauer, MS |
msilva@mednet.ucla.edu | SBauer@mednet.ucla.edu | ||
Phone | 213-742-1369 | Phone | 2137426537 |
Phone Extension | 6537 |
Facility Investigators
Sequence: | 18332474 |
Facility Id | 200107763 |
Role | Principal Investigator |
Name | Mauricio Silva, MD |
Browse Interventions
Sequence: | 96049968 | Sequence: | 96049969 | Sequence: | 96049970 | Sequence: | 96049971 | Sequence: | 96049972 | Sequence: | 96049973 | Sequence: | 96049974 |
Mesh Term | Ropivacaine | Mesh Term | Anesthetics, Local | Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents |
Downcase Mesh Term | ropivacaine | Downcase Mesh Term | anesthetics, local | Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52171053 | Sequence: | 52171054 | Sequence: | 52171055 |
Name | Fractures, Closed | Name | Humeral Fractures | Name | Pain |
Downcase Name | fractures, closed | Downcase Name | humeral fractures | Downcase Name | pain |
Id Information
Sequence: | 40158503 |
Id Source | org_study_id |
Id Value | 18-001552 |
Countries
Sequence: | 42568815 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55592988 | Sequence: | 55592989 |
Group Type | Experimental | Group Type | Sham Comparator |
Title | Infraclavicular Regional Block | Title | Puncture Wound |
Description | This group is given ropivacaine 0.5% up to a max of .5 ml/kg until appropriate ultrasound guided spread is achieved. | Description | This group is given the same puncture wound and dressing given to the experimental group. |
Interventions
Sequence: | 52485302 | Sequence: | 52485303 |
Intervention Type | Drug | Intervention Type | Other |
Name | Ropivacaine | Name | Puncture Wound and Dressing |
Description | Regional anesthesia protocol of open reduction percutaneous pinning of lateral condyle humerus fracture Ropivacaine | Description | No regional anesthesia is given for open reduction percutaneous pinning of lateral condyle humerus fracture |
Keywords
Sequence: | 79868224 | Sequence: | 79868225 | Sequence: | 79868226 |
Name | lateral condyle | Name | infraclavicular | Name | regional block |
Downcase Name | lateral condyle | Downcase Name | infraclavicular | Downcase Name | regional block |
Design Outcomes
Sequence: | 177378105 | Sequence: | 177378106 | Sequence: | 177378107 | Sequence: | 177378108 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other |
Measure | Change in Wong-Baker FACES Pain Scale-Revised (FPSR) | Measure | Total Quality Pain Management (TQPM) Instrument: 30 question questionnaire | Measure | Pain Medication Logs (Amount Taken) | Measure | Pain Medication Logs (Side Effects) |
Time Frame | 24 hours, 48 hours, and 1 week post-operatively | Time Frame | 1 week at first post-operative follow-up | Time Frame | Immediately after surgery. Until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days. | Time Frame | Immediately after surgery. Until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days. |
Description | Self reported measure of pain on scale ranging from 0 to 10. 0 (best) equals no pain and 10 (worst) equals worse pain imaginable. | Description | 30 question questionnaire used to measure the quality of children's post-operative pain management in which parents and patients are asked multiple questions. Questions are partitioned into the following categories: "What were you told about the hurt or pain?", "How did the pain medicine make you feel?", "How long did the hurt or pain last?", "How much hurt or pain did you feel?", "How happy were you with the pain?", and "Tell us how we could get an A+ for taking the hurt or pain away." Specific questions were aimed at gaining information on the following topics: post-operative pain management including domains in pain experience, pain relief, adverse affects, and future analgesic uses. The majority of the questions are binary (yes or no) and there are a few questions that include mild (best), moderate, and severe (worst) option. There is no numerical output or subscales; every question is evaluated independently and not combined for summary scores. | Description | Self report take home medications logs recording time, type, and dosage of medication to record total amount of medication (mg) taken by patient. | Description | Self report take home medications logs recording associated side effects of medication taken. |
Browse Conditions
Sequence: | 193485973 | Sequence: | 193485974 | Sequence: | 193485975 | Sequence: | 193485976 | Sequence: | 193485977 |
Mesh Term | Fractures, Bone | Mesh Term | Humeral Fractures | Mesh Term | Fractures, Closed | Mesh Term | Wounds and Injuries | Mesh Term | Arm Injuries |
Downcase Mesh Term | fractures, bone | Downcase Mesh Term | humeral fractures | Downcase Mesh Term | fractures, closed | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | arm injuries |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319111 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of California, Los Angeles |
Central Contacts
Sequence: | 12008832 | Sequence: | 12008833 |
Contact Type | primary | Contact Type | backup |
Name | Samantha C Bauer, MS | Name | Sierra M Pinal, BS |
Phone | 2137426537 | Phone | 2137421057 |
SBauer@mednet.ucla.edu | spinal@mednet.ucla.edu | ||
Phone Extension | 6537 | Phone Extension | 1057 |
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68148922 | Sequence: | 68148923 |
Design Group Id | 55592988 | Design Group Id | 55592989 |
Intervention Id | 52485302 | Intervention Id | 52485303 |
Eligibilities
Sequence: | 30765244 |
Gender | All |
Minimum Age | 4 Years |
Maximum Age | 12 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Isolated lateral condyle humerus fracture Exclusion Criteria: Open fractures |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253875075 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 4 |
Maximum Age Num | 12 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 2 |
Designs
Sequence: | 30511411 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Masking Description | Randomized envelopes used to allocate treatment groups. |
Intervention Model Description | Double-blinded randomized control trial |
Subject Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28877705 |
Responsible Party Type | Principal Investigator |
Name | Mauricio Silva |
Title | Mauricio Silva, M.D., Associate Clinical Professor, UCLA/Orthopaedic Institute for Children Department of Orthopaedic Surgery, Principal Investigator |
Affiliation | University of California, Los Angeles |
]]>
https://zephyrnet.com/NCT03796559
2019-06-13
https://zephyrnet.com/?p=NCT03796559
NCT03796559https://www.clinicaltrials.gov/study/NCT03796559?tab=tableMatt Womack, PhDmwomack@endomag.com+447851247439The purpose of this study is to provide prospective evidence that the use of Magseed/Sentimag in marking axillary lymph nodes and guiding surgical localization in patients with breast cancer following neo-adjuvant chemotherapy (NAC) is effective.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-08 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-02-16 |
Start Month Year | June 13, 2019 |
Primary Completion Month Year | December 2023 |
Verification Month Year | February 2023 |
Verification Date | 2023-02-28 |
Last Update Posted Date | 2023-02-16 |
Detailed Descriptions
Sequence: | 20556335 |
Description | This is a post-market, prospective, open-label, single arm study of Magseed and Sentimag in patients with breast cancer with biopsy-proven axillary node metastases who had a clip placed to mark the metastatic node and are having that clipped node selectively removed at surgery following neo-adjuvant chemotherapy (NAC). Subjects will have the Magseed placed to mark axillary lymph nodes with biopsy-proven metastasis under ultrasound guidance before initiating NAC. After completion of NAC, the Magseed will be localized using the Sentimag system during surgery and removed with the targeted lymph node. |
Facilities
Sequence: | 198466531 | Sequence: | 198466532 |
Status | Recruiting | Status | Recruiting |
Name | Baylor Medicine | Name | MD Anderson Cancer Center |
City | Houston | City | Houston |
State | Texas | State | Texas |
Zip | 77030 | Zip | 77030 |
Country | United States | Country | United States |
Facility Contacts
Sequence: | 27924867 | Sequence: | 27924868 |
Facility Id | 198466531 | Facility Id | 198466532 |
Contact Type | primary | Contact Type | primary |
Name | Ivan Marin | Name | Veronika Noregil |
ivan.marin@bcm.edu | VYNovegil@mdanderson.org | ||
Facility Investigators
Sequence: | 18218864 |
Facility Id | 198466532 |
Role | Sub-Investigator |
Name | Kelly Hunt, MD, F.A.C.S. |
Conditions
Sequence: | 51746384 | Sequence: | 51746385 |
Name | Breast Cancer | Name | Axillary Lymph Nodes |
Downcase Name | breast cancer | Downcase Name | axillary lymph nodes |
Id Information
Sequence: | 39819961 |
Id Source | org_study_id |
Id Value | US-003 |
Countries
Sequence: | 42219089 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55167194 |
Group Type | Experimental |
Title | Magseed marker |
Description | Magseed marker deployed percutaneously, prior to patient undergoing neo-adjuvant chemotherapy (NAC), under ultrasound guidance to mark a lymph node intended for selective surgical removal post NAC. |
Interventions
Sequence: | 52067994 |
Intervention Type | Device |
Name | Magseed Marker |
Description | Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe. |
Keywords
Sequence: | 79173101 |
Name | Neo-adjuvant chemotherapy |
Downcase Name | neo-adjuvant chemotherapy |
Design Outcomes
Sequence: | 176003852 | Sequence: | 176003853 | Sequence: | 176003854 | Sequence: | 176003855 | Sequence: | 176003856 | Sequence: | 176003857 | Sequence: | 176003858 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Retrieval rate of clipped node and Magseed in the excised specimen | Measure | Rates of device and serious device-related events | Measure | Radiologic rated ease of Magseed placement | Measure | Radiologic placement accuracy | Measure | Radiologic seed position | Measure | Surgical nodes localized | Measure | Ease of surgical localization |
Time Frame | Time of surgery | Time Frame | Up to 42 days post-surgery | Time Frame | Time of Magseed marker placement | Time Frame | Between completion of NAC time of surgery | Time Frame | After completion of NAC | Time Frame | Time of surgery | Time Frame | Time of surgery |
Description | The retrieval rate of the clipped node and Magseed in the excised specimen. This is defined as the number of subjects in whom the clipped node and Magseed are retrieved in a single excised specimen divided by the total number of subjects. | Description | Rates of device-related adverse events and serious device-related adverse events | Description | 5 point Likert scale, very easy = 5, very difficult = 1 | Description | Success rate of seed placement (placement accuracy) | Description | Success rate of maintained seed position at the completion of NAC | Description | Number of nodes retrieved within the surgical specimen containing the Magseed | Description | 5 point Likert scalevery easy = 5, very difficult = 1 |
Browse Conditions
Sequence: | 191775728 | Sequence: | 191775729 | Sequence: | 191775730 | Sequence: | 191775731 | Sequence: | 191775732 |
Mesh Term | Breast Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Breast Diseases | Mesh Term | Skin Diseases |
Downcase Mesh Term | breast neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | breast diseases | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47924541 | Sequence: | 47924542 |
Agency Class | INDUSTRY | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Endomagnetics Inc | Name | M.D. Anderson Cancer Center |
Overall Officials
Sequence: | 29037399 |
Role | Principal Investigator |
Name | Abigail Caudle, MD, MS |
Affiliation | MD Anderson Cancer Center, Houston, TX |
Central Contacts
Sequence: | 11922967 |
Contact Type | primary |
Name | Matt Womack, PhD |
Phone | +447851247439 |
mwomack@endomag.com | |
Role | Contact |
Design Group Interventions
Sequence: | 67633091 |
Design Group Id | 55167194 |
Intervention Id | 52067994 |
Eligibilities
Sequence: | 30517389 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age 18 years or older at time of consent Exclusion Criteria: Distant metastases |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254069554 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30266416 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28646624 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796546
2019-01-22
https://zephyrnet.com/?p=NCT03796546
NCT03796546https://www.clinicaltrials.gov/study/NCT03796546?tab=tableNANANAProspective, multi-site, study to evaluate the diagnosis rate of DNA and RNA sequencing of cerebrospinal fluid for identification of pathogens directly in patients who have already had a spinal tap to evaluate for infection and were found to have a pleocytosis. Diagnostic rate and clinical utility of concurrent standard testing will be compared to diagnostic rate and clinical utility of DNA and RNA sequencing.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-19 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-11-10 |
Start Month Year | January 22, 2019 |
Primary Completion Month Year | October 7, 2020 |
Verification Month Year | November 2020 |
Verification Date | 2020-11-30 |
Last Update Posted Date | 2020-11-10 |
Detailed Descriptions
Sequence: | 20727562 |
Description | IDbyDNA, Inc. has developed a robust sequencing reference database for viruses, bacteria, fungi and parasites and developed novel analysis methods to analyze next-generation (NGS) sequencing data to rapidly identify infectious agents. This technology suite, known as the Explify™ platform, holds the promise to improve patient care and efficiently guide provider treatment planning for those suffering from infectious disease.
The PIPSEC trial, developed by pediatric physicians specializing in genomic medicine, is intended to facilitate the acquisition of high quality and clinically annotated biospecimens for the purpose of research discovery. This project intends to advance metagenomics, microbial genetics, bioinformatics and data analytics, for pathogen detection utilizing cerebral spinal fluid (CSF) specimens to contribute to the diagnosis of infectious agents impacting the central nervous system among pediatric patients. Clinically annotated specimens will facilitate continued development and validation of the Explify test and its clinical utility for providers treating central nervous system (CNS) infections. The primary objective is to assess clinical utility of the Explify test compared to concurrent standard of care testing to identify pathogens from CSF fluid within a pediatric patient population. |
Facilities
Sequence: | 200161382 | Sequence: | 200161383 | Sequence: | 200161384 |
Name | CHOC Children's Hospital Orange County | Name | Rady Children's Hospital | Name | Nicklaus Children's Hospital |
City | Orange | City | San Diego | City | Miami |
State | California | State | California | State | Florida |
Zip | 92868 | Zip | 92123 | Zip | 33155 |
Country | United States | Country | United States | Country | United States |
Conditions
Sequence: | 52186460 | Sequence: | 52186461 |
Name | Infection | Name | Meningitis |
Downcase Name | infection | Downcase Name | meningitis |
Id Information
Sequence: | 40169761 |
Id Source | org_study_id |
Id Value | PIPSEC – 01 |
Countries
Sequence: | 42581381 |
Name | United States |
Removed | False |
Keywords
Sequence: | 79890177 |
Name | Pediatric |
Downcase Name | pediatric |
Design Outcomes
Sequence: | 177435469 | Sequence: | 177435470 | Sequence: | 177435471 | Sequence: | 177435472 | Sequence: | 177435473 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Diagnostic Rate | Measure | Clinical Utilization | Measure | Post-Hoc Analysis – Economic Evaluation (1) | Measure | Post-Hoc Analysis – Economic Evaluation (2) | Measure | Post-Hoc Analysis – Host Response |
Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 24 months |
Description | Comparison of the sensitivity, specificity, positive and negative predictive values of IDbyDNA NGS results with the Explify diagnostic platform compared with standard care. | Description | Change of Management resulting from NGS diagnosis versus diagnosis based on standard of care. Change of Management is a binary (yes or no) based on assignments made by the PI or designee at each site using the following domains:
Diagnosis specific pharmacological treatment |
Description | Economic evaluation of cost of standard of care testing compared to economic cost of NGS testing:
Determination of what diagnosis made could have been made with best possible clinical tests currently available. |
Description | Cost analysis of what best available testing would have cost. | Description | RNA sequencing to determine if there is a specific host response to either specific infectious or noninfectious etiologies. |
Browse Conditions
Sequence: | 193543662 | Sequence: | 193543663 | Sequence: | 193543664 | Sequence: | 193543665 |
Mesh Term | Infections | Mesh Term | Meningitis | Mesh Term | Neuroinflammatory Diseases | Mesh Term | Nervous System Diseases |
Downcase Mesh Term | infections | Downcase Mesh Term | meningitis | Downcase Mesh Term | neuroinflammatory diseases | Downcase Mesh Term | nervous system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48333181 | Sequence: | 48333182 |
Agency Class | INDUSTRY | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | IDbyDNA, Inc. | Name | Rady Children's Hospital, San Diego |
Eligibilities
Sequence: | 30774159 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 0 Years |
Maximum Age | 17 Years |
Healthy Volunteers | No |
Population | This project will enroll children who are having an evaluation for central nervous system (CNS) infection and have already had a lumbar puncture to obtain cerebrospinal fluid (CSF) to evaluate for infection and host immune response. As such enrolled patients will be undergoing an evaluation for suspected meningitis, encephalitis, ventriculitis and VP shunt infection.
Patients in whom there is CSF remaining after standard testing has been obtained and who meet the other inclusion criteria will be approached for enrollment in the study. |
Criteria | Inclusion Criteria:
Age 0-17 years of age (not yet 18) Exclusion Criteria: CSF Red blood cell (RBC) count > 5000 cells/µL on same CSF sample as with pleocytosis |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253955427 |
Number Of Facilities | 3 |
Registered In Calendar Year | 2018 |
Actual Duration | 20 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 0 |
Maximum Age Num | 17 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 3 |
Designs
Sequence: | 30520287 |
Observational Model | Other |
Time Perspective | Prospective |
Links
Sequence: | 4389291 |
Url | http://idbydna.com |
Description | Sponsor Website |
Responsible Parties
Sequence: | 28886591 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796533
2018-12-10
https://zephyrnet.com/?p=NCT03796533
NCT03796533https://www.clinicaltrials.gov/study/NCT03796533?tab=tableMohamed EL HAMRImohamed.el-hamri@chu-lyon.fr04 78 86 22 20Among its authorized indications, posaconazole (PCZ) is prescribed for prophylaxis in onco-hematology patients at high risk of invasive fungal infections. This azole antifungal has a low bioavailability. The enteric-coated tablets form available since mid-2015 has significantly improved its pharmacokinetic profile compared to the oral suspension form initially used. According to the recommendations of The European Conference on Infections in Leukemia (ECIL-6), the minimum serum concentration desirable for prophylaxis is 0.7 mg/L. This concentration threshold was difficult to achieve in onco-hematology patients treated with oral suspension.
The investigators retrospectively collected and analyzed 201 results of residual PCZ serum concentrations from 91 onco-hematology patients on Noxafil® tablets prophylaxis. The median concentration of PCZ was 1.08 mg/L. In this study, the pharmacokinetics of tablet-PCZ showed significant inter-individual variability. Thus, while 25% of the concentrations remained below the recommended threshold of 0.7 mg/L (25% percentile = 0.69 mg/L), exposure to PCZ was greater than 2.63 mg/L in 10% of cases. This level of exposure, however, did not have obvious hepatic repercussions. Nevertheless, further studies involving larger cohorts are needed to clarify a hypothetical relationship between serum PCZ concentration and the occurrence of hepatic toxicity.
In addition, the investigators found significant intra-individual variability in PCZ exposure (CV = 48.8%), especially in leukemic patients. This variability is probably related to a modification during the treatment of the physio-pathological conditions of the patient likely to impact the pharmacokinetics of PCZ (absorption, distribution, metabolism, etc.) as well as the effect of possible pharmacokinetic drug interactions.
The metabolism of PCZ is mediated primarily by the uridine diphosphate (UDP)-glucuronosyltransferase 1A4 (UGT1A4) pathway. Although hepatic metabolism of PCZ is low compared with other azoles (such as itraconazole or voriconazole), differences in the metabolic capacity of UGT1A4 may alter PCZ exposure. A previous study of the oral suspension form had shown that low concentrations of PCZ were associated with a high ratio of PCZ-glucuronide / PCZ concentrations. Two genetic variants of the gene encoding UGT1A4 are associated with a decrease in the metabolic clearance of glucuronide drugs via UGT1A4. A recent study suggests less exposure to PCZ in the presence of UGT1A4 polymorphism.
The main objective of the investigator’s project is to study prospectively in a homogeneous population of patients treated by intensive chemotherapy for acute myeloid leukemia (induction and consolidation) the pharmacokinetics of PCZ administered in its tablet formulation, and in particular:
Clinical and biological tolerance of high concentrations of PCZ
The influence of clinical and demographic covariates on PCZ and PCZ-glucuronide ratio
The influence of genetic variants of UGT1A4 on PCZ metabolism (PCZ-glucuronide / PCZ ratio).
<![CDATA[
Studies
Study First Submitted Date | 2018-11-16 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-02-24 |
Start Month Year | December 10, 2018 |
Primary Completion Month Year | April 10, 2023 |
Verification Month Year | February 2022 |
Verification Date | 2022-02-28 |
Last Update Posted Date | 2022-02-24 |
Facilities
Sequence: | 200159515 |
Status | Recruiting |
Name | Centre Hospitalier Lyon Sud, Hematology department |
City | Pierre-Bénite |
Country | France |
Facility Contacts
Sequence: | 28113751 | Sequence: | 28113752 |
Facility Id | 200159515 | Facility Id | 200159515 |
Contact Type | primary | Contact Type | backup |
Name | Sophie DUCASTELLE-LEPRETRE, MD | Name | Mohamed EL HAMRI, MD |
Sophie.ducastelle-lepretre@chu-lyon.fr | mohamed.el-hamri@chu-lyon.fr | ||
Phone | 04 78 86 22 36 | Phone | 04 78 86 22 20 |
Phone Extension | +33 | Phone Extension | +33 |
Facility Investigators
Sequence: | 18336495 | Sequence: | 18336496 | Sequence: | 18336497 | Sequence: | 18336498 | Sequence: | 18336499 | Sequence: | 18336500 | Sequence: | 18336501 | Sequence: | 18336502 | Sequence: | 18336503 | Sequence: | 18336504 |
Facility Id | 200159515 | Facility Id | 200159515 | Facility Id | 200159515 | Facility Id | 200159515 | Facility Id | 200159515 | Facility Id | 200159515 | Facility Id | 200159515 | Facility Id | 200159515 | Facility Id | 200159515 | Facility Id | 200159515 |
Role | Principal Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator |
Name | Sophie Ducastelle-Lepretre, MD | Name | Xavier THOMAS, MD | Name | Fiorenza BARRACO, MD | Name | Etienne PAUBELLE, MD | Name | Hélène Labussiere-Wallet, MD | Name | Eric Wattel | Name | Marie Virginie Larcher, MD | Name | Clement Rocher, MD | Name | Gaelle Fossard, MD | Name | Marie Balsat, MD |
Browse Interventions
Sequence: | 96074323 | Sequence: | 96074322 | Sequence: | 96074312 | Sequence: | 96074313 | Sequence: | 96074314 | Sequence: | 96074315 | Sequence: | 96074316 | Sequence: | 96074317 | Sequence: | 96074318 | Sequence: | 96074319 | Sequence: | 96074320 | Sequence: | 96074321 | Sequence: | 96074324 | Sequence: | 96074325 |
Mesh Term | Hormone Antagonists | Mesh Term | Steroid Synthesis Inhibitors | Mesh Term | Posaconazole | Mesh Term | Antifungal Agents | Mesh Term | Anti-Infective Agents | Mesh Term | Trypanocidal Agents | Mesh Term | Antiprotozoal Agents | Mesh Term | Antiparasitic Agents | Mesh Term | 14-alpha Demethylase Inhibitors | Mesh Term | Cytochrome P-450 Enzyme Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Hormones, Hormone Substitutes, and Hormone Antagonists | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | hormone antagonists | Downcase Mesh Term | steroid synthesis inhibitors | Downcase Mesh Term | posaconazole | Downcase Mesh Term | antifungal agents | Downcase Mesh Term | anti-infective agents | Downcase Mesh Term | trypanocidal agents | Downcase Mesh Term | antiprotozoal agents | Downcase Mesh Term | antiparasitic agents | Downcase Mesh Term | 14-alpha demethylase inhibitors | Downcase Mesh Term | cytochrome p-450 enzyme inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | hormones, hormone substitutes, and hormone antagonists | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52185592 |
Name | Leukemia, Myeloid, Acute |
Downcase Name | leukemia, myeloid, acute |
Id Information
Sequence: | 40169137 | Sequence: | 40169138 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 69HCL18_0429 | Id Value | 2018-003488-67 |
Id Type | Other Identifier | ||
Id Type Description | ID-RCB | ||
Countries
Sequence: | 42580723 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55609224 |
Group Type | Other |
Title | Posaconazole pharmacokinetics |
Description | Patients with AML over the age of 18 years treated with intensive chemotherapy in induction and consolidation whose was under antifungal prophylaxis by PCZ formulation tablets. |
Interventions
Sequence: | 52499526 |
Intervention Type | Drug |
Name | Posaconazole |
Description | PCZ will be used as recommended in tablet formulation at an initial dosage of 300 mg twice a day on the first day and then once a day at a dose of 300 mg the following days. PCZ prophylaxis will be started on the same day as the start of chemotherapy and will be continued until the end of aplasia. The dosage of the PCZ can be adjusted according to the results of the PCZ assay. It may be interrupted if the transaminase level is greater than 3 times higher than normal (3N) or on medical decision. |
Keywords
Sequence: | 79888912 |
Name | AML-PCZ-UGT1A4 gene |
Downcase Name | aml-pcz-ugt1a4 gene |
Design Outcomes
Sequence: | 177432362 | Sequence: | 177432363 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Evolution of the blood concentration of posaconazole and its metabolite from the beginning of treatment to the end of the induction phase (pharmacokinetic). | Measure | Search and identification by sequencing gene variants of UGT1A4 |
Time Frame | Day 21 | Time Frame | At diagnosis |
Description | Posaconazole (PCZ) treatment will start at Day 1 at the beginning of induction/ consolidation therapy.
For the pharmacokinetics study of PCZ during induction, blood samples (5 mL) will be taken on days 3, 7, 14 and 21. Predoses (just prior to a daily dose) or trough concentrations (C0) will be collected on days 3, 7, 14 and 21. A peak concentration (at 3 hours post dose) will also be collected on day 14. |
Description | The blood sample (5 mL) for the study of polymorphisms of the UGT1A4 gene will be performed before the initiation of induction. |
Browse Conditions
Sequence: | 193540512 | Sequence: | 193540513 | Sequence: | 193540514 | Sequence: | 193540515 | Sequence: | 193540516 |
Mesh Term | Leukemia | Mesh Term | Leukemia, Myeloid | Mesh Term | Leukemia, Myeloid, Acute | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms |
Downcase Mesh Term | leukemia | Downcase Mesh Term | leukemia, myeloid | Downcase Mesh Term | leukemia, myeloid, acute | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332415 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Hospices Civils de Lyon |
Central Contacts
Sequence: | 12012326 | Sequence: | 12012327 |
Contact Type | primary | Contact Type | backup |
Name | Sophie Ducastelle-lepretre | Name | Mohamed EL HAMRI |
Phone | 04 78 86 22 36 | Phone | 04 78 86 22 20 |
Sophie.ducastelle-lepretre@chu-lyon.fr | mohamed.el-hamri@chu-lyon.fr | ||
Phone Extension | +33 | Phone Extension | +33 |
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68168301 |
Design Group Id | 55609224 |
Intervention Id | 52499526 |
Eligibilities
Sequence: | 30773633 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patient aged 18 or over Exclusion Criteria: Patients with acute promyelocytic leukemia (AML3) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952974 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30519764 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Health Services Research |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26680460 |
Intervention Id | 52499526 |
Name | PCZ |
Responsible Parties
Sequence: | 28886065 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796520
2019-06-02
https://zephyrnet.com/?p=NCT03796520
NCT03796520https://www.clinicaltrials.gov/study/NCT03796520?tab=tableNANANAAn algorithm has been developed for simplified classification of epileptic seizures, in order to optimize choice of antiepileptic drugs.
The objective of this study was to clinically validate the algorithm.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-02-17 |
Start Month Year | June 2, 2019 |
Primary Completion Month Year | December 31, 2020 |
Verification Month Year | February 2021 |
Verification Date | 2021-02-28 |
Last Update Posted Date | 2021-02-17 |
Detailed Descriptions
Sequence: | 20716321 |
Description | Optimal choice of antiepileptic drugs (AEDs) depend on the patients´ seizure-types. Over the last four decades, several classification systems have been proposed for epileptic seizures. The recent position paper of the International League Against Epilepsy defines 63 seizure-types. While this complex system might be useful for detailed phenotyping, currently there is no evidence that each of these seizure-types needs different clinical management strategy, and many clinicians find it difficult to implement.
To help physicians with optimizing the choice of AEDs, the investigators developed a simplified seizure classification, consisting of the minimal number of seizure-types, necessary for choice of AEDs, and the investigators developed an algorithm that identifies the patient´s seizure-type, based on a set of 10 simple questions, that can be answered by physicians even without extensive training in epilepsy. The current form of the algorithm was developed for patients whose seizures started in adolescence or adulthood (at the age of 10 years or older). In this study, the investigators aim to validate the diagnostic algorithm, by comparing the seizure-type identified by the algorithm with the diagnosis and seizure-type as defined by trained experts, in the clinical workup of the patients. |
Facilities
Sequence: | 200053414 | Sequence: | 200053415 | Sequence: | 200053416 | Sequence: | 200053417 | Sequence: | 200053418 |
Name | Thomas Jefferson University | Name | Aarhus University Hospital | Name | Danish Epilepsy Centre | Name | Shiraz University of Medical Sciences | Name | University of Pavia |
City | Philadelphia | City | Aarhus | City | Dianalund | City | Shiraz | City | Pavia |
State | Pennsylvania | ||||||||
Zip | 19107 | Zip | 8000 | Zip | 4293 | Zip | 27100 | ||
Country | United States | Country | Denmark | Country | Denmark | Country | Iran, Islamic Republic of | Country | Italy |
Conditions
Sequence: | 52156560 |
Name | Epilepsy |
Downcase Name | epilepsy |
Id Information
Sequence: | 40148250 |
Id Source | org_study_id |
Id Value | EpiPick-1 |
Countries
Sequence: | 42557784 | Sequence: | 42557785 | Sequence: | 42557786 | Sequence: | 42557787 |
Name | United States | Name | Denmark | Name | Iran, Islamic Republic of | Name | Italy |
Removed | False | Removed | False | Removed | False | Removed | False |
Design Groups
Sequence: | 55577958 |
Title | Patients suspected for epilepsy |
Description | The cohort includes patients referred to the participating centers on suspicion of epilepsy, provided their seizure onset was at 10 years of age or older. |
Interventions
Sequence: | 52472060 |
Intervention Type | Diagnostic Test |
Name | EpiPick simplified seizure classification algorithm |
Description | EpiPick simplified seizure classification algorithm input:
Grey matter brain lesion Exclusively nocturnal seizures First seizure at age > 20 years Lip smacking or chewing during seizures Staring with impaired awareness, lasting less than 20s without postictal confusion Sudden irregular jerks, in isolation or brief series, if none of the following applies: Are the jerks consistently in the same limb? When resting in bed when falling asleep? Bilateral tonic-clonic seizures within 1h of awakening or immediately preceded by irregular jerks Any of the following is present: Skin turning pale pre-ictally; Loss of consciousness immediately after urination or defecation; Sudden slump with loss of awareness, lasting less than 10 seconds; Seizure lasting longer than 10 minutes, with eyes closed throughout the seizure; Severe pre-ictal headache; Episodes consisting of falls that occur always after change in posture to the upright position, or coughing or feeling pain. |
Design Outcomes
Sequence: | 177328232 |
Outcome Type | primary |
Measure | AC1 |
Time Frame | Through study completion, an average of 8 months. |
Description | Agreement coefficient between index test (EpiPick) and the reference standard (expert classification) |
Browse Conditions
Sequence: | 193432263 | Sequence: | 193432264 | Sequence: | 193432265 |
Mesh Term | Seizures | Mesh Term | Nervous System Diseases | Mesh Term | Neurologic Manifestations |
Downcase Mesh Term | seizures | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | neurologic manifestations |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306142 | Sequence: | 48306143 | Sequence: | 48306144 | Sequence: | 48306145 | Sequence: | 48306146 |
Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Sándor Beniczky | Name | Danish Epilepsy Centre | Name | Shiraz University of Medical Sciences | Name | University of Pavia | Name | Thomas Jefferson University |
Overall Officials
Sequence: | 29277959 | Sequence: | 29277960 | Sequence: | 29277961 | Sequence: | 29277962 | Sequence: | 29277963 |
Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator |
Name | Sandor Beniczky, MD, PhD | Name | Guido Rubboli, MD, PhD | Name | Michael Sperling, MD, PhD | Name | Emilio Perucca, MD, PhD | Name | Ali A Asadi-Pooya, MD, PhD |
Affiliation | Aarhus University Hospital | Affiliation | Danich Epilepsy Centre | Affiliation | Thomas Jefferson University | Affiliation | University of Pavia | Affiliation | Shiraz University of Medical Sciences |
Design Group Interventions
Sequence: | 68130922 |
Design Group Id | 55577958 |
Intervention Id | 52472060 |
Eligibilities
Sequence: | 30757391 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 10 Years |
Maximum Age | 120 Years |
Population | The study population includes patients referred to the participating centers on suspicion of epilepsy, provided their seizure onset was at 10 years of age or older. |
Criteria | Inclusion Criteria:
patients referred to the participating centers on suspicion of epilepsy Exclusion Criteria: none |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254228506 |
Number Of Facilities | 5 |
Registered In Calendar Year | 2019 |
Actual Duration | 19 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 10 |
Maximum Age Num | 120 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30503616 |
Observational Model | Case-Only |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28869894 |
Responsible Party Type | Sponsor-Investigator |
Name | Sándor Beniczky |
Title | professor |
Affiliation | Aarhus University Hospital |
Study References
Sequence: | 52049432 | Sequence: | 52049433 | Sequence: | 52049434 | Sequence: | 52049435 | Sequence: | 52049436 | Sequence: | 52049437 | Sequence: | 52049438 |
Pmid | 28276060 | Pmid | 26507832 | Pmid | 21763207 | Pmid | 19853218 | Pmid | 19800848 | Pmid | 28677857 | Pmid | 34420206 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | derived |
Citation | Fisher RS, Cross JH, French JA, Higurashi N, Hirsch E, Jansen FE, Lagae L, Moshe SL, Peltola J, Roulet Perez E, Scheffer IE, Zuberi SM. Operational classification of seizure types by the International League Against Epilepsy: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):522-530. doi: 10.1111/epi.13670. Epub 2017 Mar 8. | Citation | Brodie MJ. Practical Use of Newer Antiepileptic Drugs as Adjunctive Therapy in Focal Epilepsy. CNS Drugs. 2015 Nov;29(11):893-904. doi: 10.1007/s40263-015-0285-4. | Citation | Brodie MJ, Covanis A, Gil-Nagel A, Lerche H, Perucca E, Sills GJ, White HS. Antiepileptic drug therapy: does mechanism of action matter? Epilepsy Behav. 2011 Aug;21(4):331-41. doi: 10.1016/j.yebeh.2011.05.025. Epub 2011 Jul 16. | Citation | Stephen LJ, Brodie MJ. Selection of antiepileptic drugs in adults. Neurol Clin. 2009 Nov;27(4):967-992. doi: 10.1016/j.ncl.2009.06.007. | Citation | Brodie MJ, Elder AT, Kwan P. Epilepsy in later life. Lancet Neurol. 2009 Nov;8(11):1019-30. doi: 10.1016/S1474-4422(09)70240-6. Epub 2009 Oct 1. | Citation | Beniczky S, Rubboli G, Aurlien H, Hirsch LJ, Trinka E, Schomer DL; SCORE consortium. The new ILAE seizure classification: 63 seizure types? Epilepsia. 2017 Jul;58(7):1298-1300. doi: 10.1111/epi.13799. No abstract available. | Citation | Beniczky S, Asadi-Pooya AA, Perucca E, Rubboli G, Tartara E, Meritam Larsen P, Ebrahimi S, Farzinmehr S, Rampp S, Sperling MR. A web-based algorithm to rapidly classify seizures for the purpose of drug selection. Epilepsia. 2021 Oct;62(10):2474-2484. doi: 10.1111/epi.17039. Epub 2021 Aug 22. |
Ipd Information Types
Sequence: | 3332719 | Sequence: | 3332720 |
Name | Study Protocol | Name | Statistical Analysis Plan (SAP) |
]]>
https://zephyrnet.com/NCT03796507
2021-09-01
https://zephyrnet.com/?p=NCT03796507
NCT03796507https://www.clinicaltrials.gov/study/NCT03796507?tab=tableNANANAThe purpose of this study is to investigate the feasibility of a possible treatment regimen that could be used to delay tumor progression in patients with glioblastoma. The study is being conducted in patients who qualify for inpatient rehabilitation, as this population is particularly vulnerable to delays in initiation of chemoradiation and further tumor growth in the period between surgical resection and the start of treatment.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-04-09 |
Start Month Year | September 1, 2021 |
Primary Completion Month Year | December 15, 2021 |
Verification Month Year | April 2021 |
Verification Date | 2021-04-30 |
Last Update Posted Date | 2021-04-09 |
Detailed Descriptions
Sequence: | 20735715 |
Description | This is a pilot study to evaluate the feasibility and safety of early postsurgical temozolomide therapy prior to initiation of standard chemoradiation regimen in patients with glioblastoma who undergo inpatient rehabilitation. The study will be conducted with adult patients who qualify for inpatient rehabilitation following surgical resection of pathologically confirmed Grade IV glioma. Patients will begin a 21-day cycle of temozolomide starting 14 days after surgery at 75mg per square meter of body surface area daily to serve as bridge therapy. Patients will then progress to receive standard therapy following their rehabilitation stay. Patients will be assessed for their ability to complete the chemotherapy protocol without dose-limiting toxicity as well as complete inpatient rehabilitation successfully. Additionally, we will be assessing for tumor progression between the time of surgery and the time of treatment initiation.
If this study shows the expected results, the research team plans to proceed to a larger trial assessing the efficacy of early TMZ in patients with glioblastoma (GBM) who are admitted to acute inpatient rehabilitation compared to the current standard of care. |
Facilities
Sequence: | 200243986 |
Name | University of Rochester Medical Center |
City | Rochester |
State | New York |
Zip | 14642 |
Country | United States |
Browse Interventions
Sequence: | 96112884 | Sequence: | 96112885 | Sequence: | 96112886 | Sequence: | 96112887 | Sequence: | 96112888 |
Mesh Term | Temozolomide | Mesh Term | Antineoplastic Agents, Alkylating | Mesh Term | Alkylating Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antineoplastic Agents |
Downcase Mesh Term | temozolomide | Downcase Mesh Term | antineoplastic agents, alkylating | Downcase Mesh Term | alkylating agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antineoplastic agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52207915 |
Name | Glioma of Brain |
Downcase Name | glioma of brain |
Id Information
Sequence: | 40186043 |
Id Source | org_study_id |
Id Value | RSRB00003258 |
Countries
Sequence: | 42599551 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55634513 |
Group Type | Experimental |
Title | Temozolomide Arm |
Description | This study will only include one treatment group who will receive oral temozolomide at 75 mg per square meter of body surface area daily for 21 days before progressing to standard chemoradiation treatment. |
Interventions
Sequence: | 52521929 |
Intervention Type | Drug |
Name | Temozolomide |
Description | oral temozolomide at 75 mg per square meter of body surface area daily for 21 days |
Design Outcomes
Sequence: | 177510689 | Sequence: | 177510690 | Sequence: | 177510691 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The number of patient who fail to complete temozolomide (TMZ) | Measure | Mean functional independence measure (FIM) score | Measure | Response rate to TMZ |
Time Frame | 1 month | Time Frame | 1 month | Time Frame | 1 month |
Description | The number of subjects who fail to complete early TMZ plus inpatient rehabilitation for any reason, including adverse events or progression or patient withdrawal | Description | FIM is comprised of 18 items, grouped into 2 subscales -motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item therefore the better the health outcome. The total score for the FIM instrument (the sum of the motor and cognition subscale scores) will be a value between 18 and 126. | Description | The response rate to early TMZ will be evaluated by comparing the MRI of the head before and after one course using the Response Assessment in Neuro-Oncology (RANO) criteria. The response rate will be reported with a (two-sided) 90% confidence interval. The RANO criteria consists of 5 elements: T1 Gadolinium enhancing disease, T2/FLAIR assessment, new lesions, use of corticosteroids and clinical status. Patients will be categorized as complete response, partial response, stable disease or progressive disease. |
Browse Conditions
Sequence: | 193626388 | Sequence: | 193626389 | Sequence: | 193626390 | Sequence: | 193626391 | Sequence: | 193626392 | Sequence: | 193626393 | Sequence: | 193626394 | Sequence: | 193626395 |
Mesh Term | Glioma | Mesh Term | Neoplasms, Neuroepithelial | Mesh Term | Neuroectodermal Tumors | Mesh Term | Neoplasms, Germ Cell and Embryonal | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms, Nerve Tissue |
Downcase Mesh Term | glioma | Downcase Mesh Term | neoplasms, neuroepithelial | Downcase Mesh Term | neuroectodermal tumors | Downcase Mesh Term | neoplasms, germ cell and embryonal | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms, nerve tissue |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48353554 | Sequence: | 48353555 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Rochester | Name | National Institutes of Health (NIH) |
Overall Officials
Sequence: | 29305907 |
Role | Principal Investigator |
Name | Kevin A Walter, MD |
Affiliation | University of Rochester Medical Center, Dept. of Neurosurgery |
Design Group Interventions
Sequence: | 68199003 |
Design Group Id | 55634513 |
Intervention Id | 52521929 |
Eligibilities
Sequence: | 30786785 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Adult patients, aged 18+ Subject must meet the following laboratory parameters: Absolute neutrophil count > 1.5 x103/uL Exclusion Criteria: Subject has received previous treatment for high-grade glioma |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989450 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30532856 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28899149 |
Responsible Party Type | Principal Investigator |
Name | Kevin Walter |
Title | Professor |
Affiliation | University of Rochester |
]]>
https://zephyrnet.com/NCT03796494
2019-03-01
https://zephyrnet.com/?p=NCT03796494
NCT03796494https://www.clinicaltrials.gov/study/NCT03796494?tab=tableNANANAThis is a randomized, single-blind, split-mouth clinical trial to evaluate the performance of peri-implant tissues (bone and soft tissues) in conventionally loaded Galimplant implants, using a classic multi-position, anti-rotational abutment, comparing it to the new multi-abutment aesthetic slim anti-rotational placed both at the time of the implant surgery. To this end, 80 Galimplant implants with a diameter of 4 mm and 10 mm in length will be placed in areas of mature scarred post-extraction bone. Patients be divided into 2 study groups, group C: straight pillar; Group T: Slim pillar. The bone and clinical radiological stability of the peri-implant tissues will be evaluated at 6 weeks post-surgery and at 6-12 months post-prosthetic loading.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-04-01 |
Start Month Year | March 1, 2019 |
Primary Completion Month Year | April 1, 2019 |
Verification Month Year | March 2020 |
Verification Date | 2020-03-31 |
Last Update Posted Date | 2020-04-01 |
Facilities
Sequence: | 200107764 |
Name | Mario Pérez Sayáns |
City | Santiago De Compostela |
State | A Coruña |
Zip | 15785 |
Country | Spain |
Conditions
Sequence: | 52171056 | Sequence: | 52171057 |
Name | Dental Implant Failed | Name | Dental Prosthesis Failure |
Downcase Name | dental implant failed | Downcase Name | dental prosthesis failure |
Id Information
Sequence: | 40158504 |
Id Source | org_study_id |
Id Value | CT-2019-01 |
Countries
Sequence: | 42568816 |
Name | Spain |
Removed | False |
Design Groups
Sequence: | 55592990 | Sequence: | 55592991 |
Group Type | Active Comparator | Group Type | Experimental |
Title | Control Group | Title | Test group |
Description | The control group is considered, using the company's classic multi-position straight anti-rotational abutment | Description | The test group is considered, where the new multi-position straight esthetic anti-rotational slim abutment is used |
Interventions
Sequence: | 52485304 | Sequence: | 52485305 |
Intervention Type | Procedure | Intervention Type | Procedure |
Name | Straight abutment | Name | Slim abutment |
Description | This is the classic abutment, straight and anti-rotational for dental implants which have been tested before | Description | This is the new concept of the prostheses abutment, slim and anti-rotational to improve the width of biologic space |
Keywords
Sequence: | 79868227 | Sequence: | 79868228 |
Name | dental implant | Name | periimplant tissues |
Downcase Name | dental implant | Downcase Name | periimplant tissues |
Design Outcomes
Sequence: | 177378109 | Sequence: | 177378110 | Sequence: | 177378111 | Sequence: | 177378112 | Sequence: | 177378113 | Sequence: | 177378114 | Sequence: | 177378115 | Sequence: | 177378116 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other |
Measure | Primary stability of implants and peri-implant tissues | Measure | Basal Peri-implant tissue level: implant stability | Measure | Basal Radiological Bone Implant level | Measure | Basal Peri-implant tissue level: probing depth | Measure | Radiological bone implant stability | Measure | Peri-implant tissue stability: probing depth | Measure | Peri-implant tissue stability: ISQ | Measure | Long-term evaluation of definitive prostheses |
Time Frame | 10 months | Time Frame | 1 day | Time Frame | 1 day | Time Frame | 1 day | Time Frame | 8 weeks | Time Frame | 8 weeks | Time Frame | 8 weeks | Time Frame | 6 months |
Description | Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol. Investigators will evaluate the immediate post-surgical stability of implants and peri-implant tissues through the Ostell system, based on the resonance frequency analysis (RFA). The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ | Description | Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol. We will load the crowns 8 weeks after implant surgery. Investigators will evaluate the stability at different moments, 8 weeks, 6 months and 12 months. The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ. ISQ values are obtained using resonance frequency analysis (RFA). | Description | At the moment of placing the implant, clinical variables will be evaluated: depth of probing (distance from the peri-implant margin to the most depth of the peri-implant sulcus). This will be the basal measure of the implant stability and peri-implant tissue levels. Investigators will calculate the difference between the basal measure and the future measurements. | Description | At the moment of placing the implant, clinical variables will be evaluated: depth of probing (distance from the peri-implant margin to the most depth of the peri-implant sulcus). This will be the basal measure of the implant stability and peri-implant tissue levels. Investigators will calculate the difference between the basal measure and the future measurements. | Description | After the implantation, we´ll load the temporary 8 weeks after the implantation. Investigators will evaluate the bone level stability at 6 weeks in both groups, through a dental X-ray radiography. The bone stability will be measured as a difference between de basal bone level and the actual one in mm. | Description | After the implantation, we´ll load the definitive prostheses in 8 weeks. Investigators will evaluate the peri-implant tissue stability by measuring the probing depth or just in case, the recession of the gingival margin. The stability will be given by the differences between both measures, basal and actual in mm. | Description | After the implantation, we´ll load the temporary prostheses in 8 weeks. Investigators will evaluate the peri-implant tissue stability by measuring the ISQ through RFA. The stability will be given by the differences between both measures, basal and actual. | Description | After 6 months of loading of final ceramic restoration, investigators will evaluate the differences of clinical (mm of probing depth, ISQ implant stability) and radiological aspects (bone implant level in mm calculated from the neck to the actual bone level, comparing on the basal and final values. |
Browse Conditions
Sequence: | 193485978 | Sequence: | 193485979 | Sequence: | 193485980 |
Mesh Term | Prosthesis Failure | Mesh Term | Postoperative Complications | Mesh Term | Pathologic Processes |
Downcase Mesh Term | prosthesis failure | Downcase Mesh Term | postoperative complications | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319112 | Sequence: | 48319113 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Santiago de Compostela | Name | Galimplant Dental Implants |
Design Group Interventions
Sequence: | 68148924 | Sequence: | 68148925 |
Design Group Id | 55592990 | Design Group Id | 55592991 |
Intervention Id | 52485304 | Intervention Id | 52485305 |
Eligibilities
Sequence: | 30765245 |
Gender | All |
Minimum Age | 20 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Patients without systemic pathology that are grounds for absolute contraindication Exclusion Criteria: Immunosuppressed |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253875099 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 1 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 20 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30511412 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Links
Sequence: | 4388070 |
Url | http://imaisd.usc.es/grupoficha.asp?idpersoatipogrupo=75189&i=es&s=-2-26-148 |
Description | GI-1319 |
Responsible Parties
Sequence: | 28877706 |
Responsible Party Type | Principal Investigator |
Name | Mario Pérez Sayáns |
Title | Professor Mario Perez Sayans MD, PhD (Principal investigator) |
Affiliation | University of Santiago de Compostela |
Ipd Information Types
Sequence: | 3334110 | Sequence: | 3334111 | Sequence: | 3334112 | Sequence: | 3334113 |
Name | Study Protocol | Name | Statistical Analysis Plan (SAP) | Name | Clinical Study Report (CSR) | Name | Analytic Code |
]]>
https://zephyrnet.com/NCT03796481
2019-01-08
https://zephyrnet.com/?p=NCT03796481
NCT03796481https://www.clinicaltrials.gov/study/NCT03796481?tab=tableNANANAThis study is focused on people with chronic spinal pain. To investigate the impact of sleep problems on pain and function, 45 people with chronic spinal pain and comorbid insomnia will be compared to 45 people with chronic spinal pain without insomnia.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-19 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-12-01 |
Start Month Year | January 8, 2019 |
Primary Completion Month Year | July 28, 2022 |
Verification Month Year | November 2022 |
Verification Date | 2022-11-30 |
Last Update Posted Date | 2022-12-01 |
Facilities
Sequence: | 200682757 | Sequence: | 200682758 |
Name | Vrije Universiteit Brussel | Name | Ghent University |
City | Brussel | City | Ghent |
Country | Belgium | Country | Belgium |
Conditions
Sequence: | 52347516 | Sequence: | 52347517 | Sequence: | 52347518 |
Name | Chronic Low Back Pain | Name | Chronic Neck Pain | Name | Chronic Insomnia |
Downcase Name | chronic low back pain | Downcase Name | chronic neck pain | Downcase Name | chronic insomnia |
Id Information
Sequence: | 40285053 |
Id Source | org_study_id |
Id Value | EC/2018/0277/Amend |
Countries
Sequence: | 42706069 |
Name | Belgium |
Removed | False |
Design Groups
Sequence: | 55790044 | Sequence: | 55790045 |
Title | Cases | Title | Controls |
Description | People with chronic spinal pain (i.e. chronic low back pain or chronic neck pain) with comorbid insomnia | Description | People with chronic spinal pain (i.e. chronic low back pain or chronic neck pain) without comorbid insomnia |
Design Outcomes
Sequence: | 178030461 | Sequence: | 178030462 | Sequence: | 178030463 | Sequence: | 178030464 | Sequence: | 178030465 | Sequence: | 178030466 | Sequence: | 178030467 | Sequence: | 178030468 | Sequence: | 178030469 | Sequence: | 178030470 | Sequence: | 178030471 | Sequence: | 178030472 | Sequence: | 178030473 | Sequence: | 178030474 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Brief Pain Inventory (Numeric Rating Scale): Pain intensity | Measure | Brief Pain Inventory: Pain Interference | Measure | Central sensitization Inventory | Measure | Pressure Pain Thresholds | Measure | Sleep: Polysomnography (PSG) using the portable Alice PDX system, Philips Respironics Inc | Measure | Pittsburg Sleep Quality Index | Measure | Insomnia Severity Index | Measure | DBAS (i.e. Dysfunctional Beliefs and Attitudes about Sleep) | Measure | Epworth Sleepiness Scale | Measure | Brugmann Fatigue Scale | Measure | Hospital Anxiety and Depression rating scale | Measure | Physical Activity using Actigraphy | Measure | Short Form Health Survey – 36 items Mental Health | Measure | Short Form Health Survey – 36 items Physical Health |
Time Frame | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. | Time Frame | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. | Time Frame | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. | Time Frame | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. | Time Frame | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. | Time Frame | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. | Time Frame | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. | Time Frame | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. | Time Frame | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. | Time Frame | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. | Time Frame | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. | Time Frame | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. | Time Frame | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. | Time Frame | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. |
Description | Self-reported pain: The question "please rate your pain by circling the one number that best describes your pain on the AVERAGE" is used as the primary outcome measure to evaluate pain intensity. Scale ranges from 0 to 10, with higher scores indicating more self-reported pain. | Description | Self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization. | Description | Self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization. | Description | Pressure Pain Thresholds at measured bilaterally with a digital pressure algometer (Wagner Instruments), both at symptomatic levels (trapezius muscle and 5 centimetres lateral to the spinous process of L3) and at remote sites (i.e. secondary hyperalgesia). | Description | Participants will be monitored in the comfort of their own home by ambulatory polysomnography. This will provide the following parameters: time in bed, total sleep time, sleep onset latency, wake duration after sleep onset, early morning awakening, sleep staging, sleep efficiency, sleep fragmentation, respiratory parameters, cardiac and myoclonic activity. | Description | Self-reported perceived sleep quality. Score ranges from 0 to 21, 0 indicating no difficulty and 21 indicating severe sleep difficulties. | Description | Self-reported insomnia severity. Score ranges from 0 to 28, with 0 indicating no clinically significant insomnia and 28 indicating severe clinical insomnia. | Description | Change in self-reported dysfunctional beliefs and attitudes about sleep. Score ranges from 0 to 10. Scores above 4 indicate unrealistic expectations for sleep or unrealistic thoughts about sleep. | Description | Self-reported sleep propensity. Score ranges from 0 to 24, with 0 indicating normal daytime sleepiness and 24 indicating severe excessive daytime sleepiness. | Description | Self-reported fatigue severity. Score ranges from 0 to 24, with higher scores indicating higher subjective levels of fatigue. | Description | Self-reported affective symptoms. Score ranges from 0 to 21, with 0 indicating absence of depression or anxiety and 21 indicating the presence of depression or anxiety. | Description | Physical activity: Continuous assessment of physical activity and rest/activity cycles | Description | Self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better mental health. | Description | Self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better physical health. |
Browse Conditions
Sequence: | 194159164 | Sequence: | 194159165 | Sequence: | 194159166 | Sequence: | 194159167 | Sequence: | 194159168 | Sequence: | 194159169 | Sequence: | 194159170 | Sequence: | 194159171 | Sequence: | 194159172 | Sequence: | 194159173 | Sequence: | 194159174 |
Mesh Term | Sleep Initiation and Maintenance Disorders | Mesh Term | Low Back Pain | Mesh Term | Neck Pain | Mesh Term | Back Pain | Mesh Term | Pain | Mesh Term | Neurologic Manifestations | Mesh Term | Sleep Disorders, Intrinsic | Mesh Term | Dyssomnias | Mesh Term | Sleep Wake Disorders | Mesh Term | Nervous System Diseases | Mesh Term | Mental Disorders |
Downcase Mesh Term | sleep initiation and maintenance disorders | Downcase Mesh Term | low back pain | Downcase Mesh Term | neck pain | Downcase Mesh Term | back pain | Downcase Mesh Term | pain | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | sleep disorders, intrinsic | Downcase Mesh Term | dyssomnias | Downcase Mesh Term | sleep wake disorders | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48484256 | Sequence: | 48484257 | Sequence: | 48484258 | Sequence: | 48484259 | Sequence: | 48484260 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | University Ghent | Name | Vrije Universiteit Brussel | Name | University Hospital, Ghent | Name | Universitair Ziekenhuis Brussel | Name | Research Foundation Flanders |
Eligibilities
Sequence: | 30867638 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Population | People with chronic spinal pain with and without comorbid insomnia (cases vs controls) |
Criteria | Inclusion criteria cases:
nonspecific spinal pain (≥3 days per week and ≥3 months of chronic low back pain, failed back surgery syndrome > 3 years prior, chronic whiplash, or chronic non traumatic neck pain) Exclusion criteria cases: severe underlying sleep pathology (identified through baseline data of polysomnography) Inclusion criteria controls: native dutch speaking Exclusion criteria controls: specific medical conditions (neuropathic pain, specific neck of back surgery, osteoporotic vertebral fractures, or rheumatologic diseases) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254001495 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2018 |
Actual Duration | 43 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 13 |
Designs
Sequence: | 30613452 |
Observational Model | Case-Control |
Time Perspective | Cross-Sectional |
Responsible Parties
Sequence: | 28979986 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796468
2019-04-10
https://zephyrnet.com/?p=NCT03796468
NCT03796468https://www.clinicaltrials.gov/study/NCT03796468?tab=tableBertrand LAPERGUE, PHbertrand.lapergue@gmail.com1 46255973Stroke represents the fourth leading cause of death in industrialized nations, after heart disease, cancer, and chronic lower respiratory disease. Approximately one-quarter of the patients suffering a stroke die within one year after the initial event and stroke is a leading cause of serious long-term disability. Although mechanical thrombectomy (MT) has become the standard of care for acute ischemic stroke with proximal large vessel occlusion (LVO) in the anterior circulation, the management of patients harboring proximal occlusion but presenting minor-to-mild stroke symptoms, has not yet been determined by these recent randomized clinical trials. However, patients with proximal occlusions may present with a low NIHSS, a proximal intraarterial occlusion being present in up to 28% when considering patients with an NIHSS ≤ 4.
The evidence of benefit from endovascular therapy (EVT) in large vessel occlusion stroke is demonstrated, STAIR IX (Stroke Treatment Academic Industry Roundtable) consensus recommendations were developed that outline priorities for future research in EVT.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-04-27 |
Start Month Year | April 10, 2019 |
Primary Completion Month Year | July 2023 |
Verification Month Year | April 2022 |
Verification Date | 2022-04-30 |
Last Update Posted Date | 2022-04-27 |
Detailed Descriptions
Sequence: | 20853673 |
Description | Proximal intracranial arterial occlusions cause the most disabling types of ischemic strokes and are predictive of poor neurological outcomes. The "Time is Brain" assessment has been confirmed in many recent trials (MR CLEAN, SWIFT PRIME, REVASCAT, HERMES) within the first 6 hours. Recently the time window has been enlarged to 24h00 after the DAWN trial results, enforcing nevertheless the strong relation between patient disability and time loss in this extended time window.
In population-based studies, patients presenting with minor or mild stroke symptoms represent about two-thirds of stroke patients, and almost one-third of these patients are unable to ambulate independently at the time of discharge. Although mechanical thrombectomy (MT) has become the standard of care for acute ischemic stroke with proximal large vessel occlusion (LVO) in the anterior circulation, the management of patients harboring proximal occlusion but presenting minor-to-mild stroke symptoms, has not yet been determined by these recent randomized clinical trials. Indeed, the majority of patients presented with major clinical impairment, with a median NIHSS of 17. Thus, American Heart Association (AHA) gives level 1a evidence for MT performed only for patients with baseline NIHSS score ≥6. However, patients with proximal occlusions may present with a low NIHSS, a proximal intra-arterial occlusion being present in up to 28% when considering patients with an NIHSS ≤ 4. In observational study, patient with minor or mild stroke symptoms and LVO have a high risk of both clinical worsening and bad outcome. The STAIR meeting aims to advance acute stroke therapy development through collaboration between academia, industry, and regulatory institutions. In pursuit of this goal and building on the available level I evidence of benefit from endovascular therapy (EVT) in large vessel occlusion stroke, STAIR IX consensus recommendations were developed that outline priorities for future research in EVT. Recent AHA/ASA guidelines have also highlighted the need to gain more evidence to determine whether there is an overall net benefit from endovascular therapy (EVT) in patients with LVO and minor stroke. The MOSTE protocol is an International, multi-center, prospectively randomized to two parallel (1:1) arms, open to treatment with blinded endpoint trial, designed to demonstrate that mechanical thrombectomy with best medical treatment is superior to medical treatment alone, in improving clinical outcomes at 90 days, in patient presenting an acute large vessel occlusion stroke with a minor deficit, defined as NIHSS below 6 and < 24 hours from onset. If this study is positive, more patients in the future could receive urgent endovascular treatment in addition to the best medical treatment. |
Facilities
Sequence: | 201296290 |
Status | Recruiting |
Name | Hopital Gui De Chauliac |
City | Montpellier |
Zip | 34295 |
Country | France |
Facility Contacts
Sequence: | 28283102 | Sequence: | 28283103 |
Facility Id | 201296290 | Facility Id | 201296290 |
Contact Type | primary | Contact Type | backup |
Name | Caroline ARQUIZAN, MD | Name | Vincent COSTALAT, PU-PH |
c-arquizan@chu-montpellier.fr | v-costalat@chu-montpellier.fr | ||
Phone | 4 67 33 75 32 | Phone | 4 67 33 75 32 |
Phone Extension | +33 |
Facility Investigators
Sequence: | 18439293 | Sequence: | 18439294 |
Facility Id | 201296290 | Facility Id | 201296290 |
Role | Principal Investigator | Role | Principal Investigator |
Name | Bertrand LAPERGUE, MD | Name | Tudor JOVIN, MD |
Conditions
Sequence: | 52511154 |
Name | Stroke |
Downcase Name | stroke |
Id Information
Sequence: | 40401626 |
Id Source | org_study_id |
Id Value | RECHMPL18_0172 |
Countries
Sequence: | 42837794 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55967547 | Sequence: | 55967548 |
Group Type | Other | Group Type | Other |
Title | Best Medical Therapy (BMT) | Title | Mechanical Thrombectomy (MT) |
Description | Best treatment medical probably associated to the rescue endovascular treatment in case of neurological deterioration | Description | Endovascular treatment (thrombectomy) associated with the best treatment medical |
Interventions
Sequence: | 52818791 | Sequence: | 52818792 |
Intervention Type | Other | Intervention Type | Procedure |
Name | Best Medical Therapy | Name | Mechanical Thrombectomy |
Description | The administration of medications is at the treating physician's discretion (for example intravenous fibrinolysis, anticoagulants or antiplatelet) according to local standards of care but may NOT include any intra-arterial therapies. The rescue MT may be performed in case of deterioration within the 24 hours | Description | MT in the Experimental Arm can be performed with any thrombectomy (CE labeled) device usually used at study site. For the subjects randomized to the MT plus medical, the MT is performed immediately after the randomization |
Keywords
Sequence: | 80329902 | Sequence: | 80329903 | Sequence: | 80329904 | Sequence: | 80329905 |
Name | Mechanical thrombectomy | Name | stroke | Name | Proximal intracranial arterial occlusions | Name | Large vessel occlusion |
Downcase Name | mechanical thrombectomy | Downcase Name | stroke | Downcase Name | proximal intracranial arterial occlusions | Downcase Name | large vessel occlusion |
Design Outcomes
Sequence: | 178643412 | Sequence: | 178643413 | Sequence: | 178643414 | Sequence: | 178643415 | Sequence: | 178643416 | Sequence: | 178643417 | Sequence: | 178643418 | Sequence: | 178643419 | Sequence: | 178643420 | Sequence: | 178643421 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Incidence of all-cause mortality at 90 days | Measure | Incidence of symptomatic intracerebral hemorrhage | Measure | Deterioration of patient's condition | Measure | Incidence of procedure/device-related adverse events | Measure | Evaluation of functional outcome | Measure | Quality of life of the patient | Measure | Evaluation of cognitive function | Measure | Evaluation of cognitive function | Measure | Medico-economic study | Measure | Evaluation of functional outcome |
Time Frame | 3 months | Time Frame | 1 day | Time Frame | 3 months | Time Frame | 1 day | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months |
Description | Evaluation of mortality at 90 days | Description | Incidence of symptomatic intracerebral hemorrhage according to HEIDELBERG at imaging at 24 (-6/+12) hours post randomization | Description | National Intitutes of Health Stroke Scale (NIHSS) ≥ 10 points during hospitalization. this scale is constitued by 15 items and the minimum score is 1 and the maximum score is 20. | Description | Incidence of procedure/device-related adverse events (in patients treated by mechanical treatment, in the MT group or in the BMT group, in case of rescue therapy) | Description | Rate of patients with a favorable or perfect outcome at 90-days defined by mRS 0-2 or mRS 0 | Description | Quality of life at 90 days assessed by EuroQol 5D-5L (5-level EQ-5-Dimension) scale | Description | Cognitive function at 90-days according to Montreal Cognitive Assessment (MoCA) | Description | Cognitive function at 90-days according to Trail Making Test A and B | Description | Cost-effectiveness analysis (number of patients functionally independent at 3 months : mRS =< 2), cost of devices and drugs, staff hourly cost, operating room cost | Description | Rate of patients at 90-days with excellent outcome defined as Modified Rankin Scale (mRS) 0-1 |
Browse Conditions
Sequence: | 194782712 | Sequence: | 194782713 | Sequence: | 194782714 | Sequence: | 194782715 | Sequence: | 194782716 | Sequence: | 194782717 | Sequence: | 194782718 |
Mesh Term | Stroke | Mesh Term | Cerebrovascular Disorders | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases |
Downcase Mesh Term | stroke | Downcase Mesh Term | cerebrovascular disorders | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48633743 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University Hospital, Montpellier |
Overall Officials
Sequence: | 29462759 | Sequence: | 29462760 | Sequence: | 29462761 | Sequence: | 29462762 |
Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator |
Name | Vincent COSTALAT, PU-PH | Name | Caroline ARQUIZAN, PH | Name | Bertrand LAPERGUE, PH | Name | Tudor JOVIN, PU-PH |
Affiliation | Hôpital Gui de Chauliac | Affiliation | Hôpital Gui de Chauliac | Affiliation | Hôpital Foch | Affiliation | Cooper Neurological Institute |
Central Contacts
Sequence: | 12095935 | Sequence: | 12095936 |
Contact Type | primary | Contact Type | backup |
Name | Caroline ARQUIZAN, PH | Name | Bertrand LAPERGUE, PH |
Phone | 4 67 33 75 32 | Phone | 1 46255973 |
c-arquizan@chu-montpellier.fr | bertrand.lapergue@gmail.com | ||
Phone Extension | +33 | Phone Extension | +33 |
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68611705 | Sequence: | 68611706 |
Design Group Id | 55967547 | Design Group Id | 55967548 |
Intervention Id | 52818791 | Intervention Id | 52818792 |
Eligibilities
Sequence: | 30958988 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 100 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Subject is ≥ 18 years old at inclusion (no upper age limit) Exclusion Criteria: General Exclusion Criteria Anticipated impossibility to start the procedure (arterial access) within 60 minutes after randomization Imaging Exclusion Criteria Evidence of intracranial hemorrhage on CT/MRI |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253975812 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 100 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 9 |
Designs
Sequence: | 30704555 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29071280 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796455
2018-04-25
https://zephyrnet.com/?p=NCT03796455
NCT03796455https://www.clinicaltrials.gov/study/NCT03796455?tab=tableNANANAIn the present study, the role of chronic (10 weeks) intake of low dose (2g/day) of EPA+DHA in whole body protein metabolism, and functional performance and systemic inflammation will be examined, and whether adding either HMB at 3.0 g/d to the low dose of EPA+DHA (2.0 g/d) will enhance these effects even more.
<![CDATA[
Studies
Study First Submitted Date | 2018-09-28 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-02-07 |
Start Month Year | April 25, 2018 |
Primary Completion Month Year | April 1, 2020 |
Verification Month Year | February 2022 |
Verification Date | 2022-02-28 |
Last Update Posted Date | 2022-02-07 |
Detailed Descriptions
Sequence: | 20783961 |
Description | Weight loss commonly occurs in patients with Chronic Obstructive Pulmonary Disease (COPD), negatively influencing their quality of life, treatment response and survival. Furthermore, limb muscle dysfunction (weakness and/or enhanced fatigue) is a major systemic comorbidity in patients with Chronic Obstructive Pulmonary Disease (COPD), negatively affecting their exercise performance, physical activity, quality of life, and mortality. As nutritional abnormalities are main contributors to muscle loss and dysfunction in COPD, nutritional support is viewed as an essential component of integrated care in these patients.
Although nutritional support is effective in the treatment of weight loss in COPD, attempts to increase muscle mass and function in COPD by supplying large amounts of protein or calories to these patients have been small. This suggests that gains in muscle mass and function are difficult to achieve in COPD unless specific metabolic abnormalities are targeted. The investigators and other researchers found that low muscle mass in COPD was strongly associated with elevated whole body protein turnover and increased myofibrillar protein breakdown rates indicative of muscle contractile protein loss. The investigators have extended this finding recently to normal weight COPD patients characterized by muscle weakness using a more precise and accurate pulse method of tau-methylhistidine tracer. A substantial number of COPD patients, underweight as well as normal weight to obese, are characterized by an increased inflammatory response as evidenced by elevated levels of the pro-inflammatory cytokines (Tumor Necrosis Factor (TNF)-α, Interleukin (IL) 6 and 8, and the soluble TNF-α receptors (55 and 75). Furthermore, CRP levels are elevated in COPD and associated with reduced quadriceps strength, lower maximal and submaximal exercise capacity and increased morbidity. One of the few agents capable to suppress the generation of pro-inflammatory cytokines are eicosapentanoic acid (EPA) and docosahexanoic acid (DHA), primary ω-3 fatty acids found in fish oils. Previous experimental research and clinical studies in cachectic conditions (mostly malignancy) indicate that polyunsaturated fatty acids (PUFA) are able to attenuate protein degradation by improving the anabolic response to feeding and by decreasing the acute phase response. Eicosapentaenoic acid (EPA), in combination with docosahexaenoic acid (DHA), has been shown to effectively inhibit weight loss in several disease states, however weight weight and muscle mass and function increase was not present or minimal. Also in healthy older adults, fish oil can slow the decline in muscle mass and function. A randomized clinical trial in COPD patients showed that extra nutritional supplementation with PUFAs daily of 1000 mg EPA+DHA as adjunct to exercise training during 8 weeks enhanced exercise capacity but did not lead to muscle mass gain. The patients who did not respond adequately (< 2% gain in weight), had a higher TNF-α level than those who did gain sufficient weight, which is in line with previous data in COPD showing an association between an increased systemic inflammation with non-response to nutritional therapy. Although previous studies support the concept of EPA+DHA supplementation to ameliorate the systemic inflammatory response and decrease protein breakdown, there is no information present on the effects of EPA+DHA supplementation on whole body and muscle protein metabolism in COPD. The investigators have recently examined the dose-response effects of 0, 2 and 3.5 g of EPA+DHA intervention ( EPA / DHA) for 4 weeks in stable moderate to severe COPD patients (8pts /group) (unpublished data) but were not able to find a positive effect of muscle mass and strength, even with the highest dose, likely related to the relatively short (4 week) supplementation period. The effect of EPA+DHA intervention on whole body and muscle protein synthesis and breakdown rates is currently being analysed. Although numerous animal studies have shown the benefit of HMB in downregulating muscle protein breakdown under catabolic conditions, there is very little data in COPD patients. Others have tested HMB (3g/d) in COPD patients in the ICU and reported anti-inflammatory benefits and improvement in pulmonary function. In patients with bronchiectasis, 24 week supplementation with an ONS containing HMB (1.5g/d) versus standard of care during pulmonary rehabilitation program, resulted in benefits on body composition, muscle strength and QoL. A combination of HMB and EPA/DHA in a mouse model of cancer cachexia showed a synergy between the two ingredients on preventing muscle loss and downregulation of muscle protein degradation. |
Facilities
Sequence: | 200622351 |
Name | Texas A&M University-CTRAL |
City | College Station |
State | Texas |
Zip | 77843 |
Country | United States |
Conditions
Sequence: | 52330527 |
Name | Chronic Obstructive Pulmonary Disease |
Downcase Name | chronic obstructive pulmonary disease |
Id Information
Sequence: | 40272623 |
Id Source | org_study_id |
Id Value | 2017-0870 |
Countries
Sequence: | 42692662 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55770682 | Sequence: | 55770683 | Sequence: | 55770684 |
Group Type | Experimental | Group Type | Experimental | Group Type | Placebo Comparator |
Title | Fish Oil | Title | Fish Oil and HMB | Title | Placebo |
Description | 2.0 g EPA + DHA / day + placebo powder | Description | 2.0 g EPA + DHA + 3.0 g HMB / day | Description | 3 g/d soy oil: corn oil (50:50 ratio) + placebo powder |
Interventions
Sequence: | 52641463 | Sequence: | 52641464 |
Intervention Type | Dietary Supplement | Intervention Type | Other |
Name | Capsule + Powder supplementation | Name | stable tracer infusion |
Description | For Fish oil and Placebo oil, treatment will be provided in capsules.Each group will receive dose distributed to 3 capsules per day. Participants will be instructed to take all capsules with morning meal. . For HMB and a placebo powder, product will be delivered as powder taken with water or non-carbonated beverage (like juice). Product will be provided in 2 sachets/day. One sachet should be consumed with breakfast and the other prior to bedtime (approx. 10pm). | Description | labeled amino acids L-Phenylalanine (ring-13C6), L-Tyrosine (ring-D4), and tau-Methylhistidine will be infused as a single injection. Subsequently, the catheter will be used for arterialized venous blood samples (3 ml) drawn multiple through the day |
Keywords
Sequence: | 80088474 | Sequence: | 80088475 |
Name | Fish Oil supplement | Name | HMB supplement |
Downcase Name | fish oil supplement | Downcase Name | hmb supplement |
Design Outcomes
Sequence: | 177967623 | Sequence: | 177967624 | Sequence: | 177967625 | Sequence: | 177967626 | Sequence: | 177967627 | Sequence: | 177967628 | Sequence: | 177967629 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Changes to net whole body protein metabolism | Measure | muscle mass | Measure | limb muscle strength | Measure | respiratory muscle strength | Measure | functional performance via six minute walk test | Measure | systemic inflammatory markers | Measure | resting energy expenditure |
Time Frame | baseline and after 10-week supplementation | Time Frame | 15 minutes on baseline visit, visit at week 5 of supplement intake, and after 10-week supplementation | Time Frame | 15 minutes on baseline visit, visit at week 5 of supplement intake, and after 10-week supplementation | Time Frame | 15 minutes on baseline visit, visit at week 5 of supplement intake, and after 10-week supplementation | Time Frame | baseline visit, visit at week 5 of supplement intake, and after 10-week supplementation | Time Frame | baseline visit and after 10-week supplementation | Time Frame | baseline visit and after 10-week supplementation |
Description | whole body protein synthesis and myofibrillar protein breakdown measured by labeled amino acids on each study day via blood drawn at time 4, 10, 15, 20, 30, 40, 60, 120, 180, 240 minutes of infusion | Description | Body composition as measured by Dual-Energy X-ray Absorptiometry | Description | kin-com 1-leg test | Description | Micro-respiratory pressure meter to measure maximum inspiratory and expiratory pressure | Description | walk a predetermined loop of 69.77 meters (228.89 feet) at self-selected pace for six minutes | Description | blood sample will be taken to measure c-reactive protein levels | Description | Oxygen consumption and carbon dioxide production will be calculated from the airflow in a transparent plastic (Plexiglas) hood to determine concentration differences between inhaled and exhaled air |
Browse Conditions
Sequence: | 194093809 | Sequence: | 194093810 | Sequence: | 194093811 | Sequence: | 194093812 | Sequence: | 194093813 | Sequence: | 194093814 | Sequence: | 194093815 |
Mesh Term | Lung Diseases, Obstructive | Mesh Term | Pulmonary Disease, Chronic Obstructive | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | lung diseases, obstructive | Downcase Mesh Term | pulmonary disease, chronic obstructive | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48468537 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Texas A&M University |
Design Group Interventions
Sequence: | 68364618 | Sequence: | 68364619 | Sequence: | 68364620 | Sequence: | 68364621 | Sequence: | 68364622 | Sequence: | 68364623 |
Design Group Id | 55770682 | Design Group Id | 55770683 | Design Group Id | 55770684 | Design Group Id | 55770682 | Design Group Id | 55770683 | Design Group Id | 55770684 |
Intervention Id | 52641463 | Intervention Id | 52641463 | Intervention Id | 52641463 | Intervention Id | 52641464 | Intervention Id | 52641464 | Intervention Id | 52641464 |
Eligibilities
Sequence: | 30857678 |
Gender | All |
Minimum Age | 45 Years |
Maximum Age | 100 Years |
Healthy Volunteers | No |
Criteria | Inclusion criteria
Ability to walk, sit down and stand up independently Willingness and ability to comply with the protocol, including: Refraining from intense physical activities (72h) prior to each study visit Exclusion Criteria Participants 86 and older that fail to get physician approval Dietary or lifestyle characteristics: Daily use of supplements containing EPA+DHA or HMB prior to the first test day |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253868901 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 23 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 45 |
Maximum Age Num | 100 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30603513 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28970031 |
Responsible Party Type | Principal Investigator |
Name | Marielle PKJ Engelen, PhD |
Title | Associate Professor |
Affiliation | Texas A&M University |
Study References
Sequence: | 52235323 |
Pmid | 34743729 |
Reference Type | derived |
Citation | Pinson MR, Deutz NEP, Harrykissoon R, Zachria AJ, Engelen MPKJ. Disturbances in branched-chain amino acid profile and poor daily functioning in mildly depressed chronic obstructive pulmonary disease patients. BMC Pulm Med. 2021 Nov 7;21(1):351. doi: 10.1186/s12890-021-01719-9. |
]]>
https://zephyrnet.com/NCT03796442
2019-01-23
https://zephyrnet.com/?p=NCT03796442
NCT03796442https://www.clinicaltrials.gov/study/NCT03796442?tab=tableNANANAThe purpose of the study is to compare early and 1-year hemodynamic performance and clinical outcomes after aortic valve replacement using two pericardial bioprosthesis, Avalus and Carpentier Edwards Perimount Magna Ease.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-01 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-02-08 |
Start Month Year | January 23, 2019 |
Primary Completion Month Year | May 13, 2021 |
Verification Month Year | January 2023 |
Verification Date | 2023-01-31 |
Last Update Posted Date | 2023-02-08 |
Results First Posted Date | 2023-02-08 |
Detailed Descriptions
Sequence: | 20559223 |
Description | This trial was designed as a multicenter randomized, controlled trial to recruit 386 patients who undergo aortic valve replacement with pericardial bioprosthesis. Patients were randomized by use of a randomization table. Bioprosthesis was chosen between Avalus or Carpentier Edwards Perimount Magna Ease according to the randomization result. The primary end point is postoperative 1-year transvalvular mean pressure gradient. The secondary end points are postoperative 1-year effective orifice area, operative mortality, operative morbidities, 1-year overall survival, 1-year freedom from cardiac death and 1-year freedom from valve-related events. |
Facilities
Sequence: | 198497634 | Sequence: | 198497635 |
Name | Seoul National University Bundang Hospital | Name | Seoul National University Hospital |
City | Seongnam | City | Seoul |
Country | Korea, Republic of | Country | Korea, Republic of |
Conditions
Sequence: | 51753967 |
Name | Aortic Valve Disease |
Downcase Name | aortic valve disease |
Id Information
Sequence: | 39825290 |
Id Source | org_study_id |
Id Value | D-1812-024-991 |
Countries
Sequence: | 42225344 |
Name | Korea, Republic of |
Removed | False |
Design Groups
Sequence: | 55175113 | Sequence: | 55175114 |
Group Type | Experimental | Group Type | Active Comparator |
Title | AVALUS group | Title | CEPME group |
Description | patients who will undergo aortic valve replacement with Avalus bioprosthesis | Description | patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis |
Interventions
Sequence: | 52075379 | Sequence: | 52075380 |
Intervention Type | Device | Intervention Type | Device |
Name | AVR with AVALUS | Name | AVR with CEPME |
Description | aortic valve replacement with AVALUS bioprosthesis | Description | aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis |
Keywords
Sequence: | 79182620 | Sequence: | 79182621 |
Name | aortic valve replacement | Name | bioprosthesis |
Downcase Name | aortic valve replacement | Downcase Name | bioprosthesis |
Design Outcomes
Sequence: | 176032717 | Sequence: | 176032718 | Sequence: | 176032719 | Sequence: | 176032720 | Sequence: | 176032721 | Sequence: | 176032722 | Sequence: | 176032723 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Transvalvular Mean Pressure Gradient (mPG) | Measure | Effective Orifice Area (EOA) | Measure | Number of Participants With Op Mortality | Measure | Number of Participants With Op Morbidities | Measure | Number of Participants With All-cause Mortality | Measure | Number of Participants With Cardiac Death | Measure | Number of Participants With Aortic Valve-related Events |
Time Frame | at postoperative 1 year | Time Frame | at postoperative 1 year | Time Frame | at postoperative 30 days or at the time of discharge | Time Frame | at postoperative 1 year | Time Frame | at postoperative 1 year | Time Frame | at postoperative 1 year | Time Frame | at postoperative 1 year |
Description | transvalvular mean pressure gradient measured by trans-thoracic echocardiography | Description | effective orifice area measured by trans-thoracic echocardiography | Description | any death within 30 days after surgery or during the same hospital admission | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | patients who died from any cause | Description | Any death related to cardiac events, including sudden death during follow-up | Description | valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation |
Browse Conditions
Sequence: | 191804469 | Sequence: | 191804470 | Sequence: | 191804471 | Sequence: | 191804472 |
Mesh Term | Aortic Valve Disease | Mesh Term | Heart Valve Diseases | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases |
Downcase Mesh Term | aortic valve disease | Downcase Mesh Term | heart valve diseases | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47931257 | Sequence: | 47931258 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Seoul National University Hospital | Name | Seoul National University Bundang Hospital |
Overall Officials
Sequence: | 29041128 |
Role | Principal Investigator |
Name | Ho Young Hwang, MD, PhD |
Affiliation | Seoul National University Hospital |
Design Group Interventions
Sequence: | 67643255 | Sequence: | 67643256 |
Design Group Id | 55175113 | Design Group Id | 55175114 |
Intervention Id | 52075379 | Intervention Id | 52075380 |
Eligibilities
Sequence: | 30521459 |
Gender | All |
Minimum Age | 19 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
patients who are going to undergo aortic valve replacement with bioprosthesis Exclusion Criteria: heart failure with severe LV dysfunction (LV EF <30%) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254081447 |
Number Of Facilities | 2 |
Number Of Sae Subjects | 15 |
Registered In Calendar Year | 2019 |
Actual Duration | 28 |
Were Results Reported | True |
Months To Report Results | 17 |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 19 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30270472 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Milestones
Sequence: | 40739496 | Sequence: | 40739497 | Sequence: | 40739498 | Sequence: | 40739499 | Sequence: | 40739500 | Sequence: | 40739501 |
Result Group Id | 55809025 | Result Group Id | 55809026 | Result Group Id | 55809025 | Result Group Id | 55809026 | Result Group Id | 55809025 | Result Group Id | 55809026 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 70 | Count | 70 | Count | 66 | Count | 63 | Count | 4 | Count | 7 |
Outcome Analyses
Sequence: | 16449188 |
Outcome Id | 30592435 |
Non Inferiority Type | Non-Inferiority |
Non Inferiority Description | The study was designed to have 80% power to detect 1-year AVMPG of 12.6±4.3mmHg for the study prosthesis and 11.9±4.3mmHg for the control prosthesis, with a 1-sided type I error of 2.5% and a noninferiority margin of 3mmHg. The noninferiority margin was determined by the values of 15mmHg for AVMPG of clinically significant aortic stenosis and 12mmHg for AVMPG of the control prosthesis. |
P Value Modifier | |
P Value | 0.0004 |
Method | t-test, 1 sided |
Groups Description | The null hypothesis was that the AvalusTM was inferior to the CEPME based on the AVMPG at 1-year echocardiographic follow-up, with a non-inferiority margin of 3mmHg. The result for the primary endpoint was presented with 97.5% one-sided confidence interval for mean difference between groups. The non-inferiority test was performed using a t-test which compared mean difference between groups with the non-inferiority margin under the one-sided significance level of 0.025. |
Outcome Analysis Groups
Sequence: | 31901331 | Sequence: | 31901332 |
Outcome Analysis Id | 16449188 | Outcome Analysis Id | 16449188 |
Result Group Id | 55809027 | Result Group Id | 55809028 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Participant Flows
Sequence: | 3896094 |
Outcome Counts
Sequence: | 73491503 | Sequence: | 73491504 | Sequence: | 73491505 | Sequence: | 73491506 | Sequence: | 73491507 | Sequence: | 73491508 | Sequence: | 73491509 | Sequence: | 73491510 | Sequence: | 73491511 | Sequence: | 73491512 | Sequence: | 73491513 | Sequence: | 73491514 | Sequence: | 73491515 | Sequence: | 73491516 |
Outcome Id | 30592435 | Outcome Id | 30592435 | Outcome Id | 30592436 | Outcome Id | 30592436 | Outcome Id | 30592437 | Outcome Id | 30592437 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592439 | Outcome Id | 30592439 | Outcome Id | 30592440 | Outcome Id | 30592440 | Outcome Id | 30592441 | Outcome Id | 30592441 |
Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 66 | Count | 63 | Count | 66 | Count | 63 | Count | 70 | Count | 70 | Count | 70 | Count | 70 | Count | 70 | Count | 70 | Count | 70 | Count | 70 | Count | 70 | Count | 70 |
Provided Documents
Sequence: | 2563986 | Sequence: | 2563987 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2018-12-28 | Document Date | 2018-12-28 |
Url | https://ClinicalTrials.gov/ProvidedDocs/42/NCT03796442/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/42/NCT03796442/SAP_001.pdf |
Reported Event Totals
Sequence: | 27759502 | Sequence: | 27759503 | Sequence: | 27759504 | Sequence: | 27759505 | Sequence: | 27759506 | Sequence: | 27759507 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 5 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 6 | Subjects Affected | 0 | Subjects Affected | 6 |
Subjects At Risk | 70 | Subjects At Risk | 70 | Subjects At Risk | 70 | Subjects At Risk | 70 | Subjects At Risk | 70 | Subjects At Risk | 70 |
Created At | 2023-08-06 13:07:23.820187 | Created At | 2023-08-06 13:07:23.820187 | Created At | 2023-08-06 13:07:23.820187 | Created At | 2023-08-06 13:07:23.820187 | Created At | 2023-08-06 13:07:23.820187 | Created At | 2023-08-06 13:07:23.820187 |
Updated At | 2023-08-06 13:07:23.820187 | Updated At | 2023-08-06 13:07:23.820187 | Updated At | 2023-08-06 13:07:23.820187 | Updated At | 2023-08-06 13:07:23.820187 | Updated At | 2023-08-06 13:07:23.820187 | Updated At | 2023-08-06 13:07:23.820187 |
Reported Events
Sequence: | 524235338 | Sequence: | 524235339 | Sequence: | 524235340 | Sequence: | 524235341 | Sequence: | 524235342 | Sequence: | 524235343 | Sequence: | 524235344 | Sequence: | 524235345 | Sequence: | 524235346 | Sequence: | 524235347 | Sequence: | 524235348 | Sequence: | 524235349 |
Result Group Id | 55809029 | Result Group Id | 55809030 | Result Group Id | 55809029 | Result Group Id | 55809030 | Result Group Id | 55809029 | Result Group Id | 55809030 | Result Group Id | 55809029 | Result Group Id | 55809030 | Result Group Id | 55809029 | Result Group Id | 55809030 | Result Group Id | 55809029 | Result Group Id | 55809030 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year |
Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious |
Subjects Affected | 1 | Subjects Affected | 2 | Subjects Affected | 1 | Subjects Affected | 3 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 1 | Subjects Affected | 2 | Subjects Affected | 0 |
Subjects At Risk | 70 | Subjects At Risk | 70 | Subjects At Risk | 70 | Subjects At Risk | 70 | Subjects At Risk | 70 | Subjects At Risk | 70 | Subjects At Risk | 70 | Subjects At Risk | 70 | Subjects At Risk | 70 | Subjects At Risk | 70 | Subjects At Risk | 70 | Subjects At Risk | 70 |
Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders |
Adverse Event Term | cardiac deaths | Adverse Event Term | cardiac deaths | Adverse Event Term | nonstructural valve dysfunction | Adverse Event Term | nonstructural valve dysfunction | Adverse Event Term | thromboembolism | Adverse Event Term | thromboembolism | Adverse Event Term | bleeding event | Adverse Event Term | bleeding event | Adverse Event Term | prosthetic valve endocarditis | Adverse Event Term | prosthetic valve endocarditis | Adverse Event Term | permanent pacemaker implantation | Adverse Event Term | permanent pacemaker implantation |
Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 |
Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment |
Responsible Parties
Sequence: | 28650624 |
Responsible Party Type | Principal Investigator |
Name | Ho Young Hwang |
Title | Professor |
Affiliation | Seoul National University Hospital |
Result Agreements
Sequence: | 3826838 |
Pi Employee | No |
Result Contacts
Sequence: | 3826803 |
Organization | Seoul National University Hospital |
Name | Prof. Ho Young Hwang |
Phone | 00-82-2-2072-3020 |
scalpel@snu.ac.kr | |
Outcomes
Sequence: | 30592440 | Sequence: | 30592435 | Sequence: | 30592436 | Sequence: | 30592437 | Sequence: | 30592438 | Sequence: | 30592439 | Sequence: | 30592441 |
Outcome Type | Secondary | Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Number of Participants With Cardiac Death | Title | Transvalvular Mean Pressure Gradient (mPG) | Title | Effective Orifice Area (EOA) | Title | Number of Participants With Op Mortality | Title | Number of Participants With Op Morbidities | Title | Number of Participants With All-cause Mortality | Title | Number of Participants With Aortic Valve-related Events |
Description | Any death related to cardiac events, including sudden death during follow-up | Description | transvalvular mean pressure gradient measured by trans-thoracic echocardiography | Description | effective orifice area measured by trans-thoracic echocardiography | Description | any death within 30 days after surgery or during the same hospital admission | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | patients who died from any cause | Description | valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation |
Time Frame | at postoperative 1 year | Time Frame | at postoperative 1 year | Time Frame | at postoperative 1 year | Time Frame | at postoperative 30 days or at the time of discharge | Time Frame | at postoperative 1 year | Time Frame | at postoperative 1 year | Time Frame | at postoperative 1 year |
Units | Participants | Units | mmHg | Units | cm2 | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||
Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Outcome Measurements
Sequence: | 233985182 | Sequence: | 233985183 | Sequence: | 233985184 | Sequence: | 233985185 | Sequence: | 233985186 | Sequence: | 233985187 | Sequence: | 233985188 | Sequence: | 233985189 | Sequence: | 233985190 | Sequence: | 233985191 | Sequence: | 233985192 | Sequence: | 233985193 | Sequence: | 233985194 | Sequence: | 233985195 | Sequence: | 233985196 | Sequence: | 233985197 | Sequence: | 233985198 | Sequence: | 233985199 | Sequence: | 233985200 | Sequence: | 233985201 | Sequence: | 233985202 | Sequence: | 233985203 | Sequence: | 233985204 | Sequence: | 233985205 | Sequence: | 233985206 | Sequence: | 233985207 | Sequence: | 233985208 | Sequence: | 233985209 | Sequence: | 233985210 | Sequence: | 233985211 | Sequence: | 233985212 | Sequence: | 233985213 |
Outcome Id | 30592435 | Outcome Id | 30592435 | Outcome Id | 30592436 | Outcome Id | 30592436 | Outcome Id | 30592437 | Outcome Id | 30592437 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592438 | Outcome Id | 30592439 | Outcome Id | 30592439 | Outcome Id | 30592440 | Outcome Id | 30592440 | Outcome Id | 30592441 | Outcome Id | 30592441 |
Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 | Result Group Id | 55809027 | Result Group Id | 55809028 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Category | Postoperative atrial fibrillation | Category | Postoperative atrial fibrillation | Category | Respiratory complication | Category | Respiratory complication | Category | Acute kidney injury | Category | Acute kidney injury | Category | Stroke | Category | Stroke | Category | Low cardiac output | Category | Low cardiac output | Category | Complete atrioventricular block | Category | Complete atrioventricular block | Category | Bleeding reoperation | Category | Bleeding reoperation | Category | Mediastinitis | Category | Mediastinitis | Category | Infective endocarditis | Category | Infective endocarditis | Category | No complication | Category | No complication | ||||||||||||||||||||||||
Title | Transvalvular Mean Pressure Gradient (mPG) | Title | Transvalvular Mean Pressure Gradient (mPG) | Title | Effective Orifice Area (EOA) | Title | Effective Orifice Area (EOA) | Title | Number of Participants With Op Mortality | Title | Number of Participants With Op Mortality | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With Op Morbidities | Title | Number of Participants With All-cause Mortality | Title | Number of Participants With All-cause Mortality | Title | Number of Participants With Cardiac Death | Title | Number of Participants With Cardiac Death | Title | Number of Participants With Aortic Valve-related Events | Title | Number of Participants With Aortic Valve-related Events |
Description | transvalvular mean pressure gradient measured by trans-thoracic echocardiography | Description | transvalvular mean pressure gradient measured by trans-thoracic echocardiography | Description | effective orifice area measured by trans-thoracic echocardiography | Description | effective orifice area measured by trans-thoracic echocardiography | Description | any death within 30 days after surgery or during the same hospital admission | Description | any death within 30 days after surgery or during the same hospital admission | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | Description | patients who died from any cause | Description | patients who died from any cause | Description | Any death related to cardiac events, including sudden death during follow-up | Description | Any death related to cardiac events, including sudden death during follow-up | Description | valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation | Description | valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation |
Units | mmHg | Units | mmHg | Units | cm2 | Units | cm2 | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 14.1 | Param Value | 13.9 | Param Value | 1.48 | Param Value | 1.53 | Param Value | 0 | Param Value | 0 | Param Value | 21 | Param Value | 24 | Param Value | 6 | Param Value | 7 | Param Value | 4 | Param Value | 2 | Param Value | 2 | Param Value | 2 | Param Value | 2 | Param Value | 1 | Param Value | 2 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 32 | Param Value | 33 | Param Value | 1 | Param Value | 6 | Param Value | 1 | Param Value | 2 | Param Value | 5 | Param Value | 6 |
Param Value Num | 14.1 | Param Value Num | 13.9 | Param Value Num | 1.48 | Param Value Num | 1.53 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 21.0 | Param Value Num | 24.0 | Param Value Num | 6.0 | Param Value Num | 7.0 | Param Value Num | 4.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 32.0 | Param Value Num | 33.0 | Param Value Num | 1.0 | Param Value Num | 6.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 5.0 | Param Value Num | 6.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 4.3 | Dispersion Value | 5.1 | Dispersion Value | 0.39 | Dispersion Value | 0.38 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 4.3 | Dispersion Value Num | 5.1 | Dispersion Value Num | 0.39 | Dispersion Value Num | 0.38 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Study References
Sequence: | 51645986 |
Pmid | 35917824 |
Reference Type | derived |
Citation | Sohn SH, Kim JS, Choi JW, Lee JH, Kim JS, Lim C, Hwang HY. Preliminary Report from a Randomized Controlled Trial Comparing Two Bovine Pericardial Valves. Thorac Cardiovasc Surg. 2022 Aug 2. doi: 10.1055/s-0042-1753494. Online ahead of print. |
Baseline Counts
Sequence: | 11310265 | Sequence: | 11310266 | Sequence: | 11310267 |
Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 70 | Count | 70 | Count | 140 |
Result Groups
Sequence: | 55809022 | Sequence: | 55809023 | Sequence: | 55809024 | Sequence: | 55809025 | Sequence: | 55809026 | Sequence: | 55809027 | Sequence: | 55809028 | Sequence: | 55809029 | Sequence: | 55809030 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | AVALUS Group | Title | CEPME Group | Title | Total | Title | AVALUS Group | Title | CEPME Group | Title | AVALUS Group | Title | CEPME Group | Title | AVALUS Group | Title | CEPME Group |
Description | patients who will undergo aortic valve replacement with Avalus bioprosthesis
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis |
Description | patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis |
Description | Total of all reporting groups | Description | patients who will undergo aortic valve replacement with Avalus bioprosthesis
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis |
Description | patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis |
Description | patients who will undergo aortic valve replacement with Avalus bioprosthesis
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis |
Description | patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis |
Description | patients who will undergo aortic valve replacement with Avalus bioprosthesis
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis |
Description | patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis |
Baseline Measurements
Sequence: | 124800232 | Sequence: | 124800230 | Sequence: | 124800231 | Sequence: | 124800233 | Sequence: | 124800234 | Sequence: | 124800235 | Sequence: | 124800236 | Sequence: | 124800237 | Sequence: | 124800238 | Sequence: | 124800239 | Sequence: | 124800240 | Sequence: | 124800241 | Sequence: | 124800242 | Sequence: | 124800243 | Sequence: | 124800244 | Sequence: | 124800245 | Sequence: | 124800246 | Sequence: | 124800247 | Sequence: | 124800248 | Sequence: | 124800249 | Sequence: | 124800250 | Sequence: | 124800251 | Sequence: | 124800252 | Sequence: | 124800253 | Sequence: | 124800254 | Sequence: | 124800255 | Sequence: | 124800256 | Sequence: | 124800257 | Sequence: | 124800258 | Sequence: | 124800259 | Sequence: | 124800260 | Sequence: | 124800261 | Sequence: | 124800262 | Sequence: | 124800263 | Sequence: | 124800264 | Sequence: | 124800265 | Sequence: | 124800266 | Sequence: | 124800267 | Sequence: | 124800268 | Sequence: | 124800269 | Sequence: | 124800270 | Sequence: | 124800271 | Sequence: | 124800272 | Sequence: | 124800273 | Sequence: | 124800274 | Sequence: | 124800275 | Sequence: | 124800276 | Sequence: | 124800277 | Sequence: | 124800278 | Sequence: | 124800279 | Sequence: | 124800280 | Sequence: | 124800281 | Sequence: | 124800282 | Sequence: | 124800283 | Sequence: | 124800284 | Sequence: | 124800285 | Sequence: | 124800286 | Sequence: | 124800287 | Sequence: | 124800288 | Sequence: | 124800289 | Sequence: | 124800290 | Sequence: | 124800291 | Sequence: | 124800292 | Sequence: | 124800293 | Sequence: | 124800294 | Sequence: | 124800295 | Sequence: | 124800296 | Sequence: | 124800297 | Sequence: | 124800298 |
Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 | Result Group Id | 55809022 | Result Group Id | 55809023 | Result Group Id | 55809024 |
Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Classification | South Korea | Classification | South Korea | Classification | South Korea | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Asian | Category | Asian | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | White | Category | White | Category | White | Category | More than one race | Category | More than one race | Category | More than one race | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Region of Enrollment | Title | Region of Enrollment | Title | Region of Enrollment | Title | Body mass index | Title | Body mass index | Title | Body mass index | Title | Body surface area | Title | Body surface area | Title | Body surface area | Title | Diabetes mellitus | Title | Diabetes mellitus | Title | Diabetes mellitus | Title | Hypertension | Title | Hypertension | Title | Hypertension | Title | Dyslipidemia | Title | Dyslipidemia | Title | Dyslipidemia | Title | Chronic obstructive pulmonary disease | Title | Chronic obstructive pulmonary disease | Title | Chronic obstructive pulmonary disease | Title | Stroke | Title | Stroke | Title | Stroke | Title | Chronic kidney disease | Title | Chronic kidney disease | Title | Chronic kidney disease | Title | Peripheral vascular disease | Title | Peripheral vascular disease | Title | Peripheral vascular disease | Title | Atrial fibrillation | Title | Atrial fibrillation | Title | Atrial fibrillation | Title | Reoperation | Title | Reoperation | Title | Reoperation | Title | EuroSCORE II | Title | EuroSCORE II | Title | EuroSCORE II |
Description | The EuroSCORE II (European System for Cardiac Operative Risk Evaluation) is a prognostic scoring system developed in Europe for patients undergoing cardiac surgery. It calculates the risk of in-hospital mortality after major cardiac surgery. The scale ranges from 0 to 100. Higher value of the EuroSCORE II represents that the patient is predicted to have a worse outcome. | Description | The EuroSCORE II (European System for Cardiac Operative Risk Evaluation) is a prognostic scoring system developed in Europe for patients undergoing cardiac surgery. It calculates the risk of in-hospital mortality after major cardiac surgery. The scale ranges from 0 to 100. Higher value of the EuroSCORE II represents that the patient is predicted to have a worse outcome. | Description | The EuroSCORE II (European System for Cardiac Operative Risk Evaluation) is a prognostic scoring system developed in Europe for patients undergoing cardiac surgery. It calculates the risk of in-hospital mortality after major cardiac surgery. The scale ranges from 0 to 100. Higher value of the EuroSCORE II represents that the patient is predicted to have a worse outcome. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | participants | Units | participants | Units | kg/m^2 | Units | kg/m^2 | Units | kg/m^2 | Units | m^2 | Units | m^2 | Units | m^2 | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | units on a scale | Units | units on a scale | Units | units on a scale |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 72.8 | Param Value | 71.4 | Param Value | 74.3 | Param Value | 36 | Param Value | 33 | Param Value | 69 | Param Value | 34 | Param Value | 37 | Param Value | 71 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 70 | Param Value | 70 | Param Value | 140 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 70 | Param Value | 70 | Param Value | 140 | Param Value | 24.8 | Param Value | 24.4 | Param Value | 24.6 | Param Value | 1.64 | Param Value | 1.65 | Param Value | 1.65 | Param Value | 24 | Param Value | 24 | Param Value | 48 | Param Value | 52 | Param Value | 47 | Param Value | 99 | Param Value | 42 | Param Value | 31 | Param Value | 73 | Param Value | 4 | Param Value | 9 | Param Value | 13 | Param Value | 7 | Param Value | 7 | Param Value | 14 | Param Value | 8 | Param Value | 18 | Param Value | 26 | Param Value | 1 | Param Value | 2 | Param Value | 3 | Param Value | 8 | Param Value | 7 | Param Value | 15 | Param Value | 1 | Param Value | 1 | Param Value | 2 | Param Value | 1.87 | Param Value | 2.11 | Param Value | 1.99 |
Param Value Num | 72.8 | Param Value Num | 71.4 | Param Value Num | 74.3 | Param Value Num | 36.0 | Param Value Num | 33.0 | Param Value Num | 69.0 | Param Value Num | 34.0 | Param Value Num | 37.0 | Param Value Num | 71.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 70.0 | Param Value Num | 70.0 | Param Value Num | 140.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 70.0 | Param Value Num | 70.0 | Param Value Num | 140.0 | Param Value Num | 24.8 | Param Value Num | 24.4 | Param Value Num | 24.6 | Param Value Num | 1.64 | Param Value Num | 1.65 | Param Value Num | 1.65 | Param Value Num | 24.0 | Param Value Num | 24.0 | Param Value Num | 48.0 | Param Value Num | 52.0 | Param Value Num | 47.0 | Param Value Num | 99.0 | Param Value Num | 42.0 | Param Value Num | 31.0 | Param Value Num | 73.0 | Param Value Num | 4.0 | Param Value Num | 9.0 | Param Value Num | 13.0 | Param Value Num | 7.0 | Param Value Num | 7.0 | Param Value Num | 14.0 | Param Value Num | 8.0 | Param Value Num | 18.0 | Param Value Num | 26.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 3.0 | Param Value Num | 8.0 | Param Value Num | 7.0 | Param Value Num | 15.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 1.87 | Param Value Num | 2.11 | Param Value Num | 1.99 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 6.4 | Dispersion Value | 5.5 | Dispersion Value | 6.9 | Dispersion Value | 3.4 | Dispersion Value | 2.8 | Dispersion Value | 3.1 | Dispersion Value | 0.18 | Dispersion Value | 0.15 | Dispersion Value | 0.16 | Dispersion Value | 1.41 | Dispersion Value | 1.67 | Dispersion Value | 1.54 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 6.4 | Dispersion Value Num | 5.5 | Dispersion Value Num | 6.9 | Dispersion Value Num | 3.4 | Dispersion Value Num | 2.8 | Dispersion Value Num | 3.1 | Dispersion Value Num | 0.18 | Dispersion Value Num | 0.15 | Dispersion Value Num | 0.16 | Dispersion Value Num | 1.41 | Dispersion Value Num | 1.67 | Dispersion Value Num | 1.54 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 | Number Analyzed | 70 | Number Analyzed | 70 | Number Analyzed | 140 |
]]>
https://zephyrnet.com/NCT03796429
2018-12-17
https://zephyrnet.com/?p=NCT03796429
NCT03796429https://www.clinicaltrials.gov/study/NCT03796429?tab=tableTianshu Liu, Doctorliu.tianshu@zs-hospital.sh.cn+861368 1973 996Target population: patients with advanced biliary tract cancer (including gallbladder carcinoma, intrahepatic and extrahepatic cholangiocarcinoma) .
Primary objective: progression free survival (PFS)/ overall survival (OS) of first-line chemotherapy plus PD-1 antibody (Toripalimab) in patients with advanced biliary tract cancer.
Secondary objectives:
objective response rate (ORR) of first-line chemotherapy plus PD-1 antibody (Toripalimab)
safety of first-line chemotherapy plus PD-1 antibody (Toripalimab)
3.Trial design: This is a monocenter, single arm, phase II study to evaluate the efficacy and safety of first-line chemotherapy plus PD-1 antibody (Toripalimab) in patients with advanced advanced biliary tract cancer.
4.Treatment plan: Patients will be given treatment as below once recruited: PD-1 antibody Toripalimab(240mg, iv, q3w),combined with GS regimen(gemcitabine 1000mg/m2 ,d1,d8 + S1 40-60mg bid*14d,Q21d).
The treatment will be continued until emerging of disease progression or intolerable adverse effects (The upper time limit for treatment is 2 years).
5.Number of subjects: 40 patients. Number of centers: 1 sites ( Fudan University Affiliated Zhongshan Hospital).
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | December 17, 2018 |
Primary Completion Month Year | December 1, 2022 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-08 |
Detailed Descriptions
Sequence: | 20735720 |
Description | Backgrounds:
Toripalimab (JS-001) is a PD-1 antibody developed by Shanghai Jun Shi Biomedical technology Co. Ltd. Nowadays, eighteen clinical trials of this drug have been conducted in patients with different types of advanced malignant tumor. Until now, Toripalimab has exhibited favorable safety in recruited patients. Incidence rate of SAE is 14.7%. JS001-Ib-CRP-1.0 is a phase Ib/II basket trial, aiming at evaluating safety and efficacy of JS001 in treating advanced gastric adenocarcinoma, esophageal squamous cell carcinoma, nasopharyngeal carcinoma and head and neck squamous cell carcinoma.The interim analyses results of 161 patients show that the ORR is 22.4%. Now, the standard chemotherapies regimen for advanced biliary tract cancer include gemcitabine, platinum and fluorouracil; Considering the synergistic effect of chemotherapy and immune therapy, we choose GS regimen (gemcitabine+S1) to combine Toripalimab. We will shut down the study in advance, if unpredicted SAE or low efficacy occur. Patients with abnormal autoimmune status, unfavorable body function, factors impeding drug taking, absorption and metabolism will be excluded. Study participants with disease progression or severe/ intolerant toxicity during treatment will withdraw the study. Hyper-progressive disease is defined as 1) progression 2) more than doubled growth rate 3) tumor volume increase >50% in 2 months after initialing the treatment. |
Facilities
Sequence: | 200243995 |
Status | Recruiting |
Name | Zhongshan Hospital Affiliated to Fudan University |
City | Shanghai |
State | Shanghai |
Zip | 200032 |
Country | China |
Facility Contacts
Sequence: | 28127921 |
Facility Id | 200243995 |
Contact Type | primary |
Name | Tianshu Liu, Doctor |
liu.tianshu@zs-hospital.sh.cn | |
Facility Investigators
Sequence: | 18343526 |
Facility Id | 200243995 |
Role | Sub-Investigator |
Name | Yiyi Yu, master |
Conditions
Sequence: | 52207923 |
Name | Biliary Tract Cancer |
Downcase Name | biliary tract cancer |
Id Information
Sequence: | 40186052 |
Id Source | org_study_id |
Id Value | JS001-ZS-BC001 |
Countries
Sequence: | 42599558 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55634523 |
Group Type | Experimental |
Title | GS+Toripalimab |
Interventions
Sequence: | 52521940 |
Intervention Type | Drug |
Name | GS+Toripalimab |
Description | Patients will be given treatment as below once recruited: PD-1 antibody Toripalimab(240mg, iv, q3w),combined with GS regimen(gemcitabine 1000mg/m2 ,d1,d8 + S1 40-60mg bid*14d,Q21d).
The treatment will be continued until emerging of disease progression or intolerable adverse effects (The upper time limit for treatment is 2 years). |
Keywords
Sequence: | 79922728 | Sequence: | 79922729 | Sequence: | 79922730 |
Name | Advanced Biliary Tract Cancer | Name | PD-1 antibody(Toripalimab) | Name | first-line chemotherapy |
Downcase Name | advanced biliary tract cancer | Downcase Name | pd-1 antibody(toripalimab) | Downcase Name | first-line chemotherapy |
Design Outcomes
Sequence: | 177510711 | Sequence: | 177510712 | Sequence: | 177510713 | Sequence: | 177510714 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | progression free survival (PFS) of GS regimen plus PD-1 antibody (Toripalimab) | Measure | overall survival (OS) of GS regimen plus PD-1 antibody (Toripalimab) | Measure | objective response rate (ORR) of GS regimen plus PD-1 antibody (Toripalimab) | Measure | safety of GS regimen plus PD-1 antibody (Toripalimab) |
Time Frame | 36 months after the last subject participating in | Time Frame | 36 months after the last subject participating in | Time Frame | 36 months after the last subject participating in | Time Frame | 1 month after the last date of treatment |
Description | PFS is defined as time interval from recruitment to tumor progression or censoring. Tumor progression is defined as below: 1) relapse of primary lesion 2) emerging of new lesion 3) distant metastasis 4) death of any reason 5)tumor progression according to RESIST 1.1 on CT/MRI. | Description | OS is defined as time interval from recruitment to all-caused death or censoring. | Description | rate of patients with complete remission (CR) or partial remission (PR) based on RESIST1.1. ORR was evaluated by chest, abdominal & pelvic CT/MRI. Evaluation will be conducted every 6 weeks during treatment, and every 0.5 year after all treatments. | Description | Adverse events (AE) of chemotherapy will be graded and documented according to NCI-CTC AE v4.03 from the beginning of treatment to 1 months after the last date of treatment. Documentary will include severity, lasting period and occurrence time. Main AEs include vomiting, diarrhea, anemia, leukopenia, thrombocytopenia, hand-foot syndrome, immune related adverse events (including interstitial lung disease, AST/ALT elevations, hypothyroidism and hyperthyroidism,etc) and hyper-progressive tumor. |
Browse Conditions
Sequence: | 193626419 | Sequence: | 193626420 | Sequence: | 193626421 | Sequence: | 193626422 | Sequence: | 193626423 | Sequence: | 193626424 |
Mesh Term | Biliary Tract Neoplasms | Mesh Term | Digestive System Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Biliary Tract Diseases | Mesh Term | Digestive System Diseases |
Downcase Mesh Term | biliary tract neoplasms | Downcase Mesh Term | digestive system neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | biliary tract diseases | Downcase Mesh Term | digestive system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48353566 | Sequence: | 48353567 | Sequence: | 48353568 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Shanghai Zhongshan Hospital | Name | Shanghai Junshi Bioscience Co., Ltd. | Name | OrigiMed |
Overall Officials
Sequence: | 29305913 |
Role | Principal Investigator |
Name | Tianshu Liu, Doctor |
Affiliation | Shanghai Zhongshan Hospital |
Central Contacts
Sequence: | 12017165 |
Contact Type | primary |
Name | Tianshu Liu, Doctor |
Phone | +861368 1973 996 |
liu.tianshu@zs-hospital.sh.cn | |
Role | Contact |
Design Group Interventions
Sequence: | 68199013 |
Design Group Id | 55634523 |
Intervention Id | 52521940 |
Eligibilities
Sequence: | 30786793 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 75 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Male or female. Age ≥ 18 years and ≤75 years. Exclusion Criteria: history of chemo, radiation, immune therapy or radical resection for the biliary tract cancer, except those patients who relapsed after 6 months since the last time of adjuvant therapy. patients with any cardiovascular risk factors below: cardiac chest pain occurring in 28 days before recruitment, defined as moderate pain that limits daily activity. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989461 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 75 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30532863 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28899157 |
Responsible Party Type | Principal Investigator |
Name | Tianshu Liu |
Title | Doctor |
Affiliation | Shanghai Zhongshan Hospital |
]]>
https://zephyrnet.com/NCT03796416
2019-12-01
https://zephyrnet.com/?p=NCT03796416
NCT03796416https://www.clinicaltrials.gov/study/NCT03796416?tab=tableNANANAThere are more and more pregnant women who are obese. It is very difficult for obese women to get into labor. That is why when women are obese, half are likely to need a Cesarean delivery(C-section). Unfortunately, C-sections are more dangerous for obese women. There may be a combination of issues that cause obese women to need C-sections. We believe one of those reasons is that the womb of obese women respond differently to medications and devices compared to non-obese women. There are commonly two ways to help women get into labor. One way is a medication called misoprostol. The second way is a device called Foley balloon. In most studies, both ways are equally effective in helping women get into labor. However, these studies included everyone, and didn’t focus on obese women.
So far there are no studies in this area that focus only on obese women. Therefore we need to design this study to focus just on obese women and what is the best way to help them get into labor and avoid a C-section.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-03-22 |
Start Month Year | December 1, 2019 |
Primary Completion Month Year | January 2022 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-03-22 |
Browse Interventions
Sequence: | 95376750 | Sequence: | 95376751 | Sequence: | 95376752 | Sequence: | 95376753 | Sequence: | 95376754 | Sequence: | 95376755 | Sequence: | 95376756 | Sequence: | 95376757 |
Mesh Term | Misoprostol | Mesh Term | Abortifacient Agents, Nonsteroidal | Mesh Term | Abortifacient Agents | Mesh Term | Reproductive Control Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Anti-Ulcer Agents | Mesh Term | Gastrointestinal Agents | Mesh Term | Oxytocics |
Downcase Mesh Term | misoprostol | Downcase Mesh Term | abortifacient agents, nonsteroidal | Downcase Mesh Term | abortifacient agents | Downcase Mesh Term | reproductive control agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | anti-ulcer agents | Downcase Mesh Term | gastrointestinal agents | Downcase Mesh Term | oxytocics |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51829157 |
Name | Induction of Labor Affected Fetus / Newborn |
Downcase Name | induction of labor affected fetus / newborn |
Id Information
Sequence: | 39885427 |
Id Source | org_study_id |
Id Value | HP-00077208 |
Design Groups
Sequence: | 55252108 | Sequence: | 55252109 |
Group Type | Active Comparator | Group Type | Experimental |
Title | misoprostol | Title | Misoprostol and foley bulb |
Description | Induction using misoprostol:
Insert misoprostol 25 micrograms in the posterior fornix of the vagina digitally Repeat cervical exam every 4 hours |
Description | Induction using Foley balloon combined with misoprostol:
A 26 French intracervical Foley balloon will be inserted above the internal os at the start of induction, inflated using 80cc of sterile water. If a Foley balloon is not able to be inserted at the time of starting induction of labor, misoprostol 25microgram can be inserted in the posterior fornix of the vagina and the misoprostol protocol followed. |
Interventions
Sequence: | 52150121 |
Intervention Type | Drug |
Name | Misoprostol |
Description | used at a rate of 25 mcg Q4hours for cervical ripening. |
Design Outcomes
Sequence: | 176273032 |
Outcome Type | primary |
Measure | achieving complete cervical dilation |
Time Frame | 24 hours |
Browse Conditions
Sequence: | 192106937 | Sequence: | 192106938 | Sequence: | 192106939 | Sequence: | 192106940 | Sequence: | 192106941 |
Mesh Term | Obesity | Mesh Term | Overweight | Mesh Term | Overnutrition | Mesh Term | Nutrition Disorders | Mesh Term | Body Weight |
Downcase Mesh Term | obesity | Downcase Mesh Term | overweight | Downcase Mesh Term | overnutrition | Downcase Mesh Term | nutrition disorders | Downcase Mesh Term | body weight |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48001218 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Maryland, Baltimore |
Design Group Interventions
Sequence: | 67736268 | Sequence: | 67736269 |
Design Group Id | 55252109 | Design Group Id | 55252108 |
Intervention Id | 52150121 | Intervention Id | 52150121 |
Eligibilities
Sequence: | 30564635 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 45 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Morbidly obese patient (BMI≥40kg/m2) at admission for induction of labor Speaks English Gestational age between 37and0 weeks and 41and6 weeks Cervical exam: dilation <4cm and Bishop score 6 or less Contractions < 2 per 10 minutes Exclusion Criteria: History of cesarean delivery Maternal contraindications to labor Fetal contraindications to labor Maternal age <18yo Fetal growth restriction with abnormal umbilical artery Doppler indexes Cervical dilation ≥4cm or Bishop score ≥7 Contractions ≥3 per 10 minutes Non-reassuring fetal status Latex allergy |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254259129 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 45 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30312913 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28691554 |
Responsible Party Type | Principal Investigator |
Name | Sarah Crimmins |
Title | Assistant Professor |
Affiliation | University of Maryland, Baltimore |
]]>
https://zephyrnet.com/NCT03796403
2019-02-15
https://zephyrnet.com/?p=NCT03796403
NCT03796403https://www.clinicaltrials.gov/study/NCT03796403?tab=tableNANANAcompare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score (VAS).
<![CDATA[
Studies
Study First Submitted Date | 2018-09-28 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-10-23 |
Start Month Year | February 15, 2019 |
Primary Completion Month Year | September 30, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2020-10-23 |
Detailed Descriptions
Sequence: | 20741032 |
Description | The primary objective is to compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score (VAS). The secondary objective is to evaluate the time to first dose and the total amount of morphine requirement after the operation in both groups. |
Facilities
Sequence: | 200279709 |
Name | Rajavithi hospital |
City | Bangkok |
Zip | 10400 |
Country | Thailand |
Browse Interventions
Sequence: | 96132450 | Sequence: | 96132451 | Sequence: | 96132452 | Sequence: | 96132453 | Sequence: | 96132454 | Sequence: | 96132455 | Sequence: | 96132456 | Sequence: | 96132457 | Sequence: | 96132458 | Sequence: | 96132459 | Sequence: | 96132460 | Sequence: | 96132461 |
Mesh Term | Diclofenac | Mesh Term | Anti-Inflammatory Agents, Non-Steroidal | Mesh Term | Analgesics, Non-Narcotic | Mesh Term | Analgesics | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Anti-Inflammatory Agents | Mesh Term | Antirheumatic Agents | Mesh Term | Cyclooxygenase Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | diclofenac | Downcase Mesh Term | anti-inflammatory agents, non-steroidal | Downcase Mesh Term | analgesics, non-narcotic | Downcase Mesh Term | analgesics | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | anti-inflammatory agents | Downcase Mesh Term | antirheumatic agents | Downcase Mesh Term | cyclooxygenase inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52221198 |
Name | Post-operative Pain |
Downcase Name | post-operative pain |
Id Information
Sequence: | 40195401 |
Id Source | org_study_id |
Id Value | Suphetgyn2516 |
Countries
Sequence: | 42609354 |
Name | Thailand |
Removed | False |
Design Groups
Sequence: | 55649431 | Sequence: | 55649432 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | diclofenac and bupivacaine group | Title | bupivacaine only group |
Description | Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum , divided in 10 sites before closure, and diclofenac 75 mg (3 mL) was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing. | Description | Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum, divided in 10 sites before closure and a 3 mL of sterile water was intramuscularly injected immediately after complete the procedure. |
Interventions
Sequence: | 52534972 |
Intervention Type | Other |
Name | Diclofenac |
Description | Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum , divided in 10 sites before closure, and diclofenac 75 mg (3 mL) was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing. |
Design Outcomes
Sequence: | 177560132 | Sequence: | 177560133 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Post-operative pain relief | Measure | Morphine requirement |
Time Frame | During acute post operation peroid as 24 hours post operation | Time Frame | During acute post operation period as 24 hours post operation |
Description | compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score(VAS). Score 0-10 .When Score is higher than 5 score ,the pateint will gain the analgesia as opioid. | Description | evaluate the time to first dose post operation and the total amount of morphine requirement after the operation in both groups. Score 0-10 .When Score is higher than 5 score ,the pateint will gain the analgesia as opioid. |
Browse Conditions
Sequence: | 193677292 | Sequence: | 193677293 | Sequence: | 193677294 | Sequence: | 193677295 | Sequence: | 193677296 |
Mesh Term | Pain, Postoperative | Mesh Term | Postoperative Complications | Mesh Term | Pathologic Processes | Mesh Term | Pain | Mesh Term | Neurologic Manifestations |
Downcase Mesh Term | pain, postoperative | Downcase Mesh Term | postoperative complications | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | pain | Downcase Mesh Term | neurologic manifestations |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366110 |
Agency Class | OTHER_GOV |
Lead Or Collaborator | lead |
Name | Rajavithi Hospital |
Overall Officials
Sequence: | 29312755 |
Role | Principal Investigator |
Name | Suphet Tuipae, MD |
Affiliation | Rajavithi Hospital |
Design Group Interventions
Sequence: | 68216883 | Sequence: | 68216884 |
Design Group Id | 55649432 | Design Group Id | 55649431 |
Intervention Id | 52534972 | Intervention Id | 52534972 |
Eligibilities
Sequence: | 30794516 |
Gender | Female |
Minimum Age | 21 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
gynecologic cancer patients ,i.e. cervical cancer, endometrial cancer, or ovarian tumor suspicious for malignancy Exclusion Criteria: patient who had emergency conditions – indication for emergency operation operation purpose for only tumor biopsy Women who have abnormal kidney function test (Cr > 1.5) |
Gender Description | Gynecologic cancer patients |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004003 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 7 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 21 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30540556 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Intervention Model Description | randomized into two groups by simple random. In bupivacaine and diclofenac group (n=70), Twenty ml of bupivacaine was infiltrated into surgical-site peritoneum and diclofenac 75 mg was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing. In the bupivacaine alone group (n=70), 20 ml of bupivacaine was infiltrated into surgical-site peritoneum before closure and a 3 ml of sterile water was intramuscularly injected immediately after complete the procedure. Intravenous morphine injection was given if the pain score was more than 6 in the first 24 hours. Post-operation; time to first request of pain medication, doses, side effects, and vital signs were recorded. VAS was recorded at 2, 6, 12 and 24 hours post-operation and patients' satisfied score was recorded after 24 hours post-operation. |
Subject Masked | True |
Caregiver Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28906876 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796390
2018-12-26
https://zephyrnet.com/?p=NCT03796390
NCT03796390https://www.clinicaltrials.gov/study/NCT03796390?tab=tableJianqiang Li, PhD&MDlimmune@gmail.com008615511369555This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting CD123 in the treatment of Acute Myelocytic Leukemia. A total of 15 patients are planned to be enrolled following up one year.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-11 |
Start Month Year | December 26, 2018 |
Primary Completion Month Year | November 6, 2020 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-11 |
Detailed Descriptions
Sequence: | 20709977 |
Description | Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may be potential in developing the corresponding CAR-T cells to treat patients whose tumors expressing those markers. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting CD123 in patients with Acute Myelocytic Leukemia. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated. |
Facilities
Sequence: | 199965046 |
Status | Recruiting |
Name | Hebei Yanda Ludaopei Hospital |
City | Langfang |
State | Hebei |
Zip | 065000 |
Country | China |
Facility Contacts
Sequence: | 28086642 |
Facility Id | 199965046 |
Contact Type | primary |
Name | Peihua Lu, PhD&MD |
peihua_lu@126.com | |
Phone | 008618611636172 |
Facility Investigators
Sequence: | 18318885 | Sequence: | 18318886 |
Facility Id | 199965046 | Facility Id | 199965046 |
Role | Principal Investigator | Role | Sub-Investigator |
Name | Peihua Lu, PhD&MD | Name | Jianqiang Li, PhD&MD |
Conditions
Sequence: | 52138974 |
Name | Acute Myelocytic Leukemia |
Downcase Name | acute myelocytic leukemia |
Id Information
Sequence: | 40135035 |
Id Source | org_study_id |
Id Value | Daopei CD123CAR-T |
Countries
Sequence: | 42542669 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55559311 |
Group Type | Experimental |
Title | CD123 CAR-T cells |
Description | Patients will be be treated with CD123 CAR-T cells |
Interventions
Sequence: | 52454874 |
Intervention Type | Biological |
Name | CD123 CAR-T cells |
Description | Patients will be drawn 50-100 ml blood to obtain enough peripheral blood mononuclear cells (PBMC) for CAR-T manufacturing. The T cells will be purified from the PBMC, transduced with CAR lentiviral vector, expanded in vitro and then frozen for future administration. Chemotherapy will then be given. Following tumor burden reassessment, CD123 CAR-T cells will be infused. |
Keywords
Sequence: | 79822776 |
Name | AML,CD123 |
Downcase Name | aml,cd123 |
Design Outcomes
Sequence: | 177263538 | Sequence: | 177263539 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Tumor load | Measure | CAR-T cell persistence |
Time Frame | Up to 12 months | Time Frame | Up to 12 months |
Description | Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis. | Description | CAR-T cell persistence will be quantified with flow cytometry and qPCR; Percentage of CART cells in BM and copies of car per ug DNA |
Browse Conditions
Sequence: | 193366401 | Sequence: | 193366402 | Sequence: | 193366403 | Sequence: | 193366399 | Sequence: | 193366400 |
Mesh Term | Leukemia, Myeloid, Acute | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Leukemia | Mesh Term | Leukemia, Myeloid |
Downcase Mesh Term | leukemia, myeloid, acute | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | leukemia | Downcase Mesh Term | leukemia, myeloid |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list |
Sponsors
Sequence: | 48290682 | Sequence: | 48290683 |
Agency Class | INDUSTRY | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Hebei Senlang Biotechnology Inc., Ltd. | Name | Hebei Yanda Ludaopei Hospital |
Overall Officials
Sequence: | 29268523 |
Role | Study Chair |
Name | Peihua Lu, PhD&MD |
Affiliation | Hebei Yanda Ludaopei Hospital |
Central Contacts
Sequence: | 12000483 | Sequence: | 12000484 |
Contact Type | primary | Contact Type | backup |
Name | Peihua Lu, PhD&MD | Name | Jianqiang Li, PhD&MD |
Phone | 008618611636172 | Phone | 008615511369555 |
peihua_lu@126.com | limmune@gmail.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68107410 |
Design Group Id | 55559311 |
Intervention Id | 52454874 |
Eligibilities
Sequence: | 30747705 |
Gender | All |
Minimum Age | 2 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Subjects with acute myeloid leukemia who voluntarily signed informed consent and met the following criteria: Diagnosed as recurrent or refractory acute myeloid leukemia 1) EF>50%, and there is no obvious abnormality in ECG; 2) SpO2≥90%; 3)Cr≤2.5ULN; 4)ALT and AST≤4ULN, TBil≤50μmol/L 7. Subjects with a pregnancy plan must agree to take contraception before the enrollment study and after the study lasts for six months; if the subject is pregnant or suspects of pregnancy, the investigator should be notified immediately 8. Need to stop chemotherapy for at least 2 weeks before collecting the blood to manufacture CAR-T cells. 9. For allogeneic hematopoietic stem cell transplantation subjects, it is necessary to stop the immunosuppressant against GVHD for at least 2 weeks before collecting autologous blood preparation, and if the donor is preparing blood, it is of no influence; 10. If the subject has a history of central nervous system (CNS) leukemia, the tumor cells in the cerebrospinal fluid need to be cleared and the white blood cell count <5 * 10^6 / L ,then can proceed lymphodepletion 11. Subjects who participate in other studies must withdraw other studies for 2 weeks before they can be enrolled. Exclusion Criteria: Combine other diseases not effectively controlled, including but not limited to persistent or poorly controlled infections, symptomatic congestive heart failure, unstable angina, arrhythmia, poorly controlled lung disease or mental illness Exit criteria: The subjects request to withdraw from the study before CAR-T infusion 1) EF>50%, and there is no obvious abnormality in ECG 2) SpO2≥90% 3)Cr≤2.5ULN(the upper limit of normal ) 4) ALT and AST ≤ 4ULN, TBil ≤ 50μmol / L 4.Not enough T cells for manufacture standard CAR-T cells 5. Other serious adverse events occurred |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254121799 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 2 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30493988 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28860268 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796377
2019-02-13
https://zephyrnet.com/?p=NCT03796377
NCT03796377https://www.clinicaltrials.gov/study/NCT03796377?tab=tableNANANASingle-center, open-label, sequential treatment study to investigate the influence of the combined P-glycoprotein and CYP3A4 inducer hypericum perforatum on the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy volunteers.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-11-03 |
Start Month Year | February 13, 2019 |
Primary Completion Month Year | April 9, 2019 |
Verification Month Year | October 2020 |
Verification Date | 2020-10-31 |
Last Update Posted Date | 2020-11-03 |
Detailed Descriptions
Sequence: | 20727219 |
Description | Each session (one with and one without preceding CYP induction) will start with phenotyping using 25 mg fexofenadine orally for P-gp phenotyping and 2 mg midazolam orally for cytochrome P450 (CYP) 3A4 phenotyping. After a washout period of 5 days, subjects will receive a single oral dose of 20 mg rivaroxaban, a dose currently approved for human use in clinical routine. The same procedure will be repeated after pretreatment with St. John's wort extract (Jarsin®) twice daily 450 mg po (dose usually used in clinical routine) for 2 weeks. |
Facilities
Sequence: | 200159517 |
Name | Inselspital |
City | Bern |
Country | Switzerland |
Browse Interventions
Sequence: | 96074326 | Sequence: | 96074327 | Sequence: | 96074328 | Sequence: | 96074329 | Sequence: | 96074330 | Sequence: | 96074331 | Sequence: | 96074332 | Sequence: | 96074333 |
Mesh Term | Rivaroxaban | Mesh Term | Factor Xa Inhibitors | Mesh Term | Antithrombins | Mesh Term | Serine Proteinase Inhibitors | Mesh Term | Protease Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Anticoagulants |
Downcase Mesh Term | rivaroxaban | Downcase Mesh Term | factor xa inhibitors | Downcase Mesh Term | antithrombins | Downcase Mesh Term | serine proteinase inhibitors | Downcase Mesh Term | protease inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | anticoagulants |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52185594 |
Name | Drug Interaction Study |
Downcase Name | drug interaction study |
Id Information
Sequence: | 40169141 |
Id Source | org_study_id |
Id Value | Studien-Nr. 3459 |
Countries
Sequence: | 42580725 |
Name | Switzerland |
Removed | False |
Design Groups
Sequence: | 55609230 | Sequence: | 55609231 |
Group Type | Other | Group Type | Other |
Title | Rivaroxaban | Title | Rivaroxaban after CYP- and P-gp induction |
Description | Single oral dose of 20 mg rivaroxaban | Description | Single oral dose of 20 mg rivaroxaban after pretreatment with St. John's wort extract (Jarsin®) twice daily 450 mg po for 2 weeks. |
Interventions
Sequence: | 52499527 | Sequence: | 52499528 |
Intervention Type | Drug | Intervention Type | Drug |
Name | St Johns Wort Extract | Name | Rivaroxaban |
Description | 20 mg rivaroxaban after supplementation with St. John's wort extract (Jarsin®) twice daily 450 mg po for 2 weeks. | Description | 20 mg rivaroxaban. |
Design Outcomes
Sequence: | 177432367 | Sequence: | 177432368 | Sequence: | 177432369 | Sequence: | 177432370 | Sequence: | 177432371 | Sequence: | 177432372 | Sequence: | 177432373 | Sequence: | 177432374 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Pharmacokinetic outcome measures: area under the curve (AUC). | Measure | Pharmacokinetic outcome measures: maximal concentration of rivaroxaban. | Measure | Pharmacodynamic outcome measures: Factor Xa activity | Measure | Pharmacokinetic parameters: Time to reach maximal concentration | Measure | Pharmacokinetic parameters: Plasma elimination half-life | Measure | Phenotyping metrics: AUC fexofenadine | Measure | Phenotyping metrics: AUC ratios midazolam | Measure | Phenotyping metrics: Single point metabolic ratios midazolam |
Time Frame | AUC will be calculated from the concentration-time plot (time points included: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours (post-dose) during both sessions) | Time Frame | Will be obtained from the individual plasma concentration data (time points included: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours (post-dose) during both sessions) | Time Frame | Time points used for analysis: pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, and 48 hours (post-dose) during both sessions | Time Frame | Time points used for analysis: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours (post-dose) during both sessions | Time Frame | Time points used for analysis: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours (post-dose) during both sessions | Time Frame | Time points used for analysis: Before dosing and 0.5, 2, 3, 6 h after administration | Time Frame | Time points used for analysis: Before dosing and 0.5, 2, 3, 6 h after administration | Time Frame | Time points used for analysis: Before dosing and 0.5, 2, 3, 6 h after administration |
Description | Effect of pretreatment with hypericum perforatum on geometric mean AUC. | Description | Effect of pretreatment with hypericum perforatum on maximal concentration of rivaroxaban. | Description | Displayed as maximal effect (Emax) and parametrized by calculating the area under the time-effect curves (AUEC)). | Description | Time to reach maximal concentration of rivaroxaban | Description | Plasma elimination half-life of rivaroxaban | Description | Estimated AUC of fexofenadine | Description | AUC ratios of midazolam and 1'-hydroxymidazolam | Description | Single point metabolic ratios of midazolam and 1'-hydroxymidazolam |
Sponsors
Sequence: | 48332417 | Sequence: | 48332418 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Insel Gruppe AG, University Hospital Bern | Name | Bayer |
Overall Officials
Sequence: | 29293048 |
Role | Study Director |
Name | Inselpital |
Affiliation | Sponsor: Inselspital, Bern University Hospital |
Design Group Interventions
Sequence: | 68168302 | Sequence: | 68168303 | Sequence: | 68168304 |
Design Group Id | 55609231 | Design Group Id | 55609230 | Design Group Id | 55609231 |
Intervention Id | 52499527 | Intervention Id | 52499528 | Intervention Id | 52499528 |
Eligibilities
Sequence: | 30773635 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 45 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Men or women, age between 18 and 45 years (inclusive) at screening Exclusion Criteria: Known allergic reaction to any excipient of the drug formulations |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253952979 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 1 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 45 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30519766 |
Allocation | Non-Randomized |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26680461 |
Intervention Id | 52499527 |
Name | Inducer of CYP3A4 and P-gp |
Responsible Parties
Sequence: | 28886067 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52079076 |
Pmid | 32959922 |
Reference Type | result |
Citation | Scholz I, Liakoni E, Hammann F, Grafinger KE, Duthaler U, Nagler M, Krahenbuhl S, Haschke M. Effects of Hypericum perforatum (St John's wort) on the pharmacokinetics and pharmacodynamics of rivaroxaban in humans. Br J Clin Pharmacol. 2021 Mar;87(3):1466-1474. doi: 10.1111/bcp.14553. Epub 2020 Oct 25. |
]]>
https://zephyrnet.com/NCT03796364
2018-09-01
https://zephyrnet.com/?p=NCT03796364
NCT03796364https://www.clinicaltrials.gov/study/NCT03796364?tab=tableJianguo Sun, DoctorSunjg@aliYun.com8613983155736To verify the efficacy and safety of endostatin in the treatment of SRILI(symptomatic radiation-induced lung injury) and fibrosis. The results of this study are expected to be a new clinical strategy for the treatment of radiation pneumonia and fibrosis.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-25 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | September 1, 2018 |
Primary Completion Month Year | May 31, 2020 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Detailed Descriptions
Sequence: | 20716323 |
Description | Radiotherapy is an important treatment of lung cancer, symptomatic radiation-induced lung injury (SRILR) is the most common complications. In view of the important role of endostatin in inhibiting angiogenesis and pro-inflammatory factors, Combined with randomized controlled clinical study and small sample clinical exploration, the investigators concluded that endostatin is a new clinical technique for the treatment of radiation pneumonia(RP) and radiation fibrosis(RF), which can reduce the recurrence rate of RP. In order to verify the efficacy and safety of endostatin in the treatment of SRILI and fibrosis, the investigators intend to use a prospective, randomized, multicenter clinical trial to classify unresectable phase III-IV Non-small cell lung cancer(NSCLC) patients with SRILI above grade 2 into the control group (standard SRILI treatment) and observation group (Endostar® plus standard treatment) on a 1:1 randomized basis. The results of this study are expected to be a new clinical strategy for the treatment of radiation pneumonia and fibrosis. |
Facilities
Sequence: | 200053420 |
Status | Recruiting |
Name | Xinqiao Hospital of Chongqing |
City | Chongqing |
Zip | 400000 |
Country | China |
Facility Contacts
Sequence: | 28097573 |
Facility Id | 200053420 |
Contact Type | primary |
Name | Sun Jianguo |
Sunjg@aliYun.com | |
Browse Interventions
Sequence: | 96027930 | Sequence: | 96027931 | Sequence: | 96027932 | Sequence: | 96027933 | Sequence: | 96027934 | Sequence: | 96027935 | Sequence: | 96027936 |
Mesh Term | Endostar protein | Mesh Term | Angiogenesis Inhibitors | Mesh Term | Angiogenesis Modulating Agents | Mesh Term | Growth Substances | Mesh Term | Physiological Effects of Drugs | Mesh Term | Growth Inhibitors | Mesh Term | Antineoplastic Agents |
Downcase Mesh Term | endostar protein | Downcase Mesh Term | angiogenesis inhibitors | Downcase Mesh Term | angiogenesis modulating agents | Downcase Mesh Term | growth substances | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | growth inhibitors | Downcase Mesh Term | antineoplastic agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52156563 | Sequence: | 52156562 |
Name | Endostatin | Name | Radiation Pneumonitis |
Downcase Name | endostatin | Downcase Name | radiation pneumonitis |
Id Information
Sequence: | 40148252 |
Id Source | org_study_id |
Id Value | XQonc-008 |
Countries
Sequence: | 42557789 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55577960 | Sequence: | 55577961 |
Group Type | Active Comparator | Group Type | Experimental |
Title | control group | Title | observation group |
Description | standard SRILI treatment | Description | Endostar® plus standard treatment |
Interventions
Sequence: | 52472062 | Sequence: | 52472063 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Endostar | Name | standard SRILI treatment |
Description | Patients in the observation group were treated with routine radiation pneumonia and Endostar. Endostar usage: continuous intravenous pumping of Endostar(14 doses each time) over 5 days. At week 2, 4, 6, 12, 24, 36, 52, lung functional and blood oxygen saturation was measured, chest CT and the St. George Respiratory Questionnaire (SGRQ) were assessed for quality of life at week 12, 24, 52 and before treatment; collecting the related observation indexes of patients; primary endpoint; recrudescence rate of RP; secondary endpoints; remission rate of RP and incidence rate of RF; incidence rate of RF; number of acute exacerbations and quality of life. | Description | Patients in the control group were treated with current routine radiation pneumonia. At week 2, 4, 6, 12, 24, 36, 52, lung functional and blood oxygen saturation was measured, chest CT and the St. George Respiratory Questionnaire (SGRQ) were assessed for quality of life at week 12, 24, 52 and before treatment; collecting the related observation indexes of patients; primary endpoint; recrudescence rate of RP; secondary endpoints; remission rate of RP and incidence rate of RF; incidence rate of RF; number of acute exacerbations and quality of life. |
Keywords
Sequence: | 79848186 | Sequence: | 79848187 | Sequence: | 79848188 | Sequence: | 79848189 |
Name | endostatin | Name | Radiotherapy | Name | Radiation pneumonitis | Name | Radiation fibrosis |
Downcase Name | endostatin | Downcase Name | radiotherapy | Downcase Name | radiation pneumonitis | Downcase Name | radiation fibrosis |
Design Outcomes
Sequence: | 177328235 | Sequence: | 177328236 | Sequence: | 177328237 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | recrudescence rate of RP(Radiation pneumonitis) | Measure | remission rate of RP | Measure | incidence rate of RF(Radioactive fibrosis) |
Time Frame | at week12 | Time Frame | at week 12 | Time Frame | at week 12 |
Description | Patients in the observation group were treated with routine radiation pneumonia and Endostar.
Patients in the control group were treated with current routine radiation pneumonia. Chest CT were assessed for recrudescence rate of RP at week 12. The calculation method is: number of relapse cases / total number of treatment groups × 100%; RP is classified according to CTCAE4.0, patients with grade 2 or higher are improved after treatment, and those who are assessed to be grade 2 or higher are considered recrudescence). Results are expressed as a percentage. |
Description | Patients in the observation group were treated with routine radiation pneumonia and Endostar. Results are expressed as a percentage.
Patients in the control group were treated with current routine radiation pneumonia. Chest CT were assessed for remission rate of RP at week 12. |
Description | Patients in the observation group were treated with routine radiation pneumonia and Endostar.
Patients in the control group were treated with current routine radiation pneumonia. Chest CT were assessed for incidence rate of RF at week 12. |
Browse Conditions
Sequence: | 193432270 | Sequence: | 193432271 | Sequence: | 193432272 | Sequence: | 193432273 | Sequence: | 193432274 | Sequence: | 193432275 | Sequence: | 193432276 | Sequence: | 193432277 | Sequence: | 193432278 | Sequence: | 193432279 | Sequence: | 193432280 | Sequence: | 193432281 |
Mesh Term | Pneumonia | Mesh Term | Radiation Pneumonitis | Mesh Term | Fibrosis | Mesh Term | Pathologic Processes | Mesh Term | Respiratory Tract Infections | Mesh Term | Infections | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Lung Diseases, Interstitial | Mesh Term | Lung Injury | Mesh Term | Radiation Injuries | Mesh Term | Wounds and Injuries |
Downcase Mesh Term | pneumonia | Downcase Mesh Term | radiation pneumonitis | Downcase Mesh Term | fibrosis | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | respiratory tract infections | Downcase Mesh Term | infections | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | lung diseases, interstitial | Downcase Mesh Term | lung injury | Downcase Mesh Term | radiation injuries | Downcase Mesh Term | wounds and injuries |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306148 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Xinqiao Hospital of Chongqing |
Central Contacts
Sequence: | 12004757 |
Contact Type | primary |
Name | Jianguo Sun, Doctor |
Phone | 8613983155736 |
Sunjg@aliYun.com | |
Role | Contact |
Design Group Interventions
Sequence: | 68130924 | Sequence: | 68130925 | Sequence: | 68130926 |
Design Group Id | 55577961 | Design Group Id | 55577960 | Design Group Id | 55577961 |
Intervention Id | 52472062 | Intervention Id | 52472063 | Intervention Id | 52472063 |
Eligibilities
Sequence: | 30757393 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients defined as NSCLC who could not be operated on, phase III-IV; Exclusion Criteria: Patient compliance is poor and violates the test regulations; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254228569 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30503618 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26665943 |
Intervention Id | 52472062 |
Name | standard SRILI treatment |
Responsible Parties
Sequence: | 28869896 |
Responsible Party Type | Principal Investigator |
Name | Jianguo Sun |
Title | Deputy director |
Affiliation | Xinqiao Hospital of Chongqing |
]]>
https://zephyrnet.com/NCT03796351
2012-09-30
https://zephyrnet.com/?p=NCT03796351
NCT03796351https://www.clinicaltrials.gov/study/NCT03796351?tab=tableNANANAThis study design is a randomized, double-blind, intra-individual controlled, single-center, phase 1 healthy volunteer study. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the comparator at a randomized unit(2U, 5U, 10U, 20U, 30U) in each site of the Extensor digirotum brevis. Thereafter, follow-up visits will be made 14 days, 30days, 60days, 90days and pharmacodynamic and safety assessments will be conducted for total 90days.
<![CDATA[
Studies
Study First Submitted Date | 2015-11-26 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-08-26 |
Start Month Year | September 2012 |
Primary Completion Month Year | January 2013 |
Verification Month Year | August 2020 |
Verification Date | 2020-08-31 |
Last Update Posted Date | 2020-08-26 |
Detailed Descriptions
Sequence: | 20735718 |
Description | This is a randomised, double-blind, intra-individual controlled, dose escalation study to assess the safety, tolerability and preliminary effectiveness of a single dose of MT10107 in comparison to Botox®50U (BOTOX® is a registered trademark owned by Allergan). This is the first-in-human study for MT10107, and will be performed in healthy volunteers.
Subjects will be administered a single equivalent dose of MT10107 and Botox®50U by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose). The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner. |
Facilities
Sequence: | 200243993 |
Name | The Catholic University of Korea, St. Paul's Hospital |
City | Seoul |
Country | Korea, Republic of |
Conditions
Sequence: | 52207920 |
Name | Healthy Volunteers |
Downcase Name | healthy volunteers |
Id Information
Sequence: | 40186049 |
Id Source | org_study_id |
Id Value | MT_PRT_EDB01 |
Countries
Sequence: | 42599556 |
Name | Korea, Republic of |
Removed | False |
Design Groups
Sequence: | 55634519 | Sequence: | 55634520 |
Group Type | Experimental | Group Type | Active Comparator |
Title | MT10107(botulinum toxin type A) | Title | BOTOX® 50U(botulinum toxin type A) |
Description | Subjects will be administered a single equivalent dose of MT10107 by intramuscular injection to the EDB muscles of contralateral feet in five treatment group. | Description | Subjects will be administered a single equivalent dose of BOTOX® 50U by intramuscular injection to the EDB muscles of contralateral feet in five treatment group. |
Interventions
Sequence: | 52521936 | Sequence: | 52521937 |
Intervention Type | Drug | Intervention Type | Drug |
Name | MT10107 | Name | Botox |
Description | Subjects will be administered a single equivalent dose of MT10107 and Botox® by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose).
The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner. |
Description | Subjects will be administered a single equivalent dose of MT10107 and Botox® by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose).
The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner. |
Design Outcomes
Sequence: | 177510703 | Sequence: | 177510704 | Sequence: | 177510705 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The percentage change in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value. | Measure | The potential diffusion effect on the adjacent muscles (AH and ADQ) as measured by surface EMG. | Measure | The percentage change in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value. |
Time Frame | 30 days after the injection | Time Frame | 14, 30 and 90 days after the injection | Time Frame | 14 and 90 days after the injection |
Description | percentage change of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline | Description | percentage change of CMAP(Compound Muscle Action Potential) amplitude of the adjacent muscles (AH and ADQ) from baseline | Description | percentage change of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline |
Sponsors
Sequence: | 48353563 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Medy-Tox |
Overall Officials
Sequence: | 29305911 |
Role | Principal Investigator |
Name | MyungEun Chung |
Affiliation | Catholic University of Korea Saint Paul's Hospital |
Design Group Interventions
Sequence: | 68199009 | Sequence: | 68199010 |
Design Group Id | 55634519 | Design Group Id | 55634520 |
Intervention Id | 52521936 | Intervention Id | 52521937 |
Eligibilities
Sequence: | 30786790 |
Gender | Male |
Minimum Age | 20 Years |
Maximum Age | 65 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Healthy male adults aged between 20 and 65 years Exclusion Criteria: Subjects who have previously been treated in 3 month with botulinum toxin type A. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989457 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2015 |
Actual Duration | 4 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 20 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30532861 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Screening |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26691976 |
Intervention Id | 52521936 |
Name | Coretox |
Responsible Parties
Sequence: | 28899154 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796338
2018-02-01
https://zephyrnet.com/?p=NCT03796338
NCT03796338https://www.clinicaltrials.gov/study/NCT03796338?tab=tableNANANASeveral evidences in the literature suggest sleep interruption in critical care patients. Nowadays, the amount and the quality of sleep phases during the length of stay in the intensive care unit are largely unknown.
In this study, the amount of time spent by the patients in N1, N2 N3 and REM phases during sleep is quantified.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-07-22 |
Start Month Year | February 1, 2018 |
Primary Completion Month Year | January 31, 2019 |
Verification Month Year | July 2022 |
Verification Date | 2022-07-31 |
Last Update Posted Date | 2022-07-22 |
Facilities
Sequence: | 199189147 |
Name | Azienda Ospedaliero Universitaria Careggi |
City | Florence |
Zip | 50100 |
Country | Italy |
Conditions
Sequence: | 51953401 | Sequence: | 51953402 |
Name | Sleep Disturbance | Name | Critical Illness |
Downcase Name | sleep disturbance | Downcase Name | critical illness |
Id Information
Sequence: | 39989613 |
Id Source | org_study_id |
Id Value | CEAVC, 8611/2018; 11535/OSS |
Countries
Sequence: | 42380518 |
Name | Italy |
Removed | False |
Design Groups
Sequence: | 55353395 |
Title | Critically ill patients |
Description | age > 18 years |
Interventions
Sequence: | 52265629 |
Intervention Type | Device |
Name | Sleep Profiler |
Description | Patients are observed through a Sleep profiler, routinely used in the intensive care unit (ICU). This device is applied at every patient in the ICU and it acquires EEG, electrooculography, and electromyography from three frontopolar EEG signals. |
Keywords
Sequence: | 79528870 | Sequence: | 79528868 | Sequence: | 79528869 |
Name | Sleep phases | Name | intensive care unit | Name | Sleep interruption |
Downcase Name | sleep phases | Downcase Name | intensive care unit | Downcase Name | sleep interruption |
Design Outcomes
Sequence: | 176606152 | Sequence: | 176606153 | Sequence: | 176606154 | Sequence: | 176606155 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Sleep N2 phase | Measure | Sleep N1 phase | Measure | Sleep N3 phase | Measure | Sleep REM phase |
Time Frame | The sleep architecture will be observed during the first night spent in the ICU | Time Frame | The sleep architecture will be observed during the first night spent in the ICU | Time Frame | The sleep architecture will be observed during the first night spent in the ICU | Time Frame | The sleep architecture will be observed during the first night spent in the ICU |
Description | describe the percentage of the total sleep time spent by the patient in N2 stage | Description | describe the percentage of the total sleep time spent by the patient in N1 stage | Description | describe the percentage of the total sleep time spent by the patient in N3 stage | Description | describe the percentage of the total sleep time spent by the patient in REM stage |
Browse Conditions
Sequence: | 192623048 | Sequence: | 192623049 | Sequence: | 192623050 | Sequence: | 192623051 | Sequence: | 192623052 | Sequence: | 192623053 | Sequence: | 192623054 | Sequence: | 192623055 |
Mesh Term | Dyssomnias | Mesh Term | Parasomnias | Mesh Term | Critical Illness | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes | Mesh Term | Sleep Wake Disorders | Mesh Term | Nervous System Diseases | Mesh Term | Mental Disorders |
Downcase Mesh Term | dyssomnias | Downcase Mesh Term | parasomnias | Downcase Mesh Term | critical illness | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | sleep wake disorders | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48115548 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Careggi Hospital |
Overall Officials
Sequence: | 29160894 |
Role | Study Director |
Name | Gianluca Villa, MD |
Affiliation | Azienda Careggi |
Design Group Interventions
Sequence: | 67857642 |
Design Group Id | 55353395 |
Intervention Id | 52265629 |
Eligibilities
Sequence: | 30637062 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Critically ill patients |
Criteria | Inclusion Criteria:
age > 18 years Exclusion Criteria: Pregnancy |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254132261 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 12 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30383996 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28750729 |
Responsible Party Type | Principal Investigator |
Name | Gianluca Villa |
Title | M.D. |
Affiliation | Careggi Hospital |
]]>
https://zephyrnet.com/NCT03796325
2013-01-01
https://zephyrnet.com/?p=NCT03796325
NCT03796325https://www.clinicaltrials.gov/study/NCT03796325?tab=tableNANANAObesity is an epidemic disease that continues to increase causing morbidity and mortality to those who suffer. Obese patients suffer, frequently, from a depressive state, anger, and emotional disturbances. It cannot be recognized and depression causes obesity affecting eating habits or obesity causes depression based on physical, social and occupational limitations. Many times we see that obese patients are discriminated in every sense of daily life increasing their depressive state. The best treatment for obesity is bariatric surgery that causes a sufficient weight loss to correct sleep apnea, diabetes, hypertension, and many other co-morbidity. The study is based on elucidating the effect of sleeve gastrectomy in obese patients suffering from depression
<![CDATA[
Studies
Study First Submitted Date | 2018-12-29 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | January 1, 2013 |
Primary Completion Month Year | December 31, 2017 |
Verification Month Year | December 2018 |
Verification Date | 2018-12-31 |
Last Update Posted Date | 2019-01-09 |
Detailed Descriptions
Sequence: | 20783044 |
Description | The patients were classified as suffering from a depressive state before the bariatric surgery and followed until 3 years after surgery, the data was collected by personal interview or telephone survey. |
Facilities
Sequence: | 200618352 |
Name | Assuta MC |
City | Tel Aviv |
Country | Israel |
Conditions
Sequence: | 52328322 | Sequence: | 52328323 |
Name | Obesity, Morbid | Name | Depression |
Downcase Name | obesity, morbid | Downcase Name | depression |
Id Information
Sequence: | 40271101 |
Id Source | org_study_id |
Id Value | AMC 002-2018 |
Countries
Sequence: | 42691172 |
Name | Israel |
Removed | False |
Design Groups
Sequence: | 55768158 | Sequence: | 55768159 |
Title | Depression | Title | No-depression |
Description | patients characterize with morbid obesity or obesity type 2 with co-morbidities and depression | Description | patients characterize with morbid obesity or obesity type 2 with co-morbidities without depression |
Design Outcomes
Sequence: | 177959987 | Sequence: | 177959988 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Weight loss 3 years after laparoscopic sleeve gastrectomy | Measure | Depression state changes after Sleeve gastrectomy |
Time Frame | 36 month | Time Frame | 36 month |
Description | Measure of weight calculating Delta body mass index between preoperative measurement and three years after surgery | Description | Telephonic Questionnaire about feeling satisfaction (Very satisfied, satisfied, indifferent ,unsatisfied), eating mode (Volume-eater, sweet-eater, snack eater, binge eater, healthy-eater), occupations (Unemployed, employed, type of employment). |
Browse Conditions
Sequence: | 194085201 | Sequence: | 194085208 | Sequence: | 194085202 | Sequence: | 194085203 | Sequence: | 194085204 | Sequence: | 194085205 | Sequence: | 194085206 | Sequence: | 194085207 |
Mesh Term | Obesity, Morbid | Mesh Term | Body Weight | Mesh Term | Depression | Mesh Term | Behavioral Symptoms | Mesh Term | Obesity | Mesh Term | Overweight | Mesh Term | Overnutrition | Mesh Term | Nutrition Disorders |
Downcase Mesh Term | obesity, morbid | Downcase Mesh Term | body weight | Downcase Mesh Term | depression | Downcase Mesh Term | behavioral symptoms | Downcase Mesh Term | obesity | Downcase Mesh Term | overweight | Downcase Mesh Term | overnutrition | Downcase Mesh Term | nutrition disorders |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48466447 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Assuta Medical Center |
Eligibilities
Sequence: | 30856343 |
Sampling Method | Non-Probability Sample |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Patients 18 years and older with BMI at less 40 or 35-40 with co-morbidities |
Criteria | Inclusion Criteria: 18 years and older No any type of complication after surgery No difficult to drink, eat or take medicaments
Exclusion Criteria: Any surgical complication Previous gastrointestinal surgery schizofrenia |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254313063 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 60 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30602181 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28968697 |
Responsible Party Type | Principal Investigator |
Name | Sergio Gabriel Susmallian |
Title | Head of the Department of General Surgery |
Affiliation | Assuta Medical Center |
Study References
Sequence: | 52232639 |
Pmid | 30524743 |
Reference Type | background |
Citation | Griauzde DH, Ibrahim AM, Fisher N, Stricklen A, Ross R, Ghaferi AA. Understanding the psychosocial impact of weight loss following bariatric surgery: a qualitative study. BMC Obes. 2018 Dec 3;5:38. doi: 10.1186/s40608-018-0215-3. eCollection 2018. |
]]>
https://zephyrnet.com/NCT03796312
2015-11-20
https://zephyrnet.com/?p=NCT03796312
NCT03796312https://www.clinicaltrials.gov/study/NCT03796312?tab=tableNANANAThe integumentary system protects the underlying body from the external environment, such as shocks, temperature, ultraviolet radiation, chemicals, and other threats. There is a considerable body of clinical evidence highlighting the importance of the stratum corneum and its barrier functions, which are especially beneficial for newborns. Given the dramatic transition from the aqueous womb to the dry terrestrial environment at birth, studies describing adaptations made by the skin barrier within the first month of life assume greater importance. The skin of the baby is morphologically and functionally different from the skin of adults. Neonatal skin is thinner, more fragile, and drier than adult skin; it is difficult to maintain fluid-electrolyte balance and temperature regulation. Notwithstanding, structure and function of skin continues to improve during the first months and even years of life. Special care procedures are nonetheless necessary to ensure healthy development, to protect the skin from irritation and reddening, and to help the newborn feel well. Therefore, this study, taking the form of a randomized controlled trial, aims to examine the effectiveness of tub bathing and sponge bathing on the physiological parameters (heart rate, respiration rate, oxygen saturation, body temperature) and comfort of late preterm infants. Increasing comfort and physiological stabilization in premature infants during neonatal care improves their neurophysiological development. Bathing procedures that support this development and will not expose the newborn to stress should be preferred.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-26 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | November 20, 2015 |
Primary Completion Month Year | November 29, 2016 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-08 |
Detailed Descriptions
Sequence: | 20709970 |
Description | Increasing comfort and physiological stabilization in premature infants during neonatal care improves their neurophysiological development. Bathing procedures that support this improves and will not expose the newborn to stress should be preferred.This study aimed to examine the effectiveness of tub bathing and sponge bathing methods on the comfort and physiological parameters of late preterm infants. The study was conducted in the Neonatal Intensive Care Unit of a university hospital in Turkey, between November 2015 and November 2016. Skin care is routinely performed between 08.00 and 09.00 in the form of sponge bathing. This research study sampled 120 stable, late preterm infants being cared for in the NICU. This sample was deemed adequate based on a sample size calculation conducted in PS Power and Sample Size Calculations (Version 3.0). Information concerning allocation was available only to the principal investigator. Participants were assigned a sequential number that was placed in an opaque, sealed envelope by the researcher who received the signed parental informed consent. When the participant was scheduled to be bathing, the envelope was opened by the researcher who then performed the test. The nurses could not be blinded to the allocation because of the nature of the intervention. However, the outcome assessment of the participants was blinded. Participats were randomly assigned to either sponge bathing or tub bathing groups. Bathing was performed anywhere from 6 to 48 hours post-birth, based on individual participant needs. Participants were subsequently placed in a preheated incubator, which varied according to the participant's weight and age. In order to compensate for such differences, the heads of all participants were placed at a height of 30 degrees in a right lateral position after bathing and they were monitored. The participants were not dressed during the observation period. After bathing, participants were left without intervention or contact for approximately 10 minutes or until settled before being assessed. The data collection instrument, the Preterm Infant Bathing Study Record, was designed specifically for this study. The instrument incorporates a number of scales for the measurement of outcome variables, physiological parameters, and demographic information (age, gender, type of delivery, gestational age, birth weight, body weight at study time, etc.). Outcome measures include neonatal comfort behavior and physiological parameters (body temperature, heart rate, oxygen saturation, respiratory rate). Those responsible for data collection were blinded as to the allocation of participants they were assessing. The ComfortNeo scale was used to measure newborns' comfort and pain intensity. Comfort was inferred based on infant behavior, which was evaluated on two separate occasions, 10 minutes before bathing and 10 minutes after bathing. Measurement took approximately 1-2 minutes. Internal consistency was measured by way of Cronbach's alpha coefficient, which was 0.94 before bathing, 0.93 after bathing for the second researcher, and 0.92 after bathing for the nurse. Kappa coefficients were approximately 0.84 for each sub-item. Thus, there was harmony between the two observers. Infant physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature) were evaluated on three separate occasions (10 minutes before bathing, 15 minutes and 30 minutes after bathing).Statistical analysis was performed using SPSS 20.0 and SAS (ver.9.3), with statistical significance set at p<0.05.
Data was presented as means and standard deviations for continuous variables, and frequencies for categorical variables. For participant characteristics, such as the type of delivery and sex, a Chi-square test was applied to determine whether there were significant between-group differences. participant characteristics, such as birth weight and body weight at the time of the study, were evaluated for significant between-group differences using a one way ANOVA test. For a comparison of the different phases, measurement parameters (comfort score, heart rate, oxygen saturation, respiratory rate, body temperature) through the baths were averaged separately. Repeated measurement analysis of variance was performed to analyze both between and within-group differences, followed by the Bonferroni post-hoc test. |
Facilities
Sequence: | 199964478 |
Name | Akdeniz Universty |
City | Antalya |
Zip | 07000 |
Country | Turkey |
Conditions
Sequence: | 52138954 | Sequence: | 52138955 |
Name | Preterm Infant | Name | Premature Birth |
Downcase Name | preterm infant | Downcase Name | premature birth |
Id Information
Sequence: | 40135021 |
Id Source | org_study_id |
Id Value | 455111 |
Countries
Sequence: | 42542642 |
Name | Turkey |
Removed | False |
Design Groups
Sequence: | 55559292 | Sequence: | 55559293 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Tub Bathing | Title | Sponge Bathing |
Description | In this group, preterm infants were given tub bathing. | Description | Separate cotton cloths were prepared for each body area in the sponge bath. The room temperature was set to 26-27°C to prevent hypothermia. The temperature of the water used for sponge bathing was set to 37-38°C. Alongside the bath, the infant was placed on a flat, protected surface and washed from a bowl of water, using the same mild cleanser. The eyes, face, and head were wiped and dried while the baby was wrapped in a blanket. The wrap was opened so that body parts could be washed, dried, and then immediately rewrapped, after which infants were diapered. |
Interventions
Sequence: | 52454854 | Sequence: | 52454855 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Tub Bathing | Name | Sponge Bathing |
Description | The infant's face was washed and dried while still wrapped before being immersed. The water level in the tub was set at approximately 9-12 cm or deep enough to cover the baby's shoulders. A folded cloth towel was placed into the tub before bathing. The temperature of the bath water was controlled using a special water thermometer and adjusted to 37-38°C. The infant was held securely; the head and neck were supported on the researcher's forearm, and the shoulder was grasped using the researcher's thumb and finger. Cleaning was performed using a soft cloth and baby skin cleaner. The front and back areas were cleaned without turning the infant. The newborn was safely removed from the water and wrapped in a clean towel. | Description | Sponge bathing is routine care of the clinic |
Keywords
Sequence: | 79822750 | Sequence: | 79822751 | Sequence: | 79822752 | Sequence: | 79822753 | Sequence: | 79822754 | Sequence: | 79822755 |
Name | Bathing | Name | Comfort | Name | Neonatal intensive care unit | Name | Nursing care | Name | Premature infant | Name | Skin care |
Downcase Name | bathing | Downcase Name | comfort | Downcase Name | neonatal intensive care unit | Downcase Name | nursing care | Downcase Name | premature infant | Downcase Name | skin care |
Design Outcomes
Sequence: | 177263403 | Sequence: | 177263404 | Sequence: | 177263405 | Sequence: | 177263406 | Sequence: | 177263407 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Neonatal Comfort | Measure | Heart Rate | Measure | Oxygen Saturation | Measure | Respiration Rate | Measure | Body Temperature |
Time Frame | An average of 1 year | Time Frame | An average of 1 year | Time Frame | An average of 1 year | Time Frame | An average of 1 year | Time Frame | An average of 1 year |
Description | Data on comfort behavior was collected by a second researcher and by research nurses who had been trained by the lead researcher. Those responsible for data collection were blinded as to the allocation of infants they were assessing. The ComfortNeo scale was used to measure newborns' comfort. The ComfortNeo is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, crying, body movement, facial tension, and (body) muscle tone. The lowest score that can be obtained using this scale is 6, and the highest score is 30. Scores in the range of 6 to 13 indicate that the newborn is comfortable, while scores 14-30 are indicative of pain or distress in the newborn, thus necessitating comforting. Comfort was inferred based on infant behavior 10 minutes before bathing and 10 minutes after bathing. | Description | The number of heartbeats per minute was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants. | Description | Oxygen saturation (SpO2) was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants. Pulse oximetry measures peripheral arterial oxygen saturation (%) as a surrogate marker for tissue oxygenation. | Description | The respiration rate is the number of breaths a person takes per minute. The rate is usually measured when a person is at rest and simply involves counting the number of breaths for one minute by counting how many times the chest rises. | Description | Body temperature was measured using the axillary method (under the armpit)in degrees Celsius. |
Browse Conditions
Sequence: | 193366342 | Sequence: | 193366343 | Sequence: | 193366344 | Sequence: | 193366345 | Sequence: | 193366346 | Sequence: | 193366347 |
Mesh Term | Premature Birth | Mesh Term | Obstetric Labor, Premature | Mesh Term | Obstetric Labor Complications | Mesh Term | Pregnancy Complications | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases |
Downcase Mesh Term | premature birth | Downcase Mesh Term | obstetric labor, premature | Downcase Mesh Term | obstetric labor complications | Downcase Mesh Term | pregnancy complications | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290671 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Akdeniz University |
Overall Officials
Sequence: | 29268512 |
Role | Study Director |
Name | Emine EFE |
Affiliation | Akdeniz University Children's Health and the Nursing Department |
Design Group Interventions
Sequence: | 68107385 | Sequence: | 68107386 |
Design Group Id | 55559292 | Design Group Id | 55559293 |
Intervention Id | 52454854 | Intervention Id | 52454855 |
Eligibilities
Sequence: | 30747695 |
Gender | All |
Minimum Age | 34 Weeks |
Maximum Age | 36 Weeks |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
All inborn infants with a gestational age of 34 weeks and 0 days to 36 weeks and 6 days (late preterm) were eligible to participate in this study. Exclusion Criteria: Participants were excluded from the study if they were connected to |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254121789 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 12 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 34 |
Maximum Age Num | 36 |
Minimum Age Unit | Weeks |
Maximum Age Unit | Weeks |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30493978 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | Single |
Masking Description | Physiological data was collected by nurses trained by the lead researcher. Data on neonatal comfort behavior was collected by a second researcher and by research nurses who had been trained by the lead researcher. Those responsible for data collection were blinded as to the allocation of infants they were assessing. |
Intervention Model Description | A randomized controlled two-group pre-test and repeated post-test study design were adopted. Preterm infants were randomly allocated before bathing by the researcher using a random computer-generated table to one of two groups: sponge bathing (routine care) or tub bathing. The bathing procedures were performed by the researcher. Nurses and a second researcher were blinded to the study hypotheses. |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28860258 |
Responsible Party Type | Principal Investigator |
Name | Halil Ibrahim Tasdemir |
Title | Research Assistant |
Affiliation | Akdeniz University |
Study References
Sequence: | 52032542 | Sequence: | 52032543 | Sequence: | 52032544 |
Pmid | 15561658 | Pmid | 22375955 | Pmid | 31442786 |
Reference Type | background | Reference Type | background | Reference Type | derived |
Citation | Bryanton J, Walsh D, Barrett M, Gaudet D. Tub bathing versus traditional sponge bathing for the newborn. J Obstet Gynecol Neonatal Nurs. 2004 Nov-Dec;33(6):704-12. doi: 10.1177/0884217504270651. | Citation | Loring C, Gregory K, Gargan B, LeBlanc V, Lundgren D, Reilly J, Stobo K, Walker C, Zaya C. Tub bathing improves thermoregulation of the late preterm infant. J Obstet Gynecol Neonatal Nurs. 2012 Mar;41(2):171-179. doi: 10.1111/j.1552-6909.2011.01332.x. Epub 2012 Feb 29. | Citation | Tasdemir HI, Efe E. The effect of tub bathing and sponge bathing on neonatal comfort and physiological parameters in late preterm infants: A randomized controlled trial. Int J Nurs Stud. 2019 Nov;99:103377. doi: 10.1016/j.ijnurstu.2019.06.008. Epub 2019 Jun 21. |
]]>
https://zephyrnet.com/NCT03796299
2019-01-31
https://zephyrnet.com/?p=NCT03796299
NCT03796299https://www.clinicaltrials.gov/study/NCT03796299?tab=tableNANANAIn patients with non-muscle-invasive bladder cancer, the development and introduction to the clinical practice of an adequately accurate biomarker may allow to limit the indications for performing control cystoscopy. Thus, it will reduce the discomfort and stress of patients, the risk of complications of the invasive procedure and probably significantly reduce the costs incurred by healthcare systems.
The aim of the present study is to determine the usefulness of the determination of MCM5 protein expression in the urine of patients with urinary bladder or upper urinary tract cancer.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-27 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | January 2019 |
Primary Completion Month Year | August 2019 |
Verification Month Year | December 2018 |
Verification Date | 2018-12-31 |
Last Update Posted Date | 2019-01-08 |
Facilities
Sequence: | 200159518 |
Name | Medical University of Warsaw, Dept. of Urology |
City | Warsaw |
Zip | 02005 |
Country | Poland |
Conditions
Sequence: | 52185595 |
Name | Bladder Cancer |
Downcase Name | bladder cancer |
Id Information
Sequence: | 40169142 |
Id Source | org_study_id |
Id Value | 4-2018 |
Countries
Sequence: | 42580726 |
Name | Poland |
Removed | False |
Design Groups
Sequence: | 55609232 | Sequence: | 55609233 | Sequence: | 55609234 |
Title | 1 | Title | 2 | Title | 3 (control) |
Description | Patients with bladder cancer | Description | Patients with upper urinary tract cancer | Description | Controls |
Interventions
Sequence: | 52499529 |
Intervention Type | Diagnostic Test |
Name | Assessment of expression of MCM5 in the urine (ADX Bladder) |
Description | Each participant will be asked to urinate in a plastic container. Urine will be centrifuged afterwards, then the expression of MCM5 protein will be examined in cells from urine sediment. For this purpose, it is planned to use the Arquer Diagnostics ADXBLADDER test. It is an enzyme linked immunosorbent assay (ELISA) using two monoclonal antibodies directed against two different epitopes. Both antibodies have high affinity and specificity for the MCM5 antigen. |
Keywords
Sequence: | 79888915 | Sequence: | 79888916 | Sequence: | 79888917 | Sequence: | 79888918 |
Name | bladder cancer | Name | biomarker | Name | urothelial cancer | Name | cystoscopy |
Downcase Name | bladder cancer | Downcase Name | biomarker | Downcase Name | urothelial cancer | Downcase Name | cystoscopy |
Design Outcomes
Sequence: | 177432375 |
Outcome Type | primary |
Measure | Expression of MCM-5 in the urine |
Time Frame | Within 48 hours after subject enrollment |
Description | Expression of MCM-5 will be determined in urine sediment by Arquer Diagnostics ADXBLADDER test (ELISA test using two monoclonal antibodies directed against epitopes of high affinity and specificity for the MCM5 antigen). |
Browse Conditions
Sequence: | 193540518 | Sequence: | 193540519 | Sequence: | 193540520 | Sequence: | 193540521 | Sequence: | 193540522 | Sequence: | 193540523 | Sequence: | 193540524 | Sequence: | 193540525 | Sequence: | 193540526 | Sequence: | 193540527 | Sequence: | 193540528 |
Mesh Term | Urinary Bladder Neoplasms | Mesh Term | Urologic Neoplasms | Mesh Term | Urogenital Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Urinary Bladder Diseases | Mesh Term | Urologic Diseases | Mesh Term | Male Urogenital Diseases |
Downcase Mesh Term | urinary bladder neoplasms | Downcase Mesh Term | urologic neoplasms | Downcase Mesh Term | urogenital neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | urinary bladder diseases | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | male urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332419 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Medical University of Warsaw |
Design Group Interventions
Sequence: | 68168305 | Sequence: | 68168306 | Sequence: | 68168307 |
Design Group Id | 55609232 | Design Group Id | 55609233 | Design Group Id | 55609234 |
Intervention Id | 52499529 | Intervention Id | 52499529 | Intervention Id | 52499529 |
Eligibilities
Sequence: | 30773636 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | Patients qualified for surgery due to bladder or upper urinary tract tumors and controls. |
Criteria | Inclusion Criteria:
age >18 years, Exclusion Criteria: urinary tracy infection, |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952981 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30519767 |
Observational Model | Case-Control |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28886068 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52079077 |
Pmid | 32924986 |
Reference Type | derived |
Citation | Bialek L, Czerwinska K, Fus L, Krajewski W, Sadowska A, Radziszewski P, Dobruch J, Kryst P, Poletajew S. MCM5 urine expression (ADXBLADDER) is a reliable biomarker of high-risk non- muscle-invasive bladder cancer recurrence: A prospective matched case-control study. Cancer Biomark. 2021;30(2):139-143. doi: 10.3233/CBM-200316. |
]]>
https://zephyrnet.com/NCT03796286
2018-12-14
https://zephyrnet.com/?p=NCT03796286
NCT03796286https://www.clinicaltrials.gov/study/NCT03796286?tab=tableNANANAThis randomized, crossover study will include four clinic visits: one screening (day -7) and three test visits (days 0, 2, 4). The objective of this study is to assess the effects of dietary fiber-containing bars, at two doses of fiber, compared to a control product, on postprandial glucose and insulin responses in healthy adult men and women.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-07-24 |
Start Month Year | December 14, 2018 |
Primary Completion Month Year | February 27, 2019 |
Verification Month Year | July 2019 |
Verification Date | 2019-07-31 |
Last Update Posted Date | 2019-07-24 |
Facilities
Sequence: | 200053455 | Sequence: | 200053456 |
Name | MB Clinical Research | Name | Great Lakes Clinical Trials |
City | Boca Raton | City | Chicago |
State | Florida | State | Illinois |
Zip | 33487 | Zip | 60640 |
Country | United States | Country | United States |
Conditions
Sequence: | 52156573 | Sequence: | 52156574 | Sequence: | 52156575 |
Name | Blood Glucose | Name | Insulin Sensitivity | Name | Dietary Fiber |
Downcase Name | blood glucose | Downcase Name | insulin sensitivity | Downcase Name | dietary fiber |
Id Information
Sequence: | 40148259 |
Id Source | org_study_id |
Id Value | MB-1805 |
Countries
Sequence: | 42557795 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55577976 | Sequence: | 55577977 | Sequence: | 55577978 |
Group Type | Placebo Comparator | Group Type | Experimental | Group Type | Experimental |
Title | Control bar (0 g fiber) | Title | Medium-fiber bar | Title | High-fiber bar |
Description | Each subject will be randomly assigned to consume a control sports bar-type product (0 grams of fiber) at one treatment visit. | Description | Each subject will be randomly assigned to consume sports bar-type product (containing 10 grams of fiber) at one treatment visit. | Description | Each subject will be randomly assigned to consume sports bar-type product (containing 20 grams of fiber) at one treatment visit. |
Interventions
Sequence: | 52472078 | Sequence: | 52472079 | Sequence: | 52472080 |
Intervention Type | Other | Intervention Type | Other | Intervention Type | Other |
Name | Medium-fiber bar | Name | High-fiber bar | Name | Control bar (0 g fiber) |
Description | Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber. | Description | Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber. | Description | Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber. |
Keywords
Sequence: | 79848196 | Sequence: | 79848197 |
Name | Postprandial glucose | Name | Meal tolerance test |
Downcase Name | postprandial glucose | Downcase Name | meal tolerance test |
Design Outcomes
Sequence: | 177328346 | Sequence: | 177328347 | Sequence: | 177328348 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in the incremental area under the curve for capillary glucose. | Measure | Change in the incremental area under the curve for venous glucose. | Measure | Change in the incremental area under the curve for venous insulin. |
Time Frame | Up to 120 minutes – measured at each treatment visit | Time Frame | Up to 120 minutes – measured at each treatment visit | Time Frame | Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous glucose. |
Description | Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for capillary glucose. | Description | Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous glucose. | Description | Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous insulin. |
Browse Conditions
Sequence: | 193432315 | Sequence: | 193432316 | Sequence: | 193432317 | Sequence: | 193432318 |
Mesh Term | Insulin Resistance | Mesh Term | Hyperinsulinism | Mesh Term | Glucose Metabolism Disorders | Mesh Term | Metabolic Diseases |
Downcase Mesh Term | insulin resistance | Downcase Mesh Term | hyperinsulinism | Downcase Mesh Term | glucose metabolism disorders | Downcase Mesh Term | metabolic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306159 | Sequence: | 48306160 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Midwest Center for Metabolic and Cardiovascular Research | Name | Ingredion Incorporated |
Overall Officials
Sequence: | 29277986 |
Role | Study Director |
Name | Kevin Maki, PhD |
Affiliation | MB Clinical Research and Consulting LLC |
Design Group Interventions
Sequence: | 68130949 | Sequence: | 68130950 | Sequence: | 68130951 |
Design Group Id | 55577977 | Design Group Id | 55577978 | Design Group Id | 55577976 |
Intervention Id | 52472078 | Intervention Id | 52472079 | Intervention Id | 52472080 |
Eligibilities
Sequence: | 30757399 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Male or female, 18-65 y of age, inclusive. Exclusion Criteria: Individual has a clinically significant gastrointestinal, endocrine (including Type 1 and Type 2 diabetes mellitus), cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254228953 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2019 |
Actual Duration | 2 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30503624 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Quadruple |
Masking Description | The study site will be provided pre-packaged, sealed containers of control (a bar with no fiber) and active study products (a bar with 10 grams of fiber and a bar with 20 grams of fiber). Each product container will be labeled with the lot number, expiration date, and blinded product code. |
Intervention Model Description | Randomized, controlled, three-treatment, crossover trial with one screening/baseline visit and three test visits. At each testing visit, the study product (a bar) will be consumed with water. |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28869902 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796273
2019-03-13
https://zephyrnet.com/?p=NCT03796273
NCT03796273https://www.clinicaltrials.gov/study/NCT03796273?tab=tableNANANAThis trial studies the side effects and how well ketoconazole works before surgery in treating patients with glioma that has come back or breast cancer that has spread to the brain. Ketoconazole is an antifungal drug that may be able to block a protein, tGLI1 and may help to treat brain tumors.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-26 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-06-01 |
Start Month Year | March 13, 2019 |
Primary Completion Month Year | July 2023 |
Verification Month Year | May 2023 |
Verification Date | 2023-05-31 |
Last Update Posted Date | 2023-06-01 |
Detailed Descriptions
Sequence: | 20758300 |
Description | PRIMARY OBJECTIVES:
I. To determine if ketoconazole alters the tGLI1 activation signature (tGAS) which is consisted of eight validated tGLI1 regulated genes (CD24, CD44, VEGF-A, VEGF-C, VEGFR2, TEM7, OCT-4. and heparanase) in tGLI1 expressing brain biospecimens. SECONDARY OBJECTIVES: I. To determine if pre-treatment with ketoconazole, an inhibitor of the tGLI1 pathway in tissue culture and animal models, reduces circulating tGLI1 associated exosomal miRNA expression (miR1290 and miR1246) in brain tumor patients. II. To describe the safety of ketoconazole when administered peri-operatively to patients with primary and secondary brain tumors. III. To measure the blood brain penetrance of ketoconazole in serum relative to enhancing brain tissue. EXPLORATORY OBJECTIVES: I. To measure blood brain penetration of ketoconazole in serum relative to cerebrospinal fluid (CSF) and serum relative to non-enhancing brain tissue (exploratory recurrent glioma patients only). II. To compare tGLI1 expression and pathway modulation with ketoconazole pre-treatment in patients with recurrent gliomas relative to breast cancer brain metastases (BCBM). III. To determine the overall survival and toxicity outcomes for patients that continue ketoconazole after surgery, at the discretion of the treating physician. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive ketoconazole orally (PO) once daily (QD) on days 1-4 before standard surgery in the absence of disease progression or unacceptable toxicity. ARM II: Patients undergo standard surgery. After completion of study treatment, patients are followed up at 30 days. |
Facilities
Sequence: | 200417177 |
Status | Recruiting |
Name | Wake Forest University Health Sciences |
City | Winston-Salem |
State | North Carolina |
Zip | 27157 |
Country | United States |
Facility Contacts
Sequence: | 28150961 |
Facility Id | 200417177 |
Contact Type | primary |
Name | Roy E. Strowd |
rstrowd@wakehealth.edu | |
Phone | 336-716-7422 |
Facility Investigators
Sequence: | 18356783 |
Facility Id | 200417177 |
Role | Principal Investigator |
Name | Roy E. Strowd |
Browse Interventions
Sequence: | 96202594 | Sequence: | 96202595 | Sequence: | 96202596 | Sequence: | 96202597 | Sequence: | 96202598 | Sequence: | 96202599 | Sequence: | 96202600 | Sequence: | 96202601 | Sequence: | 96202602 | Sequence: | 96202603 | Sequence: | 96202604 | Sequence: | 96202605 |
Mesh Term | Ketoconazole | Mesh Term | Antifungal Agents | Mesh Term | Anti-Infective Agents | Mesh Term | 14-alpha Demethylase Inhibitors | Mesh Term | Cytochrome P-450 Enzyme Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Steroid Synthesis Inhibitors | Mesh Term | Hormone Antagonists | Mesh Term | Hormones, Hormone Substitutes, and Hormone Antagonists | Mesh Term | Physiological Effects of Drugs | Mesh Term | Cytochrome P-450 CYP3A Inhibitors |
Downcase Mesh Term | ketoconazole | Downcase Mesh Term | antifungal agents | Downcase Mesh Term | anti-infective agents | Downcase Mesh Term | 14-alpha demethylase inhibitors | Downcase Mesh Term | cytochrome p-450 enzyme inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | steroid synthesis inhibitors | Downcase Mesh Term | hormone antagonists | Downcase Mesh Term | hormones, hormone substitutes, and hormone antagonists | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | cytochrome p-450 cyp3a inhibitors |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52265400 | Sequence: | 52265401 | Sequence: | 52265402 | Sequence: | 52265403 | Sequence: | 52265404 | Sequence: | 52265405 | Sequence: | 52265406 | Sequence: | 52265407 |
Name | Anatomic Stage IV Breast Cancer AJCC v8 | Name | Astrocytoma | Name | Breast Carcinoma Metastatic in the Brain | Name | Glioma | Name | Invasive Breast Carcinoma | Name | Oligodendroglioma | Name | Prognostic Stage IV Breast Cancer AJCC v8 | Name | Recurrent Glioma |
Downcase Name | anatomic stage iv breast cancer ajcc v8 | Downcase Name | astrocytoma | Downcase Name | breast carcinoma metastatic in the brain | Downcase Name | glioma | Downcase Name | invasive breast carcinoma | Downcase Name | oligodendroglioma | Downcase Name | prognostic stage iv breast cancer ajcc v8 | Downcase Name | recurrent glioma |
Id Information
Sequence: | 40227073 | Sequence: | 40227074 | Sequence: | 40227075 | Sequence: | 40227076 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | IRB00054587 | Id Value | NCI-2018-03087 | Id Value | CCCWFU 91118 | Id Value | P30CA012197 |
Id Type | Registry Identifier | Id Type | Other Identifier | Id Type | U.S. NIH Grant/Contract | ||
Id Type Description | CTRP (Clinical Trial Reporting Program) | Id Type Description | Wake Forest University Health Sciences | ||||
Id Link | https://reporter.nih.gov/quickSearch/P30CA012197 |
Countries
Sequence: | 42643472 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55698704 | Sequence: | 55698705 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Arm I (ketoconazole) | Title | Arm II (standard surgery) |
Description | Patients receive ketoconazole PO QD on days 1-4 before standard surgery in the absence of disease progression or unacceptable toxicity. | Description | Patients undergo standard surgery. |
Interventions
Sequence: | 52578072 | Sequence: | 52578073 |
Intervention Type | Other | Intervention Type | Drug |
Name | Best Practice | Name | Ketoconazole |
Description | Undergo standard surgery | Description | Given PO |
Design Outcomes
Sequence: | 177725770 | Sequence: | 177725771 | Sequence: | 177725772 | Sequence: | 177725773 | Sequence: | 177725774 | Sequence: | 177725775 | Sequence: | 177725776 | Sequence: | 177725777 | Sequence: | 177725778 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | tGLI1 activation signature 8 (t-GAS 8) | Measure | tGLI1 pathway activation | Measure | Incidence of adverse events (AEs) | Measure | Blood brain penetrance of ketoconazole in serum relative to enhancing brain tissue | Measure | Serum ketoconazole concentrations in Cerebrospinal Fluid (CSF) | Measure | Serum ketoconazole concentrations in enhancing brain tissue | Measure | Serum ketoconzcole concentrations in unenhancing brain tissue | Measure | Changes in tGLI1 signaling pathway | Measure | Overall survival (OS) |
Time Frame | Up to 30 days after surgery | Time Frame | Up to 30 days after surgery | Time Frame | Up to 30 days after surgery | Time Frame | Up to 30 days after surgery | Time Frame | Up to 30 days after surgery | Time Frame | Up to 30 days after surgery | Time Frame | Up to 30 days after surgery | Time Frame | Baseline up to 30 days after surgery | Time Frame | From the date of the starting ketoconazole to the date of death from any cause, assessed up to 30 days after ketoconazole treatment completion |
Description | The primary outcome of this study is modulation of the tGLI1 pathway as assessed by the tGLI1 activation signature 8 (t-GAS 8) [29, 40]. t-GAS 8 consists of eight validated tGLI1 regulated genes (CD24, CD44, VEGF-A, VEGF-C, VEGFR2, TEM7, OCT-4. and heparanase) and is measured using qPCR in patients whose brain tissue expresses tGLI1 (by IHC). The distribution of the tGAS will be examined and transformed to approximate the conditional normality assumption if necessary. Analysis of variance (ANOVA) methods will be used to determine the effects of different factors of interest (e.g., treatment or tumor type) on the outcomes measured. | Description | tGLI1 pathway activation will be compared between treatment groups using ANOVA as described for the analysis of primary objective. | Description | The safety of ketoconazole will be defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 criteria and determined by adverse event proportions. The adverse event proportions will be compared between treatment groups using chi-squared tests. If feasible, a logistic regression model will be used to detect whether the adverse event proportion is higher in the treatment group after adjusting for the tumor type. | Description | The analysis will be the same as that for the analysis of primary objective. | Description | Measured using mass spectroscopy. The analysis will be the same as that for the analysis of primary objective. If the sample size is too small, the nonparametric approach will be considered as the primary analysis. | Description | Measured using mass spectroscopy. The analysis will be the same as that for the analysis of primary objective. If the sample size is too small, the nonparametric approach will be considered as the primary analysis. | Description | Measured using mass spectroscopy. The analysis will be the same as that for the analysis of primary objective. If the sample size is too small, the nonparametric approach will be considered as the primary analysis. | Description | Will be calculated and compared between treatment groups. Ideally analysis of covariance should be done. However, due to the small sample size, ANOVA as described for the primary analysis approach or the 2-sample t test will be used. If needed, non-parametric approaches will be used instead. | Description | The Kaplan-Meier method will be used to estimate OS probability and median time of survival along with the 95% confidence interval. |
Browse Conditions
Sequence: | 193847071 | Sequence: | 193847072 | Sequence: | 193847073 | Sequence: | 193847074 | Sequence: | 193847075 | Sequence: | 193847076 | Sequence: | 193847077 | Sequence: | 193847078 | Sequence: | 193847079 | Sequence: | 193847080 | Sequence: | 193847081 | Sequence: | 193847082 | Sequence: | 193847083 | Sequence: | 193847084 | Sequence: | 193847085 | Sequence: | 193847086 | Sequence: | 193847087 | Sequence: | 193847088 | Sequence: | 193847089 | Sequence: | 193847090 | Sequence: | 193847091 |
Mesh Term | Carcinoma | Mesh Term | Breast Neoplasms | Mesh Term | Glioma | Mesh Term | Brain Neoplasms | Mesh Term | Astrocytoma | Mesh Term | Oligodendroglioma | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Breast Diseases | Mesh Term | Skin Diseases | Mesh Term | Neoplasms, Neuroepithelial | Mesh Term | Neuroectodermal Tumors | Mesh Term | Neoplasms, Germ Cell and Embryonal | Mesh Term | Neoplasms, Nerve Tissue | Mesh Term | Central Nervous System Neoplasms | Mesh Term | Nervous System Neoplasms | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases |
Downcase Mesh Term | carcinoma | Downcase Mesh Term | breast neoplasms | Downcase Mesh Term | glioma | Downcase Mesh Term | brain neoplasms | Downcase Mesh Term | astrocytoma | Downcase Mesh Term | oligodendroglioma | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | breast diseases | Downcase Mesh Term | skin diseases | Downcase Mesh Term | neoplasms, neuroepithelial | Downcase Mesh Term | neuroectodermal tumors | Downcase Mesh Term | neoplasms, germ cell and embryonal | Downcase Mesh Term | neoplasms, nerve tissue | Downcase Mesh Term | central nervous system neoplasms | Downcase Mesh Term | nervous system neoplasms | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48407258 | Sequence: | 48407259 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Wake Forest University Health Sciences | Name | National Cancer Institute (NCI) |
Overall Officials
Sequence: | 29336401 |
Role | Principal Investigator |
Name | Roy Strowd |
Affiliation | Wake Forest University Health Sciences |
Design Group Interventions
Sequence: | 68276462 | Sequence: | 68276463 | Sequence: | 68276464 |
Design Group Id | 55698704 | Design Group Id | 55698705 | Design Group Id | 55698704 |
Intervention Id | 52578072 | Intervention Id | 52578072 | Intervention Id | 52578073 |
Eligibilities
Sequence: | 30820183 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Subjects must have a history of: Histologically confirmed primary breast cancer including primary invasive and metastatic breast cancers with imaging findings consistent with brain metastasis. In the event that a patient presents with an initial diagnosis of metastatic breast cancer with imaging findings of a new brain metastases and unequivocal imaging findings of a primary breast cancer, consideration for study enrollment requires approval from the study chair (primary cohort) OR Histologically confirmed primary glioma including astrocytoma or oligodendroglioma of any World Health Organization grade with imaging findings consistent with recurrent or progressive disease (exploratory cohort). Patients with ependymoma will not be included. Subjects must be undergoing surgical resection for clinical purposes with anticipated resection of at least 300 mg of tissue. Exclusion Criteria: Subjects with contraindication to ketoconazole including: Prior allergic reaction or intolerance of ketoconazole |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254104462 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Number Of Other Outcomes To Measure | 5 |
Designs
Sequence: | 30566130 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26717243 | Sequence: | 26717244 | Sequence: | 26717245 | Sequence: | 26717246 | Sequence: | 26717247 | Sequence: | 26717248 | Sequence: | 26717249 | Sequence: | 26717250 | Sequence: | 26717251 | Sequence: | 26717252 | Sequence: | 26717253 |
Intervention Id | 52578072 | Intervention Id | 52578072 | Intervention Id | 52578073 | Intervention Id | 52578073 | Intervention Id | 52578073 | Intervention Id | 52578073 | Intervention Id | 52578073 | Intervention Id | 52578073 | Intervention Id | 52578073 | Intervention Id | 52578073 | Intervention Id | 52578073 |
Name | standard of care | Name | standard therapy | Name | Fungarest | Name | Fungoral | Name | Ketoderm | Name | Ketoisdin | Name | Nizoral | Name | Orifungal M | Name | Panfungol | Name | R-41400 | Name | Xolegel |
Responsible Parties
Sequence: | 28932525 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796260
2019-01-09
https://zephyrnet.com/?p=NCT03796260
NCT03796260https://www.clinicaltrials.gov/study/NCT03796260?tab=tableNANANAThis study aims to investigate the relative bioavailability, safety, and tolerability of entrectinib capsule formulations F1 and F06 under fed conditions in healthy adult male and female participants.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-02-26 |
Start Month Year | January 9, 2019 |
Primary Completion Month Year | February 4, 2019 |
Verification Month Year | February 2020 |
Verification Date | 2020-02-29 |
Last Update Posted Date | 2020-02-26 |
Results First Posted Date | 2020-02-26 |
Facilities
Sequence: | 198630696 |
Name | Covance Research Unit – Daytona |
City | Daytona Beach |
State | Florida |
Zip | 32117 |
Country | United States |
Browse Interventions
Sequence: | 95307601 | Sequence: | 95307602 | Sequence: | 95307603 | Sequence: | 95307604 |
Mesh Term | Entrectinib | Mesh Term | Protein Kinase Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | entrectinib | Downcase Mesh Term | protein kinase inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51790014 |
Name | Healthy Volunteers |
Downcase Name | healthy volunteers |
Id Information
Sequence: | 39855188 |
Id Source | org_study_id |
Id Value | GP41048 |
Countries
Sequence: | 42254027 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55210668 | Sequence: | 55210669 |
Group Type | Experimental | Group Type | Experimental |
Title | F1 to F06 Crossover | Title | F06 to F1 Crossover |
Description | Participants first randomized to this arm will receive a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 after a standardized meal. This dose will be followed by a minimum 14-day washout period, after which participants will receive a single oral dose of entrectinib F06 (reference formulation) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days). | Description | Participants first randomized to this arm will receive a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 after a standardized meal. This dose will be followed by a minimum 14-day washout period, after which participants will receive a single oral dose of entrectinib F1 (test formulation) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days). |
Interventions
Sequence: | 52112623 | Sequence: | 52112624 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Entrectinib Test Formulation (F1) | Name | Entrectinib Reference Formulation (F06) |
Description | Participants will receive a single oral dose of entrectinib F1 after completion of a standardized meal. | Description | Participants will receive a single oral dose of entrectinib F06 after completion of a standardized meal. |
Design Outcomes
Sequence: | 176153640 | Sequence: | 176153638 | Sequence: | 176153639 | Sequence: | 176153641 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary |
Measure | Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite | Measure | Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Entrectinib and M5 Metabolite | Measure | Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite | Measure | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
Time Frame | At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days) | Time Frame | At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days) | Time Frame | At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) |
Description | The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | The area under the concentration-time curve extrapolated to infinity is calculated using the formula: AUC0-inf = AUC0-t + (Ct/λz) where Ct is the last measurable concentration and λz is the apparent terminal elimination rate constant. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | The area under the concentration-time curve calculated from Hour 0 to the last measurable concentration, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
Browse Conditions
Sequence: | 191950712 | Sequence: | 191950713 |
Mesh Term | Malnutrition | Mesh Term | Nutrition Disorders |
Downcase Mesh Term | malnutrition | Downcase Mesh Term | nutrition disorders |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47964008 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Genentech, Inc. |
Overall Officials
Sequence: | 29060524 |
Role | Study Director |
Name | Clinical Trials |
Affiliation | Hoffmann-La Roche |
Design Group Interventions
Sequence: | 67689831 | Sequence: | 67689832 | Sequence: | 67689833 | Sequence: | 67689834 |
Design Group Id | 55210669 | Design Group Id | 55210668 | Design Group Id | 55210669 | Design Group Id | 55210668 |
Intervention Id | 52112623 | Intervention Id | 52112623 | Intervention Id | 52112624 | Intervention Id | 52112624 |
Eligibilities
Sequence: | 30541671 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Healthy in the opinion of the investigator. Healthy is defined by the absence of evidence of any active disease or clinically significant medical condition based on a detailed medical history and examination Exclusion Criteria: History of gastrointestinal surgery or other gastrointestinal disorder that might affect absorption of medicines from the gastrointestinal tract |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254206585 |
Number Of Facilities | 1 |
Number Of Nsae Subjects | 12 |
Registered In Calendar Year | 2019 |
Actual Duration | 0 |
Were Results Reported | True |
Months To Report Results | 11 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30290205 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Milestones
Sequence: | 40799729 | Sequence: | 40799730 | Sequence: | 40799731 | Sequence: | 40799732 | Sequence: | 40799733 | Sequence: | 40799734 | Sequence: | 40799735 | Sequence: | 40799736 | Sequence: | 40799737 | Sequence: | 40799738 | Sequence: | 40799739 | Sequence: | 40799740 |
Result Group Id | 55879888 | Result Group Id | 55879889 | Result Group Id | 55879888 | Result Group Id | 55879889 | Result Group Id | 55879888 | Result Group Id | 55879889 | Result Group Id | 55879888 | Result Group Id | 55879889 | Result Group Id | 55879888 | Result Group Id | 55879889 | Result Group Id | 55879888 | Result Group Id | 55879889 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Period 1 | Period | Period 1 | Period | Period 1 | Period | Period 1 | Period | Period 1 | Period | Period 1 | Period | Period 2 | Period | Period 2 | Period | Period 2 | Period | Period 2 | Period | Period 2 | Period | Period 2 |
Count | 7 | Count | 7 | Count | 7 | Count | 7 | Count | 0 | Count | 0 | Count | 7 | Count | 7 | Count | 7 | Count | 7 | Count | 0 | Count | 0 |
Participant Flows
Sequence: | 3902854 |
Outcome Counts
Sequence: | 73593026 | Sequence: | 73593027 | Sequence: | 73593028 | Sequence: | 73593029 | Sequence: | 73593030 | Sequence: | 73593031 | Sequence: | 73593032 | Sequence: | 73593033 |
Outcome Id | 30636654 | Outcome Id | 30636654 | Outcome Id | 30636655 | Outcome Id | 30636655 | Outcome Id | 30636656 | Outcome Id | 30636656 | Outcome Id | 30636657 | Outcome Id | 30636657 |
Result Group Id | 55879890 | Result Group Id | 55879891 | Result Group Id | 55879890 | Result Group Id | 55879891 | Result Group Id | 55879890 | Result Group Id | 55879891 | Result Group Id | 55879890 | Result Group Id | 55879891 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 |
Provided Documents
Sequence: | 2568503 | Sequence: | 2568504 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2018-11-02 | Document Date | 2019-01-28 |
Url | https://ClinicalTrials.gov/ProvidedDocs/60/NCT03796260/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/60/NCT03796260/SAP_001.pdf |
Reported Event Totals
Sequence: | 27805375 | Sequence: | 27805376 | Sequence: | 27805377 | Sequence: | 27805378 | Sequence: | 27805379 | Sequence: | 27805380 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 4 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 3 | Subjects Affected | 0 |
Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 |
Created At | 2023-08-06 18:18:15.231472 | Created At | 2023-08-06 18:18:15.231472 | Created At | 2023-08-06 18:18:15.231472 | Created At | 2023-08-06 18:18:15.231472 | Created At | 2023-08-06 18:18:15.231472 | Created At | 2023-08-06 18:18:15.231472 |
Updated At | 2023-08-06 18:18:15.231472 | Updated At | 2023-08-06 18:18:15.231472 | Updated At | 2023-08-06 18:18:15.231472 | Updated At | 2023-08-06 18:18:15.231472 | Updated At | 2023-08-06 18:18:15.231472 | Updated At | 2023-08-06 18:18:15.231472 |
Reported Events
Sequence: | 524777667 | Sequence: | 524777668 | Sequence: | 524777669 | Sequence: | 524777670 | Sequence: | 524777671 | Sequence: | 524777672 | Sequence: | 524777673 | Sequence: | 524777674 | Sequence: | 524777675 | Sequence: | 524777676 | Sequence: | 524777677 | Sequence: | 524777678 | Sequence: | 524777679 | Sequence: | 524777680 | Sequence: | 524777681 | Sequence: | 524777682 | Sequence: | 524777683 | Sequence: | 524777684 |
Result Group Id | 55879892 | Result Group Id | 55879893 | Result Group Id | 55879892 | Result Group Id | 55879893 | Result Group Id | 55879892 | Result Group Id | 55879893 | Result Group Id | 55879892 | Result Group Id | 55879893 | Result Group Id | 55879892 | Result Group Id | 55879893 | Result Group Id | 55879892 | Result Group Id | 55879893 | Result Group Id | 55879892 | Result Group Id | 55879893 | Result Group Id | 55879892 | Result Group Id | 55879893 | Result Group Id | 55879892 | Result Group Id | 55879893 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) |
Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other |
Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 |
Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 |
Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. |
Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | General disorders | Organ System | General disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders |
Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Paraesthesia | Adverse Event Term | Paraesthesia | Adverse Event Term | Cognitive disorder | Adverse Event Term | Cognitive disorder | Adverse Event Term | Parosmia | Adverse Event Term | Parosmia | Adverse Event Term | Paraesthesia oral | Adverse Event Term | Paraesthesia oral | Adverse Event Term | Dyspepsia | Adverse Event Term | Dyspepsia | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite |
Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 |
Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 |
Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment |
Responsible Parties
Sequence: | 28669165 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3833598 |
Pi Employee | No |
Restriction Type | OTHER |
Other Details | The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights. |
Restrictive Agreement | The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights. |
Result Contacts
Sequence: | 3833563 |
Organization | Hoffmann-La Roche |
Name | Medical Communications |
Phone | 800 821-8590 |
genentech@druginfo.com | |
Outcomes
Sequence: | 30636654 | Sequence: | 30636655 | Sequence: | 30636656 | Sequence: | 30636657 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary |
Title | Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Entrectinib and M5 Metabolite | Title | Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite | Title | Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite | Title | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
Description | The area under the concentration-time curve extrapolated to infinity is calculated using the formula: AUC0-inf = AUC0-t + (Ct/λz) where Ct is the last measurable concentration and λz is the apparent terminal elimination rate constant. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | The area under the concentration-time curve calculated from Hour 0 to the last measurable concentration, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
Time Frame | At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days) | Time Frame | At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days) | Time Frame | At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days) | Time Frame | Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days]) |
Population | The PK Population included all participants who received at least 1 dose of study drug and had at least 1 evaluable postdose pharmacokinetic (PK) sample. | Population | The PK Population included all participants who received at least 1 dose of study drug and had at least 1 evaluable postdose PK sample. | Population | The PK Population included all participants who received at least 1 dose of study drug and had at least 1 evaluable postdose PK sample. | Population | The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. |
Units | nmol*h/L | Units | nmol*h/L | Units | nmol/L | Units | Percentage of Participants |
Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | ||
Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Number |
Outcome Measurements
Sequence: | 234242646 | Sequence: | 234242647 | Sequence: | 234242648 | Sequence: | 234242649 | Sequence: | 234242650 | Sequence: | 234242651 | Sequence: | 234242652 | Sequence: | 234242653 | Sequence: | 234242654 | Sequence: | 234242655 | Sequence: | 234242656 | Sequence: | 234242657 | Sequence: | 234242658 | Sequence: | 234242659 |
Outcome Id | 30636654 | Outcome Id | 30636654 | Outcome Id | 30636654 | Outcome Id | 30636654 | Outcome Id | 30636655 | Outcome Id | 30636655 | Outcome Id | 30636655 | Outcome Id | 30636655 | Outcome Id | 30636656 | Outcome Id | 30636656 | Outcome Id | 30636656 | Outcome Id | 30636656 | Outcome Id | 30636657 | Outcome Id | 30636657 |
Result Group Id | 55879890 | Result Group Id | 55879891 | Result Group Id | 55879890 | Result Group Id | 55879891 | Result Group Id | 55879890 | Result Group Id | 55879891 | Result Group Id | 55879890 | Result Group Id | 55879891 | Result Group Id | 55879890 | Result Group Id | 55879891 | Result Group Id | 55879890 | Result Group Id | 55879891 | Result Group Id | 55879890 | Result Group Id | 55879891 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Classification | Entrectinib | Classification | Entrectinib | Classification | M5 Metabolite | Classification | M5 Metabolite | Classification | Entrectinib | Classification | Entrectinib | Classification | M5 Metabolite | Classification | M5 Metabolite | Classification | Entrectinib | Classification | Entrectinib | Classification | M5 Metabolite | Classification | M5 Metabolite | ||||
Title | Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Entrectinib and M5 Metabolite | Title | Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Entrectinib and M5 Metabolite | Title | Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Entrectinib and M5 Metabolite | Title | Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Entrectinib and M5 Metabolite | Title | Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite | Title | Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite | Title | Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite | Title | Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite | Title | Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite | Title | Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite | Title | Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite | Title | Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite | Title | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Title | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
Description | The area under the concentration-time curve extrapolated to infinity is calculated using the formula: AUC0-inf = AUC0-t + (Ct/λz) where Ct is the last measurable concentration and λz is the apparent terminal elimination rate constant. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | The area under the concentration-time curve extrapolated to infinity is calculated using the formula: AUC0-inf = AUC0-t + (Ct/λz) where Ct is the last measurable concentration and λz is the apparent terminal elimination rate constant. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | The area under the concentration-time curve extrapolated to infinity is calculated using the formula: AUC0-inf = AUC0-t + (Ct/λz) where Ct is the last measurable concentration and λz is the apparent terminal elimination rate constant. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | The area under the concentration-time curve extrapolated to infinity is calculated using the formula: AUC0-inf = AUC0-t + (Ct/λz) where Ct is the last measurable concentration and λz is the apparent terminal elimination rate constant. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | The area under the concentration-time curve calculated from Hour 0 to the last measurable concentration, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | The area under the concentration-time curve calculated from Hour 0 to the last measurable concentration, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | The area under the concentration-time curve calculated from Hour 0 to the last measurable concentration, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | The area under the concentration-time curve calculated from Hour 0 to the last measurable concentration, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern. | Description | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Description | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
Units | nmol*h/L | Units | nmol*h/L | Units | nmol*h/L | Units | nmol*h/L | Units | nmol*h/L | Units | nmol*h/L | Units | nmol*h/L | Units | nmol*h/L | Units | nmol/L | Units | nmol/L | Units | nmol/L | Units | nmol/L | Units | Percentage of Participants | Units | Percentage of Participants |
Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Number | Param Type | Number |
Param Value | 44000 | Param Value | 44900 | Param Value | 14400 | Param Value | 15000 | Param Value | 41200 | Param Value | 42100 | Param Value | 11600 | Param Value | 12600 | Param Value | 1870 | Param Value | 2000 | Param Value | 427 | Param Value | 487 | Param Value | 28.6 | Param Value | 21.4 |
Param Value Num | 44000.0 | Param Value Num | 44900.0 | Param Value Num | 14400.0 | Param Value Num | 15000.0 | Param Value Num | 41200.0 | Param Value Num | 42100.0 | Param Value Num | 11600.0 | Param Value Num | 12600.0 | Param Value Num | 1870.0 | Param Value Num | 2000.0 | Param Value Num | 427.0 | Param Value Num | 487.0 | Param Value Num | 28.6 | Param Value Num | 21.4 |
Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | ||||
Dispersion Value | 52.0 | Dispersion Value | 50.1 | Dispersion Value | 51.09 | Dispersion Value | 50.8 | Dispersion Value | 50.9 | Dispersion Value | 48.5 | Dispersion Value | 49.4 | Dispersion Value | 48.2 | Dispersion Value | 49.4 | Dispersion Value | 37.6 | Dispersion Value | 60.8 | Dispersion Value | 50.6 | ||||
Dispersion Value Num | 52.0 | Dispersion Value Num | 50.1 | Dispersion Value Num | 51.09 | Dispersion Value Num | 50.8 | Dispersion Value Num | 50.9 | Dispersion Value Num | 48.5 | Dispersion Value Num | 49.4 | Dispersion Value Num | 48.2 | Dispersion Value Num | 49.4 | Dispersion Value Num | 37.6 | Dispersion Value Num | 60.8 | Dispersion Value Num | 50.6 | ||||
Baseline Counts
Sequence: | 11328794 | Sequence: | 11328795 | Sequence: | 11328796 |
Result Group Id | 55879885 | Result Group Id | 55879886 | Result Group Id | 55879887 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 7 | Count | 7 | Count | 14 |
Result Groups
Sequence: | 55879885 | Sequence: | 55879886 | Sequence: | 55879887 | Sequence: | 55879888 | Sequence: | 55879889 | Sequence: | 55879890 | Sequence: | 55879891 | Sequence: | 55879892 | Sequence: | 55879893 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | F1 to F06 Crossover | Title | F06 to F1 Crossover | Title | Total | Title | F1 to F06 Crossover | Title | F06 to F1 Crossover | Title | F1 Test Formulation | Title | F06 Reference Formulation | Title | F1 Test Formulation | Title | F06 Reference Formulation |
Description | Participants first randomized to F1/F06 arm and received a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 after a standardized meal. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib F06 (reference formulation) under fed conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days). | Description | Participants first randomized to this arm received a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 after a standardized meal. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib F1 (test formulation) under fed conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days). | Description | Total of all reporting groups | Description | Participants first randomized to F1/F06 arm and received a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 after a standardized meal. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib F06 (reference formulation) under fed conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days). | Description | Participants first randomized to this arm received a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 after a standardized meal. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib F1 (test formulation) under fed conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days). | Description | Participants who received a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days). | Description | Participants who received a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days). | Description | Participants who received a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days). | Description | Participants who received a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 and Day 1 of Period 2 after a standardized meal (Periods 1 and 2 = 6 days). |
Baseline Measurements
Sequence: | 124996058 | Sequence: | 124996059 | Sequence: | 124996060 | Sequence: | 124996061 | Sequence: | 124996062 | Sequence: | 124996063 | Sequence: | 124996064 | Sequence: | 124996065 | Sequence: | 124996066 | Sequence: | 124996067 | Sequence: | 124996068 | Sequence: | 124996069 | Sequence: | 124996070 | Sequence: | 124996071 | Sequence: | 124996072 | Sequence: | 124996073 | Sequence: | 124996074 | Sequence: | 124996075 | Sequence: | 124996076 | Sequence: | 124996077 | Sequence: | 124996078 | Sequence: | 124996079 | Sequence: | 124996080 | Sequence: | 124996081 |
Result Group Id | 55879885 | Result Group Id | 55879886 | Result Group Id | 55879887 | Result Group Id | 55879885 | Result Group Id | 55879886 | Result Group Id | 55879887 | Result Group Id | 55879885 | Result Group Id | 55879886 | Result Group Id | 55879887 | Result Group Id | 55879885 | Result Group Id | 55879886 | Result Group Id | 55879887 | Result Group Id | 55879885 | Result Group Id | 55879886 | Result Group Id | 55879887 | Result Group Id | 55879885 | Result Group Id | 55879886 | Result Group Id | 55879887 | Result Group Id | 55879885 | Result Group Id | 55879886 | Result Group Id | 55879887 | Result Group Id | 55879885 | Result Group Id | 55879886 | Result Group Id | 55879887 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | White | Category | White | Category | White | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Multiple | Category | Multiple | Category | Multiple | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | ||||||
Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized |
Units | Years | Units | Years | Units | Years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 37.3 | Param Value | 33.3 | Param Value | 36 | Param Value | 4 | Param Value | 3 | Param Value | 7 | Param Value | 3 | Param Value | 4 | Param Value | 7 | Param Value | 5 | Param Value | 7 | Param Value | 12 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 4 | Param Value | 6 | Param Value | 10 | Param Value | 3 | Param Value | 1 | Param Value | 4 |
Param Value Num | 37.3 | Param Value Num | 33.3 | Param Value Num | 36.0 | Param Value Num | 4.0 | Param Value Num | 3.0 | Param Value Num | 7.0 | Param Value Num | 3.0 | Param Value Num | 4.0 | Param Value Num | 7.0 | Param Value Num | 5.0 | Param Value Num | 7.0 | Param Value Num | 12.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 4.0 | Param Value Num | 6.0 | Param Value Num | 10.0 | Param Value Num | 3.0 | Param Value Num | 1.0 | Param Value Num | 4.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 11.7 | Dispersion Value | 10.5 | Dispersion Value | 11.6 | ||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 11.7 | Dispersion Value Num | 10.5 | Dispersion Value Num | 11.6 | ||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 7 | Number Analyzed | 7 | Number Analyzed | 14 | Number Analyzed | 7 | Number Analyzed | 7 | Number Analyzed | 14 | Number Analyzed | 7 | Number Analyzed | 7 | Number Analyzed | 14 | Number Analyzed | 7 | Number Analyzed | 7 | Number Analyzed | 14 | Number Analyzed | 7 | Number Analyzed | 7 | Number Analyzed | 14 | Number Analyzed | 7 | Number Analyzed | 7 | Number Analyzed | 14 | Number Analyzed | 7 | Number Analyzed | 7 | Number Analyzed | 14 | Number Analyzed | 7 | Number Analyzed | 7 | Number Analyzed | 14 |
]]>
https://zephyrnet.com/NCT03796247
2011-05-02
https://zephyrnet.com/?p=NCT03796247
NCT03796247https://www.clinicaltrials.gov/study/NCT03796247?tab=tableNANANAPrevalence of alexithymia in multiple sclerosis (MS) is closed to 50% but is unknown in clinically isolated syndrome (CIS).The present study sought to characterize alexithymia in CIS patients and his link between psycho behavioral and cognitive disturbances.
In this context, the objectives of the present study were to (a ) define the prevalence of alexithymia in CIS patients, (b ) to study this relation between psycho behavioral and cognitive disorders frequently encountered in MS.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | May 2, 2011 |
Primary Completion Month Year | May 2016 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-08 |
Detailed Descriptions
Sequence: | 20783047 |
Description | The aim to recruit 40 CIS patients with at least two subclinical lesions on brain MRI. Patients are tested only one month at least after steroids intake and after 6 weeks at least after any relapse. The control group include 40 right -handed participants; each of them are matched for age, gender, and education level with a CIS patient.
The parameters to be evaluated are: The prevalence of alexithymia is assessed by The Toronto Alexithymia Scale TAS-20, a self-reported scale. The TAS-20 total score corresponds to global level of alexithymia, as the sum of these three subdomains: 1.Difficulties in Identifying Feelings (DIF); 2. Difficulties in Describing Feelings (DDF); 3. Externally Oriented Thinking (EOT). Standard neurological examination is performed by a neurologist using the Kurtzke Expanded Disability Status Scale (EDSS ). The standardized neuropsychological battery, named BCcogSEP, is administrated. The BCcogSEP is made of eight tests commonly impaired in MS. Fourteen scores were obtained and a score was considered impaired when it was inferior to 5th percentile range compared to the normal range. The number of impaired scores are considered and a cognitive impairment is considered when 4 scores are superior or equal to percentile 5th. For psychobehavioral assessments, the investigators estimated (a) depression (according to the Beck Depression Inventory; BDI (30)) and anxiety (according to the State-Trait Anxiety Inventory (31)); (b) apathy (according to the Lille Apathy Rating Scale (32)); (c) empathy (according to Interpersonal Reactivity Index; IRI). |
Facilities
Sequence: | 200618356 |
Name | Hôpital Roger Salengro, CHRU de Lille |
City | Lille |
Country | France |
Conditions
Sequence: | 52328327 |
Name | Multiple Sclerosis |
Downcase Name | multiple sclerosis |
Id Information
Sequence: | 40271106 | Sequence: | 40271107 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 2010_39 | Id Value | 2011-A00016-35 |
Id Type | Other Identifier | ||
Id Type Description | ID-RCB number, ANSM | ||
Countries
Sequence: | 42691176 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55768163 | Sequence: | 55768164 |
Title | multiple sclerosis | Title | healthy control |
Keywords
Sequence: | 80085358 | Sequence: | 80085359 |
Name | cognition | Name | alexithymia |
Downcase Name | cognition | Downcase Name | alexithymia |
Design Outcomes
Sequence: | 177960001 | Sequence: | 177960002 | Sequence: | 177960003 | Sequence: | 177960004 | Sequence: | 177960005 | Sequence: | 177960006 | Sequence: | 177960007 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Frequency of alexithymia in the CIS population | Measure | relation between alexithymia and cognitive impairment in CIS patients and controls | Measure | relation between alexithymia and thymic disorder in CIS and controls | Measure | relation between alexithymia and thymic disorder in CIS and controls | Measure | relation between alexithymia and thymic disorder in CIS and controls | Measure | relation between alexithymia and thymic disorder in CIS and controls | Measure | to evaluate the callosal functions and inter-hemispheric transfer in CIS and controls |
Time Frame | Baseline: one session | Time Frame | Baseline: one session | Time Frame | Baseline: one session | Time Frame | Baseline: one session | Time Frame | Baseline: one session | Time Frame | Baseline: one session | Time Frame | Baseline: one session |
Description | alexithymia is defined according to TAS-20 (Toronto Alexithymia Scale) The Toronto Alexithymia Scale is a measure of deficiency in understanding, processing, or describing emotions. The current version has twenty statements rated on a five-point Likert scale. ( range : Strongly disagree/Disagree/ Neither agree nor disagree/ Agree/ Strongly agree) | Description | cognitive functions are evaluated by the standardized neuropsychological battery, named BCcogSEP. The BCcogSEP is made of eight tests commonly impaired in MS. Fourteen scores are obtained and a score is considered impaired when it is inferior to 5th percentile range compared to the normal range. The number of impaired scores is considered and a cognitive impairment is considered when 4 scores are superior or equal to percentile 5th. | Description | Psychobehavioral assessments use the following Tools :
We estimated depression according to the Beck Depression Inventory (BDI) The BDI consisted of twenty-one questions about how the subject has been feeling in the last week. Each question had a set of at least four possible responses, ranging in intensity. (0) I do not feel sad/ (1) I feel sad./ (2) I am sad all the time and I can't snap out of it/ (3) I am so sad or unhappy that I can't stand it. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows:0-9: indicates minimal depression/ 10-18: indicates mild depression/ 19-29: indicates moderate depression/ 30-63: indicates severe depression. |
Description | Psychobehavioral assessments use the following Tools We estimated anxiety according to the State-Trait Anxiety Inventory (STAI) STAI is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis | Description | Psychobehavioral assessments use the following Tools :
We estimated apathy according to the Lille Apathy Rating Scale (LARS) The LARS is based on a structured interview. It includes 33 items, divided into nine domains. Responses are scored on a dichotomous scale |
Description | Psychobehavioral assessments use the following Tools :
We estimated empathy according to Interpersonal Reactivity Index( IRI) The tool is a self-report comprising 28-items answered on a 5-point Likert scale ranging from "Does not describe me well" to "Describes me very well". |
Description | dichotic listening tasks (number of sounds recognized from right or left ears) ; tactile localization recognition (number of right localization of right or left touch); letter matching test (number of right letter matching with right or left visual field) All those parameters are evaluated with qualitative assessment of functional MRI parameters |
Browse Conditions
Sequence: | 194085225 | Sequence: | 194085224 | Sequence: | 194085226 | Sequence: | 194085227 | Sequence: | 194085228 | Sequence: | 194085229 | Sequence: | 194085230 | Sequence: | 194085231 | Sequence: | 194085232 | Sequence: | 194085233 | Sequence: | 194085234 |
Mesh Term | Sclerosis | Mesh Term | Multiple Sclerosis | Mesh Term | Affective Symptoms | Mesh Term | Pathologic Processes | Mesh Term | Demyelinating Autoimmune Diseases, CNS | Mesh Term | Autoimmune Diseases of the Nervous System | Mesh Term | Nervous System Diseases | Mesh Term | Demyelinating Diseases | Mesh Term | Autoimmune Diseases | Mesh Term | Immune System Diseases | Mesh Term | Behavioral Symptoms |
Downcase Mesh Term | sclerosis | Downcase Mesh Term | multiple sclerosis | Downcase Mesh Term | affective symptoms | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | demyelinating autoimmune diseases, cns | Downcase Mesh Term | autoimmune diseases of the nervous system | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | demyelinating diseases | Downcase Mesh Term | autoimmune diseases | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | behavioral symptoms |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48466453 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University Hospital, Lille |
Overall Officials
Sequence: | 29368912 |
Role | Principal Investigator |
Name | Hélène Zephir, MD, PhD |
Affiliation | University Hospital, Lille |
Eligibilities
Sequence: | 30856347 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | No |
Population | MS patients admited in MS center of Lille after the first neurological inflammatory clinical event |
Criteria | Inclusion Criteria:
right-handed patient Exclusion Criteria: patients with steroids in the last month |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254313067 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 61 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30602185 |
Observational Model | Case-Control |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28968701 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796234
2018-03-01
https://zephyrnet.com/?p=NCT03796234
NCT03796234https://www.clinicaltrials.gov/study/NCT03796234?tab=tableNANANAA multidisciplinary program based on physiotherapy and diet education will be carried out for 3 months in patients with coronary artery disease with percutaneous coronary intervention. Educational lectures on nutrition and high intensity interval training will be developed in old patients with chronic heart disease. A control group will not develop any program. Effectiveness on anthropometric parameters, eating habits, physical activity, quality of life, anxiety and depression will be assessed at baseline and at 3 months.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-09-17 |
Start Month Year | March 1, 2018 |
Primary Completion Month Year | June 30, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2020-09-17 |
Detailed Descriptions
Sequence: | 20709978 |
Description | A multidisciplinary program based on high intensity interval training and diet education will be carried out for 3 months for patients with coronary artery disease with percutaneous coronary intervention. Three educational lectures on nutrition and a 3-month high intensity interval training will be developed in old patients with chronic heart disease. A control group will not develop any program. Effectiveness on anthropometric parameters, eating habits, physical activity, quality of life, anxiety and depression will be assessed at baseline and at 3 months. |
Facilities
Sequence: | 199965047 |
Name | University of Valencia |
City | Valencia |
Zip | 46010 |
Country | Spain |
Conditions
Sequence: | 52138975 |
Name | Coronary Artery Disease |
Downcase Name | coronary artery disease |
Id Information
Sequence: | 40135036 |
Id Source | org_study_id |
Id Value | 147697976792 |
Countries
Sequence: | 42542670 |
Name | Spain |
Removed | False |
Design Groups
Sequence: | 55559312 | Sequence: | 55559313 |
Group Type | Experimental | Group Type | Experimental |
Title | Dietary and physiotherapy | Title | Physiotherapy |
Description | A multidisciplinary program was developed. 3 group talks were carried out, in a period of 3 months, in which different topics related to healthy eating were treated. In addition, a 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests. | Description | A 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests. |
Interventions
Sequence: | 52454875 | Sequence: | 52454876 |
Intervention Type | Other | Intervention Type | Other |
Name | Dietary and physiotherapy | Name | Physiotherapy |
Description | 3 group talks were carried out, in a period of 3 months, in which different topics related to healthy eating were treated. In addition, a 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests. | Description | A 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests. |
Design Outcomes
Sequence: | 177263540 | Sequence: | 177263541 | Sequence: | 177263542 | Sequence: | 177263543 | Sequence: | 177263544 | Sequence: | 177263545 | Sequence: | 177263546 | Sequence: | 177263547 | Sequence: | 177263548 | Sequence: | 177263549 | Sequence: | 177263550 | Sequence: | 177263551 | Sequence: | 177263552 | Sequence: | 177263553 | Sequence: | 177263554 | Sequence: | 177263555 | Sequence: | 177263556 | Sequence: | 177263557 | Sequence: | 177263558 | Sequence: | 177263559 | Sequence: | 177263560 | Sequence: | 177263561 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Adherence to the mediterranean diet | Measure | Adherence to the mediterranean diet | Measure | Food consumption frequency questonnaire | Measure | Food consumption frequency questonnaire | Measure | Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in % | Measure | Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in % | Measure | Weight (in kilograms) | Measure | Weight (in kilograms) | Measure | Body mass index | Measure | Body mass index | Measure | Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm | Measure | Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm | Measure | Triceps fat fold in mm | Measure | Triceps fat fold in mm | Measure | Physical activity | Measure | Physical activity | Measure | Health related quality of life | Measure | Health related quality of life | Measure | Anxiety | Measure | Anxiety | Measure | Depression | Measure | Depression |
Time Frame | baseline | Time Frame | 3 months | Time Frame | baseline | Time Frame | 3 months | Time Frame | baseline | Time Frame | 3 months | Time Frame | baseline | Time Frame | 3 months | Time Frame | baseline | Time Frame | 3 months | Time Frame | baseline | Time Frame | 3 months | Time Frame | Baseline | Time Frame | 3 months | Time Frame | baseline | Time Frame | 3 months | Time Frame | baseline | Time Frame | 3 months | Time Frame | baseline | Time Frame | 3 months | Time Frame | baseline | Time Frame | 3 months |
Description | Test of adherence to the mediterranean diet, which consists of 14 questions related to the Mediterranean diet. Depending on the answer of the question it can be obtained 1 point or 0 points, being the value of each item 0 or 1. If the sum of the points is 9 or higher the subject has a good adhesion to the mediterranean diet. If it is less than 9 points is considered bad adhesion. The range can vary between 0 points (minimum adhesion) and 14 points (maximum adhesion) (PREDIMED, 2017). | Description | Test of adherence to the mediterranean diet, which consists of 14 questions related to the Mediterranean diet. Depending on the answer of the question it can be obtained 1 point or 0 points, being the value of each item 0 or 1. If the sum of the points is 9 or higher the subject has a good adhesion to the mediterranean diet. If it is less than 9 points is considered bad adhesion. The range can vary between 0 points (minimum adhesion) and 14 points (maximum adhesion) (PREDIMED, 2017). | Description | Food consumption frequency questionnaire: registers the number of times/week or the number of times/month a series of foods is consumed, so that information about the foods the individual consumes most frequently during the week can be obtained. The list of foods that are part of the questionnaire is made up of those most common among the population, with a total of 45 items (yoghurts, fish, fruits, etc.). It also includes a table called Table of Weight of the Item Ration (PRI), in which the weight of the ration of each item is collected to facilitate the completion of the questionnaire (Trinidad et al., 2008). | Description | Food consumption frequency questionnaire: registers the number of times/week or the number of times/month a series of foods is consumed, so that information about the foods the individual consumes most frequently during the week can be obtained. The list of foods that are part of the questionnaire is made up of those most common among the population, with a total of 45 items (yoghurts, fish, fruits, etc.). It also includes a table called Table of Weight of the Item Ration (PRI), in which the weight of the ration of each item is collected to facilitate the completion of the questionnaire (Trinidad et al., 2008). | Description | Bioimpedanciometer OMRON HBF-500INT | Description | Bioimpedanciometer OMRON HBF-500INT | Description | Weight (in kilograms) | Description | Weight (in kilograms) | Description | weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2 | Description | weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2 | Description | Circumferences by using a measuring tape | Description | Circumferences by using a measuring tape | Description | Lipocalibre Holtain | Description | Lipocalibre Holtain | Description | International physical activity questionnaire: it has 9 items and provides information on the time spent while walking, in activities of low, moderate and vigorous intensity and in sedentary activities. Based on the estimated METS consumed, the IPAQ divides the subjects into three levels or categories: Low, moderate and high physical activity.
The score of the different types of activity is expressed in METS-minutes per week. |
Description | International physical activity questionnaire: it has 9 items and provides information on the time spent while walking, in activities of low, moderate and vigorous intensity and in sedentary activities. Based on the estimated METS consumed, the IPAQ divides the subjects into three levels or categories: Low, moderate and high physical activity.
The score of the different types of activity is expressed in METS-minutes per week. |
Description | Short-form 36: the questionnaire is composed of 36 questions that value both positive and negative health status. It was developed from an extensive battery of questionnaires employed at WHO, which included 40 concepts related to health. The questionnaire contains 8 scales, which represent the concepts of health most frequently used in the main health questionnaires. The 36 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role, Mental health. The scores of each of the 8 dimensions of the SF-36 oscillate between 0 and 100. A result of 100 indicates optimal health and 0 would reflect a very poor state of health. | Description | Short-form 36: the questionnaire is composed of 36 questions that value both positive and negative health status. It was developed from an extensive battery of questionnaires employed at WHO, which included 40 concepts related to health. The questionnaire contains 8 scales, which represent the concepts of health most frequently used in the main health questionnaires. The 36 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role, Mental health. The scores of each of the 8 dimensions of the SF-36 oscillate between 0 and 100. A result of 100 indicates optimal health and 0 would reflect a very poor state of health. | Description | Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient. Two subsets of 7 items each, on Likert scale 0-3. For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21. A higher score means greater anxiety and depression. For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case". The internal consistency for the Spanish population is HAD-A α = .83 and HAD-D α = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012). | Description | Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient. Two subsets of 7 items each, on Likert scale 0-3. For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21. A higher score means greater anxiety and depression. For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case". The internal consistency for the Spanish population is HAD-A α = .83 and HAD-D α = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012). | Description | Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient. Two subsets of 7 items each, on Likert scale 0-3. For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21. A higher score means greater anxiety and depression. For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case". The internal consistency for the Spanish population is HAD-A α = .83 and HAD-D α = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012). | Description | Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient. Two subsets of 7 items each, on Likert scale 0-3. For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21. A higher score means greater anxiety and depression. For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case". The internal consistency for the Spanish population is HAD-A α = .83 and HAD-D α = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012). |
Browse Conditions
Sequence: | 193366404 | Sequence: | 193366405 | Sequence: | 193366406 | Sequence: | 193366407 | Sequence: | 193366408 | Sequence: | 193366409 | Sequence: | 193366410 | Sequence: | 193366411 |
Mesh Term | Coronary Artery Disease | Mesh Term | Myocardial Ischemia | Mesh Term | Coronary Disease | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Arteriosclerosis | Mesh Term | Arterial Occlusive Diseases | Mesh Term | Vascular Diseases |
Downcase Mesh Term | coronary artery disease | Downcase Mesh Term | myocardial ischemia | Downcase Mesh Term | coronary disease | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | arteriosclerosis | Downcase Mesh Term | arterial occlusive diseases | Downcase Mesh Term | vascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290684 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Valencia |
Overall Officials
Sequence: | 29268524 |
Role | Principal Investigator |
Name | Elena Marques-Sule, PT, PhD |
Affiliation | University of Valencia |
Design Group Interventions
Sequence: | 68107411 | Sequence: | 68107412 |
Design Group Id | 55559312 | Design Group Id | 55559313 |
Intervention Id | 52454875 | Intervention Id | 52454876 |
Eligibilities
Sequence: | 30747706 |
Gender | All |
Minimum Age | 40 Years |
Maximum Age | 100 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
infarction or angina pectoris. Exclusion Criteria: Present another type of cardiac disease different from ischemic heart disease. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121810 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 4 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 40 |
Maximum Age Num | 100 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 18 |
Designs
Sequence: | 30493989 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28860269 |
Responsible Party Type | Principal Investigator |
Name | Elena Marques-Sule |
Title | Doctor in Physiotherapy |
Affiliation | University of Valencia |
]]>
https://zephyrnet.com/NCT03796221
2019-03-11
https://zephyrnet.com/?p=NCT03796221
NCT03796221https://www.clinicaltrials.gov/study/NCT03796221?tab=tableNANANAThe purpose of this study is to see if educational videos about how to help children develop healthy behaviors, paired with treatment in a pediatric obesity clinic, can increase caregiver confidence and improve child behaviors and weight. Caregivers of children between the ages of 4 and 11 years old who are new patients to a pediatric obesity clinic will be invited to take part in the study. All families will receive the standard treatment provided in the pediatric obesity clinic. Half of the caregivers will be assigned to also watch a few educational videos every month for 3 months in between clinic visits.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-03-23 |
Start Month Year | March 11, 2019 |
Primary Completion Month Year | February 19, 2021 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-03-23 |
Facilities
Sequence: | 198738354 |
Name | Nemours Alfred I. duPont Hospital for Children |
City | Wilmington |
State | Delaware |
Zip | 19803 |
Country | United States |
Conditions
Sequence: | 51829158 | Sequence: | 51829159 |
Name | Childhood Obesity | Name | Parenting |
Downcase Name | childhood obesity | Downcase Name | parenting |
Id Information
Sequence: | 39885428 | Sequence: | 39885429 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | K23HD083439 | Id Value | K23HD083439 |
Id Type | U.S. NIH Grant/Contract | Id Type | U.S. NIH Grant/Contract |
Id Link | https://reporter.nih.gov/quickSearch/K23HD083439 | Id Link | https://reporter.nih.gov/quickSearch/K23HD083439 |
Countries
Sequence: | 42283956 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55252110 | Sequence: | 55252111 |
Group Type | Active Comparator | Group Type | Experimental |
Title | Control Group | Title | Intervention Group |
Description | Will receive standard pediatric obesity treatment | Description | Will receive standard pediatric obesity treatment and parenting videos |
Interventions
Sequence: | 52150122 | Sequence: | 52150123 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Parenting videos | Name | Standard pediatric obesity treatment |
Description | Brief online videos, featuring families of children with obesity of diverse backgrounds, to provide education on parenting skills and motivate families to adopt healthy lifestyle behaviors as a family. Videos will be delivered monthly for three months in between pediatric obesity clinic visits. | Description | Standard treatment in a hospital-based pediatric obesity clinic with a team of medical providers, dietitians, exercise specialists, and behavioral health specialists. Treatment includes management of obesity-related medical conditions, nutrition education, physical activity counseling, and discussion of behavioral strategies such as goal-setting and self-monitoring, with elements of motivational interviewing used to encourage behavior change and adoption of healthy lifestyle behaviors by the entire family. |
Keywords
Sequence: | 79309365 | Sequence: | 79309366 | Sequence: | 79309367 | Sequence: | 79309368 |
Name | Childhood obesity | Name | Parenting intervention | Name | Video intervention | Name | Healthcare delivery |
Downcase Name | childhood obesity | Downcase Name | parenting intervention | Downcase Name | video intervention | Downcase Name | healthcare delivery |
Design Outcomes
Sequence: | 176273033 | Sequence: | 176273034 | Sequence: | 176273035 | Sequence: | 176273036 | Sequence: | 176273037 | Sequence: | 176273038 | Sequence: | 176273039 | Sequence: | 176273040 | Sequence: | 176273041 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in child weight status | Measure | Change in child weight status | Measure | Change in caregiver confidence managing child lifestyle behaviors | Measure | Change in child lifestyle behaviors | Measure | Discussion of parenting topics during visits to the pediatric obesity clinic | Measure | Change in child weight status | Measure | Change in child weight status | Measure | Change in caregiver confidence managing child lifestyle behaviors | Measure | Change in child lifestyle behaviors |
Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 1 month, 2 months, 3 months, 6 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months |
Description | Change in child BMI-z score | Description | Change in child BMI percentile (referenced to the 95th percentile) | Description | Change in Lifestyle Behavior Checklist Confidence score | Description | Change in Lifestyle Behavior Checklist Problem score | Description | Discussion helpfulness ratings at each visit | Description | Change in child BMI-z score | Description | Change in child BMI percentile (referenced to the 95th percentile) | Description | Change in Lifestyle Behavior Checklist Confidence score | Description | Change in Lifestyle Behavior Checklist Problem score |
Browse Conditions
Sequence: | 192106942 | Sequence: | 192106943 | Sequence: | 192106944 | Sequence: | 192106945 | Sequence: | 192106946 | Sequence: | 192106947 |
Mesh Term | Obesity | Mesh Term | Pediatric Obesity | Mesh Term | Overweight | Mesh Term | Overnutrition | Mesh Term | Nutrition Disorders | Mesh Term | Body Weight |
Downcase Mesh Term | obesity | Downcase Mesh Term | pediatric obesity | Downcase Mesh Term | overweight | Downcase Mesh Term | overnutrition | Downcase Mesh Term | nutrition disorders | Downcase Mesh Term | body weight |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48001219 | Sequence: | 48001220 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Nemours Children's Health System | Name | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Overall Officials
Sequence: | 29084328 |
Role | Principal Investigator |
Name | Thao-Ly T Phan, MD MPH |
Affiliation | Nemours Children's Health System |
Design Group Interventions
Sequence: | 67736270 | Sequence: | 67736271 | Sequence: | 67736272 |
Design Group Id | 55252111 | Design Group Id | 55252110 | Design Group Id | 55252111 |
Intervention Id | 52150122 | Intervention Id | 52150123 | Intervention Id | 52150123 |
Eligibilities
Sequence: | 30564636 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 100 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Legal guardian of a new patient to the Nemours pediatric obesity clinic Exclusion Criteria: Not proficient in English or Spanish |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254259130 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 23 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 100 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30312914 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28691555 |
Responsible Party Type | Principal Investigator |
Name | Thao-Ly Phan |
Title | Associate Professor of Pediatrics |
Affiliation | Nemours Children's Health System |
]]>
https://zephyrnet.com/NCT03796208
2018-12-12
https://zephyrnet.com/?p=NCT03796208
NCT03796208https://www.clinicaltrials.gov/study/NCT03796208?tab=tableNANANAThis study tests an intervention for tobacco cessation (named B-EPIC) in an established community medication assisted treatment (MAT) clinic for pregnant and postpartum women with opioid dependence. Half of the participants will receive the intervention for tobacco cessation, which is standard cessation counseling from the provider plus additional cessation support from a Certified Tobacco Treatment Specialist (CTTS). The other half of participants will receive standard tobacco cessation from their provider. The project will also determine the economic impact of the B-EPIC intervention on healthcare expenditures.
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Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-07-15 |
Start Month Year | December 12, 2018 |
Primary Completion Month Year | May 24, 2021 |
Verification Month Year | December 2021 |
Verification Date | 2021-12-31 |
Last Update Posted Date | 2022-07-15 |
Results First Posted Date | 2022-07-15 |
Detailed Descriptions
Sequence: | 20722598 |
Description | The study will use a prospective, 2-group, randomized, comparative effectiveness design to determine if the B-EPIC tobacco intervention is superior to tobacco 'treatment as usual (TAU)' for opioid dependent pregnant women maintained on buprenorphine; the outcomes for the first aim will be quitting smoking and/or reducing cigarette consumption during pregnancy. The project design also will determine the economic impact the B-EPIC intervention (10-months) has on healthcare expenditures.
After informed consent, eligible participants will be randomized (1:1) to the B-EPIC group (tobacco intervention) or TAU tobacco treatment (control group). All will continue to receive opioid dependence treatment with buprenorphine, regardless of treatment assignment. Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the American College of Obstetricians and Gynecologists (ACOG) 5'A's approach by their healthcare provider. This standard tobacco cessation counseling takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed. The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. The intervention will be led by a certified tobacco treatment specialist (CTTS). |
Facilities
Sequence: | 200114672 | Sequence: | 200114673 |
Name | Baptist Health Lexington | Name | University of Kentucky Polk Dalton Clinic |
City | Lexington | City | Lexington |
State | Kentucky | State | Kentucky |
Zip | 40503 | Zip | 40536 |
Country | United States | Country | United States |
Conditions
Sequence: | 52173884 |
Name | Smoking Cessation |
Downcase Name | smoking cessation |
Id Information
Sequence: | 40160339 | Sequence: | 40160340 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 45062 | Id Value | 1R34DA046005-01 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/1R34DA046005-01 |
Countries
Sequence: | 42570715 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55595949 | Sequence: | 55595950 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Tobacco Intervention | Title | Treatment As Usual |
Description | Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention. | Description | Participants in this group will be randomized to tobacco treatment as usual. |
Interventions
Sequence: | 52487905 | Sequence: | 52487906 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) | Name | Treatment As Usual |
Description | Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS). | Description | Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy. |
Keywords
Sequence: | 79871975 | Sequence: | 79871976 | Sequence: | 79871977 |
Name | Opioid Use Disorder | Name | Pregnancy | Name | tobacco |
Downcase Name | opioid use disorder | Downcase Name | pregnancy | Downcase Name | tobacco |
Design Outcomes
Sequence: | 177388857 | Sequence: | 177388858 | Sequence: | 177388859 | Sequence: | 177388860 | Sequence: | 177388861 | Sequence: | 177388862 | Sequence: | 177388863 | Sequence: | 177388864 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in the Number of Cigarettes Smoked Per Day | Measure | Change in Urine Cotinine Concentration Level | Measure | Change in Electronic Cigarette Usage Per Day | Measure | Change in Cigarette Dependence | Measure | Change in Electronic Cigarette Dependence | Measure | Change in Maternal Depression Over Time | Measure | Change in Maternal Anxiety Over Time | Measure | Change in Maternal Perceived Stress Over Time |
Time Frame | up to 50 weeks (third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) | Time Frame | up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) | Time Frame | up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) | Time Frame | up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery)) | Time Frame | up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) | Time Frame | Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) | Time Frame | Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) | Time Frame | Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
Description | Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report the number of cigarettes smoked per day. Data will be presented as the change in the number of cigarettes smoked per day compared between groups. | Description | Participants will provide a urine sample to be measured by litmus analysis during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The litmus levels range from 0 (minimum) to 6 (maximum). Data will be presented as the change in cotinine levels by the litmus measure over the course of the study compared between groups. | Description | Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report electronic cigarette (e-cig) usage per day. Data will be presented as the change in e-cig usage per day compared between groups. | Description | Participants will complete the Fagerstrom Test for Cigarette Dependence during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks seven questions related to cigarette dependency. For scoring, yes/no questions are scored from 0 to 1, and multiple choice questions from 0 to 3. Items are then summed to yield a total score of 0-10. The higher the total score, the more intense the patient's nicotine dependence. Any score greater than 8 is considered high dependency, a score of 5-7 is considered moderately dependent, 3-4 is low to moderate dependence and 1-2 is low dependence. Data will be presented as the change in cigarette dependency over time compared between groups. | Description | Participants will complete the Penn State Electronic Cigarette Dependence Index (PSECDI) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks ten questions and responses are scored on a scale from zero to 20. Summed scores correlate to a dependence category; 0-3 is not dependent, 4-8 is low dependence, 9-12 is medium dependence, and above 12 is high dependence. Data will be presented as the change in electronic cigarette dependency over time compared between groups. | Description | Participants will complete the Edinburgh Postnatal Depression Scale (EPDS) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 10 multiple choice questions with scores for each question ranging from 0-3. Scores are then summed for a total score, ranging from 0-30. Questions 1, 2 & 4 are scored 0-3 with the first answer to each question scored as 0 and the fourth answer scored as 3. Questions 3 & 5-10 are reverse scored, with the first answer to each question scored as 3 and the fourth answer scored as 0. A score of 10 or greater is interpreted as "possible depression". A score of greater than 0 on item 10 indicates "suicidal thoughts". Data will be presented as the change in depression over time compared between groups. | Description | Participants will complete the Generalized Anxiety Disorder 7-item (GAD-7) scale during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 7 questions scored between zero and 21. A score of 5-9 indicates mild severity, 10-14 is moderate, and 15 and greater is considered severe. Data will be presented as the change in anxiety over time compared between groups. | Description | Participants will complete the Perceived Stress Scale 4-item (PSS4) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 4 questions scored between zero and 16. Higher scores are correlated with more stress. Data will be presented as the change in stress over time compared between groups. |
Sponsors
Sequence: | 48321551 | Sequence: | 48321552 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Kristin Ashford | Name | National Institute on Drug Abuse (NIDA) |
Overall Officials
Sequence: | 29286619 | Sequence: | 29286620 |
Role | Principal Investigator | Role | Principal Investigator |
Name | Kristin Ashford | Name | Amanda Fallin-Bennett |
Affiliation | University of Kentucky | Affiliation | University of Kentucky |
Design Group Interventions
Sequence: | 68152443 | Sequence: | 68152444 |
Design Group Id | 55595949 | Design Group Id | 55595950 |
Intervention Id | 52487905 | Intervention Id | 52487906 |
Eligibilities
Sequence: | 30766792 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 49 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Current diagnosis of opioid dependence with participation in the University of Kentucky Healthcare and Baptist Health Lexington buprenorphine treatment program Exclusion Criteria: Current prisoner status |
Gender Description | All participants in this study will be pregnant females. |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253920427 |
Number Of Facilities | 2 |
Number Of Nsae Subjects | 13 |
Number Of Sae Subjects | 12 |
Registered In Calendar Year | 2019 |
Actual Duration | 29 |
Were Results Reported | True |
Months To Report Results | 12 |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 49 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 5 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30512954 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Drop Withdrawals
Sequence: | 28988535 | Sequence: | 28988536 | Sequence: | 28988537 | Sequence: | 28988538 | Sequence: | 28988539 | Sequence: | 28988540 | Sequence: | 28988541 | Sequence: | 28988542 |
Result Group Id | 56094235 | Result Group Id | 56094236 | Result Group Id | 56094235 | Result Group Id | 56094236 | Result Group Id | 56094235 | Result Group Id | 56094236 | Result Group Id | 56094235 | Result Group Id | 56094236 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Loss of pregnancy | Reason | Loss of pregnancy | Reason | Changed prenatal clinics | Reason | Changed prenatal clinics | Reason | Lost to Follow-up | Reason | Lost to Follow-up |
Count | 3 | Count | 0 | Count | 1 | Count | 1 | Count | 0 | Count | 5 | Count | 20 | Count | 16 |
Milestones
Sequence: | 41007548 | Sequence: | 41007549 | Sequence: | 41007550 | Sequence: | 41007551 | Sequence: | 41007552 | Sequence: | 41007553 |
Result Group Id | 56094235 | Result Group Id | 56094236 | Result Group Id | 56094235 | Result Group Id | 56094236 | Result Group Id | 56094235 | Result Group Id | 56094236 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 40 | Count | 38 | Count | 16 | Count | 16 | Count | 24 | Count | 22 |
Participant Flows
Sequence: | 3921354 |
Recruitment Details | Number of individuals consented and further screened for eligibility = 79; Number of participants randomized to intervention = 40; Number of participants randomized to treatment as usual = 38 |
Pre Assignment Details | Participants may have been excluded prior to randomization for the following reason:
1. Withdrawal (changed mind) |
Outcome Counts
Sequence: | 74002700 | Sequence: | 74002701 | Sequence: | 74002702 | Sequence: | 74002703 | Sequence: | 74002704 | Sequence: | 74002705 | Sequence: | 74002706 | Sequence: | 74002707 | Sequence: | 74002708 | Sequence: | 74002709 | Sequence: | 74002710 | Sequence: | 74002711 | Sequence: | 74002712 | Sequence: | 74002713 | Sequence: | 74002714 | Sequence: | 74002715 |
Outcome Id | 30805782 | Outcome Id | 30805782 | Outcome Id | 30805783 | Outcome Id | 30805783 | Outcome Id | 30805784 | Outcome Id | 30805784 | Outcome Id | 30805785 | Outcome Id | 30805785 | Outcome Id | 30805786 | Outcome Id | 30805786 | Outcome Id | 30805787 | Outcome Id | 30805787 | Outcome Id | 30805788 | Outcome Id | 30805788 | Outcome Id | 30805789 | Outcome Id | 30805789 |
Result Group Id | 56094237 | Result Group Id | 56094238 | Result Group Id | 56094237 | Result Group Id | 56094238 | Result Group Id | 56094237 | Result Group Id | 56094238 | Result Group Id | 56094237 | Result Group Id | 56094238 | Result Group Id | 56094237 | Result Group Id | 56094238 | Result Group Id | 56094237 | Result Group Id | 56094238 | Result Group Id | 56094237 | Result Group Id | 56094238 | Result Group Id | 56094237 | Result Group Id | 56094238 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 15 | Count | 18 | Count | 22 | Count | 24 | Count | 4 | Count | 6 | Count | 26 | Count | 24 | Count | 1 | Count | 2 | Count | 26 | Count | 26 | Count | 26 | Count | 25 | Count | 26 | Count | 24 |
Provided Documents
Sequence: | 2579526 |
Document Type | Study Protocol, Statistical Analysis Plan, and Informed Consent Form |
Has Protocol | True |
Has Icf | True |
Has Sap | True |
Document Date | 2018-06-12 |
Url | https://ClinicalTrials.gov/ProvidedDocs/08/NCT03796208/Prot_SAP_ICF_000.pdf |
Reported Event Totals
Sequence: | 27943855 | Sequence: | 27943856 | Sequence: | 27943857 | Sequence: | 27943858 | Sequence: | 27943859 | Sequence: | 27943860 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 9 | Subjects Affected | 10 | Subjects Affected | 0 | Subjects Affected | 3 | Subjects Affected | 3 | Subjects Affected | 0 |
Subjects At Risk | 38 | Subjects At Risk | 38 | Subjects At Risk | 38 | Subjects At Risk | 38 | Subjects At Risk | 38 | Subjects At Risk | 38 |
Created At | 2023-08-09 01:04:31.345542 | Created At | 2023-08-09 01:04:31.345542 | Created At | 2023-08-09 01:04:31.345542 | Created At | 2023-08-09 01:04:31.345542 | Created At | 2023-08-09 01:04:31.345542 | Created At | 2023-08-09 01:04:31.345542 |
Updated At | 2023-08-09 01:04:31.345542 | Updated At | 2023-08-09 01:04:31.345542 | Updated At | 2023-08-09 01:04:31.345542 | Updated At | 2023-08-09 01:04:31.345542 | Updated At | 2023-08-09 01:04:31.345542 | Updated At | 2023-08-09 01:04:31.345542 |
Reported Events
Sequence: | 528239201 | Sequence: | 528239202 | Sequence: | 528239197 | Sequence: | 528239198 | Sequence: | 528239199 | Sequence: | 528239200 | Sequence: | 528239193 | Sequence: | 528239194 | Sequence: | 528239195 | Sequence: | 528239196 |
Result Group Id | 56094239 | Result Group Id | 56094240 | Result Group Id | 56094239 | Result Group Id | 56094240 | Result Group Id | 56094239 | Result Group Id | 56094240 | Result Group Id | 56094239 | Result Group Id | 56094240 | Result Group Id | 56094239 | Result Group Id | 56094240 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Time Frame | Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery) | Time Frame | Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery) | Time Frame | Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery) | Time Frame | Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery) | Time Frame | Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery) | Time Frame | Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery) | Time Frame | Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery) | Time Frame | Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery) | Time Frame | Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery) | Time Frame | Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery) |
Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious |
Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 4 | Subjects Affected | 1 | Subjects Affected | 4 | Subjects Affected | 2 | Subjects Affected | 5 | Subjects Affected | 1 | Subjects Affected | 4 | Subjects Affected | 2 |
Subjects At Risk | 38 | Subjects At Risk | 38 | Subjects At Risk | 38 | Subjects At Risk | 38 | Subjects At Risk | 38 | Subjects At Risk | 38 | Subjects At Risk | 38 | Subjects At Risk | 38 | Subjects At Risk | 38 | Subjects At Risk | 38 |
Organ System | General disorders | Organ System | General disorders | Organ System | Social circumstances | Organ System | Social circumstances | Organ System | General disorders | Organ System | General disorders | Organ System | Pregnancy, puerperium and perinatal conditions | Organ System | Pregnancy, puerperium and perinatal conditions | Organ System | General disorders | Organ System | General disorders |
Adverse Event Term | Treatment for dehydration | Adverse Event Term | Treatment for dehydration | Adverse Event Term | Incarceration | Adverse Event Term | Incarceration | Adverse Event Term | Positive response to depression evaluation | Adverse Event Term | Positive response to depression evaluation | Adverse Event Term | Initial or prolonged hospitalization | Adverse Event Term | Initial or prolonged hospitalization | Adverse Event Term | Initial or prolonged hospitalization | Adverse Event Term | Initial or prolonged hospitalization |
Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 |
Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment |
Responsible Parties
Sequence: | 28879253 |
Responsible Party Type | Sponsor-Investigator |
Name | Kristin Ashford |
Title | Professor and Dean of Undergraduate Faculty Affairs |
Affiliation | University of Kentucky |
Result Agreements
Sequence: | 3852098 |
Pi Employee | No |
Result Contacts
Sequence: | 3852063 |
Organization | University of Kentucky |
Name | Kristin Ashford, PhD, Study MPI |
Phone | 859-257-9333 |
khashf0@uky.edu | |
Outcomes
Sequence: | 30805782 | Sequence: | 30805783 | Sequence: | 30805784 | Sequence: | 30805785 | Sequence: | 30805786 | Sequence: | 30805787 | Sequence: | 30805788 | Sequence: | 30805789 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Change in the Number of Cigarettes Smoked Per Day | Title | Change in Urine Cotinine Concentration Level | Title | Change in Electronic Cigarette Usage Per Day | Title | Change in Cigarette Dependence | Title | Change in Electronic Cigarette Dependence | Title | Change in Maternal Depression Over Time | Title | Change in Maternal Anxiety Over Time | Title | Change in Maternal Perceived Stress Over Time |
Description | Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report the number of cigarettes smoked per day. Data will be presented as the change in the number of cigarettes smoked per day compared between groups. | Description | Participants will provide a urine sample to be measured by litmus analysis during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The litmus levels range from 0 (minimum) to 6 (maximum). Data will be presented as the change in cotinine levels by the litmus measure over the course of the study compared between groups. | Description | Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report electronic cigarette (e-cig) usage per day. Data will be presented as the change in e-cig usage per day compared between groups. | Description | Participants will complete the Fagerstrom Test for Cigarette Dependence during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks seven questions related to cigarette dependency. For scoring, yes/no questions are scored from 0 to 1, and multiple choice questions from 0 to 3. Items are then summed to yield a total score of 0-10. The higher the total score, the more intense the patient's nicotine dependence. Any score greater than 8 is considered high dependency, a score of 5-7 is considered moderately dependent, 3-4 is low to moderate dependence and 1-2 is low dependence. Data will be presented as the change in cigarette dependency over time compared between groups. | Description | Participants will complete the Penn State Electronic Cigarette Dependence Index (PSECDI) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks ten questions and responses are scored on a scale from zero to 20. Summed scores correlate to a dependence category; 0-3 is not dependent, 4-8 is low dependence, 9-12 is medium dependence, and above 12 is high dependence. Data will be presented as the change in electronic cigarette dependency over time compared between groups. | Description | Participants will complete the Edinburgh Postnatal Depression Scale (EPDS) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 10 multiple choice questions with scores for each question ranging from 0-3. Scores are then summed for a total score, ranging from 0-30. Questions 1, 2 & 4 are scored 0-3 with the first answer to each question scored as 0 and the fourth answer scored as 3. Questions 3 & 5-10 are reverse scored, with the first answer to each question scored as 3 and the fourth answer scored as 0. A score of 10 or greater is interpreted as "possible depression". A score of greater than 0 on item 10 indicates "suicidal thoughts". Data will be presented as the change in depression over time compared between groups. | Description | Participants will complete the Generalized Anxiety Disorder 7-item (GAD-7) scale during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 7 questions scored between zero and 21. A score of 5-9 indicates mild severity, 10-14 is moderate, and 15 and greater is considered severe. Data will be presented as the change in anxiety over time compared between groups. | Description | Participants will complete the Perceived Stress Scale 4-item (PSS4) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 4 questions scored between zero and 16. Higher scores are correlated with more stress. Data will be presented as the change in stress over time compared between groups. |
Time Frame | up to 50 weeks (third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) | Time Frame | up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) | Time Frame | up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) | Time Frame | up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery)) | Time Frame | up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) | Time Frame | Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) | Time Frame | Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) | Time Frame | Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
Population | Overall number of participants analyzed in each Group is based on number of participants with cigarettes smoked per day data available at third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Enrollment (up to 31.6 weeks gestation) was not used in this analysis due to a change in the data collection format from categorical to continuous. Disruptions by COVID-19 created many challenges with longitudinal data collection. | Population | Overall number of participants analyzed in each Group is based on the number of participants with cotinine levels data available at enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change in the level of urine cotinine using NICALERT, an immunochromatographic assay test strip (Nymox Pharmaceutical Corporation, Montreal, Quebec). Disruptions caused by COVID-19 created many challenges in longitudinal data collection. | Population | Overall number of participants analyzed in each Group is based on the number of participants with self-report electronic cigarette (e-cig) usage per day and with data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection. | Population | Overall number of participants analyzed in each Group is based on the number of participants with Fagerstrom Test for Cigarette Dependence data available at study time points enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection. | Population | Overall number of participants analyzed in each Group is based on the number of participants with Penn State Electronic Cigarette Dependence Index (PSECDI) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection. | Population | Overall number of participants analyzed in each Group is based on the number of participants with Edinburgh Postnatal Depression Scale (EPDS) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection. | Population | Overall number of participants analyzed in each Group is based on the number of participants with Generalized Anxiety Disorder 7-item (GAD-7) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection. | Population | Overall number of participants analyzed in each Group is based on the number of participants with Perceived Stress Scale 4-item (PSS4) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection. |
Units | cigarettes per day | Units | litmus levels | Units | e-cig use times per day | Units | Score on a scale | Units | scores on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale |
Dispersion Type | Inter-Quartile Range | Dispersion Type | Standard Deviation | Dispersion Type | Inter-Quartile Range | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Param Type | Median | Param Type | Mean | Param Type | Median | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 235667197 | Sequence: | 235667193 | Sequence: | 235667194 | Sequence: | 235667195 | Sequence: | 235667196 | Sequence: | 235667198 | Sequence: | 235667199 | Sequence: | 235667200 | Sequence: | 235667201 | Sequence: | 235667202 | Sequence: | 235667203 | Sequence: | 235667204 | Sequence: | 235667205 | Sequence: | 235667206 | Sequence: | 235667207 | Sequence: | 235667208 |
Outcome Id | 30805784 | Outcome Id | 30805782 | Outcome Id | 30805782 | Outcome Id | 30805783 | Outcome Id | 30805783 | Outcome Id | 30805784 | Outcome Id | 30805785 | Outcome Id | 30805785 | Outcome Id | 30805786 | Outcome Id | 30805786 | Outcome Id | 30805787 | Outcome Id | 30805787 | Outcome Id | 30805788 | Outcome Id | 30805788 | Outcome Id | 30805789 | Outcome Id | 30805789 |
Result Group Id | 56094237 | Result Group Id | 56094237 | Result Group Id | 56094238 | Result Group Id | 56094237 | Result Group Id | 56094238 | Result Group Id | 56094238 | Result Group Id | 56094237 | Result Group Id | 56094238 | Result Group Id | 56094237 | Result Group Id | 56094238 | Result Group Id | 56094237 | Result Group Id | 56094238 | Result Group Id | 56094237 | Result Group Id | 56094238 | Result Group Id | 56094237 | Result Group Id | 56094238 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Title | Change in Electronic Cigarette Usage Per Day | Title | Change in the Number of Cigarettes Smoked Per Day | Title | Change in the Number of Cigarettes Smoked Per Day | Title | Change in Urine Cotinine Concentration Level | Title | Change in Urine Cotinine Concentration Level | Title | Change in Electronic Cigarette Usage Per Day | Title | Change in Cigarette Dependence | Title | Change in Cigarette Dependence | Title | Change in Electronic Cigarette Dependence | Title | Change in Electronic Cigarette Dependence | Title | Change in Maternal Depression Over Time | Title | Change in Maternal Depression Over Time | Title | Change in Maternal Anxiety Over Time | Title | Change in Maternal Anxiety Over Time | Title | Change in Maternal Perceived Stress Over Time | Title | Change in Maternal Perceived Stress Over Time |
Description | Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report electronic cigarette (e-cig) usage per day. Data will be presented as the change in e-cig usage per day compared between groups. | Description | Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report the number of cigarettes smoked per day. Data will be presented as the change in the number of cigarettes smoked per day compared between groups. | Description | Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report the number of cigarettes smoked per day. Data will be presented as the change in the number of cigarettes smoked per day compared between groups. | Description | Participants will provide a urine sample to be measured by litmus analysis during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The litmus levels range from 0 (minimum) to 6 (maximum). Data will be presented as the change in cotinine levels by the litmus measure over the course of the study compared between groups. | Description | Participants will provide a urine sample to be measured by litmus analysis during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The litmus levels range from 0 (minimum) to 6 (maximum). Data will be presented as the change in cotinine levels by the litmus measure over the course of the study compared between groups. | Description | Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report electronic cigarette (e-cig) usage per day. Data will be presented as the change in e-cig usage per day compared between groups. | Description | Participants will complete the Fagerstrom Test for Cigarette Dependence during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks seven questions related to cigarette dependency. For scoring, yes/no questions are scored from 0 to 1, and multiple choice questions from 0 to 3. Items are then summed to yield a total score of 0-10. The higher the total score, the more intense the patient's nicotine dependence. Any score greater than 8 is considered high dependency, a score of 5-7 is considered moderately dependent, 3-4 is low to moderate dependence and 1-2 is low dependence. Data will be presented as the change in cigarette dependency over time compared between groups. | Description | Participants will complete the Fagerstrom Test for Cigarette Dependence during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks seven questions related to cigarette dependency. For scoring, yes/no questions are scored from 0 to 1, and multiple choice questions from 0 to 3. Items are then summed to yield a total score of 0-10. The higher the total score, the more intense the patient's nicotine dependence. Any score greater than 8 is considered high dependency, a score of 5-7 is considered moderately dependent, 3-4 is low to moderate dependence and 1-2 is low dependence. Data will be presented as the change in cigarette dependency over time compared between groups. | Description | Participants will complete the Penn State Electronic Cigarette Dependence Index (PSECDI) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks ten questions and responses are scored on a scale from zero to 20. Summed scores correlate to a dependence category; 0-3 is not dependent, 4-8 is low dependence, 9-12 is medium dependence, and above 12 is high dependence. Data will be presented as the change in electronic cigarette dependency over time compared between groups. | Description | Participants will complete the Penn State Electronic Cigarette Dependence Index (PSECDI) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks ten questions and responses are scored on a scale from zero to 20. Summed scores correlate to a dependence category; 0-3 is not dependent, 4-8 is low dependence, 9-12 is medium dependence, and above 12 is high dependence. Data will be presented as the change in electronic cigarette dependency over time compared between groups. | Description | Participants will complete the Edinburgh Postnatal Depression Scale (EPDS) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 10 multiple choice questions with scores for each question ranging from 0-3. Scores are then summed for a total score, ranging from 0-30. Questions 1, 2 & 4 are scored 0-3 with the first answer to each question scored as 0 and the fourth answer scored as 3. Questions 3 & 5-10 are reverse scored, with the first answer to each question scored as 3 and the fourth answer scored as 0. A score of 10 or greater is interpreted as "possible depression". A score of greater than 0 on item 10 indicates "suicidal thoughts". Data will be presented as the change in depression over time compared between groups. | Description | Participants will complete the Edinburgh Postnatal Depression Scale (EPDS) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 10 multiple choice questions with scores for each question ranging from 0-3. Scores are then summed for a total score, ranging from 0-30. Questions 1, 2 & 4 are scored 0-3 with the first answer to each question scored as 0 and the fourth answer scored as 3. Questions 3 & 5-10 are reverse scored, with the first answer to each question scored as 3 and the fourth answer scored as 0. A score of 10 or greater is interpreted as "possible depression". A score of greater than 0 on item 10 indicates "suicidal thoughts". Data will be presented as the change in depression over time compared between groups. | Description | Participants will complete the Generalized Anxiety Disorder 7-item (GAD-7) scale during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 7 questions scored between zero and 21. A score of 5-9 indicates mild severity, 10-14 is moderate, and 15 and greater is considered severe. Data will be presented as the change in anxiety over time compared between groups. | Description | Participants will complete the Generalized Anxiety Disorder 7-item (GAD-7) scale during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 7 questions scored between zero and 21. A score of 5-9 indicates mild severity, 10-14 is moderate, and 15 and greater is considered severe. Data will be presented as the change in anxiety over time compared between groups. | Description | Participants will complete the Perceived Stress Scale 4-item (PSS4) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 4 questions scored between zero and 16. Higher scores are correlated with more stress. Data will be presented as the change in stress over time compared between groups. | Description | Participants will complete the Perceived Stress Scale 4-item (PSS4) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 4 questions scored between zero and 16. Higher scores are correlated with more stress. Data will be presented as the change in stress over time compared between groups. |
Units | e-cig use times per day | Units | cigarettes per day | Units | cigarettes per day | Units | litmus levels | Units | litmus levels | Units | e-cig use times per day | Units | Score on a scale | Units | Score on a scale | Units | scores on a scale | Units | scores on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale |
Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Mean | Param Type | Mean | Param Type | Median | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | -0.09 | Param Value | 0.17 | Param Value | -6 | Param Value | 2.04 | Param Value | 1.42 | Param Value | -5.0 | Param Value | -1.5 | Param Value | 2.42 | Param Value | 2.58 | Param Value | 2.0 | Param Value | 1.52 | Param Value | 0.73 | Param Value | 1.04 |
Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | -0.09 | Param Value Num | 0.17 | Param Value Num | -6.0 | Param Value Num | 2.04 | Param Value Num | 1.42 | Param Value Num | -5.0 | Param Value Num | -1.5 | Param Value Num | 2.42 | Param Value Num | 2.58 | Param Value Num | 2.0 | Param Value Num | 1.52 | Param Value Num | 0.73 | Param Value Num | 1.04 |
Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Inter-Quartile Range | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Dispersion Value | 0.68 | Dispersion Value | 0.56 | Dispersion Value | 3.14 | Dispersion Value | 2.9 | Dispersion Value | 2.12 | Dispersion Value | 3.86 | Dispersion Value | 5.64 | Dispersion Value | 5.68 | Dispersion Value | 4.57 | Dispersion Value | 2.79 | Dispersion Value | 3.17 | ||||||||||
Dispersion Value Num | 0.68 | Dispersion Value Num | 0.56 | Dispersion Value Num | 3.14 | Dispersion Value Num | 2.9 | Dispersion Value Num | 2.12 | Dispersion Value Num | 3.86 | Dispersion Value Num | 5.64 | Dispersion Value Num | 5.68 | Dispersion Value Num | 4.57 | Dispersion Value Num | 2.79 | Dispersion Value Num | 3.17 | ||||||||||
Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | -10.0 | Dispersion Lower Limit | -5.0 | Dispersion Lower Limit | -20.0 | ||||||||||||||||||||||||
Dispersion Upper Limit | 18.0 | Dispersion Upper Limit | 5.0 | Dispersion Upper Limit | 3.0 | Dispersion Upper Limit | 4.0 | ||||||||||||||||||||||||
Baseline Counts
Sequence: | 11383653 | Sequence: | 11383654 | Sequence: | 11383655 |
Result Group Id | 56094232 | Result Group Id | 56094233 | Result Group Id | 56094234 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 38 | Count | 38 | Count | 76 |
Result Groups
Sequence: | 56094232 | Sequence: | 56094233 | Sequence: | 56094234 | Sequence: | 56094235 | Sequence: | 56094236 | Sequence: | 56094237 | Sequence: | 56094238 | Sequence: | 56094239 | Sequence: | 56094240 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Tobacco Intervention | Title | Treatment As Usual | Title | Total | Title | Tobacco Intervention | Title | Treatment As Usual | Title | Tobacco Intervention | Title | Treatment As Usual | Title | Tobacco Intervention | Title | Treatment As Usual |
Description | Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS). |
Description | Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy. |
Description | Total of all reporting groups | Description | Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS). |
Description | Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy. |
Description | Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS). |
Description | Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy. |
Description | Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS). |
Description | Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy. |
Baseline Measurements
Sequence: | 125592037 | Sequence: | 125592038 | Sequence: | 125592039 | Sequence: | 125592040 | Sequence: | 125592041 | Sequence: | 125592042 | Sequence: | 125592043 | Sequence: | 125592044 | Sequence: | 125592045 | Sequence: | 125592046 | Sequence: | 125592047 | Sequence: | 125592048 | Sequence: | 125592049 | Sequence: | 125592050 | Sequence: | 125592051 | Sequence: | 125592052 | Sequence: | 125592053 | Sequence: | 125592054 | Sequence: | 125592055 | Sequence: | 125592056 | Sequence: | 125592057 | Sequence: | 125592058 | Sequence: | 125592059 | Sequence: | 125592060 | Sequence: | 125592061 | Sequence: | 125592062 | Sequence: | 125592063 | Sequence: | 125592064 | Sequence: | 125592065 | Sequence: | 125592066 | Sequence: | 125592067 | Sequence: | 125592068 | Sequence: | 125592069 | Sequence: | 125592070 | Sequence: | 125592071 | Sequence: | 125592072 | Sequence: | 125592073 | Sequence: | 125592074 | Sequence: | 125592075 | Sequence: | 125592076 | Sequence: | 125592077 | Sequence: | 125592078 |
Result Group Id | 56094232 | Result Group Id | 56094233 | Result Group Id | 56094234 | Result Group Id | 56094232 | Result Group Id | 56094233 | Result Group Id | 56094234 | Result Group Id | 56094232 | Result Group Id | 56094233 | Result Group Id | 56094234 | Result Group Id | 56094232 | Result Group Id | 56094233 | Result Group Id | 56094234 | Result Group Id | 56094232 | Result Group Id | 56094233 | Result Group Id | 56094234 | Result Group Id | 56094232 | Result Group Id | 56094233 | Result Group Id | 56094234 | Result Group Id | 56094232 | Result Group Id | 56094233 | Result Group Id | 56094234 | Result Group Id | 56094232 | Result Group Id | 56094233 | Result Group Id | 56094234 | Result Group Id | 56094232 | Result Group Id | 56094233 | Result Group Id | 56094234 | Result Group Id | 56094232 | Result Group Id | 56094233 | Result Group Id | 56094234 | Result Group Id | 56094232 | Result Group Id | 56094233 | Result Group Id | 56094234 | Result Group Id | 56094232 | Result Group Id | 56094233 | Result Group Id | 56094234 | Result Group Id | 56094232 | Result Group Id | 56094233 | Result Group Id | 56094234 | Result Group Id | 56094232 | Result Group Id | 56094233 | Result Group Id | 56094234 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Classification | United States | Classification | United States | Classification | United States | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Category | <=18 years | Category | <=18 years | Category | <=18 years | Category | Between 18 and 65 years | Category | Between 18 and 65 years | Category | Between 18 and 65 years | Category | >=65 years | Category | >=65 years | Category | >=65 years | Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Asian | Category | Asian | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | White | Category | White | Category | White | Category | More than one race | Category | More than one race | Category | More than one race | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | ||||||||||||
Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Region of Enrollment | Title | Region of Enrollment | Title | Region of Enrollment |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 38 | Param Value | 38 | Param Value | 76 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 30.9 | Param Value | 30.8 | Param Value | 30.9 | Param Value | 38 | Param Value | 38 | Param Value | 76 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 33 | Param Value | 35 | Param Value | 68 | Param Value | 3 | Param Value | 2 | Param Value | 5 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 38 | Param Value | 38 | Param Value | 76 |
Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 38.0 | Param Value Num | 38.0 | Param Value Num | 76.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 30.9 | Param Value Num | 30.8 | Param Value Num | 30.9 | Param Value Num | 38.0 | Param Value Num | 38.0 | Param Value Num | 76.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 33.0 | Param Value Num | 35.0 | Param Value Num | 68.0 | Param Value Num | 3.0 | Param Value Num | 2.0 | Param Value Num | 5.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 38.0 | Param Value Num | 38.0 | Param Value Num | 76.0 |
Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Lower Limit | 22.7 | Dispersion Lower Limit | 21.8 | Dispersion Lower Limit | 21.8 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Upper Limit | 43.5 | Dispersion Upper Limit | 41.8 | Dispersion Upper Limit | 43.5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 38 | Number Analyzed | 38 | Number Analyzed | 76 | Number Analyzed | 38 | Number Analyzed | 38 | Number Analyzed | 76 | Number Analyzed | 38 | Number Analyzed | 38 | Number Analyzed | 76 | Number Analyzed | 38 | Number Analyzed | 38 | Number Analyzed | 76 | Number Analyzed | 38 | Number Analyzed | 38 | Number Analyzed | 76 | Number Analyzed | 38 | Number Analyzed | 38 | Number Analyzed | 76 | Number Analyzed | 38 | Number Analyzed | 38 | Number Analyzed | 76 | Number Analyzed | 38 | Number Analyzed | 38 | Number Analyzed | 76 | Number Analyzed | 38 | Number Analyzed | 38 | Number Analyzed | 76 | Number Analyzed | 38 | Number Analyzed | 38 | Number Analyzed | 76 | Number Analyzed | 38 | Number Analyzed | 38 | Number Analyzed | 76 | Number Analyzed | 38 | Number Analyzed | 38 | Number Analyzed | 76 | Number Analyzed | 38 | Number Analyzed | 38 | Number Analyzed | 76 | Number Analyzed | 38 | Number Analyzed | 38 | Number Analyzed | 76 |
]]>
https://zephyrnet.com/NCT03796195
2019-11-13
https://zephyrnet.com/?p=NCT03796195
NCT03796195https://www.clinicaltrials.gov/study/NCT03796195?tab=tableNANANAAndrogen Deprivation Therapy (ADT) is a critical component of advanced prostate cancer treatment but causes numerous adverse effects including decreased bone mass, decreased muscle mass, gynecomastia, erectile dysfunction, loss of sexual desire, depression, disordered sleep, urinary symptoms, and hot flashes (HF). HF are unpleasant paroxysmal episodes of flushing, sweating with vasodilation of the face, neck, and chest. These episodes can last for seconds to minutes and are often associated with night sweats, anxiety, and insomnia and have negative effects on quality of life.
Stellate ganglion blockade (SGB) with local anesthetic may be an effective treatment of HF in men on ADT, but has not been studied in any published clinical trials.
The stellate ganglion is a neural structure in the anterior cervical spine region and is part of the sympathetic nervous system. It has been injected safely in the practice of pain management for more than 50 years in cases of post herpetic neuralgia (shingles), complex regional pain syndrome (CRPS) and other painful neuropathies as well as some types of cardiac dysrhythmias.
Given the frequency and severity and interference of HF in men on ADT for prostate cancer, in addition to the negative effects HF impose on this patient population and a paucity of effective treatments, finding alternative treatments for HF in this population is needed.
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Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-01-25 |
Start Month Year | November 13, 2019 |
Primary Completion Month Year | July 16, 2021 |
Verification Month Year | January 2023 |
Verification Date | 2023-01-31 |
Last Update Posted Date | 2023-01-25 |
Results First Posted Date | 2023-01-25 |
Facilities
Sequence: | 200887837 |
Name | Northwestern Memorial Hospital |
City | Chicago |
State | Illinois |
Zip | 60611 |
Country | United States |
Browse Interventions
Sequence: | 96419639 | Sequence: | 96419640 | Sequence: | 96419641 | Sequence: | 96419642 | Sequence: | 96419643 | Sequence: | 96419644 | Sequence: | 96419645 |
Mesh Term | Bupivacaine | Mesh Term | Anesthetics, Local | Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents |
Downcase Mesh Term | bupivacaine | Downcase Mesh Term | anesthetics, local | Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52409999 | Sequence: | 52410000 |
Name | Prostate Cancer | Name | Hot Flashes |
Downcase Name | prostate cancer | Downcase Name | hot flashes |
Id Information
Sequence: | 40327353 |
Id Source | org_study_id |
Id Value | STU00208657 |
Countries
Sequence: | 42750534 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55857548 |
Group Type | Experimental |
Title | .5% Bupivacaine |
Description | Guided right sided stelate ganglion block using .5% bupivacaine (5mLs) |
Interventions
Sequence: | 52718000 |
Intervention Type | Drug |
Name | .5% Bupivacaine |
Description | Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs) |
Keywords
Sequence: | 80191107 |
Name | Stelate Ganglion Block |
Downcase Name | stelate ganglion block |
Design Outcomes
Sequence: | 178262198 | Sequence: | 178262199 | Sequence: | 178262200 | Sequence: | 178262201 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Hot Flash Frequency Change Baseline to 3 Months After Treatment. | Measure | Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block | Measure | PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block. | Measure | Patient Global Impression of Change Score (PGIC) |
Time Frame | 3 months after SGB procedure | Time Frame | 3 months after stellate ganglion block | Time Frame | 4 weeks after stellate ganglion block | Time Frame | 4 weeks after stellate ganglion block |
Description | Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block. | Description | The change in hot flash severity (hot flash frequency x hot flash intensity) between baseline and 3 months after SGB. Hot flash severity is determined using the mean frequency= ((Fmo+Fse))7 where FMi, Fmo and Fse are the weekly total number of mild, moderate or severe HF events. The mean severity= (Fmi+2x Fmo + 3 x Fse)/7 where FMI, Fmo and Fse are the weekly total number of mild, moderate or severe/very severe hot flash events in the case of mean severity, frequency of mild vasomotor symptoms is not counted at baseline. | Description | PROMIS SF4a (sleep) Patient Reportee Outcomes Measurement Information System. The PROMIS SF4a is a 4 item questionnaire that queries sleep duration, quality and interruption. This instrument accesses self reported perceptions of sleep quality, sleep depth and restoratoin associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy and satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality). | Description | The PGIC assesses the participants improvement in hot flashes from the time of the stellate ganglion block to 4 weeks after the procedure. The PGIC queries how much the hot flashes have improved on a scale of 1 (very much improved) to 7 (very much worse). |
Browse Conditions
Sequence: | 194393177 | Sequence: | 194393178 | Sequence: | 194393179 | Sequence: | 194393180 | Sequence: | 194393181 | Sequence: | 194393182 | Sequence: | 194393183 | Sequence: | 194393184 | Sequence: | 194393185 | Sequence: | 194393186 | Sequence: | 194393187 |
Mesh Term | Prostatic Neoplasms | Mesh Term | Hot Flashes | Mesh Term | Genital Neoplasms, Male | Mesh Term | Urogenital Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Genital Diseases, Male | Mesh Term | Genital Diseases | Mesh Term | Urogenital Diseases | Mesh Term | Prostatic Diseases | Mesh Term | Male Urogenital Diseases |
Downcase Mesh Term | prostatic neoplasms | Downcase Mesh Term | hot flashes | Downcase Mesh Term | genital neoplasms, male | Downcase Mesh Term | urogenital neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | genital diseases, male | Downcase Mesh Term | genital diseases | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | prostatic diseases | Downcase Mesh Term | male urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48541438 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Northwestern University |
Overall Officials
Sequence: | 29409164 |
Role | Principal Investigator |
Name | David Walega, MD, MS |
Affiliation | Northwestern University |
Design Group Interventions
Sequence: | 68471860 |
Design Group Id | 55857548 |
Intervention Id | 52718000 |
Eligibilities
Sequence: | 30902762 |
Gender | Male |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Men with prostate cancer (with or without metastatic disease) on ADT for at least 2 months Exclusion Criteria: Conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the anterior neck or cervical spine; metastatic disease in or near the cervical spine; goiter;cardiac/pulmonary compromise; sleep apnea; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic or contrast dye) |
Gender Description | Men with prostate cancer with bothersome hot flashes. |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254157677 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 20 |
Were Results Reported | True |
Months To Report Results | 12 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30648479 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Drop Withdrawals
Sequence: | 29097759 |
Result Group Id | 56225515 |
Ctgov Group Code | FG000 |
Period | Overall Study |
Reason | Study closed early |
Count | 1 |
Intervention Other Names
Sequence: | 26787930 |
Intervention Id | 52718000 |
Name | Right sided stelate ganglion block (SGB) |
Milestones
Sequence: | 41146746 | Sequence: | 41146747 | Sequence: | 41146748 |
Result Group Id | 56225515 | Result Group Id | 56225515 | Result Group Id | 56225515 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG000 |
Title | STARTED | Title | COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 1 | Count | 0 | Count | 1 |
Participant Flows
Sequence: | 3932135 |
Outcome Counts
Sequence: | 74261238 | Sequence: | 74261239 | Sequence: | 74261240 | Sequence: | 74261241 |
Outcome Id | 30909163 | Outcome Id | 30909164 | Outcome Id | 30909165 | Outcome Id | 30909166 |
Result Group Id | 56225516 | Result Group Id | 56225516 | Result Group Id | 56225516 | Result Group Id | 56225516 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 1 | Count | 1 | Count | 1 | Count | 1 |
Provided Documents
Sequence: | 2595938 | Sequence: | 2595939 |
Document Type | Study Protocol and Statistical Analysis Plan | Document Type | Informed Consent Form |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | True |
Has Sap | True | Has Sap | False |
Document Date | 2020-09-16 | Document Date | 2020-09-16 |
Url | https://ClinicalTrials.gov/ProvidedDocs/95/NCT03796195/Prot_SAP_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/95/NCT03796195/ICF_001.pdf |
Reported Event Totals
Sequence: | 28028941 | Sequence: | 28028942 | Sequence: | 28028943 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 1 | Subjects At Risk | 1 | Subjects At Risk | 1 |
Created At | 2023-08-10 13:09:51.353110 | Created At | 2023-08-10 13:09:51.353110 | Created At | 2023-08-10 13:09:51.353110 |
Updated At | 2023-08-10 13:09:51.353110 | Updated At | 2023-08-10 13:09:51.353110 | Updated At | 2023-08-10 13:09:51.353110 |
Responsible Parties
Sequence: | 29015122 |
Responsible Party Type | Principal Investigator |
Name | David Walega |
Title | Principal Investigator |
Affiliation | Northwestern University |
Result Agreements
Sequence: | 3862879 |
Pi Employee | Yes |
Result Contacts
Sequence: | 3862844 |
Organization | Northwestern University |
Name | David Walega, MD |
Phone | 3126952500 |
d-walega@northwestern.edu | |
Outcomes
Sequence: | 30909163 | Sequence: | 30909164 | Sequence: | 30909165 | Sequence: | 30909166 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Hot Flash Frequency Change Baseline to 3 Months After Treatment. | Title | Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block | Title | PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block. | Title | Patient Global Impression of Change Score (PGIC) |
Description | Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block. | Description | The change in hot flash severity (hot flash frequency x hot flash intensity) between baseline and 3 months after SGB. Hot flash severity is determined using the mean frequency= ((Fmo+Fse))7 where FMi, Fmo and Fse are the weekly total number of mild, moderate or severe HF events. The mean severity= (Fmi+2x Fmo + 3 x Fse)/7 where FMI, Fmo and Fse are the weekly total number of mild, moderate or severe/very severe hot flash events in the case of mean severity, frequency of mild vasomotor symptoms is not counted at baseline. | Description | PROMIS SF4a (sleep) Patient Reportee Outcomes Measurement Information System. The PROMIS SF4a is a 4 item questionnaire that queries sleep duration, quality and interruption. This instrument accesses self reported perceptions of sleep quality, sleep depth and restoratoin associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy and satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality). | Description | The PGIC assesses the participants improvement in hot flashes from the time of the stellate ganglion block to 4 weeks after the procedure. The PGIC queries how much the hot flashes have improved on a scale of 1 (very much improved) to 7 (very much worse). |
Time Frame | 3 months after SGB procedure | Time Frame | 3 months after stellate ganglion block | Time Frame | 4 weeks after stellate ganglion block | Time Frame | 4 weeks after stellate ganglion block |
Units | Hot flashes/day | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale |
Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number |
Outcome Measurements
Sequence: | 236519221 | Sequence: | 236519218 | Sequence: | 236519219 | Sequence: | 236519220 |
Outcome Id | 30909166 | Outcome Id | 30909163 | Outcome Id | 30909164 | Outcome Id | 30909165 |
Result Group Id | 56225516 | Result Group Id | 56225516 | Result Group Id | 56225516 | Result Group Id | 56225516 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Title | Patient Global Impression of Change Score (PGIC) | Title | Hot Flash Frequency Change Baseline to 3 Months After Treatment. | Title | Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block | Title | PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block. |
Description | The PGIC assesses the participants improvement in hot flashes from the time of the stellate ganglion block to 4 weeks after the procedure. The PGIC queries how much the hot flashes have improved on a scale of 1 (very much improved) to 7 (very much worse). | Description | Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block. | Description | The change in hot flash severity (hot flash frequency x hot flash intensity) between baseline and 3 months after SGB. Hot flash severity is determined using the mean frequency= ((Fmo+Fse))7 where FMi, Fmo and Fse are the weekly total number of mild, moderate or severe HF events. The mean severity= (Fmi+2x Fmo + 3 x Fse)/7 where FMI, Fmo and Fse are the weekly total number of mild, moderate or severe/very severe hot flash events in the case of mean severity, frequency of mild vasomotor symptoms is not counted at baseline. | Description | PROMIS SF4a (sleep) Patient Reportee Outcomes Measurement Information System. The PROMIS SF4a is a 4 item questionnaire that queries sleep duration, quality and interruption. This instrument accesses self reported perceptions of sleep quality, sleep depth and restoratoin associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy and satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality). |
Units | Score on a scale | Units | Hot flashes/day | Units | Score on a scale | Units | Score on a scale |
Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number |
Param Value | 4 | Param Value | -1.78 | Param Value | -55.94 | Param Value | 8 |
Param Value Num | 4.0 | Param Value Num | -1.78 | Param Value Num | -55.94 | Param Value Num | 8.0 |
Study References
Sequence: | 52321013 | Sequence: | 52321014 | Sequence: | 52321015 | Sequence: | 52321016 | Sequence: | 52321017 | Sequence: | 52321018 | Sequence: | 52321019 | Sequence: | 52321020 | Sequence: | 52321021 |
Pmid | 29072790 | Pmid | 28712786 | Pmid | 27294289 | Pmid | 11872028 | Pmid | 15379937 | Pmid | 19962840 | Pmid | 23021559 | Pmid | 27993906 | Pmid | 23893467 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Gonzalez BD, Small BJ, Cases MG, Williams NL, Fishman MN, Jacobsen PB, Jim HSL. Sleep disturbance in men receiving androgen deprivation therapy for prostate cancer: The role of hot flashes and nocturia. Cancer. 2018 Feb 1;124(3):499-506. doi: 10.1002/cncr.31024. Epub 2017 Oct 26. | Citation | Dosani M, Morris WJ, Tyldesley S, Pickles T. The Relationship between Hot Flashes and Testosterone Recovery after 12 Months of Androgen Suppression for Men with Localised Prostate Cancer in the ASCENDE-RT Trial. Clin Oncol (R Coll Radiol). 2017 Oct;29(10):696-701. doi: 10.1016/j.clon.2017.06.009. Epub 2017 Jul 13. | Citation | Grunfeld EA, Hunter MS, Yousaf O. Men's experience of a guided self-help intervention for hot flushes associated with prostate cancer treatment. Psychol Health Med. 2017 Apr;22(4):425-433. doi: 10.1080/13548506.2016.1195504. Epub 2016 Jun 13. | Citation | Kouriefs C, Georgiou M, Ravi R. Hot flushes and prostate cancer: pathogenesis and treatment. BJU Int. 2002 Mar;89(4):379-83. doi: 10.1046/j.1464-4096.2001.01761.x. No abstract available. | Citation | Nishiyama T, Kanazawa S, Watanabe R, Terunuma M, Takahashi K. Influence of hot flashes on quality of life in patients with prostate cancer treated with androgen deprivation therapy. Int J Urol. 2004 Sep;11(9):735-41. doi: 10.1111/j.1442-2042.2004.00896.x. | Citation | Frisk J. Managing hot flushes in men after prostate cancer–a systematic review. Maturitas. 2010 Jan;65(1):15-22. doi: 10.1016/j.maturitas.2009.10.017. Epub 2009 Dec 4. | Citation | Trump DL. Commentary on "association of androgen deprivation therapy with cardiovascular death in patients with prostate cancer: a meta-analysis of randomized trials." Nguyen PL, Je Y, Schutz FA, Hoffman KE, Hu JC, Parekh A, Beckman JA, Choueiri TK, Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA: JAMA 2011;306(21):2359-66. Urol Oncol. 2012 Sep;30(5):746-7. doi: 10.1016/j.urolonc.2012.06.007. No abstract available. | Citation | Gavin AT, Donnelly D, Donnelly C, Drummond FJ, Morgan E, Gormley GJ, Sharp L. Effect of investigation intensity and treatment differences on prostate cancer survivor's physical symptoms, psychological well-being and health-related quality of life: a two country cross-sectional study. BMJ Open. 2016 Dec 19;6(12):e012952. doi: 10.1136/bmjopen-2016-012952. Erratum In: BMJ Open. 2017 Jan 23;7(1):e012952corr1. | Citation | Eziefula CU, Grunfeld EA, Hunter MS. 'You know I've joined your club… I'm the hot flush boy': a qualitative exploration of hot flushes and night sweats in men undergoing androgen deprivation therapy for prostate cancer. Psychooncology. 2013 Dec;22(12):2823-30. doi: 10.1002/pon.3355. Epub 2013 Jul 28. |
Baseline Counts
Sequence: | 11417217 |
Result Group Id | 56225514 |
Ctgov Group Code | BG000 |
Units | Participants |
Scope | overall |
Count | 1 |
Result Groups
Sequence: | 56225514 | Sequence: | 56225515 | Sequence: | 56225516 | Sequence: | 56225517 |
Ctgov Group Code | BG000 | Ctgov Group Code | FG000 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 |
Result Type | Baseline | Result Type | Participant Flow | Result Type | Outcome | Result Type | Reported Event |
Title | .5% Bupivacaine | Title | .5% Bupivacaine | Title | .5% Bupivacaine | Title | .5% Bupivacaine |
Description | Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs) |
Description | Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs) |
Description | Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs) |
Description | Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs) |
Baseline Measurements
Sequence: | 126051364 | Sequence: | 126051365 | Sequence: | 126051366 | Sequence: | 126051367 | Sequence: | 126051368 | Sequence: | 126051380 | Sequence: | 126051369 | Sequence: | 126051370 | Sequence: | 126051371 | Sequence: | 126051372 | Sequence: | 126051373 | Sequence: | 126051374 | Sequence: | 126051375 | Sequence: | 126051376 | Sequence: | 126051377 | Sequence: | 126051378 | Sequence: | 126051379 | Sequence: | 126051381 |
Result Group Id | 56225514 | Result Group Id | 56225514 | Result Group Id | 56225514 | Result Group Id | 56225514 | Result Group Id | 56225514 | Result Group Id | 56225514 | Result Group Id | 56225514 | Result Group Id | 56225514 | Result Group Id | 56225514 | Result Group Id | 56225514 | Result Group Id | 56225514 | Result Group Id | 56225514 | Result Group Id | 56225514 | Result Group Id | 56225514 | Result Group Id | 56225514 | Result Group Id | 56225514 | Result Group Id | 56225514 | Result Group Id | 56225514 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 |
Classification | United States | ||||||||||||||||||||||||||||||||||
Category | <=18 years | Category | Between 18 and 65 years | Category | >=65 years | Category | Female | Category | Male | Category | American Indian or Alaska Native | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | White | Category | More than one race | Category | Unknown or Not Reported | ||||||||||||
Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Continuous | Title | Sex: Female, Male | Title | Baseline mean daily hot flashes | Title | Sex: Female, Male | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Region of Enrollment | Title | Body Mass Index (kg/m^2) | Title | Baseline Hot Flash-Related Daily Interference Scale (HFRDIS) | Title | PROMIS SF4a Sleep Score |
Description | Baseline mean daily hot flashes reported by subject using daily diary. | Description | HFRIDS is a 10 question survey scored on a scale of 0=no interference and 10=high interference.
Questions inquire about work, social activities, leisure activities,sleep, mood,concentratoin, relationship with others, sexuality,enjoyment of life and overqll quality of life. Low score=0 is the lowest interference score and the highest interference score is 100. |
Description | PROMIS SF4a (sleep) Patient Reported Outcomes Measurement Information System. The PROMIS SF4a is a 4 item questionnaire that queries sleep duration, quality and interruption. This instrument accesses self reported perceptions of sleep quality. sleep depth and restoratoin associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality). | ||||||||||||||||||||||||||||||
Units | Participants | Units | Participants | Units | Participants | Units | years | Units | Participants | Units | Hot flashes/day | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | (kg/m^2) | Units | score on a scale | Units | Score on a scale |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Count of Participants | Param Type | Number | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number |
Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 67 | Param Value | 0 | Param Value | 9.78 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 25 | Param Value | 48 | Param Value | 11 |
Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 67.0 | Param Value Num | 0.0 | Param Value Num | 9.78 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 25.0 | Param Value Num | 48.0 | Param Value Num | 11.0 |
Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||
Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 |
]]>
https://zephyrnet.com/NCT03796182
2019-01-10
https://zephyrnet.com/?p=NCT03796182
NCT03796182https://www.clinicaltrials.gov/study/NCT03796182?tab=tableNANANAThis is a Phase 1, randomized, 2 way crossover, open label study of the effect of PF-04965842 on metformin (a probe for MATE1/2K activity) PK in healthy adult participants. The effect of PF-04965842 on N1-methylnicotinamide (NMN; an endogenous biomarker for MATE1/2K) PK and its correlation to the effect on metformin PK will also be assessed. Participants will be randomized to 1 of 2 treatment sequences as described below. A total of 12 healthy male and/or female participants will be enrolled in the study so that 6 participants will be enrolled in each treatment sequence. Each treatment sequence will consist of 2 periods.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-02-05 |
Start Month Year | January 10, 2019 |
Primary Completion Month Year | February 13, 2019 |
Verification Month Year | January 2020 |
Verification Date | 2020-01-31 |
Last Update Posted Date | 2020-02-05 |
Results First Posted Date | 2020-02-05 |
Detailed Descriptions
Sequence: | 20573953 |
Description | This is a Phase 1, randomized, 2 way crossover, open label study of the effect of PF-04965842 on metformin (a probe for MATE1/2K activity) PK in healthy adult participants. The effect of PF-04965842 on N1-methylnicotinamide (NMN; an endogenous biomarker for MATE1/2K) PK and its correlation to the effect on metformin PK will also be assessed. Participants will be randomized to 1 of 2 treatment sequences as described below. A total of 12 healthy male and/or female participants will be enrolled in the study so that 6 participants will be enrolled in each treatment sequence. Each treatment sequence will consist of 2 periods. Participants who discontinue from the study may be replaced at the sponsor's discretion. The replacement participant will receive the same treatment sequence as the participant who discontinued.
Participants will be screened within 28 days of the first dose of investigational product. Participants will report to the clinical research unit (CRU) the day prior to Day 1 (ie Day -1) dosing in Period 1 for both treatment sequences. In both sequences, participants will remain in the CRU for a total of 8 days and 7 nights (including Period 1 and Period 2). There will be a minimum 4 day washout period between metformin dosing events. NMN and metformin PK will be assessed in plasma and urine over 24 and 48 hours, respectively. |
Facilities
Sequence: | 198630697 |
Name | Pfizer Clinical Research Unit |
City | Brussels |
Zip | B-1070 |
Country | Belgium |
Browse Interventions
Sequence: | 95307605 | Sequence: | 95307606 | Sequence: | 95307607 | Sequence: | 95307608 | Sequence: | 95307609 | Sequence: | 95307610 | Sequence: | 95307611 |
Mesh Term | Metformin | Mesh Term | Abrocitinib | Mesh Term | Hypoglycemic Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Protein Kinase Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | metformin | Downcase Mesh Term | abrocitinib | Downcase Mesh Term | hypoglycemic agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | protein kinase inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51790015 |
Name | Healthy |
Downcase Name | healthy |
Id Information
Sequence: | 39855189 | Sequence: | 39855190 | Sequence: | 39855191 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | B7451034 | Id Value | DDI | Id Value | 2018-003683-31 |
Id Type | Other Identifier | Id Type | EudraCT Number | ||
Id Type Description | Alias Study Number | ||||
Countries
Sequence: | 42254028 |
Name | Belgium |
Removed | False |
Design Groups
Sequence: | 55210670 | Sequence: | 55210671 |
Group Type | Experimental | Group Type | Experimental |
Title | Sequence 1 | Title | Sequence 2 |
Description | Patients in sequence 1 will received treatment A (metformin) in Period 1 then complete at least 4 days of washout and continue to period 2 where treatment B (PF-04965842 + metformin) will be administered. | Description | Patients in Sequence 2 will start treatment B (PF-04965842 + metformin) then go through a washout period of at least 4 days and continue to Period 2 where treatment A (metformin) will be administered. |
Interventions
Sequence: | 52112625 | Sequence: | 52112626 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Metformin | Name | PF-04965842 |
Description | Commercially available metformin (GLUCOPHAGE®) as 500 mg tablets. | Description | PF 04965842 100 mg tablets |
Keywords
Sequence: | 79242342 | Sequence: | 79242343 | Sequence: | 79242344 |
Name | Phase 1 | Name | Metformin | Name | Atopic dermatitis |
Downcase Name | phase 1 | Downcase Name | metformin | Downcase Name | atopic dermatitis |
Design Outcomes
Sequence: | 176153642 | Sequence: | 176153643 | Sequence: | 176153644 | Sequence: | 176153645 | Sequence: | 176153646 | Sequence: | 176153647 | Sequence: | 176153648 | Sequence: | 176153649 | Sequence: | 176153650 | Sequence: | 176153651 | Sequence: | 176153652 | Sequence: | 176153653 | Sequence: | 176153654 | Sequence: | 176153655 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Renal Clearance (CLr) of Metformin | Measure | Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Metformin | Measure | Maximum Plasma Concentration (Cmax) of Metformin | Measure | Time for Cmax (Tmax) of Metformin | Measure | Area Under the Plasma Concentration Time Profile From Time 0 to the Time of Last Quantifiable Concentration (AUClast) of Metformin | Measure | Apparent Clearance (CL/F) of Metformin | Measure | Apparent Volume of Distribution (Vz/F) of Metformin | Measure | Terminal Half-life (t1/2) of Metformin | Measure | Cumulative Amount of Drug Recovered Unchanged in Urine From 0 to 48 Hours (Ae) of Metformin | Measure | Percent of Dose Recovered Unchanged in Urine From 0 to 24 Hours (Ae%) of Metformin | Measure | Number of Participants With Laboratory Abnormalities | Measure | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Measure | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | Measure | Percentage of Participants With Treatment-Emergent AEs and SAEs (All Causalities and Treatment-related) |
Time Frame | For both Period 1 and Period 2 at intervals of 0-12, 12-24, 24-36, and 36-48 hours post metformin dose | Time Frame | Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2 | Time Frame | Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2 | Time Frame | Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2 | Time Frame | Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2 | Time Frame | Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2 | Time Frame | Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2 | Time Frame | Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2 | Time Frame | For both Period 1 and Period 2 at intervals of 0-12, 12-24, 24-36, and 36-48 hours post metformin dose | Time Frame | For both Period 1 and Period 2 at intervals of 0-12 and 12-24 hours post metformin dose | Time Frame | Screening (within 28 days prior to Day 1) to Day 7 | Time Frame | Screening (within 28 days prior to Day 1) to Day 7 | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) |
Description | CLr was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau). | Description | AUCinf is a measure of the serum concentration of the drug over time. It was used to characterize drug absorption. | Description | Cmax is maximum observed plasma concentration. | Description | Tmax of metformin administrated with or without PF-04965842. | Description | AUClast of metformin administrated with or without PF-04965842. | Description | CL/F is a quantitative measure of the rate at which drug was removed from the blood. | Description | Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | Description | t1/2 is the time measured for the plasma concentration to decrease by one half. | Description | Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL is the approximate specific gravity of urine. | Description | Ae% is percent of dose recovered unchanged in urine from 0 to 24 hours post-dose of metformin. | Description | Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio, large unstained cells/leukocytes and large unstained cells), clinical chemistry (bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate, urobilinogen and glucose -FASTING), urinalysis (specific gravity, pH, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite and leukocytes). Clinical significance of laboratory parameters is determined at the investigator's discretion. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
Sponsors
Sequence: | 47964009 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Pfizer |
Overall Officials
Sequence: | 29060525 |
Role | Study Director |
Name | Pfizer CT.gov Call Center |
Affiliation | Pfizer |
Design Group Interventions
Sequence: | 67689835 | Sequence: | 67689836 | Sequence: | 67689837 | Sequence: | 67689838 |
Design Group Id | 55210670 | Design Group Id | 55210671 | Design Group Id | 55210670 | Design Group Id | 55210671 |
Intervention Id | 52112625 | Intervention Id | 52112625 | Intervention Id | 52112626 | Intervention Id | 52112626 |
Eligibilities
Sequence: | 30541672 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 55 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Male and female participants who are overtly healthy as determined by medical evaluation including a detailed medical history, complete physical examination, laboratory tests, and cardiovascular tests. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease. |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254206588 |
Number Of Facilities | 1 |
Number Of Nsae Subjects | 14 |
Registered In Calendar Year | 2019 |
Actual Duration | 1 |
Were Results Reported | True |
Months To Report Results | 11 |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 55 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 13 |
Designs
Sequence: | 30290206 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | This is a Phase 1, randomized, 2 way crossover, open label study of the effect of PF 04965842 on metformin PK in healthy adult participants. The effect of PF 04965842 on N1 methylnicotinamide (NMN) PK and its correlation to the effect on metformin PK will also be assessed.
A total of approximately 12 healthy male and/or female participants will be enrolled in the study so that approximately 6 participants will be enrolled in each treatment sequence. Each treatment sequence will consist of 2 periods. Participants who discontinue from the study may be replaced at the sponsor's discretion. The replacement participant will receive the same treatment sequence as the participant who discontinued. Participants will be screened within 28 days of the first dose of investigational product. Participants will report to the clinical research unit (CRU) the day prior to Day 1 (ie Day -1) dosing in Period 1 for both treatment sequences. In both sequences, participants will remain in the CRU for |
Intervention Other Names
Sequence: | 26490678 |
Intervention Id | 52112625 |
Name | Glucophage |
Milestones
Sequence: | 40799741 | Sequence: | 40799742 | Sequence: | 40799743 | Sequence: | 40799744 | Sequence: | 40799745 | Sequence: | 40799746 | Sequence: | 40799747 | Sequence: | 40799748 | Sequence: | 40799749 | Sequence: | 40799750 | Sequence: | 40799751 | Sequence: | 40799752 | Sequence: | 40799753 | Sequence: | 40799754 | Sequence: | 40799755 | Sequence: | 40799756 | Sequence: | 40799757 | Sequence: | 40799758 |
Result Group Id | 55879895 | Result Group Id | 55879896 | Result Group Id | 55879895 | Result Group Id | 55879896 | Result Group Id | 55879895 | Result Group Id | 55879896 | Result Group Id | 55879895 | Result Group Id | 55879896 | Result Group Id | 55879895 | Result Group Id | 55879896 | Result Group Id | 55879895 | Result Group Id | 55879896 | Result Group Id | 55879895 | Result Group Id | 55879896 | Result Group Id | 55879895 | Result Group Id | 55879896 | Result Group Id | 55879895 | Result Group Id | 55879896 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Period 1 | Period | Period 1 | Period | Period 1 | Period | Period 1 | Period | Period 1 | Period | Period 1 | Period | Washout Period | Period | Washout Period | Period | Washout Period | Period | Washout Period | Period | Washout Period | Period | Washout Period | Period | Period 2 | Period | Period 2 | Period | Period 2 | Period | Period 2 | Period | Period 2 | Period | Period 2 |
Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 0 | Count | 0 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 0 | Count | 0 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 0 | Count | 0 |
Outcome Analyses
Sequence: | 16467542 | Sequence: | 16467543 | Sequence: | 16467544 | Sequence: | 16467545 |
Outcome Id | 30636658 | Outcome Id | 30636659 | Outcome Id | 30636660 | Outcome Id | 30636662 |
Non Inferiority Type | Equivalence | Non Inferiority Type | Equivalence | Non Inferiority Type | Equivalence | Non Inferiority Type | Equivalence |
Non Inferiority Description | The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range. | Non Inferiority Description | The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range. | Non Inferiority Description | The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range. | Non Inferiority Description | The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range. |
Param Type | Ratio | Param Type | Ratio | Param Type | Ratio | Param Type | Ratio |
Param Value | 98.5 | Param Value | 93.49 | Param Value | 88.07 | Param Value | 94.25 |
P Value Modifier | P Value Modifier | P Value Modifier | P Value Modifier | ||||
Ci N Sides | 2-Sided | Ci N Sides | 2-Sided | Ci N Sides | 2-Sided | Ci N Sides | 2-Sided |
Ci Percent | 90.0 | Ci Percent | 90.0 | Ci Percent | 90.0 | Ci Percent | 90.0 |
Ci Lower Limit | 82.09 | Ci Lower Limit | 85.15 | Ci Lower Limit | 80.99 | Ci Lower Limit | 88.19 |
Ci Upper Limit | 118.2 | Ci Upper Limit | 102.65 | Ci Upper Limit | 95.76 | Ci Upper Limit | 100.73 |
Outcome Analysis Groups
Sequence: | 31936344 | Sequence: | 31936345 | Sequence: | 31936346 | Sequence: | 31936347 | Sequence: | 31936348 | Sequence: | 31936349 | Sequence: | 31936350 | Sequence: | 31936351 |
Outcome Analysis Id | 16467542 | Outcome Analysis Id | 16467542 | Outcome Analysis Id | 16467543 | Outcome Analysis Id | 16467543 | Outcome Analysis Id | 16467544 | Outcome Analysis Id | 16467544 | Outcome Analysis Id | 16467545 | Outcome Analysis Id | 16467545 |
Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Links
Sequence: | 4355568 |
Url | https://pmiform.com/clinical-trial-info-request?StudyID=B7451034 |
Description | To obtain contact information for a study center near you, click here. |
Participant Flows
Sequence: | 3902855 |
Pre Assignment Details | A total of 12 healthy participants were enrolled in the study and 6 participants were assigned in each of the 2 treatment sequences, all receiving study treatment. |
Outcome Counts
Sequence: | 73593034 | Sequence: | 73593035 | Sequence: | 73593036 | Sequence: | 73593037 | Sequence: | 73593038 | Sequence: | 73593039 | Sequence: | 73593040 | Sequence: | 73593041 | Sequence: | 73593042 | Sequence: | 73593043 | Sequence: | 73593044 | Sequence: | 73593045 | Sequence: | 73593046 | Sequence: | 73593047 | Sequence: | 73593048 | Sequence: | 73593049 | Sequence: | 73593050 | Sequence: | 73593051 | Sequence: | 73593052 | Sequence: | 73593053 | Sequence: | 73593054 | Sequence: | 73593055 | Sequence: | 73593056 | Sequence: | 73593057 | Sequence: | 73593058 | Sequence: | 73593059 | Sequence: | 73593060 | Sequence: | 73593061 |
Outcome Id | 30636658 | Outcome Id | 30636658 | Outcome Id | 30636659 | Outcome Id | 30636659 | Outcome Id | 30636660 | Outcome Id | 30636660 | Outcome Id | 30636661 | Outcome Id | 30636661 | Outcome Id | 30636662 | Outcome Id | 30636662 | Outcome Id | 30636663 | Outcome Id | 30636663 | Outcome Id | 30636664 | Outcome Id | 30636664 | Outcome Id | 30636665 | Outcome Id | 30636665 | Outcome Id | 30636666 | Outcome Id | 30636666 | Outcome Id | 30636667 | Outcome Id | 30636667 | Outcome Id | 30636668 | Outcome Id | 30636668 | Outcome Id | 30636669 | Outcome Id | 30636669 | Outcome Id | 30636670 | Outcome Id | 30636670 | Outcome Id | 30636671 | Outcome Id | 30636671 |
Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 11 | Count | 12 | Count | 8 | Count | 11 | Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 8 | Count | 11 | Count | 8 | Count | 11 | Count | 8 | Count | 11 | Count | 11 | Count | 12 | Count | 11 | Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 12 |
Provided Documents
Sequence: | 2568505 | Sequence: | 2568506 |
Document Type | Statistical Analysis Plan | Document Type | Study Protocol |
Has Protocol | False | Has Protocol | True |
Has Icf | False | Has Icf | False |
Has Sap | True | Has Sap | False |
Document Date | 2018-12-14 | Document Date | 2018-11-01 |
Url | https://ClinicalTrials.gov/ProvidedDocs/82/NCT03796182/SAP_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/82/NCT03796182/Prot_001.pdf |
Reported Event Totals
Sequence: | 27805381 | Sequence: | 27805382 | Sequence: | 27805383 | Sequence: | 27805384 | Sequence: | 27805385 | Sequence: | 27805386 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 6 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 4 | Subjects Affected | 0 |
Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 |
Created At | 2023-08-06 18:18:16.420335 | Created At | 2023-08-06 18:18:16.420335 | Created At | 2023-08-06 18:18:16.420335 | Created At | 2023-08-06 18:18:16.420335 | Created At | 2023-08-06 18:18:16.420335 | Created At | 2023-08-06 18:18:16.420335 |
Updated At | 2023-08-06 18:18:16.420335 | Updated At | 2023-08-06 18:18:16.420335 | Updated At | 2023-08-06 18:18:16.420335 | Updated At | 2023-08-06 18:18:16.420335 | Updated At | 2023-08-06 18:18:16.420335 | Updated At | 2023-08-06 18:18:16.420335 |
Reported Events
Sequence: | 524777685 | Sequence: | 524777686 | Sequence: | 524777687 | Sequence: | 524777688 | Sequence: | 524777689 | Sequence: | 524777690 | Sequence: | 524777691 | Sequence: | 524777692 | Sequence: | 524777693 | Sequence: | 524777694 | Sequence: | 524777695 | Sequence: | 524777696 | Sequence: | 524777697 | Sequence: | 524777698 | Sequence: | 524777699 | Sequence: | 524777700 |
Result Group Id | 55879899 | Result Group Id | 55879900 | Result Group Id | 55879899 | Result Group Id | 55879900 | Result Group Id | 55879899 | Result Group Id | 55879900 | Result Group Id | 55879899 | Result Group Id | 55879900 | Result Group Id | 55879899 | Result Group Id | 55879900 | Result Group Id | 55879899 | Result Group Id | 55879900 | Result Group Id | 55879899 | Result Group Id | 55879900 | Result Group Id | 55879899 | Result Group Id | 55879900 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) |
Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other |
Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 4 | Subjects Affected | 3 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 |
Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 |
Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 4 | Event Count | 3 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 |
Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | General disorders | Organ System | General disorders | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders |
Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Anorectal discomfort | Adverse Event Term | Anorectal discomfort | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Neck pain | Adverse Event Term | Neck pain |
Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 |
Vocab | MedDRA v21.1 | Vocab | MedDRA v21.1 | Vocab | MedDRA v21.1 | Vocab | MedDRA v21.1 | Vocab | MedDRA v21.1 | Vocab | MedDRA v21.1 | Vocab | MedDRA v21.1 | Vocab | MedDRA v21.1 | Vocab | MedDRA v21.1 | Vocab | MedDRA v21.1 | Vocab | MedDRA v21.1 | Vocab | MedDRA v21.1 | Vocab | MedDRA v21.1 | Vocab | MedDRA v21.1 | Vocab | MedDRA v21.1 | Vocab | MedDRA v21.1 |
Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment |
Responsible Parties
Sequence: | 28669166 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3833599 |
Pi Employee | Yes |
Restriction Type | OTHER |
Other Details | Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results. |
Restrictive Agreement | Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results. |
Result Contacts
Sequence: | 3833564 |
Organization | Pfizer, Inc |
Name | Pfizer ClinicalTrials.gov Call Center |
Phone | 1-800-718-1021 |
ClinicalTrials.gov_Inquires@pfizer.com | |
Outcomes
Sequence: | 30636658 | Sequence: | 30636659 | Sequence: | 30636660 | Sequence: | 30636661 | Sequence: | 30636662 | Sequence: | 30636663 | Sequence: | 30636664 | Sequence: | 30636665 | Sequence: | 30636666 | Sequence: | 30636667 | Sequence: | 30636668 | Sequence: | 30636669 | Sequence: | 30636670 | Sequence: | 30636671 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Renal Clearance (CLr) of Metformin | Title | Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Metformin | Title | Maximum Plasma Concentration (Cmax) of Metformin | Title | Time for Cmax (Tmax) of Metformin | Title | Area Under the Plasma Concentration Time Profile From Time 0 to the Time of Last Quantifiable Concentration (AUClast) of Metformin | Title | Apparent Clearance (CL/F) of Metformin | Title | Apparent Volume of Distribution (Vz/F) of Metformin | Title | Terminal Half-life (t1/2) of Metformin | Title | Cumulative Amount of Drug Recovered Unchanged in Urine From 0 to 48 Hours (Ae) of Metformin | Title | Percent of Dose Recovered Unchanged in Urine From 0 to 24 Hours (Ae%) of Metformin | Title | Number of Participants With Laboratory Abnormalities | Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | Title | Percentage of Participants With Treatment-Emergent AEs and SAEs (All Causalities and Treatment-related) |
Description | CLr was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau). | Description | AUCinf is a measure of the serum concentration of the drug over time. It was used to characterize drug absorption. | Description | Cmax is maximum observed plasma concentration. | Description | Tmax of metformin administrated with or without PF-04965842. | Description | AUClast of metformin administrated with or without PF-04965842. | Description | CL/F is a quantitative measure of the rate at which drug was removed from the blood. | Description | Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | Description | t1/2 is the time measured for the plasma concentration to decrease by one half. | Description | Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL is the approximate specific gravity of urine. | Description | Ae% is percent of dose recovered unchanged in urine from 0 to 24 hours post-dose of metformin. | Description | Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio, large unstained cells/leukocytes and large unstained cells), clinical chemistry (bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate, urobilinogen and glucose -FASTING), urinalysis (specific gravity, pH, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite and leukocytes). Clinical significance of laboratory parameters is determined at the investigator's discretion. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
Time Frame | For both Period 1 and Period 2 at intervals of 0-12, 12-24, 24-36, and 36-48 hours post metformin dose | Time Frame | Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2 | Time Frame | Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2 | Time Frame | Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2 | Time Frame | Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2 | Time Frame | Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2 | Time Frame | Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2 | Time Frame | Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2 | Time Frame | For both Period 1 and Period 2 at intervals of 0-12, 12-24, 24-36, and 36-48 hours post metformin dose | Time Frame | For both Period 1 and Period 2 at intervals of 0-12 and 12-24 hours post metformin dose | Time Frame | Screening (within 28 days prior to Day 1) to Day 7 | Time Frame | Screening (within 28 days prior to Day 1) to Day 7 | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) | Time Frame | Day 1 up to Day 40 (35 days after the last dose of metformin) |
Population | This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure. | Population | This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure. | Population | This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Population | This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Population | This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Population | This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure. | Population | This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure. | Population | This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure. | Population | This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure. | Population | This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure. | Population | This analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product. | Population | This analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product. | Population | This analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product. | Population | This analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product. |
Units | litre per hour (L/hr) | Units | nanogram*hour per milliliter (ng*hr/mL) | Units | nanogram per milliliter (ng/mL) | Units | Hours (hrs) | Units | ng*h/mL | Units | L/hr | Units | liter (L) | Units | hrs | Units | milligram (mg) | Units | percentage of dose | Units | Participants | Units | Participants | Units | Participants | Units | percentage of participants |
Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Full Range | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Standard Deviation | Dispersion Type | Full Range | Dispersion Type | Full Range | ||||||||
Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Median | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Mean | Param Type | Median | Param Type | Median | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number |
Outcome Measurements
Sequence: | 234242685 | Sequence: | 234242686 | Sequence: | 234242660 | Sequence: | 234242661 | Sequence: | 234242662 | Sequence: | 234242663 | Sequence: | 234242664 | Sequence: | 234242665 | Sequence: | 234242666 | Sequence: | 234242667 | Sequence: | 234242668 | Sequence: | 234242669 | Sequence: | 234242670 | Sequence: | 234242671 | Sequence: | 234242672 | Sequence: | 234242673 | Sequence: | 234242674 | Sequence: | 234242675 | Sequence: | 234242676 | Sequence: | 234242677 | Sequence: | 234242678 | Sequence: | 234242679 | Sequence: | 234242680 | Sequence: | 234242681 | Sequence: | 234242682 | Sequence: | 234242683 | Sequence: | 234242684 | Sequence: | 234242687 | Sequence: | 234242691 | Sequence: | 234242688 | Sequence: | 234242689 | Sequence: | 234242690 | Sequence: | 234242692 | Sequence: | 234242693 | Sequence: | 234242694 | Sequence: | 234242695 | Sequence: | 234242696 | Sequence: | 234242697 | Sequence: | 234242698 | Sequence: | 234242699 | Sequence: | 234242700 | Sequence: | 234242701 | Sequence: | 234242702 | Sequence: | 234242703 | Sequence: | 234242704 | Sequence: | 234242705 | Sequence: | 234242706 | Sequence: | 234242707 | Sequence: | 234242708 | Sequence: | 234242709 | Sequence: | 234242710 | Sequence: | 234242711 | Sequence: | 234242712 | Sequence: | 234242713 |
Outcome Id | 30636669 | Outcome Id | 30636669 | Outcome Id | 30636658 | Outcome Id | 30636658 | Outcome Id | 30636659 | Outcome Id | 30636659 | Outcome Id | 30636660 | Outcome Id | 30636660 | Outcome Id | 30636661 | Outcome Id | 30636661 | Outcome Id | 30636662 | Outcome Id | 30636662 | Outcome Id | 30636663 | Outcome Id | 30636663 | Outcome Id | 30636664 | Outcome Id | 30636664 | Outcome Id | 30636665 | Outcome Id | 30636665 | Outcome Id | 30636666 | Outcome Id | 30636666 | Outcome Id | 30636667 | Outcome Id | 30636667 | Outcome Id | 30636668 | Outcome Id | 30636668 | Outcome Id | 30636669 | Outcome Id | 30636669 | Outcome Id | 30636669 | Outcome Id | 30636669 | Outcome Id | 30636669 | Outcome Id | 30636669 | Outcome Id | 30636669 | Outcome Id | 30636669 | Outcome Id | 30636669 | Outcome Id | 30636669 | Outcome Id | 30636669 | Outcome Id | 30636669 | Outcome Id | 30636669 | Outcome Id | 30636669 | Outcome Id | 30636670 | Outcome Id | 30636670 | Outcome Id | 30636670 | Outcome Id | 30636670 | Outcome Id | 30636670 | Outcome Id | 30636670 | Outcome Id | 30636670 | Outcome Id | 30636670 | Outcome Id | 30636671 | Outcome Id | 30636671 | Outcome Id | 30636671 | Outcome Id | 30636671 | Outcome Id | 30636671 | Outcome Id | 30636671 | Outcome Id | 30636671 | Outcome Id | 30636671 |
Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 | Result Group Id | 55879897 | Result Group Id | 55879898 |
Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Classification | Supine DBP Chg ≥ 20 mmHg increase | Classification | Supine DBP Chg ≥ 20 mmHg decrease | Classification | Supine DBP Value < 50 mmHg | Classification | Supine DBP Value < 50 mmHg | Classification | Supine DBP Chg ≥ 20 mmHg increase | Classification | Supine DBP Chg ≥ 20 mmHg decrease | Classification | Supine pulse rate Value > 120 bpm | Classification | Supine pulse rate Value < 40 bpm | Classification | Supine pulse rate Value < 40 bpm | Classification | Supine pulse rate Value > 120 bpm | Classification | Supine SBP Value < 90 mmHg | Classification | Supine SBP Value < 90 mmHg | Classification | Supine SBP Chg ≥ 30 mmHg increase | Classification | Supine SBP Chg ≥ 30 mmHg increase | Classification | Supine SBP Chg ≥ 30 mmHg decrease | Classification | Supine SBP Chg ≥ 30 mmHg decrease | Classification | AEs (all causalities) | Classification | AEs (all causalities) | Classification | AEs (treatment-related) | Classification | AEs (treatment-related) | Classification | SAEs (all causalities) | Classification | SAEs (all causalities) | Classification | SAEs (treatment-related) | Classification | SAEs (treatment-related) | Classification | AEs (all causalities) | Classification | AEs (all causalities) | Classification | AEs (treatment-related) | Classification | AEs (treatment-related) | Classification | SAEs (all causalities) | Classification | SAEs (all causalities) | Classification | SAEs (treatment-related) | Classification | SAEs (treatment-related) | ||||||||||||||||||||||||||||||||||||||||||||
Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Renal Clearance (CLr) of Metformin | Title | Renal Clearance (CLr) of Metformin | Title | Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Metformin | Title | Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Metformin | Title | Maximum Plasma Concentration (Cmax) of Metformin | Title | Maximum Plasma Concentration (Cmax) of Metformin | Title | Time for Cmax (Tmax) of Metformin | Title | Time for Cmax (Tmax) of Metformin | Title | Area Under the Plasma Concentration Time Profile From Time 0 to the Time of Last Quantifiable Concentration (AUClast) of Metformin | Title | Area Under the Plasma Concentration Time Profile From Time 0 to the Time of Last Quantifiable Concentration (AUClast) of Metformin | Title | Apparent Clearance (CL/F) of Metformin | Title | Apparent Clearance (CL/F) of Metformin | Title | Apparent Volume of Distribution (Vz/F) of Metformin | Title | Apparent Volume of Distribution (Vz/F) of Metformin | Title | Terminal Half-life (t1/2) of Metformin | Title | Terminal Half-life (t1/2) of Metformin | Title | Cumulative Amount of Drug Recovered Unchanged in Urine From 0 to 48 Hours (Ae) of Metformin | Title | Cumulative Amount of Drug Recovered Unchanged in Urine From 0 to 48 Hours (Ae) of Metformin | Title | Percent of Dose Recovered Unchanged in Urine From 0 to 24 Hours (Ae%) of Metformin | Title | Percent of Dose Recovered Unchanged in Urine From 0 to 24 Hours (Ae%) of Metformin | Title | Number of Participants With Laboratory Abnormalities | Title | Number of Participants With Laboratory Abnormalities | Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria | Title | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | Title | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | Title | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | Title | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | Title | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | Title | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | Title | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | Title | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | Title | Percentage of Participants With Treatment-Emergent AEs and SAEs (All Causalities and Treatment-related) | Title | Percentage of Participants With Treatment-Emergent AEs and SAEs (All Causalities and Treatment-related) | Title | Percentage of Participants With Treatment-Emergent AEs and SAEs (All Causalities and Treatment-related) | Title | Percentage of Participants With Treatment-Emergent AEs and SAEs (All Causalities and Treatment-related) | Title | Percentage of Participants With Treatment-Emergent AEs and SAEs (All Causalities and Treatment-related) | Title | Percentage of Participants With Treatment-Emergent AEs and SAEs (All Causalities and Treatment-related) | Title | Percentage of Participants With Treatment-Emergent AEs and SAEs (All Causalities and Treatment-related) | Title | Percentage of Participants With Treatment-Emergent AEs and SAEs (All Causalities and Treatment-related) |
Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | CLr was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau). | Description | CLr was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau). | Description | AUCinf is a measure of the serum concentration of the drug over time. It was used to characterize drug absorption. | Description | AUCinf is a measure of the serum concentration of the drug over time. It was used to characterize drug absorption. | Description | Cmax is maximum observed plasma concentration. | Description | Cmax is maximum observed plasma concentration. | Description | Tmax of metformin administrated with or without PF-04965842. | Description | Tmax of metformin administrated with or without PF-04965842. | Description | AUClast of metformin administrated with or without PF-04965842. | Description | AUClast of metformin administrated with or without PF-04965842. | Description | CL/F is a quantitative measure of the rate at which drug was removed from the blood. | Description | CL/F is a quantitative measure of the rate at which drug was removed from the blood. | Description | Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | Description | Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | Description | t1/2 is the time measured for the plasma concentration to decrease by one half. | Description | t1/2 is the time measured for the plasma concentration to decrease by one half. | Description | Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL is the approximate specific gravity of urine. | Description | Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL is the approximate specific gravity of urine. | Description | Ae% is percent of dose recovered unchanged in urine from 0 to 24 hours post-dose of metformin. | Description | Ae% is percent of dose recovered unchanged in urine from 0 to 24 hours post-dose of metformin. | Description | Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio, large unstained cells/leukocytes and large unstained cells), clinical chemistry (bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate, urobilinogen and glucose -FASTING), urinalysis (specific gravity, pH, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite and leukocytes). Clinical significance of laboratory parameters is determined at the investigator's discretion. | Description | Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio, large unstained cells/leukocytes and large unstained cells), clinical chemistry (bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate, urobilinogen and glucose -FASTING), urinalysis (specific gravity, pH, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite and leukocytes). Clinical significance of laboratory parameters is determined at the investigator's discretion. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Description | AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
Units | Participants | Units | Participants | Units | litre per hour (L/hr) | Units | litre per hour (L/hr) | Units | nanogram*hour per milliliter (ng*hr/mL) | Units | nanogram*hour per milliliter (ng*hr/mL) | Units | nanogram per milliliter (ng/mL) | Units | nanogram per milliliter (ng/mL) | Units | Hours (hrs) | Units | Hours (hrs) | Units | ng*h/mL | Units | ng*h/mL | Units | L/hr | Units | L/hr | Units | liter (L) | Units | liter (L) | Units | hrs | Units | hrs | Units | milligram (mg) | Units | milligram (mg) | Units | percentage of dose | Units | percentage of dose | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | percentage of participants | Units | percentage of participants | Units | percentage of participants | Units | percentage of participants | Units | percentage of participants | Units | percentage of participants | Units | percentage of participants | Units | percentage of participants |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Median | Param Type | Median | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Mean | Param Type | Mean | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number |
Param Value | 0 | Param Value | 0 | Param Value | 32.18 | Param Value | 33.33 | Param Value | 5050 | Param Value | 5202 | Param Value | 634.7 | Param Value | 720.7 | Param Value | 4.00 | Param Value | 4.00 | Param Value | 4849 | Param Value | 5145 | Param Value | 98.97 | Param Value | 96.13 | Param Value | 1087 | Param Value | 1211 | Param Value | 8.318 | Param Value | 9.261 | Param Value | 168.0 | Param Value | 170.5 | Param Value | 33.60 | Param Value | 34.05 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 6 | Param Value | 4 | Param Value | 5 | Param Value | 4 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 50.0 | Param Value | 33.3 | Param Value | 41.7 | Param Value | 33.3 | Param Value | 0.0 | Param Value | 0.0 | Param Value | 0.0 | Param Value | 0.0 |
Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 32.18 | Param Value Num | 33.33 | Param Value Num | 5050.0 | Param Value Num | 5202.0 | Param Value Num | 634.7 | Param Value Num | 720.7 | Param Value Num | 4.0 | Param Value Num | 4.0 | Param Value Num | 4849.0 | Param Value Num | 5145.0 | Param Value Num | 98.97 | Param Value Num | 96.13 | Param Value Num | 1087.0 | Param Value Num | 1211.0 | Param Value Num | 8.318 | Param Value Num | 9.261 | Param Value Num | 168.0 | Param Value Num | 170.5 | Param Value Num | 33.6 | Param Value Num | 34.05 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 6.0 | Param Value Num | 4.0 | Param Value Num | 5.0 | Param Value Num | 4.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 50.0 | Param Value Num | 33.3 | Param Value Num | 41.7 | Param Value Num | 33.3 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 |
Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 39 | Dispersion Value | 28 | Dispersion Value | 16 | Dispersion Value | 19 | Dispersion Value | 14 | Dispersion Value | 20 | Dispersion Value | 18 | Dispersion Value | 18 | Dispersion Value | 16 | Dispersion Value | 19 | Dispersion Value | 42 | Dispersion Value | 37 | Dispersion Value | 4.2508 | Dispersion Value | 3.5165 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 39.0 | Dispersion Value Num | 28.0 | Dispersion Value Num | 16.0 | Dispersion Value Num | 19.0 | Dispersion Value Num | 14.0 | Dispersion Value Num | 20.0 | Dispersion Value Num | 18.0 | Dispersion Value Num | 18.0 | Dispersion Value Num | 16.0 | Dispersion Value Num | 19.0 | Dispersion Value Num | 42.0 | Dispersion Value Num | 37.0 | Dispersion Value Num | 4.2508 | Dispersion Value Num | 3.5165 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Lower Limit | 2.0 | Dispersion Lower Limit | 1.0 | Dispersion Lower Limit | 70.7 | Dispersion Lower Limit | 114.0 | Dispersion Lower Limit | 14.1 | Dispersion Lower Limit | 22.7 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Upper Limit | 4.0 | Dispersion Upper Limit | 4.0 | Dispersion Upper Limit | 210.0 | Dispersion Upper Limit | 248.0 | Dispersion Upper Limit | 42.0 | Dispersion Upper Limit | 49.7 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Study References
Sequence: | 51685542 |
Pmid | 35344588 |
Reference Type | derived |
Citation | Vourvahis M, Byon W, Chang C, Le V, Diehl A, Graham D, Tripathy S, Raha N, Luo L, Mathialagan S, Dowty M, Rodrigues AD, Malhotra B. Evaluation of the Effect of Abrocitinib on Drug Transporters by Integrated Use of Probe Drugs and Endogenous Biomarkers. Clin Pharmacol Ther. 2022 Sep;112(3):665-675. doi: 10.1002/cpt.2594. Epub 2022 May 9. |
Baseline Counts
Sequence: | 11328797 |
Result Group Id | 55879894 |
Ctgov Group Code | BG000 |
Units | Participants |
Scope | overall |
Count | 12 |
Result Groups
Sequence: | 55879894 | Sequence: | 55879895 | Sequence: | 55879896 | Sequence: | 55879897 | Sequence: | 55879898 | Sequence: | 55879899 | Sequence: | 55879900 |
Ctgov Group Code | BG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | All Participants | Title | Metformin Then Metformin + PF-04965842 | Title | Metformin + PF-04965842 Then Metformin | Title | Metformin + PF-04965842 | Title | Metformin | Title | Metformin + PF-04965842 | Title | Metformin |
Description | This reporting group refers to the total 12 participants who were enrolled in the study. | Description | Participants were administered a single oral dose of metformin 500 mg on Day 1 in Period 1 followed by a washout period of at least 4 days. Then in Period 2 participants were administered a single oral dose of metformin 500 mg on Day 1 along with oral doses of PF-04965842 200 mg once daily (QD) for 2 days on Days 1-2. | Description | Participants were administered a single oral dose of metformin 500 mg on Day 1 along with oral doses of PF-04965842 200 mg QD for 2 days on Days 1-2 in Period 1 followed by a washout period of at least 4 days. Then in Period 2 participants were administered a single oral dose of metformin 500 mg on Day 1. | Description | This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods. | Description | This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods. | Description | This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods. | Description | This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods. |
Baseline Measurements
Sequence: | 124996082 | Sequence: | 124996083 | Sequence: | 124996084 | Sequence: | 124996085 | Sequence: | 124996086 | Sequence: | 124996087 | Sequence: | 124996088 | Sequence: | 124996089 | Sequence: | 124996090 | Sequence: | 124996091 | Sequence: | 124996092 | Sequence: | 124996093 | Sequence: | 124996094 |
Result Group Id | 55879894 | Result Group Id | 55879894 | Result Group Id | 55879894 | Result Group Id | 55879894 | Result Group Id | 55879894 | Result Group Id | 55879894 | Result Group Id | 55879894 | Result Group Id | 55879894 | Result Group Id | 55879894 | Result Group Id | 55879894 | Result Group Id | 55879894 | Result Group Id | 55879894 | Result Group Id | 55879894 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 |
Category | Female | Category | Male | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Unknown or Not Reported | Category | American Indian or Alaska Native | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | White | Category | More than one race | Category | Unknown or Not Reported | ||
Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) |
Units | Years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 39.0 | Param Value | 0 | Param Value | 12 | Param Value | 1 | Param Value | 11 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 10 | Param Value | 0 | Param Value | 0 |
Param Value Num | 39.0 | Param Value Num | 0.0 | Param Value Num | 12.0 | Param Value Num | 1.0 | Param Value Num | 11.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 10.0 | Param Value Num | 0.0 | Param Value Num | 0.0 |
Dispersion Type | Standard Deviation | ||||||||||||||||||||||||
Dispersion Value | 8.42 | ||||||||||||||||||||||||
Dispersion Value Num | 8.42 | ||||||||||||||||||||||||
Number Analyzed | 12 | Number Analyzed | 12 | Number Analyzed | 12 | Number Analyzed | 12 | Number Analyzed | 12 | Number Analyzed | 12 | Number Analyzed | 12 | Number Analyzed | 12 | Number Analyzed | 12 | Number Analyzed | 12 | Number Analyzed | 12 | Number Analyzed | 12 | Number Analyzed | 12 |
]]>
https://zephyrnet.com/NCT03796169
2018-12-12
https://zephyrnet.com/?p=NCT03796169
NCT03796169https://www.clinicaltrials.gov/study/NCT03796169?tab=tableNANANAThis study aims to investigate whether the personal characteristics of the endoscopist is associated with effect of interventions for colonoscopy quality improvement.
This is a prospective, 9-month, multicenter, single-blind study. Baseline quality indicators including adenoma detection rate, polyp detection rate, withdrawal time and adenomas per colonoscopy of each endoscopist were measured in the health promotion centers of academic hospitals for 3 months. Follow-up measurements of quality indicators were repeated every 3 months after each interventions (personal notification of quality indicators, open notification of quality indicators, and colonoscopy quality education by a GI faculty. At the end of the study, personal characteristics of each endoscopist was evaluated using fear of negative evaluation scale, cognitive flexibility inventory, and almost perfect scale.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-16 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-09-09 |
Start Month Year | December 12, 2018 |
Primary Completion Month Year | December 12, 2019 |
Verification Month Year | September 2020 |
Verification Date | 2020-09-30 |
Last Update Posted Date | 2020-09-09 |
Detailed Descriptions
Sequence: | 20741058 |
Description | Suboptimal colonoscopy quality is associated with development of interval colorectal cancer and colorectal cancer-related death. It is uncertain how to improve colonoscopy quality effectively. The quality of screening colonoscopy for colorectal cancer depends on the endoscopist who performed the examination. The aim of this study was to investigate the impact of endoscopists' personal characteristics on the quality of colonoscopy and effectiveness of intervention. |
Facilities
Sequence: | 200279951 |
Name | Division of Gastroenterology; Seoul St. Mary's hospital |
City | Seoul |
Zip | 137-701 |
Country | Korea, Republic of |
Conditions
Sequence: | 52221249 | Sequence: | 52221250 |
Name | Colonoscopy | Name | Human Characteristics |
Downcase Name | colonoscopy | Downcase Name | human characteristics |
Id Information
Sequence: | 40195438 |
Id Source | org_study_id |
Id Value | XC15FIMI0020K |
Countries
Sequence: | 42609412 |
Name | Korea, Republic of |
Removed | False |
Design Groups
Sequence: | 55649497 |
Group Type | Experimental |
Title | Endoscopist |
Description | Intervention for personal notification, open notification and colonoscopy quality education by a GI faculty |
Interventions
Sequence: | 52535024 | Sequence: | 52535025 | Sequence: | 52535026 |
Intervention Type | Behavioral | Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Personal notification | Name | Open notification | Name | Education |
Description | Baseline quality indicators of each endoscopist were measured and those were notified individually. | Description | Quality indicators were measured for 3 months after 1st interventions and those were notified openly | Description | Quality indicators were measured for 3 months after 2nd interventions and educated the importance of colonoscopy quality by a GI faculty |
Design Outcomes
Sequence: | 177560372 | Sequence: | 177560373 | Sequence: | 177560374 | Sequence: | 177560375 | Sequence: | 177560376 | Sequence: | 177560377 | Sequence: | 177560378 | Sequence: | 177560379 | Sequence: | 177560380 | Sequence: | 177560381 | Sequence: | 177560382 | Sequence: | 177560383 | Sequence: | 177560384 | Sequence: | 177560385 | Sequence: | 177560386 | Sequence: | 177560387 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Measurement of overall adenoma detection rate | Measure | Measurement of adenoma detection rate after personal notification | Measure | Measurement of adenoma detection rate after open notification | Measure | Measurement of adenoma detection rate after education | Measure | Measurement of overall polyp detection rate | Measure | Measurement of overall withdrawal time | Measure | Measurement of overall adenomas per colonoscopy | Measure | Measurement of polyp detection rate after personal notification | Measure | Measurement of polyp detection rate after open notification | Measure | Measurement of polyp detection rate after education | Measure | Measurement of withdrawal time after personal notification | Measure | Measurement of withdrawal time after open notification | Measure | Measurement of withdrawal time after education | Measure | Measurement of adenomas per colonoscopy after personal notification | Measure | Measurement of adenomas per colonoscopy after open notification | Measure | Measurement of adenomas per colonoscopy after education |
Time Frame | 9 months | Time Frame | 3 months after personal notification | Time Frame | 3 months after open notification | Time Frame | 3 months after education | Time Frame | 9 months | Time Frame | 9 months | Time Frame | 9 months | Time Frame | 3 months after personal notification | Time Frame | 3 months after open notification | Time Frame | 3 months after education | Time Frame | 3 months after personal notification | Time Frame | 3 months after open notification | Time Frame | 3 months after education | Time Frame | 3 months after personal notification | Time Frame | 3 months after open notification | Time Frame | 3 months after education |
Description | Primary outcome measures include overall adenoma detection rate. | Description | Primary outcome measures include adenoma detection rate after personal notification | Description | Primary outcome measures include adenoma detection rate after open notification | Description | Primary outcome measures include adenoma detection rate after education | Description | Secondary outcome measures include overall polyp detection rate. | Description | Secondary outcome measures include overall withdrawal time. | Description | Secondary outcome measures include overall adenomas per colonoscopy. | Description | Primary outcome measures include polyp detection rate after personal notification | Description | Primary outcome measures include polyp detection rate after open notification | Description | Primary outcome measures include polyp detection rate after education | Description | Primary outcome measures include withdrawal time after personal notification | Description | Primary outcome measures include withdrawal time after open notification | Description | Primary outcome measures include withdrawal time after education | Description | Primary outcome measures include adenomas per colonoscopy after personal notification. | Description | Primary outcome measures include adenomas per colonoscopy after open notification | Description | Primary outcome measures include adenoma detection rate after education |
Sponsors
Sequence: | 48366157 | Sequence: | 48366158 | Sequence: | 48366159 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Seoul St. Mary's Hospital | Name | Saint Vincent's Hospital, Korea | Name | Uijeongbu St. Mary Hospital |
Overall Officials
Sequence: | 29312781 |
Role | Principal Investigator |
Name | Bo-In Lee, MD, PhD |
Affiliation | Division of Gastroenterology; Seoul St. Mary's hospital |
Design Group Interventions
Sequence: | 68216954 | Sequence: | 68216955 | Sequence: | 68216956 |
Design Group Id | 55649497 | Design Group Id | 55649497 | Design Group Id | 55649497 |
Intervention Id | 52535024 | Intervention Id | 52535025 | Intervention Id | 52535026 |
Eligibilities
Sequence: | 30794549 |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Highly experienced board-certified gastroenterologists performed colonoscopies in health screening endoscopy centers. Patients for quality indicators of endoscopists routinely perform outpatient screening, surveillance and diagnostic colonoscopy (first-time screening colonoscopies performed and had no previous colonoscopy within 3 years). Exclusion Criteria: endoscopists who refuse to sign the consent Patients for quality indicators of endoscopists Known hereditary polyposis syndrome, Inflammatory bowel disease, those with surgically altered anatomy, undergone previous colonoscopy within 3 years |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254004048 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 12 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 12 |
Designs
Sequence: | 30540589 |
Allocation | N/A |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Screening |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28906909 |
Responsible Party Type | Principal Investigator |
Name | Bo-In Lee |
Title | Professor, MD, PhD |
Affiliation | Seoul St. Mary's Hospital |
Study References
Sequence: | 52117952 | Sequence: | 52117953 | Sequence: | 52117954 |
Pmid | 23295274 | Pmid | 19665583 | Pmid | 26845473 |
Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Coe SG, Crook JE, Diehl NN, Wallace MB. An endoscopic quality improvement program improves detection of colorectal adenomas. Am J Gastroenterol. 2013 Feb;108(2):219-26; quiz 227. doi: 10.1038/ajg.2012.417. Epub 2013 Jan 8. | Citation | Shaukat A, Oancea C, Bond JH, Church TR, Allen JI. Variation in detection of adenomas and polyps by colonoscopy and change over time with a performance improvement program. Clin Gastroenterol Hepatol. 2009 Dec;7(12):1335-40. doi: 10.1016/j.cgh.2009.07.027. Epub 2009 Aug 7. | Citation | Jover R, Zapater P, Bujanda L, Hernandez V, Cubiella J, Pellise M, Ponce M, Ono A, Lanas A, Seoane A, Marin-Gabriel JC, Chaparro M, Cacho G, Herreros-de-Tejada A, Fernandez-Diez S, Peris A, Nicolas-Perez D, Murcia O, Castells A, Quintero E; COLONPREV Study Investigators. Endoscopist characteristics that influence the quality of colonoscopy. Endoscopy. 2016 Mar;48(3):241-7. doi: 10.1055/s-0042-100185. Epub 2016 Feb 4. |
]]>
https://zephyrnet.com/NCT03796156
2019-02-25
https://zephyrnet.com/?p=NCT03796156
NCT03796156https://www.clinicaltrials.gov/study/NCT03796156?tab=tableDiane Stevensondiane.stevenson@nottingham.ac.uk00441158231053This study aims to find out whether people with chronic kidney disease [CKD] should take low dose aspirin to reduce the risk of first heart attack or stroke (cardiovascular disease [CVD]). CKD is common and is associated with an increased risk of CVD.
CVD is caused by small blood clots and aspirin thins the blood to reduce the risk of such clots developing but it also increases the risk of bleeding.
Aspirin is recommended to prevent further CVD in people who have already had a first CVD event (so called secondary prevention). Here the investigators want to study the use of aspirin as primary prevention in people with CKD who have not had a CVD to prevent the first event, to assess whether the potential benefits exceed the risks.
Eligible patients will be recruited from their United Kingdom (UK) general practices and allocated by chance to be prescribed once daily low dose aspirin or usual care only. Follow-up will be for several years both electronically (for general practice, hospital and mortality data) and by annual questionnaires to ascertain CVD and bleeding events.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-20 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-05-23 |
Start Month Year | February 25, 2019 |
Primary Completion Month Year | December 2025 |
Verification Month Year | May 2023 |
Verification Date | 2023-05-31 |
Last Update Posted Date | 2023-05-23 |
Detailed Descriptions
Sequence: | 20779606 |
Description | Aim To test the hypothesis that the addition of 75mg aspirin once daily to usual care reduces the risk of major vascular events in patients with chronic kidney disease (CKD) who do not have pre-existing cardiovascular disease (CVD)
Design Open label, multi-centre randomised controlled trial Setting UK general practices Sample size 25,210 patients (12,605 per arm). A total of 1,827 major vascular events overall are required. Eligibility Inclusion Criteria Males and females aged 18 years and over at the date of screening Exclusion Criteria Subjects with CKD eGFR category 5 Interventions Suitable participants will be randomised to receive: 75mg non-enteric coated or dispersible aspirin once daily in addition to their usual medication; or no additional treatment and avoidance of aspirin. Duration The trial will continue until at least 1,827 adjudicated primary endpoint events (major vascular events) have occurred, or before if the trial is discontinued after the internal pilot or for any other reason. It is anticipated that at least 6 years of recruitment (taking account a recruitment pause for the Covid-19 pandemic) and 2.5 years of follow-up will be required to complete the trial. Randomisation and blinding Eligible participants, based on results of routine blood and urine tests at screening, will be randomised (open label randomisation) 1:1 to general practitioner (GP) prescription of aspirin vs. no prescription, stratified by age, diabetes and CKD severity. Follow-up Data on potential CVD and bleeding outcomes will be collected electronically from GP records and national hospitalisation and mortality records. Adjudication panels (for CVD and for bleeding) will asses the information blind to allocation. Patients will complete an annual quality of life questionnaire (EQ5D). Outcomes. Primary outcome measure Time to first major vascular event from the date of randomisation. A major vascular event is defined as a primary composite outcome of non-fatal myocardial infarction (MI), non-fatal stroke and cardiovascular death (excluding confirmed intracranial haemorrhage and other fatal cardiovascular haemorrhage). Secondary outcome measures (all time to event except quality of life) Efficacy Death from any cause Safety Composite outcome of intracranial haemorrhage (fatal and non-fatal), fatal extracranial haemorrhage and non-fatal major extracranial haemorrhage (adjudicated) Tertiary (exploratory) outcome measures (all time to event except hospitalisation) Transient ischaemic attack Statistical methods The primary outcome measure of time to first major vascular event will be analysed for the intention-to-treat (ITT) population. Deaths from other causes (including fatal bleeding) will be treated as competing events. Patients who do not experience a major vascular event will be censored at the date of last follow-up. All primary, secondary and tertiary time to event outcomes will be described using Kaplan-Meier curves or Cumulative Hazard plots for time to event outcomes involving competing risks for the ITT population. Analyses of time to event outcomes will be performed using Cox proportional hazards models or Competing Risk regression models, both unadjusted and adjusted for stratification factors: age, diabetes and CKD severity. The adjusted Competing Risk regression model for time to first major vascular event, with deaths from other causes (including fatal bleeding) treated as competing events, and patients who do not experience a major vascular event censored, will form the primary endpoint analysis model. Other secondary and tertiary endpoints will be assessed by arm using summary statistics (e.g. Pearson's χ² tests) in the ITT population. The amount of missing data and reasons for the incompleteness will be explored and presented overall i.e. not by group. If the amount of missing data is deemed too high and if appropriate (i.e. assuming the missing data is either missing at random [MAR] or missing completely at random [MCAR] and censoring assumed to be non-informative), multiple imputation will be performed accordingly, for which all covariates included in the multivariable model, together with the censoring/event indicator and the cumulative baseline hazard will be included in the multiple imputation model. Health economic analysis will also be undertaken. |
Facilities
Sequence: | 200584876 |
Status | Recruiting |
Name | Nottingham Digestive Diseases Centre |
City | Nottingham |
Zip | NG72UH |
Country | United Kingdom |
Facility Contacts
Sequence: | 28180480 | Sequence: | 28180481 |
Facility Id | 200584876 | Facility Id | 200584876 |
Contact Type | primary | Contact Type | backup |
Name | Jennifer Dumbleton | Name | Diane Stevenson |
jennifer.dumbleton@nottingham.ac.uk | diane.stevenson@nottingham.ac.uk | ||
Phone | 00441158231053 | Phone | 00441158231053 |
Browse Interventions
Sequence: | 96284055 | Sequence: | 96284056 | Sequence: | 96284057 | Sequence: | 96284058 | Sequence: | 96284059 | Sequence: | 96284060 | Sequence: | 96284061 | Sequence: | 96284062 | Sequence: | 96284063 | Sequence: | 96284064 | Sequence: | 96284065 | Sequence: | 96284066 | Sequence: | 96284067 | Sequence: | 96284068 | Sequence: | 96284069 | Sequence: | 96284070 |
Mesh Term | Aspirin | Mesh Term | Anti-Inflammatory Agents, Non-Steroidal | Mesh Term | Analgesics, Non-Narcotic | Mesh Term | Analgesics | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Anti-Inflammatory Agents | Mesh Term | Antirheumatic Agents | Mesh Term | Fibrinolytic Agents | Mesh Term | Fibrin Modulating Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Platelet Aggregation Inhibitors | Mesh Term | Cyclooxygenase Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Antipyretics |
Downcase Mesh Term | aspirin | Downcase Mesh Term | anti-inflammatory agents, non-steroidal | Downcase Mesh Term | analgesics, non-narcotic | Downcase Mesh Term | analgesics | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | anti-inflammatory agents | Downcase Mesh Term | antirheumatic agents | Downcase Mesh Term | fibrinolytic agents | Downcase Mesh Term | fibrin modulating agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | platelet aggregation inhibitors | Downcase Mesh Term | cyclooxygenase inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | antipyretics |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52319485 | Sequence: | 52319486 | Sequence: | 52319487 |
Name | Chronic Kidney Diseases | Name | Cardiovascular Diseases | Name | Bleeding |
Downcase Name | chronic kidney diseases | Downcase Name | cardiovascular diseases | Downcase Name | bleeding |
Id Information
Sequence: | 40264681 |
Id Source | org_study_id |
Id Value | 31844 |
Countries
Sequence: | 42684032 |
Name | United Kingdom |
Removed | False |
Design Groups
Sequence: | 55758279 | Sequence: | 55758280 |
Group Type | Experimental | Group Type | No Intervention |
Title | Aspirin | Title | Usual care |
Description | 75mg of non enteric coated or dispersible aspirin once daily added to usual medications | Description | Usual medications only |
Interventions
Sequence: | 52630547 |
Intervention Type | Drug |
Name | Aspirin |
Description | 75mg low dose non enteric coated or dispersible |
Design Outcomes
Sequence: | 177927070 | Sequence: | 177927071 | Sequence: | 177927086 | Sequence: | 177927072 | Sequence: | 177927073 | Sequence: | 177927074 | Sequence: | 177927075 | Sequence: | 177927076 | Sequence: | 177927077 | Sequence: | 177927078 | Sequence: | 177927079 | Sequence: | 177927080 | Sequence: | 177927081 | Sequence: | 177927082 | Sequence: | 177927083 | Sequence: | 177927084 | Sequence: | 177927085 | Sequence: | 177927087 | Sequence: | 177927088 | Sequence: | 177927089 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | other | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Number of participants with a Major vascular event: Composite outcome of non-fatal myocardial infarction, non-fatal stroke and cardiovascular death (excluding confirmed intracranial haemorrhage and other fatal cardiovascular haemorrhage) | Measure | Number of participants dying from any cause | Measure | Number of participants with new diagnosis of dementia | Measure | Number of participants with major vascular events plus revascularisation | Measure | Number of participants with Non-fatal myocardial infarction | Measure | Health-related quality of life, mean utility score | Measure | Number of participants with intra-cranial haemorrhage, fatal and non fatal major extra cranial haemorrhage | Measure | Number of participants with Fatal and non-fatal intra-cranial haemorrhage | Measure | Number of participants with Fatal and non-fatal major extra-cranial haemorrhage | Measure | Number of participants with Clinically relevant non major bleeding (hospitalised) | Measure | Number of participants with Non-fatal stroke | Measure | Number of participants with Cardiovascular death | Measure | Number of participants with fatal and non fatal major extra-cranial haemorrhage and clinically relevant non major bleed (if hospitalised) | Measure | Number of participants with transient ischaemic attack | Measure | Number of Unplanned hospitalisations per participant | Measure | Number of participants with new diagnosis of cancer | Measure | Number of participants with CKD progression | Measure | Hospitalisation with heart failure | Measure | Death due to cancer (where cancer is the underlying cause of death) | Measure | Major non traumatic lower limb amputation |
Time Frame | Over average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up | Time Frame | Average 4 years follow-up |
Description | Acute MI defined according to the Third Universal Definition of myocardial infarction (MI).
Acute stroke defined in accordance with the World Health Organization (WHO) definition as "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer, with no apparent cause other than of vascular origin". This excludes cases of primary cerebral tumour, cerebral metastasis, subdural haematoma, post-seizure palsy, brain trauma and TIA. Haemorrhagic stroke (fatal and non-fatal) including intracerebral haemorrhage and SAH which has been confirmed on appropriate imaging is excluded from the primary composite endpoint and included within the secondary endpoints. |
Description | Death from any cause | Description | Coded dementia (ICD, Read) from linked GP and hospital data | Description | Primary outcome plus coronary and non coronary arterial revascularisation. It will include open and percutaneous coronary and non-coronary (including carotid, aortic and limb) procedures (as defined in Office of Population Censuses and Surveys OPCS-4 procedure codes) and will be ascertained from Hospital Episode Statistics (HES) data. | Description | Non-fatal myocardial infarction. Acute MI defined according to the Third Universal Definition of myocardial infarction (MI). | Description | Euroqol EQ-5D utility score derived from 5 states (scoring 1-5) converted to utility values using UK general population set | Description | Intra-cranial haemorrhage includes intracerebral haemorrhage, subarachnoid haemorrhage, subdural haemorrhage, and extradural haemorrhage.
Extra-cranial haemorrhage is: Fatal bleeding, or In particular, to be classified as major, bleeds in a critical area or organ should: Be associated with a symptomatic clinical presentation (not following an incidental finding) |
Description | Fatal and non-fatal intra-cranial haemorrhage as above It comprises primary haemorrhagic stroke(to distinguish from haemorrhagic transformation of ischaemic stroke) ii)other intra-cranial haemorrhage (adjudicated). Intra-cranial haemorrhage will be sub categorised as traumatic and non-traumatic. | Description | Fatal and non-fatal major extra-cranial haemorrhage as above. Categorised as i) upper-gastro-intestinal ii) lower gastro-intestinal iii) sight threatening ocular iv)multiple trauma v) other | Description | Defined in accordance with the International Society on Thrombosis and Haemostasis (ISTH) as any sign or symptom of haemorrhage (e.g. more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria:
• Leading to hospitalisation This definition excludes all minor bleeding episodes that lead to medical evaluation involving direct patient contact. |
Description | Non-fatal stroke excluding confirmed intracranial haemorrhage. Acute stroke defined in accordance with the World Health Organization (WHO) definition as "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer, with no apparent cause other than of vascular origin". This excludes cases of primary cerebral tumour, cerebral metastasis, subdural haematoma, post-seizure palsy, brain trauma and TIA. Haemorrhagic stroke ( including intracerebral haemorrhage and sub-arachnoid haemorrhage) which has been confirmed on appropriate imaging is excluded. | Description | Cardiovascular death (excluding confirmed intracranial haemorrhage and other fatal cardiovascular haemorrhage). | Description | Definitions above | Description | A transient episode of neurological dysfunction caused by focal brain spinal cord or retinal ischemia without acute infarction | Description | Defined as an official admission that is for a duration greater than 24 hours or a minimum of 2 calendar days where exact time of stay is unavailable. | Description | Any new cancer diagnosis excluding non melanotic skin cancer | Description | Defined as at least one of:
>30% fall in eGFR over two years, or |
Description | Coded heart failure (ICD) from hospitalisation data | Description | Below or above knee amputation, coded (ICD) from hospitalisation data |
Browse Conditions
Sequence: | 194051092 | Sequence: | 194051093 | Sequence: | 194051094 | Sequence: | 194051095 | Sequence: | 194051096 | Sequence: | 194051097 | Sequence: | 194051098 | Sequence: | 194051099 | Sequence: | 194051100 | Sequence: | 194051101 | Sequence: | 194051102 | Sequence: | 194051103 |
Mesh Term | Kidney Diseases | Mesh Term | Renal Insufficiency, Chronic | Mesh Term | Cardiovascular Diseases | Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Male Urogenital Diseases | Mesh Term | Renal Insufficiency | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | kidney diseases | Downcase Mesh Term | renal insufficiency, chronic | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | male urogenital diseases | Downcase Mesh Term | renal insufficiency | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48458177 | Sequence: | 48458178 | Sequence: | 48458179 | Sequence: | 48458180 | Sequence: | 48458181 | Sequence: | 48458182 | Sequence: | 48458183 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER_GOV | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | University of Southampton | Name | University of Nottingham | Name | University of Warwick | Name | Nottingham University Hospitals NHS Trust | Name | East Kent Hospitals University NHS Foundation Trust | Name | University of Durham | Name | Epsom and St Helier University Hospitals NHS Trust |
Overall Officials
Sequence: | 29364319 | Sequence: | 29364320 |
Role | Principal Investigator | Role | Principal Investigator |
Name | Hugh Gallagher, MD | Name | Paul Roderick, MD |
Affiliation | Epsom and St Helier University Hospitals NHS Trust | Affiliation | University of Southampton |
Central Contacts
Sequence: | 12045739 | Sequence: | 12045740 |
Contact Type | primary | Contact Type | backup |
Name | Jennifer Dumbleton | Name | Diane Stevenson |
Phone | 00441158231053 | Phone | 00441158231053 |
jennifer.dumbleton@nottingham.ac.uk | diane.stevenson@nottingham.ac.uk | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68349132 |
Design Group Id | 55758279 |
Intervention Id | 52630547 |
Eligibilities
Sequence: | 30851236 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Males and females aged 18 years and over at the date of screening Exclusion Criteria Subjects with CKD GFR category 5 |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254267868 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 11 |
Number Of Other Outcomes To Measure | 8 |
Designs
Sequence: | 30597093 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Single |
Masking Description | Adjudication of outcomes blinded |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28963576 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52223818 | Sequence: | 52223819 |
Pmid | 35449015 | Pmid | 35224730 |
Reference Type | derived | Reference Type | derived |
Citation | Gallagher H, Dumbleton J, Maishman T, Whitehead A, Moore MV, Fuat A, Fitzmaurice D, Henderson RA, Lord J, Griffith KE, Stevens P, Taal MW, Stevenson D, Fraser SD, Lown M, Hawkey CJ, Roderick PJ. Aspirin to target arterial events in chronic kidney disease (ATTACK): study protocol for a multicentre, prospective, randomised, open-label, blinded endpoint, parallel group trial of low-dose aspirin vs. standard care for the primary prevention of cardiovascular disease in people with chronic kidney disease. Trials. 2022 Apr 21;23(1):331. doi: 10.1186/s13063-022-06132-z. | Citation | Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4. |
]]>
https://zephyrnet.com/NCT03796143
2019-01-07
https://zephyrnet.com/?p=NCT03796143
NCT03796143https://www.clinicaltrials.gov/study/NCT03796143?tab=tableNANANAThe goal of this study is to compare the efficacy of acceptance and commitment therapy (ACT) and cognitive behavioral therapy (CBT) for depression in a bibliotherapy format and assess hypothesized mechanisms of change in depression symptomatology, quality of life, and functioning.
This study will test the following hypotheses:
CBT and ACT will both result in decreased depression, distress, and self-stigma associated with depression. Life satisfaction and values progress will increase in both conditions.
CBT will result in greater use of reappraisal than ACT.
ACT will results in greater use of defusion and decreased psychological inflexibility than CBT.
Changes in experiential avoidance and defusion will predict changes in depression in the ACT condition.
Changes in reappraisal will predict changes in depression in the CBT condition.
Participants who are given their choice of treatment will show better adherence and satisfaction in the intervention.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-04-27 |
Start Month Year | January 7, 2019 |
Primary Completion Month Year | August 15, 2020 |
Verification Month Year | April 2021 |
Verification Date | 2021-04-30 |
Last Update Posted Date | 2021-04-27 |
Detailed Descriptions
Sequence: | 20727220 |
Description | The investigators aim to recruit 150 participants for this RCT (50 per treatment condition). This will provided adequate power (0.80) to detect differences between groups of medium effect size (d=0.50). Note that detailed eligibility criteria are listed in the "Eligibility" section. Participants will be recruited via SONA, flyers, online postings, classroom announcements, and through the USU CBS lab website.
All study procedures will be completed online, on a computer/mobile phone. After completing informed consent online through Qualtrics, participants will complete an online baseline survey. Participants will then be randomized to one of three groups: a CBT book, an ACT book, or a choice between the two books. Participants will be asked not to access other self-help books during the study duration. A link will be provided to access the book online along with a 10-week suggested reading schedule. Participants will be asked to complete a midtreatment survey 5 weeks after the beginning of treatment, and a posttreatment survey 10 weeks after the beginning of treatment. A follow-up survey will be sent to participants 3 months after the posttreatment survey. In addition to psychological measures, these surveys will also ask about adherence and use of strategies taught in the book. Researcher contact will involve reminders to complete assessments and weekly reminders of the suggested reading schedule. Participants assigned to the CBT condition will receive a link to access The Cognitive Behavioral Workbook for Depression (Knaus, 2008), based on a psychosocial treatment that has shown effectiveness in reducing depression symptoms (Jiménez, 2012). The primary treatment components in this book are psychoeducation (introducing the cognitive behavioral model of depression), self-assessment worksheets (e.g. identifying depressive thought patterns, separating sensations from appraisals), cognitive restructuring, using metacognition/logic, and avoiding perfectionism. Participants assigned to the ACT condition will receive a link to access The Mindfulness and Acceptance Workbook for Depression (Strosahl & Robinson, 2008), based on a modern cognitive behavioral therapy that combines acceptance and mindfulness methods with values and behavior change methods (Hayes, Strosahl & Wilson, 2011). The primary treatment components in this book are psychoeducation (introducing the ACT model of depression), values and goals, mindfulness, acceptance, defusion, committed action, and "rewriting" inflexible life stories. An additional subset of study participants will be given their choice of the two self-help books described above after completing the baseline assessment. Participants who are randomized to receive their choice of book will be provided a brief description of the contents of each book before making a decision. |
Facilities
Sequence: | 200159519 |
Name | Utah State University |
City | Logan |
State | Utah |
Zip | 84322 |
Country | United States |
Conditions
Sequence: | 52185596 |
Name | Mental Health |
Downcase Name | mental health |
Id Information
Sequence: | 40169143 |
Id Source | org_study_id |
Id Value | 9766 |
Countries
Sequence: | 42580727 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55609235 | Sequence: | 55609236 | Sequence: | 55609237 |
Group Type | Experimental | Group Type | Active Comparator | Group Type | Other |
Title | ACT self-help book condition | Title | CBT self-help book condition | Title | Choice of two self-help books |
Description | Participants in this condition will be asked to read The Mindfulness and Acceptance Workbook for Depression by Strosahl and Robinson (2008), a self-help book based on acceptance and commitment therapy. | Description | Participants in this condition will be asked to read Cognitive Behavioral Workbook for Depression by Knaus (2006), a self-help book based on acceptance and commitment therapy. | Description | Participants in this condition will have the option of receiving either the self-help book by Strosahl and Robinson (2008) or the book by Knaus (2006). |
Interventions
Sequence: | 52499530 | Sequence: | 52499531 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | The Mindfulness and Acceptance Workbook for Depression | Name | The Cognitive Behavioral Workbook for Depression |
Description | Participants assigned to this condition will be asked to read this self-help book over an 8-week period. | Description | Participants assigned to this condition will be asked to read this self-help book over an 8-week period. |
Design Outcomes
Sequence: | 177432376 | Sequence: | 177432377 | Sequence: | 177432378 | Sequence: | 177432379 | Sequence: | 177432380 | Sequence: | 177432381 | Sequence: | 177432382 | Sequence: | 177432383 | Sequence: | 177432384 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other |
Measure | Change in Depression, Anxiety and Stress | Measure | Self-Stigma of Depression Scale (SSDS; Barney, Griffiths, Christensen, & Jorm, 2010) | Measure | Acceptance and Action Questionnaire-II (AAQ-II; Bond et al., 2011) | Measure | Cognitive Fusion Questionnaire (CFQ; Gillanders et al., 2014) | Measure | The Behavioral Activation for Depression Scale (BADS; Kanter, Mulick, Busch, Berlin, & Martell, 2007) | Measure | Automatic Thoughts Questionnaire-Frequency (ATQ-30; Hollon & Kendall, 1980) | Measure | Thought Control Questionnaire-Reappraisal Subscale (TCQ; Wells & Davies, 1994) | Measure | Adherence to self-help book | Measure | Satisfaction with self-help book |
Time Frame | Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment) | Time Frame | Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment) | Time Frame | Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment) | Time Frame | Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment) | Time Frame | Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment) | Time Frame | Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment) | Time Frame | Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment) | Time Frame | Midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline) | Time Frame | Posttreatment (10 weeks after baseline) |
Description | Depression, Anxiety and Stress Scale (DASS) : a self-report measure of depression, anxiety, and stress symptoms. Higher scores indicate higher negative emotional states of depression, anxiety, and stress. This measure assesses each of these symptoms as a distinct subscale. Items are rated on a 4-point scale ranging from 0 "did not apply to me at all" to 3 "applied to me very much, or most of the time." Ranges for depression, anxiety, and stress are 0-28, 0-20, and 0-33, respectively. | Description | The SSDS is a 16-item measure of self-directed stigma about one's own experience of depression and consists of subscales of shame, self-blame, social inadequacy, and help-seeking inhibition. The measure generates four subscales for shame, self-blame, help-seeking inhibition, and feelings of social inadequacy, with higher scores indicating greater presence of these experiences. The subscales are summed to calculate a total score which ranges from 16 to 80, with higher scores indicating greater overall self-stigma. | Description | The AAQ-II is a 10-item measure of psychological inflexibility and experiential avoidance. Items are rated on a 7-point scale ranging from 1 "never true" to 7 "always true." A total score is calculated by reverse coding so that higher scores indicate greater psychological flexibility. | Description | The CFQ is a 7-item measure of cognitive fusion. Items are rated on a 7-point scale, ranging from 1 "never true" to 7 "always true." Total scores range from 7 to 49 with higher scores indicating greater levels of cognitive fusion. | Description | The BADS is a 25-item measure of approach and avoidance behaviors in depression, separated into two subscales. Two additional subscales measure work/school and social impairment due to depressive symptoms. Within each subscale, higher scores indicate greater frequency of these behaviors. | Description | The ATQ is a 30-item measure of the frequency of automatic negative self-statements associated with depression. Items are rated on a 5-point scale, ranging from 1 "not at all" to 5 "all the time," with higher scores indicating a greater frequency of automatic thoughts. | Description | The TCQ-Reappraisal subscale is 6-item measure of cognitive reappraisal of negative thoughts. Items are rated on a 4 point scale ranging from 1 "never" to 4 "almost always" indicating the frequency of cognitive reappraisal of negative thoughts. Total scores range from 6 to 24, with higher scores indicating greater frequency of cognitive reappraisal of negative thoughts. | Description | Participants will be asked to rate their adherence to the exercises in the book with a single question on 7-point scale from "Did all recommended assignments" to "Did no recommended assignments," with higher scores indicating a greater proportion of the assignments were completed. This is adapted from previous studies of self-help adherence (Abramowitz, Moore, Braddock, & Harrington, 2009). | Description | Participants will be asked to rate 7 items evaluating their satisfaction with the self-help book on a 6-point scale from "Strongly disagree" to "Strongly agree." The scale produces a total score ranging from 7 to 42, with higher scores indicating greater satisfaction with the book. These items have been used to evaluate program satisfaction in previous self-help research conducted by our lab (e.g., Levin, Pierce, & Schoendorff, in press). |
Browse Conditions
Sequence: | 193540529 | Sequence: | 193540530 |
Mesh Term | Depression | Mesh Term | Behavioral Symptoms |
Downcase Mesh Term | depression | Downcase Mesh Term | behavioral symptoms |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332420 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Utah State University |
Overall Officials
Sequence: | 29293049 |
Role | Principal Investigator |
Name | Michael Levin, PhD |
Affiliation | Utah State University |
Design Group Interventions
Sequence: | 68168308 | Sequence: | 68168309 | Sequence: | 68168310 | Sequence: | 68168311 |
Design Group Id | 55609235 | Design Group Id | 55609237 | Design Group Id | 55609236 | Design Group Id | 55609237 |
Intervention Id | 52499530 | Intervention Id | 52499530 | Intervention Id | 52499531 | Intervention Id | 52499531 |
Eligibilities
Sequence: | 30773637 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age 18 or older Exclusion Criteria: Below the age of 18 |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952982 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 19 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Number Of Other Outcomes To Measure | 2 |
Designs
Sequence: | 30519768 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Participants will be randomly assigned to one of two active self-help interventions, or their choice of intervention, for the duration of the study. |
Responsible Parties
Sequence: | 28886069 |
Responsible Party Type | Principal Investigator |
Name | Michael Levin |
Title | Associate Professor |
Affiliation | Utah State University |
Study References
Sequence: | 52079078 | Sequence: | 52079079 | Sequence: | 52079080 | Sequence: | 52079081 | Sequence: | 52079082 | Sequence: | 52079083 | Sequence: | 52079084 | Sequence: | 52079085 | Sequence: | 52079086 | Sequence: | 52079087 | Sequence: | 52079088 | Sequence: | 52079089 | Sequence: | 52079090 | Sequence: | 52079091 | Sequence: | 52079092 | Sequence: | 52079093 | Sequence: | 52079094 | Sequence: | 52079095 | Sequence: | 52079096 | Sequence: | 52079097 | Sequence: | 52079098 | Sequence: | 52079099 | Sequence: | 52079100 | Sequence: | 52079101 | Sequence: | 52079102 | Sequence: | 52079103 | Sequence: | 52079104 | Sequence: | 52079105 |
Pmid | 18514614 | Pmid | 20683846 | Pmid | 29224000 | Pmid | 22035996 | Pmid | 21740624 | Pmid | 24411117 | Pmid | 16004657 | Pmid | 26995255 | Pmid | 12813115 | Pmid | 24313693 | Pmid | 25595660 | Pmid | 7726811 | Pmid | 28903117 | Pmid | 17107299 | Pmid | 10576301 | Pmid | 22126636 | Pmid | 10224639 | Pmid | 24000835 | Pmid | 15121346 | Pmid | 7993332 | Pmid | 12377297 | ||||||||||||||
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Abramowitz JS, Moore EL, Braddock AE, Harrington DL. Self-help cognitive-behavioral therapy with minimal therapist contact for social phobia: a controlled trial. J Behav Ther Exp Psychiatry. 2009 Mar;40(1):98-105. doi: 10.1016/j.jbtep.2008.04.004. Epub 2008 Apr 26. | Citation | Barney LJ, Griffiths KM, Christensen H, Jorm AF. The Self-Stigma of Depression Scale (SSDS): development and psychometric evaluation of a new instrument. Int J Methods Psychiatr Res. 2010 Dec;19(4):243-54. doi: 10.1002/mpr.325. | Citation | Beaufort IN, De Weert-Van Oene GH, Buwalda VAJ, de Leeuw JRJ, Goudriaan AE. The Depression, Anxiety and Stress Scale (DASS-21) as a Screener for Depression in Substance Use Disorder Inpatients: A Pilot Study. Eur Addict Res. 2017;23(5):260-268. doi: 10.1159/000485182. Epub 2017 Dec 8. | Citation | Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25. | Citation | Fledderus M, Bohlmeijer ET, Pieterse ME, Schreurs KM. Acceptance and commitment therapy as guided self-help for psychological distress and positive mental health: a randomized controlled trial. Psychol Med. 2012 Mar;42(3):485-95. doi: 10.1017/S0033291711001206. Epub 2011 Jul 11. | Citation | Gillanders DT, Bolderston H, Bond FW, Dempster M, Flaxman PE, Campbell L, Kerr S, Tansey L, Noel P, Ferenbach C, Masley S, Roach L, Lloyd J, May L, Clarke S, Remington B. The development and initial validation of the cognitive fusion questionnaire. Behav Ther. 2014 Jan;45(1):83-101. doi: 10.1016/j.beth.2013.09.001. Epub 2013 Sep 18. | Citation | Hayes, S. C., Strosahl, K. D., & Wilson, K. G. (2011). Acceptance and commitment therapy: The process and practice of mindful change. Guilford Press. | Citation | Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657. | Citation | Hollon, S. D., & Kendall, P. C. (1980). Cognitive self-statements in depression: Development of an automatic thoughts questionnaire. Cognitive Therapy and Research, 4(4), 383-395. | Citation | Jiménez, F. J. R. (2012). Acceptance and commitment therapy versus traditional cognitive behavioral therapy: A systematic review and meta-analysis of current empirical evidence. International Journal of Psychology and Psychological Therapy, 12(3), 333-358. | Citation | Fuhr K, Hautzinger M, Krisch K, Berking M, Ebert DD. Validation of the Behavioral Activation for Depression Scale (BADS)-Psychometric properties of the long and short form. Compr Psychiatry. 2016 Apr;66:209-18. doi: 10.1016/j.comppsych.2016.02.004. Epub 2016 Feb 9. | Citation | Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095. | Citation | Knaus, W. J. (2006). The cognitive behavioral workbook for depression: a step-by-step program. New Harbinger Publications. | Citation | Levin, M. E., Haeger, J., & Cruz, R. A. (2018). Tailoring Acceptance and Commitment Therapy Skill Coaching in the Moment Through Smartphones: Results from a Randomized Controlled Trial. Mindfulness, 1-11. | Citation | Levin ME, Pistorello J, Seeley JR, Hayes SC. Feasibility of a prototype web-based acceptance and commitment therapy prevention program for college students. J Am Coll Health. 2014;62(1):20-30. doi: 10.1080/07448481.2013.843533. | Citation | Lorenzo-Luaces L, German RE, DeRubeis RJ. It's complicated: The relation between cognitive change procedures, cognitive change, and symptom change in cognitive therapy for depression. Clin Psychol Rev. 2015 Nov;41:3-15. doi: 10.1016/j.cpr.2014.12.003. Epub 2014 Dec 24. | Citation | Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u. | Citation | Maslej MM, Bolker BM, Russell MJ, Eaton K, Durisko Z, Hollon SD, Swanson GM, Thomson JA Jr, Mulsant BH, Andrews PW. The Mortality and Myocardial Effects of Antidepressants Are Moderated by Preexisting Cardiovascular Disease: A Meta-Analysis. Psychother Psychosom. 2017;86(5):268-282. doi: 10.1159/000477940. Epub 2017 Sep 14. | Citation | Masuda, A., & Tully, E. C. (2012). The role of mindfulness and psychological flexibility in somatization, depression, anxiety, and general psychological distress in a nonclinical college sample. Journal of Evidence-Based Complementary & Alternative Medicine, 17(1), 66-71. | Citation | Mohr DC, Hart SL, Howard I, Julian L, Vella L, Catledge C, Feldman MD. Barriers to psychotherapy among depressed and nondepressed primary care patients. Ann Behav Med. 2006 Dec;32(3):254-8. doi: 10.1207/s15324796abm3203_12. | Citation | Reynolds M, Wells A. The Thought Control Questionnaire–psychometric properties in a clinical sample, and relationships with PTSD and depression. Psychol Med. 1999 Sep;29(5):1089-99. doi: 10.1017/s003329179900104x. | Citation | Ridgway N, Williams C. Cognitive behavioural therapy self-help for depression: an overview. J Ment Health. 2011 Dec;20(6):593-603. doi: 10.3109/09638237.2011.613956. | Citation | Rokke PD, Tomhave JA, Jocic Z. The role of client choice and target selection in self-management therapy for depression in older adults. Psychol Aging. 1999 Mar;14(1):155-69. doi: 10.1037//0882-7974.14.1.155. | Citation | Strosahl, K. D., & Robinson, P. J. (2008). The mindfulness and acceptance workbook for depression: Using acceptance and commitment therapy to move through depression and create a life worth living. New Harbinger Publications. | Citation | Tompkins KA, Swift JK, Callahan JL. Working with clients by incorporating their preferences. Psychotherapy (Chic). 2013 Sep;50(3):279-83. doi: 10.1037/a0032031. | Citation | van Schaik DJ, Klijn AF, van Hout HP, van Marwijk HW, Beekman AT, de Haan M, van Dyck R. Patients' preferences in the treatment of depressive disorder in primary care. Gen Hosp Psychiatry. 2004 May-Jun;26(3):184-9. doi: 10.1016/j.genhosppsych.2003.12.001. | Citation | Wells A, Davies MI. The Thought Control Questionnaire: a measure of individual differences in the control of unwanted thoughts. Behav Res Ther. 1994 Nov;32(8):871-8. doi: 10.1016/0005-7967(94)90168-6. | Citation | Wing RR, Phelan S, Tate D. The role of adherence in mediating the relationship between depression and health outcomes. J Psychosom Res. 2002 Oct;53(4):877-81. doi: 10.1016/s0022-3999(02)00315-x. |
]]>
https://zephyrnet.com/NCT03796130
2019-12-01
https://zephyrnet.com/?p=NCT03796130
NCT03796130https://www.clinicaltrials.gov/study/NCT03796130?tab=tableEman ElGindy, MD, PhDeman_elgindy2013@hotmail.com01227491143Intamural fibroids (myoma) do exist in some infertile women undergoing IVF treatment. There is controversy whether myomectomy before IVF treatment could improve IVF outcome. This trial will examine whether myomectomy in those patients could improve the results.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-12-16 |
Start Month Year | December 1, 2019 |
Primary Completion Month Year | April 2021 |
Verification Month Year | November 2019 |
Verification Date | 2019-11-30 |
Last Update Posted Date | 2019-12-16 |
Detailed Descriptions
Sequence: | 20716327 |
Description | This study will include women who have intramural myoma ranging from 3-5 cm
The participants will be randomly allocated into two groups. In group (1): myomectomy will be performed before ART In group (2):women will have their trial of ART without myomectomy In group A, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery |
Facilities
Sequence: | 200053454 |
Status | Recruiting |
Name | Mansoura University Hospital |
City | Mansoura |
State | Dakahlia |
Zip | 35111 |
Country | Egypt |
Conditions
Sequence: | 52156572 |
Name | Fibroid Uterus |
Downcase Name | fibroid uterus |
Id Information
Sequence: | 40148258 |
Id Source | org_study_id |
Id Value | H0008 |
Countries
Sequence: | 42557794 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55577974 | Sequence: | 55577975 |
Group Type | Experimental | Group Type | No Intervention |
Title | (A)Myomectomy | Title | (B) No myomectomy |
Description | This study will include women who have intramural myomas ranging from 3-5 cm
The participants will be randomlyallocated intotwo groups. In group (A): myomectomy will be performed before ART In group 1, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery |
Description | This study will include women who have intramural myomas ranging from 3-5 cm
The participants will be randomly allocated into two groups. In group (B):women will have their trial of ART without myomectomy |
Interventions
Sequence: | 52472077 |
Intervention Type | Procedure |
Name | Myomectomy |
Description | This study will include women who have intramural myomas ranging from 3-5 cm
The participants will be randomly allocated into two groups. In group (1): myomectomy will be performed before ART In group (2):women will have their trial of ART without myomectomy In group A, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery |
Design Outcomes
Sequence: | 177328343 | Sequence: | 177328344 | Sequence: | 177328345 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The primary outcome will be ongoing pregnancy rate | Measure | -Implantation rate | Measure | -clinical pregnancy rate |
Time Frame | 3 months after embryo transfer | Time Frame | 15 days after embryo transfer | Time Frame | 5 weeks after embryo transfer |
Description | Pregnancy continued after 12 week gestation per randomised women |
Browse Conditions
Sequence: | 193432307 | Sequence: | 193432308 | Sequence: | 193432309 | Sequence: | 193432310 | Sequence: | 193432311 | Sequence: | 193432312 | Sequence: | 193432313 | Sequence: | 193432314 |
Mesh Term | Leiomyoma | Mesh Term | Myofibroma | Mesh Term | Neoplasms, Muscle Tissue | Mesh Term | Neoplasms, Connective and Soft Tissue | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Neoplasms, Connective Tissue | Mesh Term | Connective Tissue Diseases |
Downcase Mesh Term | leiomyoma | Downcase Mesh Term | myofibroma | Downcase Mesh Term | neoplasms, muscle tissue | Downcase Mesh Term | neoplasms, connective and soft tissue | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | neoplasms, connective tissue | Downcase Mesh Term | connective tissue diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306154 | Sequence: | 48306155 | Sequence: | 48306156 | Sequence: | 48306157 | Sequence: | 48306158 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER_GOV | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Mansoura University | Name | Alexandria University | Name | Zagazig University | Name | Sohag University | Name | Assiut University |
Overall Officials
Sequence: | 29277977 | Sequence: | 29277978 | Sequence: | 29277979 | Sequence: | 29277980 | Sequence: | 29277981 | Sequence: | 29277982 | Sequence: | 29277983 | Sequence: | 29277984 | Sequence: | 29277985 |
Role | Principal Investigator | Role | Study Director | Role | Study Director | Role | Study Director | Role | Study Director | Role | Study Director | Role | Study Chair | Role | Study Director | Role | Study Chair |
Name | Ahmed Gibreel, MD | Name | Mohamed S Abdelhafez, MD | Name | Salah Rasheed, MD | Name | Ahmed Nasr, MD | Name | Hisham A Saleh, MD | Name | Hassan El Maghraby, MD | Name | Eman El Gindy, MD | Name | Hoda Sibai, MD | Name | Hamed Yossef, MD |
Affiliation | Mansoura University | Affiliation | Mansoura University | Affiliation | Sohag University | Affiliation | Assiut Universit | Affiliation | Alexandria University | Affiliation | Alexandria University | Affiliation | Zagazig University | Affiliation | Zagazig University | Affiliation | Mansoura University |
Central Contacts
Sequence: | 12004758 |
Contact Type | primary |
Name | Eman ElGindy, MD, PhD |
Phone | 01227491143 |
eman_elgindy2013@hotmail.com | |
Role | Contact |
Design Group Interventions
Sequence: | 68130948 |
Design Group Id | 55577974 |
Intervention Id | 52472077 |
Eligibilities
Sequence: | 30757398 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 35 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Inclusion criteria: Exclusion Criteria: Exclusion criteria: |
Gender Description | Women |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254228952 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 35 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30503623 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28869901 |
Responsible Party Type | Principal Investigator |
Name | Ahmed Gibreel |
Title | Assistant professor |
Affiliation | Mansoura University |
]]>
https://zephyrnet.com/NCT03796117
2019-01-08
https://zephyrnet.com/?p=NCT03796117
NCT03796117https://www.clinicaltrials.gov/study/NCT03796117?tab=tableNANANALow frequency pulsed current (PC) and medium frequency alternating current (Russian current – RC, 2.5 kHz) have been largely studied due to their clinical use. However, it is not clear which current is the most efficient due to the existente literature conflicts.Therefore, the purpose of this study is to compare the neuromuscular efficiency, evoked torque, current intensity, fatigability and level of discomfort between the PC and the RC in healthy young. The current types will be tested in the same participant by the intervention sequences randomization. On the first, second, third and fourth days, the maximum voluntary isometric contraction (MVIC), the current intensity level, discomfort level, evoked torque, and clinical and neuromuscular efficiency of each current will be evaluated. Anthropometric measurements will also be assessed on the first day. In addition, the current intensity required to produce a torque level of 20% of the MVIC, the current intensity required to generate a torque of 40 Nm and the maximum intensity tolerated by the participant will be evaluated. Three contractions will be recorded in each condition, and the level of discomfort will be assessed during the evoked contractions. Evoked torque will be evaluated at the maximum tolerated intensity level using the isokinetic dynamometer. Clinical and neuromuscular efficiency will be evaluated (1) at the current intensity necessary to evoke 20% MVIC, (2) at the current intensity necessary to generate 40 Nm, and (3) at the maximum tolerated current intensity. On the fifth and sixth days, muscle fatigue induced by the diferente current types will be evaluated. Fatigue will be evaluated with sufficient current intensity to generate 20% of the MVIC. MVIC will be performed before and after the fatigue protocol, and the fatigue will be determined by the relative variation of the MVIC before and after the fatigue protocol. Fatigue will also be evaluated through the evoked torque variation between the first and the last minute of the fatigue protocol, as well as by the total work generated in each protocol. Neuromuscular efficiency will be evaluated before and immediately after the protocol through (1) the ratio between input NMES current intensity and output evoked torque, (2) total work (area under the evoked force by time curves) generated during the fatigue protocol, and (3) by the changes in muscle architecture from rest to evoked contraction at the maximal current intensity.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-24 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-06-10 |
Start Month Year | January 8, 2019 |
Primary Completion Month Year | June 30, 2019 |
Verification Month Year | June 2021 |
Verification Date | 2021-06-30 |
Last Update Posted Date | 2021-06-10 |
Detailed Descriptions
Sequence: | 20735723 |
Description | This study is characterized by a quantitative approach, with a randomized crossover clinical study design, blinded to evaluators and participants. The objective is to compare the neuromuscular and clinical efficiency, evoked torque, current intensity, fatigue and discomfort level between the low frequency biphasic pulsed current (PC) and the median frequency sinusoidal alternating Russian current (RC) in healthy young participants. The effect of the two neuromuscular electrical stimulation (NMES) current types on the cited variables will be evaluated in the same participant, by means of the randomization of the interventions sequences for each participant. The evaluation protocols will be performed by 2 blinded raters for the current type and for the outcome variables. A blinded evaluator to the study will randomize the current type, which will be applied on the different evaluation days, through a lottery using opaque envelopes. A researcher blinded to the study groups will analyze the data. Participants will be blinded to the current type will be receiving. The evaluations will be performed in six days, and a minimum interval of 7 days will be observed between the evaluation days. On the first, second, third and fourth days, characterized as Stage 1, the currents' intensity levels, discomfort level, evoked torque, and neuromuscular and clinical efficiency of each randomized current will be evaluated. On the fifth and sixth days, characterized as Stage 2, the muscle fatigue level induced by the two electrical currents will be evaluated. The first evaluation day will be divided into two phases. Phase 1 corresponds to the initial evaluation, anthropometric data collection and physical activity level evaluation. In Phase 2, the quadriceps femoris motor point will be located with a pen-shaped electrode and a neuromuscular electrical stimulation unit, and the subcutaneous adipose layer thickness covering the motor point will be evaluated by means of ultrasonography. Subsequently, the ultrasound probe will be maintained on the vastus lateralis muscle (VL) to obtain muscle architecture data at rest, during the maximal voluntary isometric contractions (MVICs) and during the evoked contractions. Next, a warming up protocol will be performed and the participants will perform three MVICs at the knee joint angles of 60° and 90° of knee flexion (0° = full knee extension) on the isokinetic dynamometer. Subsequently, the investigators will evaluate (1) the current intensity required to produce a torque equivalent to 20% MVIC, (2) the current intensity required to produce a 40 Nm torque, the maximum current intensity (mA) tolerated by the subject (3) at an angle of 60° of knee flexion, and (4) at 90° of knee flexion. From these evaluations, the investigators will analyze the neuromuscular efficiency (ratio between current intensity and evoked torque). After each NMES test, participants will indicate, on the visual-analog scale, the discomfort level perceived with each NMES current type. Clinical efficiency will be evaluated by the ratio between the discomfort level and the evoked torque in the above-described situations. On the second, third and fourth evaluation day, participants will perform all the evaluations described in Phase 2 of the first evaluation day, but with different configurations of the type of current randomized being applied. On the fifth day, the fatigue protocol will be applied with appropriated parameters according to the randomized current type, and sufficient current intensity to generate 20% of the MVIC. The discomfort level during the fatigue protocol will be recorded immediately after the end of the fatigue test. Participants will conduct three pre- and post-fatigue protocol MVICs in order to assess the fatigue level. For the sixth evaluation day, the same evaluations reported for the fifth day will be carried out, but with the second randomized current. |
Facilities
Sequence: | 200243997 |
Name | Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul |
City | Porto Alegre |
State | Rio Grande Do Sul |
Zip | 90690-200 |
Country | Brazil |
Conditions
Sequence: | 52207926 | Sequence: | 52207927 |
Name | Healthy Young | Name | Electric Stimulation Therapy |
Downcase Name | healthy young | Downcase Name | electric stimulation therapy |
Id Information
Sequence: | 40186055 |
Id Source | org_study_id |
Id Value | 3.064.351 |
Countries
Sequence: | 42599560 |
Name | Brazil |
Removed | False |
Design Groups
Sequence: | 55634528 | Sequence: | 55634529 |
Group Type | Experimental | Group Type | Experimental |
Title | Experimental Group 1: healthy young | Title | Experimental Group 2: healthy young |
Description | Participants receive two interventions (Pulsed Current – PC, or Russian Current – RC) in a specific order, according to randomization. Evoked torque, discomfort level, current intensity, neuromuscular efficiency, clinical efficiency and fatigability level will be evaluated. | Description | Participants receive two interventions (Pulsed Current – PC, or Russian Current – RC) in a specific order, according to randomization. Evoked torque, discomfort level, current intensity, neuromuscular efficiency, clinical efficiency and fatigability level will be evaluated. |
Interventions
Sequence: | 52521945 | Sequence: | 52521946 |
Intervention Type | Device | Intervention Type | Device |
Name | Pulsed current | Name | Russian Current |
Description | For stage 1 of the study, which corresponds to analysis of the evoked torque, evaluation of the discomfort level, current intensity, analysis of neuromuscular efficiency and clinical efficiency, 2 configurations (PC1 and PC2) will be used.
PC1, will be set at a frequency of 100 Hz, phase duration of 1000 microseconds, ON-OFF time of 5s:10s. PC2, will be set at a frequency of 100 Hz, phase duration of 200 microseconds ON-OFF time of 5s:10s. For stage 2 of the study, which corresponds to the analysis of the fatigability level, only the PC1 configuration will be used. |
Description | For stage 1 of the study, which corresponds to analysis of the evoked torque, discomfort level, current intensity, neuromuscular efficiency and clinical efficiency, 2 configurations (RC1 and RC2) will be used.
RC1, will be set to a frequency of 100 Hz, burst duty cycle of 20%, ON-OFF time of 5s:10s. RC2, will be set at a frequency of 100 Hz, burst duty cycle of 50%, ON-OFF time of 5s:10s. For stage 2 of the study, which corresponds to the analysis of the fatigability level, only the RC2 configuration will be used. |
Keywords
Sequence: | 79922731 | Sequence: | 79922732 | Sequence: | 79922733 | Sequence: | 79922734 | Sequence: | 79922735 |
Name | Muscle Strength | Name | Fatigue | Name | Neuromuscular efficiency | Name | Discomfort level | Name | Electric Stimulation |
Downcase Name | muscle strength | Downcase Name | fatigue | Downcase Name | neuromuscular efficiency | Downcase Name | discomfort level | Downcase Name | electric stimulation |
Design Outcomes
Sequence: | 177510733 | Sequence: | 177510726 | Sequence: | 177510727 | Sequence: | 177510728 | Sequence: | 177510729 | Sequence: | 177510730 | Sequence: | 177510731 | Sequence: | 177510732 | Sequence: | 177510734 | Sequence: | 177510735 | Sequence: | 177510736 | Sequence: | 177510737 | Sequence: | 177510738 | Sequence: | 177510739 | Sequence: | 177510740 | Sequence: | 177510741 | Sequence: | 177510742 | Sequence: | 177510743 | Sequence: | 177510744 | Sequence: | 177510745 | Sequence: | 177510746 | Sequence: | 177510747 | Sequence: | 177510748 | Sequence: | 177510749 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Muscular architecture during the fatigue protocol | Measure | Maximum voluntary isometric contraction of the knee extensors | Measure | Knee extensors evoked torque during the tests at submaximal current intensity levels | Measure | Knee extensors evoked torque during the tests at maximal current intensity levels | Measure | Knee extensors evoked torque during the fatigue protocol | Measure | Muscular architecture during the knee extensors maximum voluntary isometric contraction tests | Measure | Muscular architecture during knee extensors evoked torque tests at submaximal current intensity levels | Measure | Muscular architecture during knee extensors evoked torque tests at maximal current intensity levels | Measure | Discomfort level generated by electrical stimulation during evoked torque tests at submaximal current intensity levels | Measure | Discomfort level generated by electrical stimulation during evoked torque tests at maximal current intensity levels | Measure | Discomfort level generated by electrical stimulation during the fatigue protocol | Measure | Current intensity required to evoke knee extensors submaximal torque | Measure | Current intensity required to evoke knee extensors maximal torque | Measure | Neuromuscular efficiency during knee extensors submaximal evoked torque tests | Measure | Neuromuscular efficiency during knee extensors maximal evoked torque tests | Measure | Neuromuscular efficiency during the fatigue protocol | Measure | Clinical efficiency during knee extensors submaximal evoked torque tests | Measure | Clinical efficiency during knee extensors maximal evoked torque tests | Measure | Clinical efficiency during the fatigue protocol | Measure | Muscle Fatigue Index | Measure | Fatigue Index from Evoked Torque | Measure | Total work generated during the fatigue protocol | Measure | Thickness of the subcutaneous fat layer on the motor point | Measure | Level of physical activity |
Time Frame | During 20 minutes of electrical stimulation | Time Frame | 14 minutes | Time Frame | During 90 seconds of electrical stimulation | Time Frame | During 90 seconds of electrical stimulation | Time Frame | During 20 minutes of electrical stimulation | Time Frame | 14 minutes | Time Frame | During 90 seconds of electrical stimulation | Time Frame | During 90 seconds of electrical stimulation | Time Frame | During 90 seconds of electrical stimulation | Time Frame | During 90 seconds of electrical stimulation | Time Frame | During 20 minutes of electrical stimulation | Time Frame | During 90 seconds of electrical stimulation | Time Frame | During 90 seconds of electrical stimulation | Time Frame | During 90 seconds of electrical stimulation | Time Frame | During 90 seconds of electrical stimulation | Time Frame | During 20 minutes of electrical stimulation | Time Frame | During 90 seconds of electrical stimulation | Time Frame | During 90 seconds of electrical stimulation | Time Frame | During 20 minutes of electrical stimulation | Time Frame | During 20 minutes of electrical stimulation | Time Frame | During 20 minutes of electrical stimulation | Time Frame | During 20 minutes of electrical stimulation | Time Frame | It will be evaluated during the first evaluation day. | Time Frame | 8 minutes. It will be evaluated during the first evaluation day |
Description | is an expression used to describe the muscle fibers arrangement within the muscle, and is evaluated by determining the muscle thickness, fascicle pennation angle and fascicle length, which will be assessed by ultrasonography. | Description | is an expression of the muscular strength, and will be evaluated by dynamometry. | Description | is an expression describing the muscular strength generated by electrical stimulation, and will be assessed by dynamometry. | Description | is an expression describing the muscular strength generated by electrical stimulation, and will be assessed by dynamometry. | Description | is an expression describing the muscular strength generated by electrical stimulation, and will be assessed by dynamometry. | Description | is an expression used to describe the muscle fibers arrangement within the muscle, and is evaluated by determining the muscle thickness, fascicle pennation angle and fascicle length, which will be assessed by ultrasonography. | Description | is an expression used to describe the muscle fibers arrangement within the muscle, and is evaluated by determining the muscle thickness, fascicle pennation angle and fascicle length, which will be assessed by ultrasonography. | Description | is an expression used to describe the muscle fibers arrangement within the muscle, and is evaluated by determining the muscle thickness, fascicle pennation angle and fascicle length, which will be assessed by ultrasonography. | Description | Discomfort will be measured with a Visual Analogue Scale (0-100mm), where 0 and 100 mm corresponded to no discomfort and worst perceived discomfort, respectively. | Description | Discomfort will be measured with a Visual Analogue Scale (0-100mm), where 0 and 100 mm corresponded to no discomfort and worst perceived discomfort, respectively. | Description | Discomfort will be measured with a Visual Analogue Scale (0-100mm), where 0 and 100 mm corresponded to no discomfort and worst perceived discomfort, respectively. | Description | Current intensity is defined as the amount or amplitude of electrical current (in milliamperes – mA) required to achieve a specific force, and will be evaluated in the electrical stimulation device. | Description | Current intensity is defined as the amount or amplitude of electrical current (in milliamperes – mA) required to achieve a specific force, and will be evaluated in the electrical stimulation device. | Description | Neuromuscular efficiency of the electrical currents will be evaluated by calculating the current intensity (input parameter or input) by the evoked torque (output parameter) ratio. | Description | Neuromuscular efficiency of the electrical currents will be evaluated by calculating the current intensity (input parameter or input) by the evoked torque (output parameter) ratio. | Description | Neuromuscular efficiency of the electrical currents will be evaluated by calculating the current intensity (input parameter or input) by the evoked torque (output parameter) ratio. | Description | Clinical efficiency of the two electrical currents will be evaluated by calculating the ratio between the evoked torque (output parameter) and the level of discomfort generated. | Description | Clinical efficiency of the two electrical currents will be evaluated by calculating the ratio between the evoked torque (output parameter) and the level of discomfort generated. | Description | Clinical efficiency of the two electrical currents will be evaluated by calculating the ratio between the evoked torque (output parameter) and the level of discomfort generated. | Description | Characterized by the force decrease after the fatigue protocol, it will be evaluated by dynamometry. | Description | Characterized by the decrease of the evoked torque during the fatigue protocol, the fatigue index from evoked torque will be evaluated by dynamometry, and obtained by the analysis of evoked torque curves. | Description | The torque-time integral of the evoked torque curves during the fatigue protocol will be evaluated. The sum of the torque curve integral of all evoked contractions during the fatigue protocol will be calculated to determine the total work evoked by each current during the fatigue protocol. | Description | Corresponds to the amount of subcutaneous adipose tissue and will be evaluated by ultrasonography. | Description | The level of physical activity (PA) of each subject will be assessed by the International Physical Activity Questionnaire (IPAQ).The scores will be assessed by calculating the metabolic equivalents (MET) for each activity level. Walking score will be achieved by the multiplication of 3.3 METs with the total walking duration in minutes in a week. Moderate physical activity scores will be achieved by the multiplication of 4.0 METs with the total moderate physical activity duration in minutes in a week. Vigorous physical activity scores will be achieved by the multiplication of 8.0 METs with the total vigorous physical activity duration in minutes in a week. Total physical activity MET-minutes/week will be obtained through sum of walking, moderate and vigorous MET minutes/week scores. Categorical Score will be classified into three levels of physical activity: low, moderate and high. |
Sponsors
Sequence: | 48353571 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Federal University of Rio Grande do Sul |
Overall Officials
Sequence: | 29305916 |
Role | Principal Investigator |
Name | Marco A Vaz, PhD |
Affiliation | Federal University of Rio Grande do Sul |
Design Group Interventions
Sequence: | 68199020 | Sequence: | 68199021 | Sequence: | 68199022 | Sequence: | 68199023 |
Design Group Id | 55634528 | Design Group Id | 55634529 | Design Group Id | 55634528 | Design Group Id | 55634529 |
Intervention Id | 52521945 | Intervention Id | 52521945 | Intervention Id | 52521946 | Intervention Id | 52521946 |
Eligibilities
Sequence: | 30786796 |
Gender | Male |
Minimum Age | 18 Years |
Maximum Age | 35 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Young male Exclusion Criteria: Health problems (neurological, musculoskeletal impairment), |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253989471 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 5 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 35 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 22 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30532866 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28899160 |
Responsible Party Type | Principal Investigator |
Name | Marco Aurélio Vaz, PhD |
Title | Principal Investigator |
Affiliation | Federal University of Rio Grande do Sul |
Study References
Sequence: | 52102861 |
Pmid | 33561279 |
Reference Type | derived |
Citation | Paz IA, Rigo GT, Sgarioni A, Baroni BM, Frasson VB, Vaz MA. Alternating Current Is More Fatigable Than Pulsed Current in People Who Are Healthy: A Double-Blind, Randomized Crossover Trial. Phys Ther. 2021 Jun 1;101(6):pzab056. doi: 10.1093/ptj/pzab056. |
]]>
https://zephyrnet.com/NCT03796104
2018-01-01
https://zephyrnet.com/?p=NCT03796104
NCT03796104https://www.clinicaltrials.gov/study/NCT03796104?tab=tableJohanna Boulant, CRAjohanna.boulant@chu-lyon.frNAThe aim of this study is to determine if delta-haemolysin production deficiency of Staphylococcus aureus is a marker in favour of chronic infections on implants
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-04-13 |
Start Month Year | January 1, 2018 |
Primary Completion Month Year | December 31, 2018 |
Verification Month Year | April 2023 |
Verification Date | 2023-04-30 |
Last Update Posted Date | 2023-04-13 |
Facilities
Sequence: | 200362608 |
Status | Recruiting |
Name | Hospices Civils de Lyon |
City | Lyon |
Zip | 69004 |
Country | France |
Facility Contacts
Sequence: | 28142683 |
Facility Id | 200362608 |
Contact Type | primary |
Name | Eugenie Mabrut, CRA |
Conditions
Sequence: | 52248625 | Sequence: | 52248626 |
Name | Bone and Joint Infection | Name | Staphylococcus Aureus |
Downcase Name | bone and joint infection | Downcase Name | staphylococcus aureus |
Id Information
Sequence: | 40215171 |
Id Source | org_study_id |
Id Value | 18-333 |
Countries
Sequence: | 42630116 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55680233 | Sequence: | 55680234 |
Title | Deficiency of delta-hemolysine | Title | Presence of delta-hemolysine |
Description | Implant infected by Staphylococcus aureus with delta-haemolysin Production Deficiency | Description | Implant infected by Staphylococcus aureus with delta-haemolysin Production |
Interventions
Sequence: | 52561782 |
Intervention Type | Other |
Name | Delta-haemolysin |
Description | comparison of groups having infection with S. aureus with and without delta-haemolysin Production |
Keywords
Sequence: | 79978437 | Sequence: | 79978438 | Sequence: | 79978439 |
Name | Bone and Joint Infection | Name | Staphylococcus Aureus | Name | chronic infection |
Downcase Name | bone and joint infection | Downcase Name | staphylococcus aureus | Downcase Name | chronic infection |
Design Outcomes
Sequence: | 177662829 | Sequence: | 177662830 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Rate of infection with or witout delta-haemolysin in Staphylococcus Aureus | Measure | Rate of Treatment Failure |
Time Frame | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | Time Frame | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption |
Description | patients, profile of the bacterium, medical and chirurgical treatment, rate. comparison between the 2 groups | Description | Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin. Analyse of risk factor. Comparison between the 2 groups |
Browse Conditions
Sequence: | 193782737 | Sequence: | 193782738 | Sequence: | 193782739 | Sequence: | 193782740 | Sequence: | 193782741 |
Mesh Term | Infections | Mesh Term | Staphylococcal Infections | Mesh Term | Gram-Positive Bacterial Infections | Mesh Term | Bacterial Infections | Mesh Term | Bacterial Infections and Mycoses |
Downcase Mesh Term | infections | Downcase Mesh Term | staphylococcal infections | Downcase Mesh Term | gram-positive bacterial infections | Downcase Mesh Term | bacterial infections | Downcase Mesh Term | bacterial infections and mycoses |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48392095 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Hospices Civils de Lyon |
Overall Officials
Sequence: | 29327533 |
Role | Principal Investigator |
Name | FLORENT VALOUR, Md,PhD |
Affiliation | Hospices Civils de Lyon |
Central Contacts
Sequence: | 12026757 |
Contact Type | primary |
Name | Johanna Boulant, CRA |
johanna.boulant@chu-lyon.fr | |
Role | Contact |
Design Group Interventions
Sequence: | 68253786 | Sequence: | 68253787 |
Design Group Id | 55680233 | Design Group Id | 55680234 |
Intervention Id | 52561782 | Intervention Id | 52561782 |
Eligibilities
Sequence: | 30810633 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 99 Years |
Population | patients having implant infection due to S. aureus treated by DAIR managed at the Lyon Bone and joint infection reference Center between 2006 and 2018 |
Criteria | Inclusion Criteria:
patients having implant infection due to S. aureus treated by DAIR Exclusion Criteria: none |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254039461 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 12 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 99 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30556616 |
Observational Model | Case-Control |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28922997 |
Responsible Party Type | Principal Investigator |
Name | Eugénie MABRUT |
Title | clinical research assistant |
Affiliation | Hospices Civils de Lyon |
]]>
https://zephyrnet.com/NCT03796091
2018-11-18
https://zephyrnet.com/?p=NCT03796091
NCT03796091https://www.clinicaltrials.gov/study/NCT03796091?tab=tableNANANAThe purpose of this clinical trial is to investigate whether symptoms of disordered eating change among participants who complete an intervention. Participants will be randomly assigned to one of three intervention conditions and will undergo assessments of symptoms before, after, and 2 months after each intervention. Investigators are evaluating which interventions are most effective in reducing eating disorder symptoms and disorder-related psychological and cardiac risk factors.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-31 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-12-09 |
Start Month Year | November 18, 2018 |
Primary Completion Month Year | April 15, 2021 |
Verification Month Year | November 2022 |
Verification Date | 2022-11-30 |
Last Update Posted Date | 2022-12-09 |
Results First Posted Date | 2022-12-09 |
Detailed Descriptions
Sequence: | 20667846 |
Description | Assessment Sessions (Preintervention, Postintervention, 2-month follow-up): Participants in all conditions will participate in a series of 3 assessment sessions. Prior to each session, participants will complete online questions assessing eating disorder symptoms and associated psychological risk factors. This process will take approximately 40 minutes. Next participants will report to the laboratory at their scheduled appointment time to have their cardiac function assessed via blood pressure measurements and electrocardiography (EKG or ECG). Participants' height and weight will also be recorded.
Prior to each assessment session, participants should: Complete the online survey (if not completed prior to each laboratory appointment this will need to be completed at the lab appointment) On the day of an assessment session, participants will drive to the assessment location. Participants will receive directions via e-mail prior to each session. During the assessment session, participants will lie down on a laboratory cot for 10 minutes while preparation for electrocardiography (EKG or ECG) occurs. Electrodes will be applied to the chest and torso and lead wires will be attached to the electrodes. Participants' blood pressure will be assessed several times throughout this interval. Next, the experimenter will collect a 5 minute and 30 second recording of participants' cardiovascular data via electrocardiography (ECG or EKG). This data will later be analyzed to examine cardiac function.Next experimenters will assess participants' height and weight. After each assessment session, participants' eating disorder symptoms, psychological risk factors, and cardiac indices will be evaluated by the research team. If the team determines that symptoms or cardiac indices are atypical and indicate a further need for evaluation, the participant will be contacted via both e-mail and phone to be informed results are atypical and the participant will be referred for further evaluation by a medical provider. If the participant is a minor, this information will be provided both to the participant and to the participant's parent and/or the participant's legal guardian. If participants' symptoms or risk factors worsen significantly over the duration of the trial, participants will also be contacted and provided with referral recommendations. All participants will receive a comprehensive symptom report at the end of the trial. Referral resources will be provided again at that time if significant eating disorder symptoms remain. Treatment Conditions: Participants will be randomly assigned to 1 of 3 treatment conditions. Brochure Treatment Condition: Participants randomly assigned to the educational brochure will receive two educational brochures which discuss eating disorder symptoms. The brochures will also include treatment referral information and recommended resources for persons struggling with disordered eating. The brochure will take approximately 10 minutes to read; follow-up with treatment or self-help referral resources is completely voluntary. Group Therapy Treatment Conditions: Participants randomly assigned to one of the two group treatment intervention conditions will complete a 4-week group treatment program with 3-8 other women and 2 trained treatment co-facilitators. For approximately 1 hour each week, participants will meet in this group to complete a series of readings, written activities, and verbal activities designed to reduce disordered eating. During the 4 intervention sessions, participants will be asked to analyze the weight and appearance-related messages received from the media, peers, family, romantic partners, and other sources. Participants will also be asked to record, analyze, and evaluate weight and appearance-related thoughts, emotions, and behaviors. Participants will engage in a variety of exercises designed to evaluate the meaning of thinness in our culture and its personal impact. These exercises are designed to combat the detrimental impact of messages which promote thinness. Other risk factors will also be addressed, depending upon program. Participants may talk about the pressures women receive to focus on appearance. The relationship between these appearance-related pressures and eating disorder symptoms will be explored. Participants will explore the way they compare themselves to others and participate in a series of discussions and activities designed to decrease appearance-based comparisons with others. After the 4-week program is complete, participants in both intervention conditions will continue to work on homework assignments related to the program for a period of 2-months until the final assessment session. |
Facilities
Sequence: | 199503355 |
Name | Cornell College Eating Disorder Institute |
City | Mount Vernon |
State | Iowa |
Zip | 52314 |
Country | United States |
Conditions
Sequence: | 52030689 |
Name | Eating Disorder |
Downcase Name | eating disorder |
Id Information
Sequence: | 40048387 | Sequence: | 40048388 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 1516-105-GRE | Id Value | R15MH113044 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/R15MH113044 |
Countries
Sequence: | 42446005 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55438552 | Sequence: | 55438553 | Sequence: | 55438554 |
Group Type | Active Comparator | Group Type | Active Comparator | Group Type | Active Comparator |
Title | Educational Brochure | Title | Body Project Traditional | Title | Body Project Expanded |
Description | Participants will read an educational brochure from the National Eating Disorder Association and will receive referral resources. | Description | Participants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project group therapy program (Stice & Shaw, 2001). | Description | Participants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project Expanded group therapy program (Green et al., 2017). |
Interventions
Sequence: | 52342940 | Sequence: | 52342941 | Sequence: | 52342942 |
Intervention Type | Behavioral | Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Educational Brochure | Name | Body Project Traditional | Name | Body Project Expanded |
Description | Participants will read an educational brochure from the National Eating Disorders Association and will receive treatment referral resources. | Description | Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Traditional group therapy program (see Stice & Shaw, 2001). | Description | Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Expanded group therapy program (see Green et al., 2017). |
Design Outcomes
Sequence: | 176892915 | Sequence: | 176892916 | Sequence: | 176892917 | Sequence: | 176892918 | Sequence: | 176892919 | Sequence: | 176892920 | Sequence: | 176892921 | Sequence: | 176892922 | Sequence: | 176892923 | Sequence: | 176892924 | Sequence: | 176892925 | Sequence: | 176892926 | Sequence: | 176892927 | Sequence: | 176892928 | Sequence: | 176892929 | Sequence: | 176892930 | Sequence: | 176892931 | Sequence: | 176892932 | Sequence: | 176892933 | Sequence: | 176892934 | Sequence: | 176892935 | Sequence: | 176892936 | Sequence: | 176892937 | Sequence: | 176892938 | Sequence: | 176892939 | Sequence: | 176892940 | Sequence: | 176892941 | Sequence: | 176892942 | Sequence: | 176892943 | Sequence: | 176892944 | Sequence: | 176892945 | Sequence: | 176892946 | Sequence: | 176892947 | Sequence: | 176892948 | Sequence: | 176892949 | Sequence: | 176892950 | Sequence: | 176892951 | Sequence: | 176892952 | Sequence: | 176892953 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Rosenberg Self-Esteem Scale (RSE). | Measure | Rosenberg Self-Esteem Scale (RSE). | Measure | Rosenberg Self-Esteem Scale (RSE). | Measure | Eating Disorder Examination Questionnaire (EDE-Q). | Measure | Eating Disorder Examination Questionnaire (EDE-Q). | Measure | Eating Disorder Examination Questionnaire (EDE-Q). | Measure | Body Shape Questionnaire (BSQ). | Measure | Body Shape Questionnaire (BSQ). | Measure | Body Shape Questionnaire (BSQ). | Measure | Social Comparison Rating Scale (SCRS). | Measure | Social Comparison Rating Scale (SCRS). | Measure | Social Comparison Rating Scale (SCRS). | Measure | Self-Objectification Questionnaire (SOQ) | Measure | Self-Objectification Questionnaire (SOQ) | Measure | Self-Objectification Questionnaire (SOQ) | Measure | Ideal Body Stereotype Scale – Revised. | Measure | Ideal Body Stereotype Scale – Revised. | Measure | Ideal Body Stereotype Scale – Revised. | Measure | State Trait Anxiety Inventory – Form Y. | Measure | State Trait Anxiety Inventory – Form Y. | Measure | State Trait Anxiety Inventory – Form Y. | Measure | Positive and Negative Affect Scale – Positive Affect | Measure | Positive and Negative Affect Scale – Positive Affect | Measure | Positive and Negative Affect Scale – Positive Affect | Measure | Mean R Wave Amplitude | Measure | Mean R Wave Amplitude | Measure | Mean R Wave Amplitude | Measure | QT Interval Length | Measure | QT Interval Length | Measure | QT Interval Length | Measure | Vagal Cardiac Tone – High Frequency Spectral Power | Measure | Vagal Cardiac Tone – High Frequency Spectral Power | Measure | Vagal Cardiac Tone – High Frequency Spectral Power | Measure | Sympathetic Cardiac Tone – Low Frequency High Frequency Spectral Power Ratio | Measure | Sympathetic Cardiac Tone – Low Frequency High Frequency Spectral Power Ratio | Measure | Sympathetic Cardiac Tone – Low Frequency High Frequency Spectral Power Ratio | Measure | Positive and Negative Affect Scale – Negative Affect | Measure | Positive and Negative Affect Scale – Negative Affect | Measure | Positive and Negative Affect Scale – Negative Affect |
Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. |
Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction. | Description | QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec. | Description | QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec. | Description | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Description | High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart. | Description | High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart. | Description | High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. |
Browse Conditions
Sequence: | 192928376 | Sequence: | 192928375 |
Mesh Term | Mental Disorders | Mesh Term | Feeding and Eating Disorders |
Downcase Mesh Term | mental disorders | Downcase Mesh Term | feeding and eating disorders |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list |
Sponsors
Sequence: | 48188116 | Sequence: | 48188117 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Cornell College | Name | National Institute of Mental Health (NIMH) |
Overall Officials
Sequence: | 29204182 |
Role | Principal Investigator |
Name | Melinda A Green, PhD |
Affiliation | Green Counseling Services PLLC |
Design Group Interventions
Sequence: | 67961690 | Sequence: | 67961691 | Sequence: | 67961692 |
Design Group Id | 55438552 | Design Group Id | 55438553 | Design Group Id | 55438554 |
Intervention Id | 52342940 | Intervention Id | 52342941 | Intervention Id | 52342942 |
Eligibilities
Sequence: | 30682906 |
Gender | Female |
Minimum Age | 15 Years |
Maximum Age | 34 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Inclusion Criteria Women Exclusion Criteria: Exclusion Criteria Must get physician clearance to participate if at medically high risk as defined in the protocol |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253884917 |
Number Of Facilities | 1 |
Number Of Sae Subjects | 3 |
Registered In Calendar Year | 2018 |
Actual Duration | 29 |
Were Results Reported | True |
Months To Report Results | 15 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 15 |
Maximum Age Num | 34 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 39 |
Designs
Sequence: | 30429636 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Randomized, controlled clinical trial with 3 treatment interventions |
Milestones
Sequence: | 40895442 | Sequence: | 40895443 | Sequence: | 40895444 | Sequence: | 40895445 | Sequence: | 40895446 | Sequence: | 40895447 | Sequence: | 40895448 | Sequence: | 40895449 | Sequence: | 40895450 |
Result Group Id | 55977669 | Result Group Id | 55977670 | Result Group Id | 55977671 | Result Group Id | 55977669 | Result Group Id | 55977670 | Result Group Id | 55977671 | Result Group Id | 55977669 | Result Group Id | 55977670 | Result Group Id | 55977671 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 |
Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 60 | Count | 60 | Count | 60 | Count | 40 | Count | 38 | Count | 45 | Count | 20 | Count | 22 | Count | 15 |
Participant Flows
Sequence: | 3911191 |
Recruitment Details | Women aged 15-35 displaying subclinical and clinical eating disorder symptoms were recruited from 2 Midwestern cities and 5 surrounding suburban communities from November of 2018 to March of 2021. All participants were treated in accordance with federal guidelines (Title 45, Code of Regulations Part 46) for the treatment of human participants. The research was approved by an Institutional Review Board at the host institution. |
Pre Assignment Details | All participants were screened to ensure inclusion criteria were met. Inclusion criteria specified female participants ages 15-34 (postmenarcheal and premenopausal) who were not pregnant. Participant selection was limited to this group to control for the effects of estrogen on cardiac function and in accordance with previous research which suggests dissonance-based programs are most effective when offered solely to females over the age of 15. |
Outcome Counts
Sequence: | 73775412 | Sequence: | 73775413 | Sequence: | 73775414 | Sequence: | 73775415 | Sequence: | 73775416 | Sequence: | 73775417 | Sequence: | 73775418 | Sequence: | 73775419 | Sequence: | 73775420 | Sequence: | 73775421 | Sequence: | 73775422 | Sequence: | 73775423 | Sequence: | 73775424 | Sequence: | 73775425 | Sequence: | 73775426 | Sequence: | 73775427 | Sequence: | 73775428 | Sequence: | 73775429 | Sequence: | 73775430 | Sequence: | 73775431 | Sequence: | 73775432 | Sequence: | 73775433 | Sequence: | 73775434 | Sequence: | 73775435 | Sequence: | 73775436 | Sequence: | 73775437 | Sequence: | 73775438 | Sequence: | 73775439 | Sequence: | 73775440 | Sequence: | 73775441 | Sequence: | 73775442 | Sequence: | 73775443 | Sequence: | 73775444 | Sequence: | 73775445 | Sequence: | 73775446 | Sequence: | 73775447 | Sequence: | 73775448 | Sequence: | 73775449 | Sequence: | 73775450 | Sequence: | 73775451 | Sequence: | 73775452 | Sequence: | 73775453 | Sequence: | 73775454 | Sequence: | 73775455 | Sequence: | 73775456 | Sequence: | 73775457 | Sequence: | 73775458 | Sequence: | 73775459 | Sequence: | 73775460 | Sequence: | 73775461 | Sequence: | 73775462 | Sequence: | 73775463 | Sequence: | 73775464 | Sequence: | 73775465 | Sequence: | 73775466 | Sequence: | 73775467 | Sequence: | 73775468 | Sequence: | 73775469 | Sequence: | 73775470 | Sequence: | 73775471 | Sequence: | 73775472 | Sequence: | 73775473 | Sequence: | 73775474 | Sequence: | 73775475 | Sequence: | 73775476 | Sequence: | 73775477 | Sequence: | 73775478 | Sequence: | 73775479 | Sequence: | 73775480 | Sequence: | 73775481 | Sequence: | 73775482 | Sequence: | 73775483 | Sequence: | 73775484 | Sequence: | 73775485 | Sequence: | 73775486 | Sequence: | 73775487 | Sequence: | 73775488 | Sequence: | 73775489 | Sequence: | 73775490 | Sequence: | 73775491 | Sequence: | 73775492 | Sequence: | 73775493 | Sequence: | 73775494 | Sequence: | 73775495 | Sequence: | 73775496 | Sequence: | 73775497 | Sequence: | 73775498 | Sequence: | 73775499 | Sequence: | 73775500 | Sequence: | 73775501 | Sequence: | 73775502 | Sequence: | 73775503 | Sequence: | 73775504 | Sequence: | 73775505 | Sequence: | 73775506 | Sequence: | 73775507 | Sequence: | 73775508 | Sequence: | 73775509 | Sequence: | 73775510 | Sequence: | 73775511 | Sequence: | 73775512 | Sequence: | 73775513 | Sequence: | 73775514 | Sequence: | 73775515 | Sequence: | 73775516 | Sequence: | 73775517 | Sequence: | 73775518 | Sequence: | 73775519 | Sequence: | 73775520 | Sequence: | 73775521 | Sequence: | 73775522 | Sequence: | 73775523 | Sequence: | 73775524 | Sequence: | 73775525 | Sequence: | 73775526 | Sequence: | 73775527 | Sequence: | 73775528 |
Outcome Id | 30711145 | Outcome Id | 30711145 | Outcome Id | 30711145 | Outcome Id | 30711146 | Outcome Id | 30711146 | Outcome Id | 30711146 | Outcome Id | 30711147 | Outcome Id | 30711147 | Outcome Id | 30711147 | Outcome Id | 30711148 | Outcome Id | 30711148 | Outcome Id | 30711148 | Outcome Id | 30711149 | Outcome Id | 30711149 | Outcome Id | 30711149 | Outcome Id | 30711150 | Outcome Id | 30711150 | Outcome Id | 30711150 | Outcome Id | 30711151 | Outcome Id | 30711151 | Outcome Id | 30711151 | Outcome Id | 30711152 | Outcome Id | 30711152 | Outcome Id | 30711152 | Outcome Id | 30711153 | Outcome Id | 30711153 | Outcome Id | 30711153 | Outcome Id | 30711154 | Outcome Id | 30711154 | Outcome Id | 30711154 | Outcome Id | 30711155 | Outcome Id | 30711155 | Outcome Id | 30711155 | Outcome Id | 30711156 | Outcome Id | 30711156 | Outcome Id | 30711156 | Outcome Id | 30711157 | Outcome Id | 30711157 | Outcome Id | 30711157 | Outcome Id | 30711158 | Outcome Id | 30711158 | Outcome Id | 30711158 | Outcome Id | 30711159 | Outcome Id | 30711159 | Outcome Id | 30711159 | Outcome Id | 30711160 | Outcome Id | 30711160 | Outcome Id | 30711160 | Outcome Id | 30711161 | Outcome Id | 30711161 | Outcome Id | 30711161 | Outcome Id | 30711162 | Outcome Id | 30711162 | Outcome Id | 30711162 | Outcome Id | 30711163 | Outcome Id | 30711163 | Outcome Id | 30711163 | Outcome Id | 30711164 | Outcome Id | 30711164 | Outcome Id | 30711164 | Outcome Id | 30711165 | Outcome Id | 30711165 | Outcome Id | 30711165 | Outcome Id | 30711166 | Outcome Id | 30711166 | Outcome Id | 30711166 | Outcome Id | 30711167 | Outcome Id | 30711167 | Outcome Id | 30711167 | Outcome Id | 30711168 | Outcome Id | 30711168 | Outcome Id | 30711168 | Outcome Id | 30711169 | Outcome Id | 30711169 | Outcome Id | 30711169 | Outcome Id | 30711170 | Outcome Id | 30711170 | Outcome Id | 30711170 | Outcome Id | 30711171 | Outcome Id | 30711171 | Outcome Id | 30711171 | Outcome Id | 30711172 | Outcome Id | 30711172 | Outcome Id | 30711172 | Outcome Id | 30711173 | Outcome Id | 30711173 | Outcome Id | 30711173 | Outcome Id | 30711174 | Outcome Id | 30711174 | Outcome Id | 30711174 | Outcome Id | 30711175 | Outcome Id | 30711175 | Outcome Id | 30711175 | Outcome Id | 30711176 | Outcome Id | 30711176 | Outcome Id | 30711176 | Outcome Id | 30711177 | Outcome Id | 30711177 | Outcome Id | 30711177 | Outcome Id | 30711178 | Outcome Id | 30711178 | Outcome Id | 30711178 | Outcome Id | 30711179 | Outcome Id | 30711179 | Outcome Id | 30711179 | Outcome Id | 30711180 | Outcome Id | 30711180 | Outcome Id | 30711180 | Outcome Id | 30711181 | Outcome Id | 30711181 | Outcome Id | 30711181 | Outcome Id | 30711182 | Outcome Id | 30711182 | Outcome Id | 30711182 | Outcome Id | 30711183 | Outcome Id | 30711183 | Outcome Id | 30711183 |
Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 | Count | 60 |
Provided Documents
Sequence: | 2573981 | Sequence: | 2573982 | Sequence: | 2573983 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan | Document Type | Informed Consent Form |
Has Protocol | True | Has Protocol | False | Has Protocol | False |
Has Icf | False | Has Icf | False | Has Icf | True |
Has Sap | False | Has Sap | True | Has Sap | False |
Document Date | 2018-05-08 | Document Date | 2018-05-08 | Document Date | 2018-12-08 |
Url | https://ClinicalTrials.gov/ProvidedDocs/91/NCT03796091/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/91/NCT03796091/SAP_001.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/91/NCT03796091/ICF_002.pdf |
Reported Event Totals
Sequence: | 27868729 | Sequence: | 27868730 | Sequence: | 27868731 | Sequence: | 27868732 | Sequence: | 27868733 | Sequence: | 27868734 | Sequence: | 27868735 | Sequence: | 27868736 | Sequence: | 27868737 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 60 | Subjects At Risk | 60 | Subjects At Risk | 60 | Subjects At Risk | 60 | Subjects At Risk | 60 | Subjects At Risk | 60 | Subjects At Risk | 60 | Subjects At Risk | 60 | Subjects At Risk | 60 |
Created At | 2023-08-08 03:32:03.780691 | Created At | 2023-08-08 03:32:03.780691 | Created At | 2023-08-08 03:32:03.780691 | Created At | 2023-08-08 03:32:03.780691 | Created At | 2023-08-08 03:32:03.780691 | Created At | 2023-08-08 03:32:03.780691 | Created At | 2023-08-08 03:32:03.780691 | Created At | 2023-08-08 03:32:03.780691 | Created At | 2023-08-08 03:32:03.780691 |
Updated At | 2023-08-08 03:32:03.780691 | Updated At | 2023-08-08 03:32:03.780691 | Updated At | 2023-08-08 03:32:03.780691 | Updated At | 2023-08-08 03:32:03.780691 | Updated At | 2023-08-08 03:32:03.780691 | Updated At | 2023-08-08 03:32:03.780691 | Updated At | 2023-08-08 03:32:03.780691 | Updated At | 2023-08-08 03:32:03.780691 | Updated At | 2023-08-08 03:32:03.780691 |
Reported Events
Sequence: | 526305423 | Sequence: | 526305424 | Sequence: | 526305425 | Sequence: | 526305426 | Sequence: | 526305427 | Sequence: | 526305428 |
Result Group Id | 55977675 | Result Group Id | 55977676 | Result Group Id | 55977677 | Result Group Id | 55977675 | Result Group Id | 55977676 | Result Group Id | 55977677 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 |
Time Frame | Information regarding adverse events were reported at baseline, postintervention (approximately 4 weeks after treatment initiation) and 2-month follow-up (approximately 8 weeks after treatment conclusion). | Time Frame | Information regarding adverse events were reported at baseline, postintervention (approximately 4 weeks after treatment initiation) and 2-month follow-up (approximately 8 weeks after treatment conclusion). | Time Frame | Information regarding adverse events were reported at baseline, postintervention (approximately 4 weeks after treatment initiation) and 2-month follow-up (approximately 8 weeks after treatment conclusion). | Time Frame | Information regarding adverse events were reported at baseline, postintervention (approximately 4 weeks after treatment initiation) and 2-month follow-up (approximately 8 weeks after treatment conclusion). | Time Frame | Information regarding adverse events were reported at baseline, postintervention (approximately 4 weeks after treatment initiation) and 2-month follow-up (approximately 8 weeks after treatment conclusion). | Time Frame | Information regarding adverse events were reported at baseline, postintervention (approximately 4 weeks after treatment initiation) and 2-month follow-up (approximately 8 weeks after treatment conclusion). |
Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious |
Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 2 |
Subjects At Risk | 60 | Subjects At Risk | 60 | Subjects At Risk | 60 | Subjects At Risk | 60 | Subjects At Risk | 60 | Subjects At Risk | 60 |
Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 2 |
Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders |
Adverse Event Term | Hospitalization | Adverse Event Term | Hospitalization | Adverse Event Term | Hospitalization | Adverse Event Term | Suicidal Ideation | Adverse Event Term | Suicidal Ideation | Adverse Event Term | Suicidal Ideation |
Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 |
Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment |
Responsible Parties
Sequence: | 28796140 |
Responsible Party Type | Principal Investigator |
Name | Dr. Melinda Green |
Title | Principal Investigator |
Affiliation | Cornell College |
Result Agreements
Sequence: | 3841935 |
Pi Employee | No |
Result Contacts
Sequence: | 3841900 |
Organization | Green Counseling Services PLLC |
Name | Dr. Melinda Green |
Phone | 5154508913 |
drgreen@greencounselingservice.com | |
Outcomes
Sequence: | 30711145 | Sequence: | 30711146 | Sequence: | 30711147 | Sequence: | 30711148 | Sequence: | 30711149 | Sequence: | 30711150 | Sequence: | 30711151 | Sequence: | 30711152 | Sequence: | 30711153 | Sequence: | 30711154 | Sequence: | 30711155 | Sequence: | 30711156 | Sequence: | 30711157 | Sequence: | 30711158 | Sequence: | 30711159 | Sequence: | 30711160 | Sequence: | 30711161 | Sequence: | 30711162 | Sequence: | 30711163 | Sequence: | 30711164 | Sequence: | 30711165 | Sequence: | 30711166 | Sequence: | 30711167 | Sequence: | 30711168 | Sequence: | 30711169 | Sequence: | 30711170 | Sequence: | 30711171 | Sequence: | 30711172 | Sequence: | 30711173 | Sequence: | 30711174 | Sequence: | 30711175 | Sequence: | 30711176 | Sequence: | 30711177 | Sequence: | 30711178 | Sequence: | 30711179 | Sequence: | 30711180 | Sequence: | 30711181 | Sequence: | 30711182 | Sequence: | 30711183 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary |
Title | Rosenberg Self-Esteem Scale (RSE). | Title | Rosenberg Self-Esteem Scale (RSE). | Title | Rosenberg Self-Esteem Scale (RSE). | Title | Eating Disorder Examination Questionnaire (EDE-Q). | Title | Eating Disorder Examination Questionnaire (EDE-Q). | Title | Eating Disorder Examination Questionnaire (EDE-Q). | Title | Body Shape Questionnaire (BSQ). | Title | Body Shape Questionnaire (BSQ). | Title | Body Shape Questionnaire (BSQ). | Title | Social Comparison Rating Scale (SCRS). | Title | Social Comparison Rating Scale (SCRS). | Title | Social Comparison Rating Scale (SCRS). | Title | Self-Objectification Questionnaire (SOQ) | Title | Self-Objectification Questionnaire (SOQ) | Title | Self-Objectification Questionnaire (SOQ) | Title | Ideal Body Stereotype Scale – Revised. | Title | Ideal Body Stereotype Scale – Revised. | Title | Ideal Body Stereotype Scale – Revised. | Title | State Trait Anxiety Inventory – Form Y. | Title | State Trait Anxiety Inventory – Form Y. | Title | State Trait Anxiety Inventory – Form Y. | Title | Positive and Negative Affect Scale – Positive Affect | Title | Positive and Negative Affect Scale – Positive Affect | Title | Positive and Negative Affect Scale – Positive Affect | Title | Mean R Wave Amplitude | Title | Mean R Wave Amplitude | Title | Mean R Wave Amplitude | Title | QT Interval Length | Title | QT Interval Length | Title | QT Interval Length | Title | Vagal Cardiac Tone – High Frequency Spectral Power | Title | Vagal Cardiac Tone – High Frequency Spectral Power | Title | Vagal Cardiac Tone – High Frequency Spectral Power | Title | Sympathetic Cardiac Tone – Low Frequency High Frequency Spectral Power Ratio | Title | Sympathetic Cardiac Tone – Low Frequency High Frequency Spectral Power Ratio | Title | Sympathetic Cardiac Tone – Low Frequency High Frequency Spectral Power Ratio | Title | Positive and Negative Affect Scale – Negative Affect | Title | Positive and Negative Affect Scale – Negative Affect | Title | Positive and Negative Affect Scale – Negative Affect |
Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction. | Description | QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec. | Description | QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec. | Description | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Description | High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart. | Description | High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart. | Description | High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. |
Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. | Time Frame | Baseline assessments occurred after screening and prior to the delivery of any interventions. | Time Frame | Postintervention assessments were conducted approximately 4 weeks following the baseline assessment. | Time Frame | Follow-up assessments began approximately 8 weeks after the postintervention assessment. |
Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Population | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. |
Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | millivolts (mV) | Units | millivolts (mV) | Units | millivolts (mV) | Units | msec | Units | msec | Units | msec | Units | Normalized units: HF (watts/Hz) | Units | Normalized units: HF (watts/Hz) | Units | Normalized units: HF (watts/Hz) | Units | ratio: LF (watts/HZ) / HF (watts/Hz) | Units | ratio: LF (watts/HZ) / HF (watts/Hz) | Units | ratio: LF (watts/HZ) / HF (watts/Hz) | Units | units on a scale | Units | units on a scale | Units | units on a scale |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 234886577 | Sequence: | 234886578 | Sequence: | 234886579 | Sequence: | 234886580 | Sequence: | 234886581 | Sequence: | 234886582 | Sequence: | 234886583 | Sequence: | 234886584 | Sequence: | 234886585 | Sequence: | 234886586 | Sequence: | 234886587 | Sequence: | 234886588 | Sequence: | 234886589 | Sequence: | 234886590 | Sequence: | 234886591 | Sequence: | 234886592 | Sequence: | 234886593 | Sequence: | 234886603 | Sequence: | 234886594 | Sequence: | 234886595 | Sequence: | 234886596 | Sequence: | 234886597 | Sequence: | 234886598 | Sequence: | 234886599 | Sequence: | 234886600 | Sequence: | 234886601 | Sequence: | 234886602 | Sequence: | 234886604 | Sequence: | 234886605 | Sequence: | 234886606 | Sequence: | 234886607 | Sequence: | 234886608 | Sequence: | 234886609 | Sequence: | 234886610 | Sequence: | 234886611 | Sequence: | 234886612 | Sequence: | 234886613 | Sequence: | 234886614 | Sequence: | 234886615 | Sequence: | 234886616 | Sequence: | 234886617 | Sequence: | 234886618 | Sequence: | 234886619 | Sequence: | 234886620 | Sequence: | 234886621 | Sequence: | 234886622 | Sequence: | 234886623 | Sequence: | 234886636 | Sequence: | 234886624 | Sequence: | 234886625 | Sequence: | 234886626 | Sequence: | 234886627 | Sequence: | 234886628 | Sequence: | 234886629 | Sequence: | 234886630 | Sequence: | 234886631 | Sequence: | 234886632 | Sequence: | 234886633 | Sequence: | 234886634 | Sequence: | 234886635 | Sequence: | 234886637 | Sequence: | 234886638 | Sequence: | 234886639 | Sequence: | 234886640 | Sequence: | 234886641 | Sequence: | 234886642 | Sequence: | 234886643 | Sequence: | 234886644 | Sequence: | 234886645 | Sequence: | 234886646 | Sequence: | 234886647 | Sequence: | 234886648 | Sequence: | 234886649 | Sequence: | 234886650 | Sequence: | 234886651 | Sequence: | 234886652 | Sequence: | 234886653 | Sequence: | 234886654 | Sequence: | 234886655 | Sequence: | 234886656 | Sequence: | 234886657 | Sequence: | 234886658 | Sequence: | 234886659 | Sequence: | 234886660 | Sequence: | 234886661 | Sequence: | 234886662 | Sequence: | 234886663 | Sequence: | 234886664 | Sequence: | 234886665 | Sequence: | 234886666 | Sequence: | 234886667 | Sequence: | 234886668 | Sequence: | 234886669 | Sequence: | 234886670 | Sequence: | 234886671 | Sequence: | 234886672 | Sequence: | 234886673 | Sequence: | 234886674 | Sequence: | 234886675 | Sequence: | 234886676 | Sequence: | 234886677 | Sequence: | 234886678 | Sequence: | 234886679 | Sequence: | 234886680 | Sequence: | 234886681 | Sequence: | 234886682 | Sequence: | 234886683 | Sequence: | 234886684 | Sequence: | 234886685 | Sequence: | 234886686 | Sequence: | 234886687 | Sequence: | 234886688 | Sequence: | 234886689 | Sequence: | 234886690 | Sequence: | 234886691 | Sequence: | 234886692 | Sequence: | 234886693 |
Outcome Id | 30711145 | Outcome Id | 30711145 | Outcome Id | 30711145 | Outcome Id | 30711146 | Outcome Id | 30711146 | Outcome Id | 30711146 | Outcome Id | 30711147 | Outcome Id | 30711147 | Outcome Id | 30711147 | Outcome Id | 30711148 | Outcome Id | 30711148 | Outcome Id | 30711148 | Outcome Id | 30711149 | Outcome Id | 30711149 | Outcome Id | 30711149 | Outcome Id | 30711150 | Outcome Id | 30711150 | Outcome Id | 30711153 | Outcome Id | 30711150 | Outcome Id | 30711151 | Outcome Id | 30711151 | Outcome Id | 30711151 | Outcome Id | 30711152 | Outcome Id | 30711152 | Outcome Id | 30711152 | Outcome Id | 30711153 | Outcome Id | 30711153 | Outcome Id | 30711154 | Outcome Id | 30711154 | Outcome Id | 30711154 | Outcome Id | 30711155 | Outcome Id | 30711155 | Outcome Id | 30711155 | Outcome Id | 30711156 | Outcome Id | 30711156 | Outcome Id | 30711156 | Outcome Id | 30711157 | Outcome Id | 30711157 | Outcome Id | 30711157 | Outcome Id | 30711158 | Outcome Id | 30711158 | Outcome Id | 30711158 | Outcome Id | 30711159 | Outcome Id | 30711159 | Outcome Id | 30711159 | Outcome Id | 30711160 | Outcome Id | 30711160 | Outcome Id | 30711164 | Outcome Id | 30711160 | Outcome Id | 30711161 | Outcome Id | 30711161 | Outcome Id | 30711161 | Outcome Id | 30711162 | Outcome Id | 30711162 | Outcome Id | 30711162 | Outcome Id | 30711163 | Outcome Id | 30711163 | Outcome Id | 30711163 | Outcome Id | 30711164 | Outcome Id | 30711164 | Outcome Id | 30711165 | Outcome Id | 30711165 | Outcome Id | 30711165 | Outcome Id | 30711166 | Outcome Id | 30711166 | Outcome Id | 30711166 | Outcome Id | 30711167 | Outcome Id | 30711167 | Outcome Id | 30711167 | Outcome Id | 30711168 | Outcome Id | 30711168 | Outcome Id | 30711168 | Outcome Id | 30711169 | Outcome Id | 30711169 | Outcome Id | 30711169 | Outcome Id | 30711170 | Outcome Id | 30711170 | Outcome Id | 30711170 | Outcome Id | 30711171 | Outcome Id | 30711171 | Outcome Id | 30711171 | Outcome Id | 30711172 | Outcome Id | 30711172 | Outcome Id | 30711172 | Outcome Id | 30711173 | Outcome Id | 30711173 | Outcome Id | 30711173 | Outcome Id | 30711174 | Outcome Id | 30711174 | Outcome Id | 30711174 | Outcome Id | 30711175 | Outcome Id | 30711175 | Outcome Id | 30711175 | Outcome Id | 30711176 | Outcome Id | 30711176 | Outcome Id | 30711176 | Outcome Id | 30711177 | Outcome Id | 30711177 | Outcome Id | 30711177 | Outcome Id | 30711178 | Outcome Id | 30711178 | Outcome Id | 30711178 | Outcome Id | 30711179 | Outcome Id | 30711179 | Outcome Id | 30711179 | Outcome Id | 30711180 | Outcome Id | 30711180 | Outcome Id | 30711180 | Outcome Id | 30711181 | Outcome Id | 30711181 | Outcome Id | 30711181 | Outcome Id | 30711182 | Outcome Id | 30711182 | Outcome Id | 30711182 | Outcome Id | 30711183 | Outcome Id | 30711183 | Outcome Id | 30711183 |
Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 | Result Group Id | 55977672 | Result Group Id | 55977673 | Result Group Id | 55977674 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 |
Title | Rosenberg Self-Esteem Scale (RSE). | Title | Rosenberg Self-Esteem Scale (RSE). | Title | Rosenberg Self-Esteem Scale (RSE). | Title | Rosenberg Self-Esteem Scale (RSE). | Title | Rosenberg Self-Esteem Scale (RSE). | Title | Rosenberg Self-Esteem Scale (RSE). | Title | Rosenberg Self-Esteem Scale (RSE). | Title | Rosenberg Self-Esteem Scale (RSE). | Title | Rosenberg Self-Esteem Scale (RSE). | Title | Eating Disorder Examination Questionnaire (EDE-Q). | Title | Eating Disorder Examination Questionnaire (EDE-Q). | Title | Eating Disorder Examination Questionnaire (EDE-Q). | Title | Eating Disorder Examination Questionnaire (EDE-Q). | Title | Eating Disorder Examination Questionnaire (EDE-Q). | Title | Eating Disorder Examination Questionnaire (EDE-Q). | Title | Eating Disorder Examination Questionnaire (EDE-Q). | Title | Eating Disorder Examination Questionnaire (EDE-Q). | Title | Body Shape Questionnaire (BSQ). | Title | Eating Disorder Examination Questionnaire (EDE-Q). | Title | Body Shape Questionnaire (BSQ). | Title | Body Shape Questionnaire (BSQ). | Title | Body Shape Questionnaire (BSQ). | Title | Body Shape Questionnaire (BSQ). | Title | Body Shape Questionnaire (BSQ). | Title | Body Shape Questionnaire (BSQ). | Title | Body Shape Questionnaire (BSQ). | Title | Body Shape Questionnaire (BSQ). | Title | Social Comparison Rating Scale (SCRS). | Title | Social Comparison Rating Scale (SCRS). | Title | Social Comparison Rating Scale (SCRS). | Title | Social Comparison Rating Scale (SCRS). | Title | Social Comparison Rating Scale (SCRS). | Title | Social Comparison Rating Scale (SCRS). | Title | Social Comparison Rating Scale (SCRS). | Title | Social Comparison Rating Scale (SCRS). | Title | Social Comparison Rating Scale (SCRS). | Title | Self-Objectification Questionnaire (SOQ) | Title | Self-Objectification Questionnaire (SOQ) | Title | Self-Objectification Questionnaire (SOQ) | Title | Self-Objectification Questionnaire (SOQ) | Title | Self-Objectification Questionnaire (SOQ) | Title | Self-Objectification Questionnaire (SOQ) | Title | Self-Objectification Questionnaire (SOQ) | Title | Self-Objectification Questionnaire (SOQ) | Title | Self-Objectification Questionnaire (SOQ) | Title | Ideal Body Stereotype Scale – Revised. | Title | Ideal Body Stereotype Scale – Revised. | Title | State Trait Anxiety Inventory – Form Y. | Title | Ideal Body Stereotype Scale – Revised. | Title | Ideal Body Stereotype Scale – Revised. | Title | Ideal Body Stereotype Scale – Revised. | Title | Ideal Body Stereotype Scale – Revised. | Title | Ideal Body Stereotype Scale – Revised. | Title | Ideal Body Stereotype Scale – Revised. | Title | Ideal Body Stereotype Scale – Revised. | Title | State Trait Anxiety Inventory – Form Y. | Title | State Trait Anxiety Inventory – Form Y. | Title | State Trait Anxiety Inventory – Form Y. | Title | State Trait Anxiety Inventory – Form Y. | Title | State Trait Anxiety Inventory – Form Y. | Title | State Trait Anxiety Inventory – Form Y. | Title | State Trait Anxiety Inventory – Form Y. | Title | State Trait Anxiety Inventory – Form Y. | Title | Positive and Negative Affect Scale – Positive Affect | Title | Positive and Negative Affect Scale – Positive Affect | Title | Positive and Negative Affect Scale – Positive Affect | Title | Positive and Negative Affect Scale – Positive Affect | Title | Positive and Negative Affect Scale – Positive Affect | Title | Positive and Negative Affect Scale – Positive Affect | Title | Positive and Negative Affect Scale – Positive Affect | Title | Positive and Negative Affect Scale – Positive Affect | Title | Positive and Negative Affect Scale – Positive Affect | Title | Mean R Wave Amplitude | Title | Mean R Wave Amplitude | Title | Mean R Wave Amplitude | Title | Mean R Wave Amplitude | Title | Mean R Wave Amplitude | Title | Mean R Wave Amplitude | Title | Mean R Wave Amplitude | Title | Mean R Wave Amplitude | Title | Mean R Wave Amplitude | Title | QT Interval Length | Title | QT Interval Length | Title | QT Interval Length | Title | QT Interval Length | Title | QT Interval Length | Title | QT Interval Length | Title | QT Interval Length | Title | QT Interval Length | Title | QT Interval Length | Title | Vagal Cardiac Tone – High Frequency Spectral Power | Title | Vagal Cardiac Tone – High Frequency Spectral Power | Title | Vagal Cardiac Tone – High Frequency Spectral Power | Title | Vagal Cardiac Tone – High Frequency Spectral Power | Title | Vagal Cardiac Tone – High Frequency Spectral Power | Title | Vagal Cardiac Tone – High Frequency Spectral Power | Title | Vagal Cardiac Tone – High Frequency Spectral Power | Title | Vagal Cardiac Tone – High Frequency Spectral Power | Title | Vagal Cardiac Tone – High Frequency Spectral Power | Title | Sympathetic Cardiac Tone – Low Frequency High Frequency Spectral Power Ratio | Title | Sympathetic Cardiac Tone – Low Frequency High Frequency Spectral Power Ratio | Title | Sympathetic Cardiac Tone – Low Frequency High Frequency Spectral Power Ratio | Title | Sympathetic Cardiac Tone – Low Frequency High Frequency Spectral Power Ratio | Title | Sympathetic Cardiac Tone – Low Frequency High Frequency Spectral Power Ratio | Title | Sympathetic Cardiac Tone – Low Frequency High Frequency Spectral Power Ratio | Title | Sympathetic Cardiac Tone – Low Frequency High Frequency Spectral Power Ratio | Title | Sympathetic Cardiac Tone – Low Frequency High Frequency Spectral Power Ratio | Title | Sympathetic Cardiac Tone – Low Frequency High Frequency Spectral Power Ratio | Title | Positive and Negative Affect Scale – Negative Affect | Title | Positive and Negative Affect Scale – Negative Affect | Title | Positive and Negative Affect Scale – Negative Affect | Title | Positive and Negative Affect Scale – Negative Affect | Title | Positive and Negative Affect Scale – Negative Affect | Title | Positive and Negative Affect Scale – Negative Affect | Title | Positive and Negative Affect Scale – Negative Affect | Title | Positive and Negative Affect Scale – Negative Affect | Title | Positive and Negative Affect Scale – Negative Affect |
Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction. | Description | QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec. | Description | QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec. | Description | QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec. | Description | QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec. | Description | QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec. | Description | QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec. | Description | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Description | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Description | Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses. | Description | High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart. | Description | High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart. | Description | High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart. | Description | High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart. | Description | High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart. | Description | High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart. | Description | High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart. | Description | High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart. | Description | High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. |
Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | millivolts (mV) | Units | millivolts (mV) | Units | millivolts (mV) | Units | millivolts (mV) | Units | millivolts (mV) | Units | millivolts (mV) | Units | millivolts (mV) | Units | millivolts (mV) | Units | millivolts (mV) | Units | msec | Units | msec | Units | msec | Units | msec | Units | msec | Units | msec | Units | msec | Units | msec | Units | msec | Units | Normalized units: HF (watts/Hz) | Units | Normalized units: HF (watts/Hz) | Units | Normalized units: HF (watts/Hz) | Units | Normalized units: HF (watts/Hz) | Units | Normalized units: HF (watts/Hz) | Units | Normalized units: HF (watts/Hz) | Units | Normalized units: HF (watts/Hz) | Units | Normalized units: HF (watts/Hz) | Units | Normalized units: HF (watts/Hz) | Units | ratio: LF (watts/HZ) / HF (watts/Hz) | Units | ratio: LF (watts/HZ) / HF (watts/Hz) | Units | ratio: LF (watts/HZ) / HF (watts/Hz) | Units | ratio: LF (watts/HZ) / HF (watts/Hz) | Units | ratio: LF (watts/HZ) / HF (watts/Hz) | Units | ratio: LF (watts/HZ) / HF (watts/Hz) | Units | ratio: LF (watts/HZ) / HF (watts/Hz) | Units | ratio: LF (watts/HZ) / HF (watts/Hz) | Units | ratio: LF (watts/HZ) / HF (watts/Hz) | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 22.71 | Param Value | 22.50 | Param Value | 22.62 | Param Value | 23.55 | Param Value | 25.45 | Param Value | 25.08 | Param Value | 24.55 | Param Value | 25.55 | Param Value | 26.60 | Param Value | 4.25 | Param Value | 3.93 | Param Value | 3.96 | Param Value | 4.17 | Param Value | 2.93 | Param Value | 3.07 | Param Value | 3.74 | Param Value | 2.73 | Param Value | 105.29 | Param Value | 2.78 | Param Value | 139.42 | Param Value | 134.37 | Param Value | 134.73 | Param Value | 137.65 | Param Value | 110.96 | Param Value | 114.50 | Param Value | 129.51 | Param Value | 105.19 | Param Value | 45.59 | Param Value | 43.83 | Param Value | 43.00 | Param Value | 51.02 | Param Value | 51.09 | Param Value | 47.35 | Param Value | 46.28 | Param Value | 53.39 | Param Value | 53.18 | Param Value | 10.13 | Param Value | 7.71 | Param Value | 6.32 | Param Value | 10.40 | Param Value | 6.70 | Param Value | 2.35 | Param Value | 9.80 | Param Value | 2.81 | Param Value | 1.78 | Param Value | 3.81 | Param Value | 3.82 | Param Value | 54.63 | Param Value | 3.76 | Param Value | 3.76 | Param Value | 3.39 | Param Value | 3.60 | Param Value | 3.76 | Param Value | 3.34 | Param Value | 3.46 | Param Value | 58.87 | Param Value | 58.02 | Param Value | 58.70 | Param Value | 57.15 | Param Value | 53.05 | Param Value | 55.63 | Param Value | 51.63 | Param Value | 52.58 | Param Value | 26.35 | Param Value | 25.53 | Param Value | 25.24 | Param Value | 25.54 | Param Value | 28.57 | Param Value | 27.82 | Param Value | 26.60 | Param Value | 27.84 | Param Value | 27.98 | Param Value | 1.27 | Param Value | 1.19 | Param Value | 1.27 | Param Value | 1.32 | Param Value | 1.19 | Param Value | 1.27 | Param Value | 1.26 | Param Value | 1.14 | Param Value | 1.12 | Param Value | .38 | Param Value | .38 | Param Value | .38 | Param Value | .38 | Param Value | .39 | Param Value | .39 | Param Value | .38 | Param Value | .38 | Param Value | .38 | Param Value | 60.08 | Param Value | 57.26 | Param Value | 61.61 | Param Value | 60.15 | Param Value | 60.04 | Param Value | 60.58 | Param Value | 51.65 | Param Value | 56.60 | Param Value | 58.81 | Param Value | 1.02 | Param Value | .99 | Param Value | .72 | Param Value | 1.45 | Param Value | 1.05 | Param Value | .85 | Param Value | 1.54 | Param Value | 1.86 | Param Value | 1.32 | Param Value | 30.15 | Param Value | 29.00 | Param Value | 29.64 | Param Value | 29.63 | Param Value | 25.61 | Param Value | 25.59 | Param Value | 28.50 | Param Value | 24.24 | Param Value | 25.00 |
Param Value Num | 22.71 | Param Value Num | 22.5 | Param Value Num | 22.62 | Param Value Num | 23.55 | Param Value Num | 25.45 | Param Value Num | 25.08 | Param Value Num | 24.55 | Param Value Num | 25.55 | Param Value Num | 26.6 | Param Value Num | 4.25 | Param Value Num | 3.93 | Param Value Num | 3.96 | Param Value Num | 4.17 | Param Value Num | 2.93 | Param Value Num | 3.07 | Param Value Num | 3.74 | Param Value Num | 2.73 | Param Value Num | 105.29 | Param Value Num | 2.78 | Param Value Num | 139.42 | Param Value Num | 134.37 | Param Value Num | 134.73 | Param Value Num | 137.65 | Param Value Num | 110.96 | Param Value Num | 114.5 | Param Value Num | 129.51 | Param Value Num | 105.19 | Param Value Num | 45.59 | Param Value Num | 43.83 | Param Value Num | 43.0 | Param Value Num | 51.02 | Param Value Num | 51.09 | Param Value Num | 47.35 | Param Value Num | 46.28 | Param Value Num | 53.39 | Param Value Num | 53.18 | Param Value Num | 10.13 | Param Value Num | 7.71 | Param Value Num | 6.32 | Param Value Num | 10.4 | Param Value Num | 6.7 | Param Value Num | 2.35 | Param Value Num | 9.8 | Param Value Num | 2.81 | Param Value Num | 1.78 | Param Value Num | 3.81 | Param Value Num | 3.82 | Param Value Num | 54.63 | Param Value Num | 3.76 | Param Value Num | 3.76 | Param Value Num | 3.39 | Param Value Num | 3.6 | Param Value Num | 3.76 | Param Value Num | 3.34 | Param Value Num | 3.46 | Param Value Num | 58.87 | Param Value Num | 58.02 | Param Value Num | 58.7 | Param Value Num | 57.15 | Param Value Num | 53.05 | Param Value Num | 55.63 | Param Value Num | 51.63 | Param Value Num | 52.58 | Param Value Num | 26.35 | Param Value Num | 25.53 | Param Value Num | 25.24 | Param Value Num | 25.54 | Param Value Num | 28.57 | Param Value Num | 27.82 | Param Value Num | 26.6 | Param Value Num | 27.84 | Param Value Num | 27.98 | Param Value Num | 1.27 | Param Value Num | 1.19 | Param Value Num | 1.27 | Param Value Num | 1.32 | Param Value Num | 1.19 | Param Value Num | 1.27 | Param Value Num | 1.26 | Param Value Num | 1.14 | Param Value Num | 1.12 | Param Value Num | 0.38 | Param Value Num | 0.38 | Param Value Num | 0.38 | Param Value Num | 0.38 | Param Value Num | 0.39 | Param Value Num | 0.39 | Param Value Num | 0.38 | Param Value Num | 0.38 | Param Value Num | 0.38 | Param Value Num | 60.08 | Param Value Num | 57.26 | Param Value Num | 61.61 | Param Value Num | 60.15 | Param Value Num | 60.04 | Param Value Num | 60.58 | Param Value Num | 51.65 | Param Value Num | 56.6 | Param Value Num | 58.81 | Param Value Num | 1.02 | Param Value Num | 0.99 | Param Value Num | 0.72 | Param Value Num | 1.45 | Param Value Num | 1.05 | Param Value Num | 0.85 | Param Value Num | 1.54 | Param Value Num | 1.86 | Param Value Num | 1.32 | Param Value Num | 30.15 | Param Value Num | 29.0 | Param Value Num | 29.64 | Param Value Num | 29.63 | Param Value Num | 25.61 | Param Value Num | 25.59 | Param Value Num | 28.5 | Param Value Num | 24.24 | Param Value Num | 25.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Dispersion Value | 4.71 | Dispersion Value | 4.81 | Dispersion Value | 4.07 | Dispersion Value | 4.30 | Dispersion Value | 4.50 | Dispersion Value | 4.57 | Dispersion Value | 4.74 | Dispersion Value | 4.09 | Dispersion Value | 4.48 | Dispersion Value | .8 | Dispersion Value | 1.15 | Dispersion Value | 1.02 | Dispersion Value | .64 | Dispersion Value | 1.20 | Dispersion Value | 1.23 | Dispersion Value | .89 | Dispersion Value | 1.20 | Dispersion Value | 28.28 | Dispersion Value | 1.14 | Dispersion Value | 23.92 | Dispersion Value | 30.15 | Dispersion Value | 28.32 | Dispersion Value | 20.91 | Dispersion Value | 33.39 | Dispersion Value | 30.96 | Dispersion Value | 23.74 | Dispersion Value | 32.23 | Dispersion Value | 17.10 | Dispersion Value | 13.18 | Dispersion Value | 13.80 | Dispersion Value | 16.34 | Dispersion Value | 11.68 | Dispersion Value | 14.82 | Dispersion Value | 17.39 | Dispersion Value | 10.93 | Dispersion Value | 15.88 | Dispersion Value | 9.75 | Dispersion Value | 13.11 | Dispersion Value | 12.46 | Dispersion Value | 9.08 | Dispersion Value | 11.39 | Dispersion Value | 13.65 | Dispersion Value | 8.34 | Dispersion Value | 12.39 | Dispersion Value | 12.61 | Dispersion Value | 0.5 | Dispersion Value | .45 | Dispersion Value | 9.31 | Dispersion Value | .5 | Dispersion Value | 0.47 | Dispersion Value | .69 | Dispersion Value | .54 | Dispersion Value | .52 | Dispersion Value | .59 | Dispersion Value | .40 | Dispersion Value | 8.42 | Dispersion Value | 7.84 | Dispersion Value | 7.90 | Dispersion Value | 7.39 | Dispersion Value | 8.22 | Dispersion Value | 9.45 | Dispersion Value | 7.00 | Dispersion Value | 9.71 | Dispersion Value | 5.76 | Dispersion Value | 7.10 | Dispersion Value | 6.46 | Dispersion Value | 6.36 | Dispersion Value | 5.64 | Dispersion Value | 6.69 | Dispersion Value | 6.44 | Dispersion Value | 5.85 | Dispersion Value | 5.26 | Dispersion Value | .36 | Dispersion Value | .31 | Dispersion Value | .36 | Dispersion Value | .32 | Dispersion Value | .24 | Dispersion Value | .36 | Dispersion Value | .31 | Dispersion Value | .26 | Dispersion Value | .26 | Dispersion Value | .02 | Dispersion Value | .02 | Dispersion Value | .02 | Dispersion Value | .02 | Dispersion Value | .01 | Dispersion Value | .01 | Dispersion Value | .02 | Dispersion Value | .01 | Dispersion Value | .01 | Dispersion Value | 19.56 | Dispersion Value | 19.78 | Dispersion Value | 5.87 | Dispersion Value | 21.20 | Dispersion Value | 23.46 | Dispersion Value | 17.52 | Dispersion Value | 20.56 | Dispersion Value | 22.83 | Dispersion Value | 19.68 | Dispersion Value | 1.55 | Dispersion Value | .84 | Dispersion Value | .53 | Dispersion Value | 3.51 | Dispersion Value | 1.17 | Dispersion Value | 1.02 | Dispersion Value | 1.99 | Dispersion Value | 4.64 | Dispersion Value | 2.84 | Dispersion Value | 7.46 | Dispersion Value | 6.88 | Dispersion Value | 6.60 | Dispersion Value | 6.67 | Dispersion Value | 6.99 | Dispersion Value | 6.89 | Dispersion Value | 7.96 | Dispersion Value | 6.24 | Dispersion Value | 5.82 |
Dispersion Value Num | 4.71 | Dispersion Value Num | 4.81 | Dispersion Value Num | 4.07 | Dispersion Value Num | 4.3 | Dispersion Value Num | 4.5 | Dispersion Value Num | 4.57 | Dispersion Value Num | 4.74 | Dispersion Value Num | 4.09 | Dispersion Value Num | 4.48 | Dispersion Value Num | 0.8 | Dispersion Value Num | 1.15 | Dispersion Value Num | 1.02 | Dispersion Value Num | 0.64 | Dispersion Value Num | 1.2 | Dispersion Value Num | 1.23 | Dispersion Value Num | 0.89 | Dispersion Value Num | 1.2 | Dispersion Value Num | 28.28 | Dispersion Value Num | 1.14 | Dispersion Value Num | 23.92 | Dispersion Value Num | 30.15 | Dispersion Value Num | 28.32 | Dispersion Value Num | 20.91 | Dispersion Value Num | 33.39 | Dispersion Value Num | 30.96 | Dispersion Value Num | 23.74 | Dispersion Value Num | 32.23 | Dispersion Value Num | 17.1 | Dispersion Value Num | 13.18 | Dispersion Value Num | 13.8 | Dispersion Value Num | 16.34 | Dispersion Value Num | 11.68 | Dispersion Value Num | 14.82 | Dispersion Value Num | 17.39 | Dispersion Value Num | 10.93 | Dispersion Value Num | 15.88 | Dispersion Value Num | 9.75 | Dispersion Value Num | 13.11 | Dispersion Value Num | 12.46 | Dispersion Value Num | 9.08 | Dispersion Value Num | 11.39 | Dispersion Value Num | 13.65 | Dispersion Value Num | 8.34 | Dispersion Value Num | 12.39 | Dispersion Value Num | 12.61 | Dispersion Value Num | 0.5 | Dispersion Value Num | 0.45 | Dispersion Value Num | 9.31 | Dispersion Value Num | 0.5 | Dispersion Value Num | 0.47 | Dispersion Value Num | 0.69 | Dispersion Value Num | 0.54 | Dispersion Value Num | 0.52 | Dispersion Value Num | 0.59 | Dispersion Value Num | 0.4 | Dispersion Value Num | 8.42 | Dispersion Value Num | 7.84 | Dispersion Value Num | 7.9 | Dispersion Value Num | 7.39 | Dispersion Value Num | 8.22 | Dispersion Value Num | 9.45 | Dispersion Value Num | 7.0 | Dispersion Value Num | 9.71 | Dispersion Value Num | 5.76 | Dispersion Value Num | 7.1 | Dispersion Value Num | 6.46 | Dispersion Value Num | 6.36 | Dispersion Value Num | 5.64 | Dispersion Value Num | 6.69 | Dispersion Value Num | 6.44 | Dispersion Value Num | 5.85 | Dispersion Value Num | 5.26 | Dispersion Value Num | 0.36 | Dispersion Value Num | 0.31 | Dispersion Value Num | 0.36 | Dispersion Value Num | 0.32 | Dispersion Value Num | 0.24 | Dispersion Value Num | 0.36 | Dispersion Value Num | 0.31 | Dispersion Value Num | 0.26 | Dispersion Value Num | 0.26 | Dispersion Value Num | 0.02 | Dispersion Value Num | 0.02 | Dispersion Value Num | 0.02 | Dispersion Value Num | 0.02 | Dispersion Value Num | 0.01 | Dispersion Value Num | 0.01 | Dispersion Value Num | 0.02 | Dispersion Value Num | 0.01 | Dispersion Value Num | 0.01 | Dispersion Value Num | 19.56 | Dispersion Value Num | 19.78 | Dispersion Value Num | 5.87 | Dispersion Value Num | 21.2 | Dispersion Value Num | 23.46 | Dispersion Value Num | 17.52 | Dispersion Value Num | 20.56 | Dispersion Value Num | 22.83 | Dispersion Value Num | 19.68 | Dispersion Value Num | 1.55 | Dispersion Value Num | 0.84 | Dispersion Value Num | 0.53 | Dispersion Value Num | 3.51 | Dispersion Value Num | 1.17 | Dispersion Value Num | 1.02 | Dispersion Value Num | 1.99 | Dispersion Value Num | 4.64 | Dispersion Value Num | 2.84 | Dispersion Value Num | 7.46 | Dispersion Value Num | 6.88 | Dispersion Value Num | 6.6 | Dispersion Value Num | 6.67 | Dispersion Value Num | 6.99 | Dispersion Value Num | 6.89 | Dispersion Value Num | 7.96 | Dispersion Value Num | 6.24 | Dispersion Value Num | 5.82 |
Baseline Counts
Sequence: | 11353580 | Sequence: | 11353581 | Sequence: | 11353582 | Sequence: | 11353583 |
Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 |
Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall | Scope | overall |
Count | 49 | Count | 51 | Count | 50 | Count | 150 |
Result Groups
Sequence: | 55977665 | Sequence: | 55977666 | Sequence: | 55977667 | Sequence: | 55977668 | Sequence: | 55977669 | Sequence: | 55977670 | Sequence: | 55977671 | Sequence: | 55977672 | Sequence: | 55977673 | Sequence: | 55977674 | Sequence: | 55977675 | Sequence: | 55977676 | Sequence: | 55977677 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event |
Title | Educational Brochure | Title | Body Project Traditional | Title | Body Project Expanded | Title | Total | Title | Educational Brochure | Title | Body Project Traditional | Title | Body Project Expanded | Title | Educational Brochure | Title | Body Project Traditional | Title | Body Project Expanded | Title | Educational Brochure | Title | Body Project Traditional | Title | Body Project Expanded |
Description | Participants will read an educational brochure from the National Eating Disorder Association and will receive referral resources.
Educational Brochure: Participants will read an educational brochure from the National Eating Disorders Association and will receive treatment referral resources. |
Description | Participants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project group therapy program (Stice & Shaw, 2001).
Body Project Traditional: Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Traditional group therapy program (see Stice & Shaw, 2001). |
Description | Participants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project Expanded group therapy program (Green et al., 2017).
Body Project Expanded: Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Expanded group therapy program (see Green et al., 2017). |
Description | Total of all reporting groups | Description | Participants will read an educational brochure from the National Eating Disorder Association and will receive referral resources.
Educational Brochure: Participants will read an educational brochure from the National Eating Disorders Association and will receive treatment referral resources. |
Description | Participants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project group therapy program (Stice & Shaw, 2001).
Body Project Traditional: Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Traditional group therapy program (see Stice & Shaw, 2001). |
Description | Participants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project Expanded group therapy program (Green et al., 2017).
Body Project Expanded: Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Expanded group therapy program (see Green et al., 2017). |
Description | Participants will read an educational brochure from the National Eating Disorder Association and will receive referral resources.
Educational Brochure: Participants will read an educational brochure from the National Eating Disorders Association and will receive treatment referral resources. |
Description | Participants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project group therapy program (Stice & Shaw, 2001).
Body Project Traditional: Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Traditional group therapy program (see Stice & Shaw, 2001). |
Description | Participants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project Expanded group therapy program (Green et al., 2017).
Body Project Expanded: Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Expanded group therapy program (see Green et al., 2017). |
Description | Participants will read an educational brochure from the National Eating Disorder Association and will receive referral resources.
Educational Brochure: Participants will read an educational brochure from the National Eating Disorders Association and will receive treatment referral resources. |
Description | Participants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project group therapy program (Stice & Shaw, 2001).
Body Project Traditional: Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Traditional group therapy program (see Stice & Shaw, 2001). |
Description | Participants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project Expanded group therapy program (Green et al., 2017).
Body Project Expanded: Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Expanded group therapy program (see Green et al., 2017). |
Baseline Measurements
Sequence: | 125269444 | Sequence: | 125269434 | Sequence: | 125269435 | Sequence: | 125269436 | Sequence: | 125269437 | Sequence: | 125269438 | Sequence: | 125269439 | Sequence: | 125269440 | Sequence: | 125269441 | Sequence: | 125269442 | Sequence: | 125269443 | Sequence: | 125269445 | Sequence: | 125269446 | Sequence: | 125269447 | Sequence: | 125269448 | Sequence: | 125269449 | Sequence: | 125269450 | Sequence: | 125269451 | Sequence: | 125269452 | Sequence: | 125269453 | Sequence: | 125269454 | Sequence: | 125269455 | Sequence: | 125269456 | Sequence: | 125269457 | Sequence: | 125269458 | Sequence: | 125269459 | Sequence: | 125269460 | Sequence: | 125269461 | Sequence: | 125269462 | Sequence: | 125269463 | Sequence: | 125269464 | Sequence: | 125269465 | Sequence: | 125269466 | Sequence: | 125269467 | Sequence: | 125269468 | Sequence: | 125269469 | Sequence: | 125269470 | Sequence: | 125269471 | Sequence: | 125269472 | Sequence: | 125269473 | Sequence: | 125269474 | Sequence: | 125269475 | Sequence: | 125269476 | Sequence: | 125269477 | Sequence: | 125269478 | Sequence: | 125269479 | Sequence: | 125269480 | Sequence: | 125269481 | Sequence: | 125269482 | Sequence: | 125269483 | Sequence: | 125269484 | Sequence: | 125269485 | Sequence: | 125269486 | Sequence: | 125269487 | Sequence: | 125269488 | Sequence: | 125269489 | Sequence: | 125269490 | Sequence: | 125269491 | Sequence: | 125269492 | Sequence: | 125269493 | Sequence: | 125269494 | Sequence: | 125269495 | Sequence: | 125269496 | Sequence: | 125269497 | Sequence: | 125269498 | Sequence: | 125269499 | Sequence: | 125269500 | Sequence: | 125269501 | Sequence: | 125269502 | Sequence: | 125269503 | Sequence: | 125269504 | Sequence: | 125269505 | Sequence: | 125269506 | Sequence: | 125269507 | Sequence: | 125269508 | Sequence: | 125269509 | Sequence: | 125269510 | Sequence: | 125269511 | Sequence: | 125269512 | Sequence: | 125269513 | Sequence: | 125269514 | Sequence: | 125269515 | Sequence: | 125269516 | Sequence: | 125269517 | Sequence: | 125269518 | Sequence: | 125269519 | Sequence: | 125269520 | Sequence: | 125269521 | Sequence: | 125269522 | Sequence: | 125269523 | Sequence: | 125269524 | Sequence: | 125269525 | Sequence: | 125269526 | Sequence: | 125269527 | Sequence: | 125269528 | Sequence: | 125269529 |
Result Group Id | 55977667 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 | Result Group Id | 55977665 | Result Group Id | 55977666 | Result Group Id | 55977667 | Result Group Id | 55977668 |
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Classification | United States | Classification | United States | Classification | United States | Classification | United States | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Category | Male | Category | Female | Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | White | Category | White | Category | White | Category | White | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Title | Sex: Female, Male | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Region of Enrollment | Title | Region of Enrollment | Title | Region of Enrollment | Title | Region of Enrollment | Title | Rosenberg Self-Esteem Scale | Title | Rosenberg Self-Esteem Scale | Title | Rosenberg Self-Esteem Scale | Title | Rosenberg Self-Esteem Scale | Title | Eating Disorder Examination Questionnaire | Title | Eating Disorder Examination Questionnaire | Title | Eating Disorder Examination Questionnaire | Title | Eating Disorder Examination Questionnaire | Title | Body Shape Questionnaire | Title | Body Shape Questionnaire | Title | Body Shape Questionnaire | Title | Body Shape Questionnaire | Title | Social Comparison Rating Scale | Title | Social Comparison Rating Scale | Title | Social Comparison Rating Scale | Title | Social Comparison Rating Scale | Title | Self-Objectification Questionnaire | Title | Self-Objectification Questionnaire | Title | Self-Objectification Questionnaire | Title | Self-Objectification Questionnaire | Title | Ideal Body Stereotype Scale Revised | Title | Ideal Body Stereotype Scale Revised | Title | Ideal Body Stereotype Scale Revised | Title | Ideal Body Stereotype Scale Revised | Title | State Trait Anxiety Inventory Form Y | Title | State Trait Anxiety Inventory Form Y | Title | State Trait Anxiety Inventory Form Y | Title | State Trait Anxiety Inventory Form Y | Title | Positive and Negative Affect Scale – Positive Affect | Title | Positive and Negative Affect Scale – Positive Affect | Title | Positive and Negative Affect Scale – Positive Affect | Title | Positive and Negative Affect Scale – Positive Affect | Title | Mean R Wave Amplitude | Title | Mean R Wave Amplitude | Title | Mean R Wave Amplitude | Title | Mean R Wave Amplitude | Title | QTc Prolongation | Title | QTc Prolongation | Title | QTc Prolongation | Title | QTc Prolongation | Title | Positive and Negative Affect Scale – Negative Affect | Title | Positive and Negative Affect Scale – Negative Affect | Title | Positive and Negative Affect Scale – Negative Affect | Title | Positive and Negative Affect Scale – Negative Affect | Title | Vagal Cardiac Tone – High Frequency Spectral Power | Title | Vagal Cardiac Tone – High Frequency Spectral Power | Title | Vagal Cardiac Tone – High Frequency Spectral Power | Title | Vagal Cardiac Tone – High Frequency Spectral Power | Title | Sympathetic Cardiac Tone – Low Frequency/High Frequency Spectral Power Ratio | Title | Sympathetic Cardiac Tone – Low Frequency/High Frequency Spectral Power Ratio | Title | Sympathetic Cardiac Tone – Low Frequency/High Frequency Spectral Power Ratio | Title | Sympathetic Cardiac Tone – Low Frequency/High Frequency Spectral Power Ratio |
Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction. | Description | The Social Comparison Rating Scale (SCRS is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Social Comparison Rating Scale (SCRS is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Social Comparison Rating Scale (SCRS is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Social Comparison Rating Scale (SCRS is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The Ideal Body Stereotype Scale – Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. | Description | Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. | Description | QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. | Description | QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. | Description | QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. | Description | QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect. | Description | Vagal tone was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. | Description | Vagal tone was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. | Description | Vagal tone was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. | Description | Vagal tone was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | Description | Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Units | Participants | Units | years | Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | mV | Units | mV | Units | mV | Units | mV | Units | msec | Units | msec | Units | msec | Units | msec | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | Normalized units: HF (watts/Hz) | Units | Normalized units: HF (watts/Hz) | Units | Normalized units: HF (watts/Hz) | Units | Normalized units: HF (watts/Hz) | Units | ratio: LF (watts/HZ) / HF (watts/Hz) | Units | ratio: LF (watts/HZ) / HF (watts/Hz) | Units | ratio: LF (watts/HZ) / HF (watts/Hz) | Units | ratio: LF (watts/HZ) / HF (watts/Hz) |
Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 0 | Param Value | 22.48 | Param Value | 23.95 | Param Value | 21.73 | Param Value | 22.75 | Param Value | 49 | Param Value | 51 | Param Value | 50 | Param Value | 150 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 2 | Param Value | 0 | Param Value | 2 | Param Value | 1 | Param Value | 3 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 2 | Param Value | 6 | Param Value | 10 | Param Value | 42 | Param Value | 42 | Param Value | 38 | Param Value | 122 | Param Value | 4 | Param Value | 3 | Param Value | 1 | Param Value | 8 | Param Value | 1 | Param Value | 1 | Param Value | 3 | Param Value | 5 | Param Value | 49 | Param Value | 51 | Param Value | 50 | Param Value | 150 | Param Value | 22.71 | Param Value | 22.50 | Param Value | 22.62 | Param Value | 22.61 | Param Value | 4.25 | Param Value | 3.93 | Param Value | 3.96 | Param Value | 4.04 | Param Value | 139.42 | Param Value | 134.37 | Param Value | 134.73 | Param Value | 136.17 | Param Value | 45.59 | Param Value | 43.83 | Param Value | 43.00 | Param Value | 44.15 | Param Value | 10.13 | Param Value | 7.71 | Param Value | 6.32 | Param Value | 8.07 | Param Value | 3.81 | Param Value | 3.82 | Param Value | 3.76 | Param Value | 3.79 | Param Value | 58.87 | Param Value | 58.02 | Param Value | 58.70 | Param Value | 58.52 | Param Value | 26.35 | Param Value | 25.53 | Param Value | 25.24 | Param Value | 25.71 | Param Value | 1.27 | Param Value | 1.19 | Param Value | 1.24 | Param Value | 1.23 | Param Value | .38 | Param Value | .38 | Param Value | .38 | Param Value | .38 | Param Value | 30.15 | Param Value | 29.00 | Param Value | 29.64 | Param Value | 29.59 | Param Value | 60.08 | Param Value | 57.26 | Param Value | 61.61 | Param Value | 58.51 | Param Value | 1.02 | Param Value | .99 | Param Value | .72 | Param Value | .91 |
Param Value Num | 0.0 | Param Value Num | 22.48 | Param Value Num | 23.95 | Param Value Num | 21.73 | Param Value Num | 22.75 | Param Value Num | 49.0 | Param Value Num | 51.0 | Param Value Num | 50.0 | Param Value Num | 150.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 6.0 | Param Value Num | 10.0 | Param Value Num | 42.0 | Param Value Num | 42.0 | Param Value Num | 38.0 | Param Value Num | 122.0 | Param Value Num | 4.0 | Param Value Num | 3.0 | Param Value Num | 1.0 | Param Value Num | 8.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 5.0 | Param Value Num | 49.0 | Param Value Num | 51.0 | Param Value Num | 50.0 | Param Value Num | 150.0 | Param Value Num | 22.71 | Param Value Num | 22.5 | Param Value Num | 22.62 | Param Value Num | 22.61 | Param Value Num | 4.25 | Param Value Num | 3.93 | Param Value Num | 3.96 | Param Value Num | 4.04 | Param Value Num | 139.42 | Param Value Num | 134.37 | Param Value Num | 134.73 | Param Value Num | 136.17 | Param Value Num | 45.59 | Param Value Num | 43.83 | Param Value Num | 43.0 | Param Value Num | 44.15 | Param Value Num | 10.13 | Param Value Num | 7.71 | Param Value Num | 6.32 | Param Value Num | 8.07 | Param Value Num | 3.81 | Param Value Num | 3.82 | Param Value Num | 3.76 | Param Value Num | 3.79 | Param Value Num | 58.87 | Param Value Num | 58.02 | Param Value Num | 58.7 | Param Value Num | 58.52 | Param Value Num | 26.35 | Param Value Num | 25.53 | Param Value Num | 25.24 | Param Value Num | 25.71 | Param Value Num | 1.27 | Param Value Num | 1.19 | Param Value Num | 1.24 | Param Value Num | 1.23 | Param Value Num | 0.38 | Param Value Num | 0.38 | Param Value Num | 0.38 | Param Value Num | 0.38 | Param Value Num | 30.15 | Param Value Num | 29.0 | Param Value Num | 29.64 | Param Value Num | 29.59 | Param Value Num | 60.08 | Param Value Num | 57.26 | Param Value Num | 61.61 | Param Value Num | 58.51 | Param Value Num | 1.02 | Param Value Num | 0.99 | Param Value Num | 0.72 | Param Value Num | 0.91 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 3.63 | Dispersion Value | 5.73 | Dispersion Value | 4.08 | Dispersion Value | 4.65 | Dispersion Value | 4.71 | Dispersion Value | 4.81 | Dispersion Value | 4.07 | Dispersion Value | 4.53 | Dispersion Value | 0.8 | Dispersion Value | 1.15 | Dispersion Value | 1.02 | Dispersion Value | 1.00 | Dispersion Value | 23.92 | Dispersion Value | 30.15 | Dispersion Value | 28.32 | Dispersion Value | 27.55 | Dispersion Value | 17.10 | Dispersion Value | 13.18 | Dispersion Value | 13.80 | Dispersion Value | 14.75 | Dispersion Value | 9.75 | Dispersion Value | 13.11 | Dispersion Value | 12.46 | Dispersion Value | 11.91 | Dispersion Value | 0.5 | Dispersion Value | .45 | Dispersion Value | 0.5 | Dispersion Value | .48 | Dispersion Value | 8.42 | Dispersion Value | 7.84 | Dispersion Value | 7.90 | Dispersion Value | 7.84 | Dispersion Value | 5.76 | Dispersion Value | 7.10 | Dispersion Value | 6.46 | Dispersion Value | 6.45 | Dispersion Value | .36 | Dispersion Value | .31 | Dispersion Value | .37 | Dispersion Value | .35 | Dispersion Value | .02 | Dispersion Value | .02 | Dispersion Value | .02 | Dispersion Value | .02 | Dispersion Value | 7.46 | Dispersion Value | 6.88 | Dispersion Value | 6.60 | Dispersion Value | 6.97 | Dispersion Value | 19.56 | Dispersion Value | 19.78 | Dispersion Value | 5.87 | Dispersion Value | 16.90 | Dispersion Value | 1.55 | Dispersion Value | .84 | Dispersion Value | .53 | Dispersion Value | 1.18 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 3.63 | Dispersion Value Num | 5.73 | Dispersion Value Num | 4.08 | Dispersion Value Num | 4.65 | Dispersion Value Num | 4.71 | Dispersion Value Num | 4.81 | Dispersion Value Num | 4.07 | Dispersion Value Num | 4.53 | Dispersion Value Num | 0.8 | Dispersion Value Num | 1.15 | Dispersion Value Num | 1.02 | Dispersion Value Num | 1.0 | Dispersion Value Num | 23.92 | Dispersion Value Num | 30.15 | Dispersion Value Num | 28.32 | Dispersion Value Num | 27.55 | Dispersion Value Num | 17.1 | Dispersion Value Num | 13.18 | Dispersion Value Num | 13.8 | Dispersion Value Num | 14.75 | Dispersion Value Num | 9.75 | Dispersion Value Num | 13.11 | Dispersion Value Num | 12.46 | Dispersion Value Num | 11.91 | Dispersion Value Num | 0.5 | Dispersion Value Num | 0.45 | Dispersion Value Num | 0.5 | Dispersion Value Num | 0.48 | Dispersion Value Num | 8.42 | Dispersion Value Num | 7.84 | Dispersion Value Num | 7.9 | Dispersion Value Num | 7.84 | Dispersion Value Num | 5.76 | Dispersion Value Num | 7.1 | Dispersion Value Num | 6.46 | Dispersion Value Num | 6.45 | Dispersion Value Num | 0.36 | Dispersion Value Num | 0.31 | Dispersion Value Num | 0.37 | Dispersion Value Num | 0.35 | Dispersion Value Num | 0.02 | Dispersion Value Num | 0.02 | Dispersion Value Num | 0.02 | Dispersion Value Num | 0.02 | Dispersion Value Num | 7.46 | Dispersion Value Num | 6.88 | Dispersion Value Num | 6.6 | Dispersion Value Num | 6.97 | Dispersion Value Num | 19.56 | Dispersion Value Num | 19.78 | Dispersion Value Num | 5.87 | Dispersion Value Num | 16.9 | Dispersion Value Num | 1.55 | Dispersion Value Num | 0.84 | Dispersion Value Num | 0.53 | Dispersion Value Num | 1.18 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 50 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 | Number Analyzed | 49 | Number Analyzed | 51 | Number Analyzed | 50 | Number Analyzed | 150 |
Ipd Information Types
Sequence: | 3325504 | Sequence: | 3325505 | Sequence: | 3325506 | Sequence: | 3325507 | Sequence: | 3325508 |
Name | Study Protocol | Name | Statistical Analysis Plan (SAP) | Name | Informed Consent Form (ICF) | Name | Clinical Study Report (CSR) | Name | Analytic Code |
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https://zephyrnet.com/NCT03796078
2018-04-30
https://zephyrnet.com/?p=NCT03796078
NCT03796078https://www.clinicaltrials.gov/study/NCT03796078?tab=tableAdaia Valls-Ontañón, PhDavalls@institutomaxilofacial.com+34933 933 185ABSTRACT OBJECTIVES: To study the correlation between pharyngeal airway volume (PAV), the clinical indicators of obstructive sleep apnea (AHI, ESS), and the impact of orthognathic surgery on them.
METHODS: A prospective, descriptive, unicentric study carried out by a multidisciplinary team to evaluate the following parameters in patients undergoing orthognathic surgery at Maxillofacial institute Teknon medical center.
During the study period:
Record of the type, magnitude and direction of surgical movements of the maxillofacial complex made during the surgery (Day 0-Month 1).
Assessment of PAS/PAV stability (relapse) at short term (1 month).
3D PAV assessment by cranial voxel-based superimposition protocol before and one month and 12 months after orthognathic surgery.
Household polysomnography (PSG) registry/ apnea-hypopnea index (Day 0, Month 1 and Month 12). (AHI evaluation bu neurophysiologist)
Assessment of the clinical indicators of obstructive sleep apnea at day 0, month 1 and month 12:, blood pressure (mm Hg) , and daytime hypersomnia test (Epworth sleepiness scale, ESS) (Day 0, Month 1 and Month 12).
Record of body mass index (BMI) (cm/Kg2)
Main Objective:
• Evaluate the impact of orthognathic surgery (bimaxillary or monomaxillary) and its movements on the PAV and the clinical indicators of OSA.
Specific objectives:
• Interrelate the degree of dentofacial deformity with the IAH.
Study the potential correlation between the volume of the VAS and the IAH.
Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with PAV/PAS increase Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with the cure of OSA (household PSG AHI assessment) and the following clinical indicators of OSA: diurnal hypersomnia test (ESD, ESS).
Evaluate negative effects of either maxillary or mandibular surgical movements in PAS/PAV increase and the cures of OSA.
Evaluate negative effects of either maxillary or mandibular surgical movements in the improvement of the clinical symptoms and the cure of OSA.
To study the possible effect of surgical complications on PAS/PAV stability at long term and the clinical symptoms of OSA.
Demonstrate that maxillomandibular surgery is a defined, predictable and a definitive cure for OSA.
Demonstrate that skeletal, linear, and cross-sectional volume parameters remain stable at long-term.
Demonstrate that AHI and OSA-related parameters stay stable at long term after mono- or bimaxillary surgery.
Hypothesis
H1a: Maxillomandibular advancement (orthognathic surgery) does correlate with the volume of the upper airway, at both short or long term.
H2a: Maxillomandibular advancement (orthognathic surgery) does correlate with the clinical indicators of obstructive sleep apnea, at both short or long term.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-05-16 |
Start Month Year | April 30, 2018 |
Primary Completion Month Year | January 1, 2024 |
Verification Month Year | May 2023 |
Verification Date | 2023-05-31 |
Last Update Posted Date | 2023-05-16 |
Facilities
Sequence: | 199057016 |
Status | Recruiting |
Name | Institute of Maxillofacial Surgery, Teknon Medical Center |
City | Barcelona |
Zip | 08022 |
Country | Spain |
Facility Contacts
Sequence: | 27991443 | Sequence: | 27991444 |
Facility Id | 199057016 | Facility Id | 199057016 |
Contact Type | primary | Contact Type | backup |
Name | Maria Giralt-Hernando, MSC | Name | Adaia Valls-Ontañón, PhD |
avalls@institutomaxilofacial.com | |||
Phone | +34933 933 185 | Phone | +34933 933 185 |
Phone Extension | 112 | Phone Extension | 112 |
Facility Investigators
Sequence: | 18259945 |
Facility Id | 199057016 |
Role | Principal Investigator |
Name | Federico Hernández-Alfaro, PhD |
Conditions
Sequence: | 51910350 | Sequence: | 51910351 | Sequence: | 51910352 | Sequence: | 51910353 |
Name | OSA | Name | OSAS | Name | Apnea, Obstructive Sleep | Name | Orthognathic Surgery |
Downcase Name | osa | Downcase Name | osas | Downcase Name | apnea, obstructive sleep | Downcase Name | orthognathic surgery |
Id Information
Sequence: | 39954133 |
Id Source | org_study_id |
Id Value | OSAS-OS |
Countries
Sequence: | 42346745 |
Name | Spain |
Removed | False |
Design Groups
Sequence: | 55317748 | Sequence: | 55317749 | Sequence: | 55317750 |
Group Type | Active Comparator | Group Type | Active Comparator | Group Type | Active Comparator |
Title | Bimaxillary surgery (MMA) | Title | monomaxillary surgery (Isolated MaxS) | Title | monomandibullary surgery (Isolated MandS) |
Description | Bimaxillary Orthognathic Surgery. MMA | Description | Monomaxillary surgery (Isolated MaxS) | Description | Monomandibular surgery (Isolated MandS) |
Interventions
Sequence: | 52224950 | Sequence: | 52224951 | Sequence: | 52224952 |
Intervention Type | Procedure | Intervention Type | Procedure | Intervention Type | Procedure |
Name | Maxillomandibular advancement | Name | monomaxillary surgery (isolated MaxS) | Name | monomandibullary surgery (MandS) |
Description | Treatment: Mono or Bimaxillary Orthognathic Surgery. The surgery of Reposition of the jaws is carried out under general anesthesia using minimally invasive techniques, the patient is extubated After surgery, antibiotics are prescribed during admission, anti-inflammatories, antiemetics and a local cold mask is applied of closed circuit at 17ºCelsius. The patient is discharged at 24 h. | Description | Monomaxillary surgery (Isolated MaxS): The surgery of Reposition of the maxilla is carried out under general anesthesia using minimally invasive techniques, the patient is extubated After surgery, antibiotics are prescribed during admission, anti-inflammatories, antiemetics and a local cold mask is applied of closed circuit at 17ºCelsius. The patient is discharged at 24 h. | Description | Monomandibullary surgery (Isolated MandS): The surgery of Reposition of the maxilla is carried out under general anesthesia using minimally invasive techniques, the patient is extubated After surgery, antibiotics are prescribed during admission, anti-inflammatories, antiemetics and a local cold mask is applied of closed circuit at 17ºCelsius. The patient is discharged at 24 h. |
Keywords
Sequence: | 79454243 | Sequence: | 79454244 |
Name | OSA | Name | orthognathic surgery |
Downcase Name | osa | Downcase Name | orthognathic surgery |
Design Outcomes
Sequence: | 176482914 | Sequence: | 176482915 | Sequence: | 176482916 | Sequence: | 176482917 | Sequence: | 176482918 | Sequence: | 176482919 | Sequence: | 176482920 | Sequence: | 176482921 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Upper airway volume change | Measure | Pharyngeal airway space (amount of movement) | Measure | Direction of movement (advancement or setback) | Measure | Apnea-hypopnea index (AHI) assessment | Measure | Blood pressure changes | Measure | Body mass index (BMI) | Measure | Lowest oxygen saturation 90% (LSat 90%) | Measure | Epworth sleepiness scale test (ESS) |
Time Frame | Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). | Time Frame | Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). | Time Frame | Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). | Time Frame | Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). | Time Frame | Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). | Time Frame | Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). | Time Frame | Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). | Time Frame | Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). |
Description | Evaluation of volume change of the pharyngeal airway before (Day 0) and month (Month 1) and 12 months (Month 12) comparing the three-dimensional measurements of maxillary /bimaxillary surgery by conical beam computed tomography superposition. Cubic millimeters (mm^3 will be used to evaluate this outcome) | Description | Evaluation of the amount of movement (pharyngeal airway space increase) before (Day 0) and month (Month 1) and 12 months (Month 12) comparing the three-dimensional measurements of maxillary /bimaxillary surgery by conical beam computed tomography superposition. Millimeters will be used to determine this outcome | Description | Evaluation of the direction of movement (advancement or setback) and its impact (negative/positive) in the total upper airway volume change, before (Day 0) and month (Month 1) and 12 months (Month 12) comparing the three-dimensional measurements of maxillary /bimaxillary surgery by conical beam computed tomography superposition. Millimetres will be used to determine this outcome. | Description | Evaluation of clinical indicators of obstructive sleep apnea: Apnea-hypopnea index by polysomnography evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). AHI scale: Mild OSA 5-15/ moderate OSA: 15-30/ severe OSA: >30 events/hour. A higher score means a worse outcome. | Description | Evaluation of clinical indicators of obstructive sleep apnea: blood pressure change evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). Systolic and diastolic pressures will be both recorded. Mean cardiac frequency will be obtained.
Evaluation of clinical indicators of obstructive sleep apnea: blood pressure change evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). Systolic and diastolic pressures will be both recorded. Mean cardiac frequency will be obtained. Evaluation of clinical indicators of obstructive sleep apnea: blood pressure change evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). Systolic and diastolic pressures will be both recorded. Mean cardiac frequency will be obtained. Assessed in mm Hg |
Description | Evaluation of Body mass index (e.g., weight in kilograms, height in m) change before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). (e.g., weight and height will be combined to report BMI in kg/m^2). | Description | Evaluation of clinical indicators of obstructive sleep apnea: lowest oxygen saturation (90%) change evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). | Description | The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. Used clinically to screen for the manifestations of the behavioral morbidity associated to obstructive sleep apnea, first used by Johns, 1991.
The ESS asks people to rate, on a four-point scale, their usual chances of falling asleep in eight different situations. These must be answered beyond 4 punctuations ranges depending on: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing or 3 = high chance of dozing. The total ESS score is the sum of item-scores and ranges between 0 and 24; the higher the score, the higher the person's level sleepines. A score of 10-12 is suggested as the cutoff among clinic populations being screened for a sleep disorder. |
Browse Conditions
Sequence: | 192438336 | Sequence: | 192438337 | Sequence: | 192438338 | Sequence: | 192438339 | Sequence: | 192438340 | Sequence: | 192438341 | Sequence: | 192438342 | Sequence: | 192438343 | Sequence: | 192438344 | Sequence: | 192438345 |
Mesh Term | Apnea | Mesh Term | Sleep Apnea, Obstructive | Mesh Term | Respiration Disorders | Mesh Term | Respiratory Tract Diseases | Mesh Term | Signs and Symptoms, Respiratory | Mesh Term | Sleep Apnea Syndromes | Mesh Term | Sleep Disorders, Intrinsic | Mesh Term | Dyssomnias | Mesh Term | Sleep Wake Disorders | Mesh Term | Nervous System Diseases |
Downcase Mesh Term | apnea | Downcase Mesh Term | sleep apnea, obstructive | Downcase Mesh Term | respiration disorders | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | signs and symptoms, respiratory | Downcase Mesh Term | sleep apnea syndromes | Downcase Mesh Term | sleep disorders, intrinsic | Downcase Mesh Term | dyssomnias | Downcase Mesh Term | sleep wake disorders | Downcase Mesh Term | nervous system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48073446 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Centro Medico Teknon |
Overall Officials
Sequence: | 29131987 | Sequence: | 29131988 |
Role | Study Chair | Role | Principal Investigator |
Name | Federico Hernández-Alfaro, PhD | Name | Adaia Valls-Ontañón, PhD |
Affiliation | Institute of Maxillofacial Surgery, Teknon Medical Center | Affiliation | Institute of Maxillofacial Surgery, Teknon Medical Center |
Central Contacts
Sequence: | 11951908 | Sequence: | 11951909 |
Contact Type | primary | Contact Type | backup |
Name | Maria Giralt-Hernando, PhD | Name | Adaia Valls-Ontañón, PhD |
Phone | +34933 933 185 | Phone | +34933 933 185 |
mgiralt@uic.es | avalls@institutomaxilofacial.com | ||
Phone Extension | 112 | Phone Extension | 112 |
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 67816450 | Sequence: | 67816451 | Sequence: | 67816452 |
Design Group Id | 55317748 | Design Group Id | 55317749 | Design Group Id | 55317750 |
Intervention Id | 52224950 | Intervention Id | 52224951 | Intervention Id | 52224952 |
Eligibilities
Sequence: | 30610336 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Patients over 18 years of age who present any kind of dentofacial deformity candidates for orthognathic surgery treatment. Exclusion Criteria: Patients with a clinical history in which any surgery would be contraindicated |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253951448 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 7 |
Designs
Sequence: | 30357580 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26546547 |
Intervention Id | 52224950 |
Name | MMA (maxillomandibular advancement) |
Provided Documents
Sequence: | 2571007 | Sequence: | 2571008 |
Document Type | Study Protocol and Statistical Analysis Plan | Document Type | Informed Consent Form |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | True |
Has Sap | True | Has Sap | False |
Document Date | 2017-10-30 | Document Date | 2017-10-30 |
Url | https://ClinicalTrials.gov/ProvidedDocs/78/NCT03796078/Prot_SAP_002.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/78/NCT03796078/ICF_003.pdf |
Responsible Parties
Sequence: | 28729449 |
Responsible Party Type | Principal Investigator |
Name | Dr. Federico Hernández-Alfaro MD, DDS, PhD, FEBOMS |
Title | Chief Oral and Maxillofacial Surgery Department |
Affiliation | Centro Medico Teknon |
Study References
Sequence: | 51797494 | Sequence: | 51797495 | Sequence: | 51797496 |
Pmid | 31673361 | Pmid | 33171114 | Pmid | 33632574 |
Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Giralt-Hernando M, Valls-Ontanon A, Guijarro-Martinez R, Masia-Gridilla J, Hernandez-Alfaro F. Impact of surgical maxillomandibular advancement upon pharyngeal airway volume and the apnoea-hypopnoea index in the treatment of obstructive sleep apnoea: systematic review and meta-analysis. BMJ Open Respir Res. 2019 Oct 9;6(1):e000402. doi: 10.1136/bmjresp-2019-000402. eCollection 2019. | Citation | Giralt-Hernando M, Valls-Ontanon A, Haas Junior OL, Masia-Gridilla J, Hernandez-Alfaro F. What are the Surgical Movements in Orthognathic Surgery That Most Affect the Upper Airways? A Three-Dimensional Analysis. J Oral Maxillofac Surg. 2021 Feb;79(2):450-462. doi: 10.1016/j.joms.2020.10.017. Epub 2020 Oct 15. | Citation | Hernandez-Alfaro F, Giralt-Hernando M, Brabyn PJ, Haas OL Jr, Valls-Ontanon A. Variation between natural head orientation and Frankfort horizontal planes in orthognathic surgery patients: 187 consecutive cases. Int J Oral Maxillofac Surg. 2021 Sep;50(9):1226-1232. doi: 10.1016/j.ijom.2021.02.011. Epub 2021 Feb 22. |
]]>
https://zephyrnet.com/NCT03796065
2018-08-27
https://zephyrnet.com/?p=NCT03796065
NCT03796065https://www.clinicaltrials.gov/study/NCT03796065?tab=tableNANANAThe proposed study will employ a cross-cultural Community Based Participatory Research (CBPR) approach to build from prior needs assessments and mixed-methods research to evaluate the effectiveness of the Family Strengthening Intervention for Refugees (FSI-R), a preventative family home-based visiting intervention intended to mitigate mental health disparities among refugee children and families using a hybrid implementation-effectiveness design. Results of the investigator’s trial will expand the evidence-base on community-based interventions for refugees and has the potential to be replicated to reduce mental health disparities affecting diverse groups of refugee children and families.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-02-08 |
Start Month Year | August 27, 2018 |
Primary Completion Month Year | June 30, 2022 |
Verification Month Year | February 2023 |
Verification Date | 2023-02-28 |
Last Update Posted Date | 2023-02-08 |
Detailed Descriptions
Sequence: | 20852498 |
Description | Using a CBPR approach, a family based prevention model, the Family Strengthening Intervention for Refugees (FSI-R) was adapted from a tested model used in Africa and designed for delivery by refugee community health workers with through a process involving stakeholder consultation and local refugee Community Advisory Board input. Pilot data on the FSI-R demonstrates strong feasibility and acceptability, but further data are needed on effectiveness as well as barriers and facilitators to implementation by community health workers embedded in refugee-serving social services agencies. Specific aims are to (1) examine the impact of a family-based preventive intervention on outcomes of parent-child relationships, family functioning, and child mental health using a Hybrid Type 2 Effectiveness-Implementation Design (families with children aged 7-17 in a two-arm randomized controlled trial); (2) identify barriers and facilitators to implementation of the FSI-R by community health workers by conducting a process evaluation concurrent with the delivery of the intervention; and (3) strengthen the science of community engagement to address health disparities by fortifying CBPR-based pathways of change via collaborative partnerships between refugee communities, service providers, and academic stakeholders. |
Facilities
Sequence: | 201290271 | Sequence: | 201290272 |
Name | Maine Immigrant and Refugee Services | Name | Jewish Family Service |
City | Lewiston | City | Springfield |
State | Maine | State | Massachusetts |
Zip | 04240 | Zip | 01108 |
Country | United States | Country | United States |
Conditions
Sequence: | 52508014 |
Name | Family Research |
Downcase Name | family research |
Id Information
Sequence: | 40399523 |
Id Source | org_study_id |
Id Value | 18.251.01 |
Countries
Sequence: | 42835837 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55964500 | Sequence: | 55964501 |
Group Type | Experimental | Group Type | No Intervention |
Title | FSI-R Treatment | Title | FSI-R Control |
Description | Families randomized into the FSI-R Treatment arm will receive the 10-module Family Strengthening Intervention in addition to any outside services or programs they are participating in. | Description | Families randomized into the FSI-R Control arm will not receive the FSI-R treatment. Instead, they will continue with their usual care, referred to as Treatment as Usual (TAU). |
Interventions
Sequence: | 52815941 |
Intervention Type | Behavioral |
Name | FSI-R Treatment |
Description | The FSI-R involves a series of separate and joint meetings with parents and children to discuss challenges the family has faced and the strengths that helped them make it through past challenging times. Additional psychoeducation on mental health and promoting resilience along with coaching to enhance parenting skills is provided throughout and may be tailored to family needs. The FSI-R provides a shared space for refugee families both to recognize their strengths and to problem-solve in a more collective way on family challenges and shared hopes for the future. The FSI-R is delivered in the home, by a trained interventionist, over the course of 10-modules. |
Keywords
Sequence: | 80325870 | Sequence: | 80325871 | Sequence: | 80325872 | Sequence: | 80325873 | Sequence: | 80325874 | Sequence: | 80325875 | Sequence: | 80325876 |
Name | refugees | Name | parental self-efficacy | Name | family communication | Name | family connectedness | Name | refugee youth | Name | youth functioning | Name | integration |
Downcase Name | refugees | Downcase Name | parental self-efficacy | Downcase Name | family communication | Downcase Name | family connectedness | Downcase Name | refugee youth | Downcase Name | youth functioning | Downcase Name | integration |
Design Outcomes
Sequence: | 178632828 | Sequence: | 178632829 | Sequence: | 178632830 | Sequence: | 178632831 | Sequence: | 178632832 | Sequence: | 178632833 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in conflict via the Family Conflict Scale | Measure | Change in communication via the Revised Parent- Adolescent Communication Form | Measure | Change in family conflict via the Intergenerational Conflict Index | Measure | Change in parenting via the Alabama Parenting Questionnaire | Measure | Change in youth externalizing behaviors via the African Youth Psychosocial Assessment | Measure | Change in youth depression via the Center for Epidemiologic Studies-Depression scale |
Time Frame | T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2) | Time Frame | T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2) | Time Frame | T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2) | Time Frame | T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2) | Time Frame | T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2) | Time Frame | T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2) |
Description | The Family Conflict Scale utilizes a 7-point Likert Scale (0-6) to assess family conflict within the past month. Higher scores reflect greater family conflict. | Description | Utilizes a 5-point Likert scale (1-5) to assess parent-child communication. Greater scores indicate higher communication between parents and their children. | Description | Utilizes a 5-point Likert scale (1-5) to assess intergenerational congruence across several domains of the parent-child relationship. Higher scores denote greater intergenerational congruence. | Description | Likert scale (1-5) that includes 5 sub-domains. Each sub-domain results in a summed score that relates to 5 domains of parenting: involvement, positive parenting, poor monitoring/supervision, inconsistent discipline, and corporal punishment. | Description | This assessment utilizes a 4-point Likert scale (1-4) to assess for externalizing problems in youth with greater scores reflecting greater conduct problems. | Description | This measures utilizes a 4-point Likert scale (0-3) to assess depression in youth with higher scores indicated increasing levels of depression. The time frame referenced is "during the past week". |
Sponsors
Sequence: | 48630935 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Boston College |
Overall Officials
Sequence: | 29461098 |
Role | Principal Investigator |
Name | Theresa Betancourt, ScD |
Affiliation | Boston College |
Design Group Interventions
Sequence: | 68607891 |
Design Group Id | 55964500 |
Intervention Id | 52815941 |
Eligibilities
Sequence: | 30957296 |
Gender | All |
Minimum Age | 7 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria for families:
being a resettled refugee family Inclusion Criteria for parents/caregivers: be aged 18 or older Exclusion Criteria: not meeting the above inclusion criteria |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 253957500 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2019 |
Actual Duration | 46 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 7 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30702872 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Single |
Masking Description | The Research Assistants (RAs) who will collect both qualitative and quantitative data will be blind to the condition in which study participants are randomized. |
Intervention Model Description | The investigators will conduct a Randomized Controlled Trial among Somali Bantu and Bhutanese families (N=300; 150 per group). Half of the families will be randomized to receive the FSI-R and half will be randomized to the control condition where the participants will receive Treatment as Usual (TAU). |
Caregiver Masked | True |
Intervention Other Names
Sequence: | 26841657 |
Intervention Id | 52815941 |
Name | Family Strengthening Intervention for Refugees |
Responsible Parties
Sequence: | 29069629 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796052
2019-05-23
https://zephyrnet.com/?p=NCT03796052
NCT03796052https://www.clinicaltrials.gov/study/NCT03796052?tab=tableNANANAThis study will test the safety and efficacy of three topical agents containing oat kernel flour to determine how well they relieve skin dryness and itching related to cancer therapies. Participants will receive a body wash, a body cream, and an anti-itch balm to use at home for 4-6 weeks.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-11-04 |
Start Month Year | May 23, 2019 |
Primary Completion Month Year | December 18, 2019 |
Verification Month Year | October 2020 |
Verification Date | 2020-10-31 |
Last Update Posted Date | 2020-11-04 |
Detailed Descriptions
Sequence: | 20716326 |
Description | Many patients undergoing cancer therapies experience skin reactions like dry skin, rash, redness, itchiness, and hyperpigmentation. Dry skin and itching are especially common for those undergoing chemotherapy and targeted treatments.
Skincare products containing Avena sativa (oat) kernel flour have a long history of tolerance and efficacy in treating various skin conditions involving pruritus (itching) and xerosis (dry skin), as Avena sativa (oat) kernel flour is known for its skin protectant properties and soothing effects on skin. This study will evaluate the safety and efficacy of a regimen of three topical agents containing Avena sativa (oat) kernel flour for cancer patients experiencing mild to moderate pruritus and/or xerosis. Participants will received the products at Baseline (Visit 1) and return to the clinical site at Week 5 +/- 1 week for Visit 2. In addition, questionnaires will be completed remotely between Baseline and Visit 2. |
Facilities
Sequence: | 200053453 |
Name | Memorial Sloan-Kettering Cancer Center |
City | New York |
State | New York |
Zip | 10022 |
Country | United States |
Conditions
Sequence: | 52156570 | Sequence: | 52156571 |
Name | Ichthyosis | Name | Pruritus |
Downcase Name | ichthyosis | Downcase Name | pruritus |
Id Information
Sequence: | 40148257 |
Id Source | org_study_id |
Id Value | CCSSKA000844 |
Countries
Sequence: | 42557793 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55577973 |
Group Type | Experimental |
Title | Avena Sativa Skincare Regimen |
Description | Avena sativa-containing body wash, body cream, and anti-itch balm |
Interventions
Sequence: | 52472076 |
Intervention Type | Other |
Name | Avena Sativa Skincare Regimen |
Description | Regimen consisting of 3 topical agents containing Avena Sativa (oat) kernel flour: a body wash (type = cosmetic), a body cream (type = cosmetic), and an anti-itch balm (type = OTC monograph drug with 0.5% Pramoxine HCl) |
Keywords
Sequence: | 79848192 | Sequence: | 79848193 | Sequence: | 79848194 | Sequence: | 79848195 |
Name | Pruritis | Name | Itching | Name | Dryness | Name | Xerosis |
Downcase Name | pruritis | Downcase Name | itching | Downcase Name | dryness | Downcase Name | xerosis |
Design Outcomes
Sequence: | 177328320 | Sequence: | 177328336 | Sequence: | 177328321 | Sequence: | 177328322 | Sequence: | 177328323 | Sequence: | 177328324 | Sequence: | 177328325 | Sequence: | 177328326 | Sequence: | 177328327 | Sequence: | 177328328 | Sequence: | 177328329 | Sequence: | 177328330 | Sequence: | 177328337 | Sequence: | 177328331 | Sequence: | 177328332 | Sequence: | 177328333 | Sequence: | 177328334 | Sequence: | 177328335 | Sequence: | 177328338 | Sequence: | 177328339 | Sequence: | 177328340 | Sequence: | 177328341 | Sequence: | 177328342 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Mean Change from Baseline to Visit 2 in CTCAE Grading of Xerosis | Measure | Mean Change from Baseline to Visit 2 in Self-Assessment of Flakiness | Measure | Mean Change from Baseline to Visit 2 in CTCAE Grading of Pruritus | Measure | Mean Change from Baseline to Visit 2 in Overall Xerosis Grading | Measure | Mean Change from Baseline to Visit 2 in Overall Pruritus Grading | Measure | Mean Change from Baseline to Visit 2 in Overall Irritation Assessment | Measure | Frequency Distribution for Overall Tolerance at Visit 2 – Subject Rating | Measure | Frequency Distribution for Overall Tolerance at Visit 2 – Investigator Rating | Measure | Mean Change from Baseline to Visit 2 in PRO-CTCAE Skin Dryness | Measure | Mean Change from Baseline to Visit 2 in PRO-CTCAE Itching | Measure | Mean Change from Baseline to Visit 2 in Skindex-16 Global Score | Measure | Mean Change from Baseline to Visit 2 in Skindex-16 Emotional Subscale | Measure | Mean Change from Baseline to Visit 2 in Self-Assessment of Itchiness | Measure | Mean Change from Baseline to Visit 2 in Skindex-16 Symptoms Subscale | Measure | Mean Change from Baseline to Visit 2 in Skindex-16 Functional Subscale | Measure | Mean Change from Baseline to Visit 2 in Skin Moisture | Measure | Mean Change from Baseline to Visit 2 in Skin Water Loss | Measure | Mean Change from Baseline to Visit 2 in Self-Assessment of Dryness | Measure | Mean Change from Baseline to Visit 2 in Self-Assessment of Roughness | Measure | Mean Change from Baseline to Visit 2 in Self-Assessment of Smoothness | Measure | Mean Change from Baseline to Visit 2 in Self-Assessment of Softness | Measure | Mean Change from Baseline to Visit 2 in Self-Assessment of Comfort | Measure | Mean Change from Baseline to Visit 2 in Self-Assessment of Overall Look/Feel |
Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Week 5 +/- 1 week | Time Frame | Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week | Time Frame | Baseline to Week 5 +/- 1 week |
Description | The investigator will evaluate subjects for overall xerosis (skin dryness) using the Common Terminology Criteria for Adverse Events (CTCAE) grading scale. For xerosis, the scale ranges from 1 (dryness covering less 10% of body surface area and no associated erythema or pruritus) to 3 (dryness covering greater than 30% of body surface area and associated with itching; limits daily self care activities of daily living). A "0" grade will be used to document subjects with no presence of the CTCAE skin adverse event symptoms for xerosis. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | Subjects will be asked to rate their overall skin flakiness on a scale of 1 (flaking very apparent) to 10 (no visible flaking). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | The investigator will evaluate subjects for overall pruritus (skin itching) using the Common Terminology Criteria for Adverse Events (CTCAE) grading scale. For pruritus, the scale ranges from 1 (Mild or localized; topical intervention indicated) to 3 (widespread and constant itching; limits daily self-care activities or sleep). A "0" grade will be used to document subjects with no presence of the CTCAE skin adverse event symptoms for pruritus. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | The investigator will evaluate subjects for overall xerosis (skin dryness) using a 0 (none) to 3 (severe) scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | The investigator will question subjects for overall pruritus (skin itching) using a 0 (none) to 3 (severe) scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | The investigator will evaluate subjects for overall irritation using a 0 (none) to 4 (very severe) scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | The subject will rate how well he/she tolerated the study regimen using the following choices: Well tolerated, tolerated, or not tolerated. | Description | The investigator will rate how well the participant tolerated the study regimen using the following choices: Well tolerated, tolerated, or not tolerated. | Description | The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be completed for Skin Dryness. The question asks subjects to rate the severity of their dry skin at its worst over the last 7 days from None to Very Severe on a 5-point scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be completed for Itching. The question asks subjects to rate the severity of their itchy skin at its worst over the last 7 days from None to Very Severe on a 5-point scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | The Skindex-16 is a dermatology-specific quality of life measuring tool. (The SKINDEX contact information and permission to use: Mapi Research Trust, Lyon, France. Internet: https://eprovide.mapi-trust.org). It contains 16 questions that ask subjects to rate how often over the last 7 days they have been bothered by various skin conditions on a scale of 0 (never bothered) to 6 (always bothered). The global score is the average score for all questions and is transformed to a linear scale ranging from 0 (never bothered) to 100 (always bothered) so a higher score indicates a lower quality of life. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | The Skindex-16 is a dermatology-specific quality of life measuring tool (The SKINDEX contact information and permission to use: Mapi Research Trust, Lyon, France. Internet: https://eprovide.mapi-trust.org). It contains 16 questions that ask subjects to rate how often over the last 7 days have they been bothered by various skin conditions on a scale of 0 (never bothered) to 6 (always bothered). The Emotional subscale looks at the average score of questions 5-11 regarding emotion; the emotional score is transformed to a linear scale ranging from 0 (never bothered) to 100 (always bothered) so a higher score indicates a lower quality of life. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | Subjects will be asked to rate their overall skin itchiness on a scale of 1 (very itchy) to 10 (not at all itchy). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 weeks). | Description | The Skindex-16 is a dermatology-specific quality of life measuring tool (The SKINDEX contact information and permission to use: Mapi Research Trust, Lyon, France. Internet: https://eprovide.mapi-trust.org). It contains 16 questions that ask subjects to rate how often over the last 7 days have they been bothered by various skin conditions on a scale of 0 (never bothered) to 6 (always bothered). The Symptoms subscale looks at the average score of questions 1-4 individual responses regarding symptoms; the symptoms score is transformed to a linear scale ranging from 0 (never bothered) to 100 (always bothered) so a higher score indicates a lower quality of life. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | The Skindex-16 is a dermatology-specific quality of life measuring tool (The SKINDEX contact information and permission to use: Mapi Research Trust, Lyon, France. Internet: https://eprovide.mapi-trust.org). It contains 16 questions that ask subjects to rate how often over the last 7 days have they been bothered by various skin conditions on a scale of 0 (never bothered) to 6 (always bothered). The Functional subscale looks at the average score of questions 12 – 16 regarding daily functioning; the functional score is transformed to a linear scale ranging from 0 (never bothered) to 100 (always bothered) so a higher score indicates a lower quality of life. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | Skin moisture will be measured with a Corneometer, with values ranging from 0 (no moisture) to 120 (most moisturized) arbitrary units. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | The amount of water lost through the skin will be measured with a Vapometer. Higher numbers indicate more water loss. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | Subjects will be asked to rate their overall skin dryness on a scale of 1 (very dry) to 10 (skin feels moisturized). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | Subjects will be asked to rate their overall skin roughness/texture on a scale of 1 (very rough) to 10 (not at all rough). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 weeks). | Description | Subjects will be asked to rate their overall skin smoothness on a scale of 1 (not at all smooth) to 10 (very smooth). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | Subjects will be asked to rate their overall skin softness on a scale of 1 (not at all soft) to 10 (very soft). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | Subjects will be asked to rate their overall skin comfort on a scale of 1 (uncomfortable/irritated) to 10 (very comfortable/not at all irritated). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). | Description | Subjects will be asked to rate the overall look and feel of their skin on a scale of 1 (not healthy looking) to 10 (healthy looking). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week). |
Browse Conditions
Sequence: | 193432306 | Sequence: | 193432299 | Sequence: | 193432300 | Sequence: | 193432301 | Sequence: | 193432302 | Sequence: | 193432303 | Sequence: | 193432304 | Sequence: | 193432305 |
Mesh Term | Keratosis | Mesh Term | Ichthyosis | Mesh Term | Pruritus | Mesh Term | Skin Diseases | Mesh Term | Skin Manifestations | Mesh Term | Skin Abnormalities | Mesh Term | Congenital Abnormalities | Mesh Term | Infant, Newborn, Diseases |
Downcase Mesh Term | keratosis | Downcase Mesh Term | ichthyosis | Downcase Mesh Term | pruritus | Downcase Mesh Term | skin diseases | Downcase Mesh Term | skin manifestations | Downcase Mesh Term | skin abnormalities | Downcase Mesh Term | congenital abnormalities | Downcase Mesh Term | infant, newborn, diseases |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306153 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Johnson & Johnson Consumer Inc. (J&JCI) |
Overall Officials
Sequence: | 29277976 |
Role | Principal Investigator |
Name | Mario Lacouture, M.D. |
Affiliation | Memorial Sloan Kettering Cancer Center |
Design Group Interventions
Sequence: | 68130947 |
Design Group Id | 55577973 |
Intervention Id | 52472076 |
Eligibilities
Sequence: | 30757397 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 75 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
able to read, write, speak, and understand English has a prior diagnosis of a solid or hematologic tumor and either: is currently undergoing therapy with a systemic agent and has completed at least 3 cycles without severe skin reactions. Exclusion Criteria: has known allergies or sensitivity to skincare products or study product ingredients. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254228941 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 6 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 75 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 5 |
Number Of Secondary Outcomes To Measure | 18 |
Designs
Sequence: | 30503622 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | All participants will receive the same study regimen consisting of 3 products: a body wash, a body cream, and an anti-itch balm. |
Links
Sequence: | 4386998 |
Url | https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&parentIdentifier=CCSSKA000844&attachmentIdentifier=48eeefb6-abfc-4be4-87ec-7d1620ff69d8&fileName=CCSSKA000844_Ribbons_Clinical_Study_Report_Synopsis_14OCT2020.pdf&versionIdentifier= |
Description | Related Info |
Responsible Parties
Sequence: | 28869900 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52049452 | Sequence: | 52049453 | Sequence: | 52049454 | Sequence: | 52049455 | Sequence: | 52049456 | Sequence: | 52049457 | Sequence: | 52049458 | Sequence: | 52049459 | Sequence: | 52049460 | Sequence: | 52049461 | Sequence: | 52049462 | Sequence: | 52049463 |
Pmid | 17373175 | Pmid | 25607551 | Pmid | 27272074 | Pmid | 18461339 | Pmid | 23204849 | Pmid | 7165009 | Pmid | 19995367 | Pmid | 11443481 | Pmid | 26994263 | ||||||
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Kurtz ES, Wallo W. Colloidal oatmeal: history, chemistry and clinical properties. J Drugs Dermatol. 2007 Feb;6(2):167-70. | Citation | Fowler JF Jr. Colloidal oatmeal formulations and the treatment of atopic dermatitis. J Drugs Dermatol. 2014 Oct;13(10):1180-3; quiz 1184-5. | Citation | Ilnytska O, Kaur S, Chon S, Reynertson KA, Nebus J, Garay M, Mahmood K, Southall MD. Colloidal Oatmeal <em>(Avena Sativa)</em> Improves Skin Barrier Through Multi-Therapy Activity. J Drugs Dermatol. 2016 Jun 1;15(6):684-90. | Citation | Sur R, Nigam A, Grote D, Liebel F, Southall MD. Avenanthramides, polyphenols from oats, exhibit anti-inflammatory and anti-itch activity. Arch Dermatol Res. 2008 Nov;300(10):569-74. doi: 10.1007/s00403-008-0858-x. Epub 2008 May 7. | Citation | Criquet M, Roure R, Dayan L, Nollent V, Bertin C. Safety and efficacy of personal care products containing colloidal oatmeal. Clin Cosmet Investig Dermatol. 2012;5:183-93. doi: 10.2147/CCID.S31375. Epub 2012 Nov 8. | Citation | Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available. | Citation | Elman S, Hynan LS, Gabriel V, Mayo MJ. The 5-D itch scale: a new measure of pruritus. Br J Dermatol. 2010 Mar;162(3):587-93. doi: 10.1111/j.1365-2133.2009.09586.x. Epub 2009 Dec 1. | Citation | Chren MM, Lasek RJ, Sahay AP, Sands LP. Measurement properties of Skindex-16: a brief quality-of-life measure for patients with skin diseases. J Cutan Med Surg. 2001 Mar-Apr;5(2):105-10. doi: 10.1007/BF02737863. Epub 2001 Mar 21. | Citation | Common Terminology Criteria for Adverse Events (CTCAE). (2018, Mar 01). Retrieved from https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm | Citation | The PRO-CTCAE Measurement System. (2018, Sep 14). Retrieved from https://healthcaredelivery.cancer.gov/pro-ctcae/measurement.html | Citation | Blume-Peytavi U, Kottner J, Sterry W, Hodin MW, Griffiths TW, Watson RE, Hay RJ, Griffiths CE. Age-Associated Skin Conditions and Diseases: Current Perspectives and Future Options. Gerontologist. 2016 Apr;56 Suppl 2:S230-42. doi: 10.1093/geront/gnw003. | Citation | Skin Conditions. (2012, Jun 26). Retrieved from https://www.cancer.net/navigating-cancer-care/side-effects/skin-conditions |
]]>
https://zephyrnet.com/NCT03796039
2019-04-01
https://zephyrnet.com/?p=NCT03796039
NCT03796039https://www.clinicaltrials.gov/study/NCT03796039?tab=tableNANANAIt is currently unknown if reducing sitting time, an activity that is highly prevalent in frail older adults living in long term care (LTC) facilities, is associated with an improvement in physical capacity such as walking speed. Simple tasks such as walking speed is associated with important outcomes for residents in LTC such as autonomy and hospitalization. The investigators hypothesize that standing an additional 100 minutes per week for 5 months will result in a clinically meaningful improvement in walking speed (0.1m/sec) in LTC residents compared to residents receiving a sitting social activity.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-20 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-06-27 |
Start Month Year | April 1, 2019 |
Primary Completion Month Year | January 23, 2020 |
Verification Month Year | May 2023 |
Verification Date | 2023-05-31 |
Last Update Posted Date | 2023-06-27 |
Results First Posted Date | 2021-07-06 |
Detailed Descriptions
Sequence: | 20731200 |
Description | LTC facilities from Moncton and Fredericton will be recruited, with half of the LTC facilities randomized as the intervention and half as the control group. The investigators are aiming to enrol half of the LTC in Fredericton and half in Moncton. A total of 88 residents (44 in the control group, 44 in the intervention group) will be enrolled in the program. |
Facilities
Sequence: | 200215712 |
Name | Pine Grove Nursing Home |
City | Fredericton |
State | New Brunswick |
Zip | E3B 2J2 |
Country | Canada |
Conditions
Sequence: | 52196216 | Sequence: | 52196217 | Sequence: | 52196218 |
Name | Frailty | Name | Sedentary Behavior | Name | Physical Disability |
Downcase Name | frailty | Downcase Name | sedentary behavior | Downcase Name | physical disability |
Id Information
Sequence: | 40177499 |
Id Source | org_study_id |
Id Value | CAT2018-15 |
Countries
Sequence: | 42591363 |
Name | Canada |
Removed | False |
Design Groups
Sequence: | 55621908 | Sequence: | 55621909 |
Group Type | Experimental | Group Type | No Intervention |
Title | Standing and Social Intervention | Title | Control Group |
Description | Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday. | Description | Control group will receive social visits, but no exposure to standing |
Interventions
Sequence: | 52511030 |
Intervention Type | Behavioral |
Name | Standing |
Description | Standing for an additional 100 minutes per week; 20 minutes Monday-Friday |
Keywords
Sequence: | 79905351 | Sequence: | 79905352 |
Name | Long Term Care | Name | Physical Function |
Downcase Name | long term care | Downcase Name | physical function |
Design Outcomes
Sequence: | 177472274 | Sequence: | 177472275 | Sequence: | 177472276 | Sequence: | 177472277 | Sequence: | 177472278 | Sequence: | 177472279 | Sequence: | 177472280 | Sequence: | 177472281 | Sequence: | 177472282 | Sequence: | 177472283 | Sequence: | 177472284 | Sequence: | 177472285 | Sequence: | 177472286 | Sequence: | 177472287 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Changes in Walking Speed | Measure | Change in Balance | Measure | Change in Leg Strength | Measure | Change Lower Limb Power | Measure | Change in Anxiety Symptoms | Measure | Depression | Measure | Loneliness | Measure | Fall Efficacy | Measure | Rate of Falls | Measure | Metabolic Profile – Triglycerides | Measure | Social Behaviours | Measure | Metabolic Profile – High Density Lipoprotein Cholesterol | Measure | Metabolic Profile – Low Density Lipoprotein Cholesterol | Measure | Metabolic Profile – Blood Glucose |
Time Frame | Pre and post intervention testing | Time Frame | Pre and post testing (following the 5 month intervention). Data was collected but investigators are still analyzing findings. | Time Frame | Pre-Post Testing (following the 5 month intervention) | Time Frame | Pre-Post Testing (following the 5 month intervention) | Time Frame | Pre-Post Testing (following the 5 month intervention) | Time Frame | Pre-Post Testing (following the 5 month intervention) | Time Frame | Pre-Post Testing (following the 5 month intervention) | Time Frame | Pre-Post Testing (following the 5 month intervention) | Time Frame | The number of falls will be collected from three timeframes: 1. Between 6 months prior to and the start of program 2. the duration of the program (5 months) 3. From the end of the program to 6 months follow up. Data is still being analyzed at this time. | Time Frame | Pre-Post Testing (before and following the 5 month intervention). | Time Frame | Pre-Post Testing (following the 5-month intervention). Data has been collected, but is still being analyzed | Time Frame | Pre and post testing (before and after the 5-month intervention) | Time Frame | Pre-Post intervention (before and after 5-month intervention) | Time Frame | Pre-Post Intervention (before and after 5-month intervention) |
Description | Measured by the 10m walking speed test | Description | Measured by a portable device (Wii Balance board), which has sensors that detects sway . | Description | Using hand-held dynamometer to quantify leg strength through knee extension | Description | Using the 30second sit-stand test following senior fitness test protocol | Description | The Geriatric Anxiety Inventory (Scale 0-20). A low score means a better outcome. | Description | Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome. | Description | Loneliness was measured using the UCLA Loneliness Scale (20-80). A low score indicates a better outcome | Description | Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score | Description | Falls, injuries due to falls and hospitalization will be collected at 3 timepoints | Description | Capillary blood analyzed with a cardiochek device. Blood collected via a finger prick and analyzed with a cardiochek device. Note that Total Cholesterol, HDL, Triglycerides, LDL and Glucose were all measured using the cardiochek device. | Description | Semi-structured interviews with residents (participants and non-participants), family members and staff will be administered at the end of the study | Description | High Density Lipoprotein (HDL) cholesterol was analyzed using the CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). A finger prick was conducted using a single use lancet and approximately 60 µL of whole blood was collected for this test. | Description | Low-density lipoprotein was assessed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). | Description | Fasted blood glucose was analyzed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). |
Browse Conditions
Sequence: | 193582011 | Sequence: | 193582012 |
Mesh Term | Frailty | Mesh Term | Pathologic Processes |
Downcase Mesh Term | frailty | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48342339 | Sequence: | 48342340 | Sequence: | 48342341 | Sequence: | 48342342 | Sequence: | 48342343 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | University of New Brunswick | Name | Horizon Health Network | Name | St. Thomas University | Name | Universite de Moncton | Name | Canadian Frailty Network |
Design Group Interventions
Sequence: | 68184471 |
Design Group Id | 55621908 |
Intervention Id | 52511030 |
Eligibilities
Sequence: | 30779945 |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Resident at one of the selected LTC facilities; Exclusion Criteria: If Identified by staff at the facility as too high risk for falling by participating in the intervention. |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 253974905 |
Number Of Facilities | 1 |
Number Of Nsae Subjects | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 9 |
Were Results Reported | True |
Months To Report Results | 15 |
Has Us Facility | False |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 13 |
Designs
Sequence: | 30526046 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | Single |
Masking Description | Investigator was masked at pre-testing. It was unknown which participants would be receiving the intervention. However, due to resources this was not repeated at post testing |
Intervention Model Description | Long term care (LTC) facilities will be recruited, with half of the LTC facilities randomized as the intervention (n=2) and half as the control group (n=2). |
Investigator Masked | True |
Drop Withdrawals
Sequence: | 29004831 | Sequence: | 29004832 | Sequence: | 29004833 | Sequence: | 29004834 |
Result Group Id | 56113141 | Result Group Id | 56113142 | Result Group Id | 56113141 | Result Group Id | 56113142 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Death | Reason | Death | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject |
Count | 2 | Count | 1 | Count | 7 | Count | 4 |
Milestones
Sequence: | 41028181 | Sequence: | 41028182 | Sequence: | 41028183 | Sequence: | 41028184 | Sequence: | 41028185 | Sequence: | 41028186 |
Result Group Id | 56113141 | Result Group Id | 56113142 | Result Group Id | 56113141 | Result Group Id | 56113142 | Result Group Id | 56113141 | Result Group Id | 56113142 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 50 | Count | 47 | Count | 41 | Count | 42 | Count | 9 | Count | 5 |
Participant Flows
Sequence: | 3922904 |
Outcome Counts
Sequence: | 74040275 | Sequence: | 74040276 | Sequence: | 74040277 | Sequence: | 74040278 | Sequence: | 74040279 | Sequence: | 74040280 | Sequence: | 74040281 | Sequence: | 74040282 | Sequence: | 74040283 | Sequence: | 74040284 | Sequence: | 74040285 | Sequence: | 74040286 | Sequence: | 74040287 | Sequence: | 74040288 | Sequence: | 74040289 | Sequence: | 74040290 | Sequence: | 74040291 | Sequence: | 74040292 | Sequence: | 74040293 | Sequence: | 74040294 | Sequence: | 74040295 | Sequence: | 74040296 |
Outcome Id | 30820885 | Outcome Id | 30820885 | Outcome Id | 30820887 | Outcome Id | 30820887 | Outcome Id | 30820888 | Outcome Id | 30820888 | Outcome Id | 30820889 | Outcome Id | 30820889 | Outcome Id | 30820890 | Outcome Id | 30820890 | Outcome Id | 30820891 | Outcome Id | 30820891 | Outcome Id | 30820892 | Outcome Id | 30820892 | Outcome Id | 30820894 | Outcome Id | 30820894 | Outcome Id | 30820896 | Outcome Id | 30820896 | Outcome Id | 30820897 | Outcome Id | 30820897 | Outcome Id | 30820898 | Outcome Id | 30820898 |
Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 50 | Count | 47 | Count | 50 | Count | 47 | Count | 50 | Count | 47 | Count | 20 | Count | 25 | Count | 20 | Count | 25 | Count | 20 | Count | 25 | Count | 20 | Count | 25 | Count | 32 | Count | 38 | Count | 32 | Count | 38 | Count | 32 | Count | 38 | Count | 32 | Count | 38 |
Provided Documents
Sequence: | 2581659 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2020-05-01 |
Url | https://ClinicalTrials.gov/ProvidedDocs/39/NCT03796039/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27956176 | Sequence: | 27956177 | Sequence: | 27956178 | Sequence: | 27956179 | Sequence: | 27956180 | Sequence: | 27956181 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 50 | Subjects At Risk | 50 | Subjects At Risk | 50 | Subjects At Risk | 47 | Subjects At Risk | 47 | Subjects At Risk | 47 |
Created At | 2023-08-09 05:38:27.102685 | Created At | 2023-08-09 05:38:27.102685 | Created At | 2023-08-09 05:38:27.102685 | Created At | 2023-08-09 05:38:27.102685 | Created At | 2023-08-09 05:38:27.102685 | Created At | 2023-08-09 05:38:27.102685 |
Updated At | 2023-08-09 05:38:27.102685 | Updated At | 2023-08-09 05:38:27.102685 | Updated At | 2023-08-09 05:38:27.102685 | Updated At | 2023-08-09 05:38:27.102685 | Updated At | 2023-08-09 05:38:27.102685 | Updated At | 2023-08-09 05:38:27.102685 |
Reported Events
Sequence: | 528513020 | Sequence: | 528513021 |
Result Group Id | 56113145 | Result Group Id | 56113146 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Time Frame | During trial (5 months) | Time Frame | During trial (5 months) |
Event Type | other | Event Type | other |
Subjects Affected | 1 | Subjects Affected | 0 |
Subjects At Risk | 50 | Subjects At Risk | 47 |
Event Count | 1 | Event Count | 0 |
Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications |
Adverse Event Term | Fall | Adverse Event Term | Fall |
Frequency Threshold | 2 | Frequency Threshold | 2 |
Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment |
Responsible Parties
Sequence: | 28892352 |
Responsible Party Type | Principal Investigator |
Name | Danielle Bouchard |
Title | Associate Investigator |
Affiliation | University of New Brunswick |
Result Agreements
Sequence: | 3853648 |
Pi Employee | No |
Result Contacts
Sequence: | 3853613 |
Organization | University of New Brunswick |
Name | Dr. Danielle Bouchard |
Phone | (506) 443-3908 |
dboucha1@unb.ca | |
Outcomes
Sequence: | 30820885 | Sequence: | 30820886 | Sequence: | 30820887 | Sequence: | 30820888 | Sequence: | 30820889 | Sequence: | 30820890 | Sequence: | 30820891 | Sequence: | 30820892 | Sequence: | 30820893 | Sequence: | 30820894 | Sequence: | 30820895 | Sequence: | 30820896 | Sequence: | 30820897 | Sequence: | 30820898 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Changes in Walking Speed | Title | Change in Balance | Title | Change in Leg Strength | Title | Change Lower Limb Power | Title | Change in Anxiety Symptoms | Title | Depression | Title | Loneliness | Title | Fall Efficacy | Title | Rate of Falls | Title | Metabolic Profile – Triglycerides | Title | Social Behaviours | Title | Metabolic Profile – High Density Lipoprotein Cholesterol | Title | Metabolic Profile – Low Density Lipoprotein Cholesterol | Title | Metabolic Profile – Blood Glucose |
Description | Measured by the 10m walking speed test | Description | Measured by a portable device (Wii Balance board), which has sensors that detects sway . | Description | Using hand-held dynamometer to quantify leg strength through knee extension | Description | Using the 30second sit-stand test following senior fitness test protocol | Description | The Geriatric Anxiety Inventory (Scale 0-20). A low score means a better outcome. | Description | Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome. | Description | Loneliness was measured using the UCLA Loneliness Scale (20-80). A low score indicates a better outcome | Description | Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score | Description | Falls, injuries due to falls and hospitalization will be collected at 3 timepoints | Description | Capillary blood analyzed with a cardiochek device. Blood collected via a finger prick and analyzed with a cardiochek device. Note that Total Cholesterol, HDL, Triglycerides, LDL and Glucose were all measured using the cardiochek device. | Description | Semi-structured interviews with residents (participants and non-participants), family members and staff will be administered at the end of the study | Description | High Density Lipoprotein (HDL) cholesterol was analyzed using the CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). A finger prick was conducted using a single use lancet and approximately 60 µL of whole blood was collected for this test. | Description | Low-density lipoprotein was assessed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). | Description | Fasted blood glucose was analyzed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). |
Time Frame | Pre and post intervention testing | Time Frame | Pre and post testing (following the 5 month intervention). Data was collected but investigators are still analyzing findings. | Time Frame | Pre-Post Testing (following the 5 month intervention) | Time Frame | Pre-Post Testing (following the 5 month intervention) | Time Frame | Pre-Post Testing (following the 5 month intervention) | Time Frame | Pre-Post Testing (following the 5 month intervention) | Time Frame | Pre-Post Testing (following the 5 month intervention) | Time Frame | Pre-Post Testing (following the 5 month intervention) | Time Frame | The number of falls will be collected from three timeframes: 1. Between 6 months prior to and the start of program 2. the duration of the program (5 months) 3. From the end of the program to 6 months follow up. Data is still being analyzed at this time. | Time Frame | Pre-Post Testing (before and following the 5 month intervention). | Time Frame | Pre-Post Testing (following the 5-month intervention). Data has been collected, but is still being analyzed | Time Frame | Pre and post testing (before and after the 5-month intervention) | Time Frame | Pre-Post intervention (before and after 5-month intervention) | Time Frame | Pre-Post Intervention (before and after 5-month intervention) |
Population | Only participants with MMSE score greater than or equal to 18 were included (to ensure participants had the cognitive abilities to respond to the questionnaires) | Population | Only participants with a MMSE score of 18 or higher were included | Population | Participants only included if MMSE score is equal to or greater than 18. | Population | This was only measured among participants who had a MMSE score of 18 or higher (to ensure they had the cognitive capacity to properly answer the questionnaire) | Population | Blood draws were difficult among this population due to participant agitation, therefore we were not able to collect blood for all participants | Population | Research assistants were not able to collect blood data for all participants (due to participant agitation or refusal) | Population | Research assistants were not able to collect blood data for all participants (due to participant agitation or refusal) | Population | Research assistants were not able to collect blood data for all participants (due to participant agitation or refusal) | ||||||||||||
Anticipated Posting Date | 2024-09-01 | Anticipated Posting Date | 2024-09-01 | Anticipated Posting Date | 2024-09-01 | ||||||||||||||||||||||
Anticipated Posting Month Year | 09/2024 | Anticipated Posting Month Year | 09/2024 | Anticipated Posting Month Year | 09/2024 | ||||||||||||||||||||||
Units | m/s | Units | kg | Units | Number of repetitions | Units | units on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | mmol/L | Units | mmol/L | Units | mmol/L | Units | mmol/L | ||||||
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 235804563 | Sequence: | 235804564 | Sequence: | 235804565 | Sequence: | 235804554 | Sequence: | 235804555 | Sequence: | 235804556 | Sequence: | 235804557 | Sequence: | 235804558 | Sequence: | 235804559 | Sequence: | 235804560 | Sequence: | 235804561 | Sequence: | 235804562 | Sequence: | 235804532 | Sequence: | 235804533 | Sequence: | 235804534 | Sequence: | 235804535 | Sequence: | 235804536 | Sequence: | 235804537 | Sequence: | 235804538 | Sequence: | 235804539 | Sequence: | 235804540 | Sequence: | 235804541 | Sequence: | 235804542 | Sequence: | 235804543 | Sequence: | 235804544 | Sequence: | 235804545 | Sequence: | 235804546 | Sequence: | 235804547 | Sequence: | 235804548 | Sequence: | 235804549 | Sequence: | 235804550 | Sequence: | 235804551 | Sequence: | 235804552 | Sequence: | 235804553 | Sequence: | 235804566 | Sequence: | 235804567 | Sequence: | 235804568 | Sequence: | 235804569 | Sequence: | 235804570 | Sequence: | 235804571 | Sequence: | 235804572 | Sequence: | 235804573 | Sequence: | 235804574 | Sequence: | 235804575 |
Outcome Id | 30820894 | Outcome Id | 30820896 | Outcome Id | 30820896 | Outcome Id | 30820891 | Outcome Id | 30820891 | Outcome Id | 30820892 | Outcome Id | 30820892 | Outcome Id | 30820892 | Outcome Id | 30820892 | Outcome Id | 30820894 | Outcome Id | 30820894 | Outcome Id | 30820894 | Outcome Id | 30820885 | Outcome Id | 30820885 | Outcome Id | 30820885 | Outcome Id | 30820885 | Outcome Id | 30820887 | Outcome Id | 30820887 | Outcome Id | 30820887 | Outcome Id | 30820887 | Outcome Id | 30820888 | Outcome Id | 30820888 | Outcome Id | 30820888 | Outcome Id | 30820888 | Outcome Id | 30820889 | Outcome Id | 30820889 | Outcome Id | 30820889 | Outcome Id | 30820889 | Outcome Id | 30820890 | Outcome Id | 30820890 | Outcome Id | 30820890 | Outcome Id | 30820890 | Outcome Id | 30820891 | Outcome Id | 30820891 | Outcome Id | 30820896 | Outcome Id | 30820896 | Outcome Id | 30820897 | Outcome Id | 30820897 | Outcome Id | 30820897 | Outcome Id | 30820897 | Outcome Id | 30820898 | Outcome Id | 30820898 | Outcome Id | 30820898 | Outcome Id | 30820898 |
Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 | Result Group Id | 56113143 | Result Group Id | 56113144 |
Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post |
Title | Metabolic Profile – Triglycerides | Title | Metabolic Profile – High Density Lipoprotein Cholesterol | Title | Metabolic Profile – High Density Lipoprotein Cholesterol | Title | Loneliness | Title | Loneliness | Title | Fall Efficacy | Title | Fall Efficacy | Title | Fall Efficacy | Title | Fall Efficacy | Title | Metabolic Profile – Triglycerides | Title | Metabolic Profile – Triglycerides | Title | Metabolic Profile – Triglycerides | Title | Changes in Walking Speed | Title | Changes in Walking Speed | Title | Changes in Walking Speed | Title | Changes in Walking Speed | Title | Change in Leg Strength | Title | Change in Leg Strength | Title | Change in Leg Strength | Title | Change in Leg Strength | Title | Change Lower Limb Power | Title | Change Lower Limb Power | Title | Change Lower Limb Power | Title | Change Lower Limb Power | Title | Change in Anxiety Symptoms | Title | Change in Anxiety Symptoms | Title | Change in Anxiety Symptoms | Title | Change in Anxiety Symptoms | Title | Depression | Title | Depression | Title | Depression | Title | Depression | Title | Loneliness | Title | Loneliness | Title | Metabolic Profile – High Density Lipoprotein Cholesterol | Title | Metabolic Profile – High Density Lipoprotein Cholesterol | Title | Metabolic Profile – Low Density Lipoprotein Cholesterol | Title | Metabolic Profile – Low Density Lipoprotein Cholesterol | Title | Metabolic Profile – Low Density Lipoprotein Cholesterol | Title | Metabolic Profile – Low Density Lipoprotein Cholesterol | Title | Metabolic Profile – Blood Glucose | Title | Metabolic Profile – Blood Glucose | Title | Metabolic Profile – Blood Glucose | Title | Metabolic Profile – Blood Glucose |
Description | Capillary blood analyzed with a cardiochek device. Blood collected via a finger prick and analyzed with a cardiochek device. Note that Total Cholesterol, HDL, Triglycerides, LDL and Glucose were all measured using the cardiochek device. | Description | High Density Lipoprotein (HDL) cholesterol was analyzed using the CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). A finger prick was conducted using a single use lancet and approximately 60 µL of whole blood was collected for this test. | Description | High Density Lipoprotein (HDL) cholesterol was analyzed using the CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). A finger prick was conducted using a single use lancet and approximately 60 µL of whole blood was collected for this test. | Description | Loneliness was measured using the UCLA Loneliness Scale (20-80). A low score indicates a better outcome | Description | Loneliness was measured using the UCLA Loneliness Scale (20-80). A low score indicates a better outcome | Description | Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score | Description | Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score | Description | Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score | Description | Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score | Description | Capillary blood analyzed with a cardiochek device. Blood collected via a finger prick and analyzed with a cardiochek device. Note that Total Cholesterol, HDL, Triglycerides, LDL and Glucose were all measured using the cardiochek device. | Description | Capillary blood analyzed with a cardiochek device. Blood collected via a finger prick and analyzed with a cardiochek device. Note that Total Cholesterol, HDL, Triglycerides, LDL and Glucose were all measured using the cardiochek device. | Description | Capillary blood analyzed with a cardiochek device. Blood collected via a finger prick and analyzed with a cardiochek device. Note that Total Cholesterol, HDL, Triglycerides, LDL and Glucose were all measured using the cardiochek device. | Description | Measured by the 10m walking speed test | Description | Measured by the 10m walking speed test | Description | Measured by the 10m walking speed test | Description | Measured by the 10m walking speed test | Description | Using hand-held dynamometer to quantify leg strength through knee extension | Description | Using hand-held dynamometer to quantify leg strength through knee extension | Description | Using hand-held dynamometer to quantify leg strength through knee extension | Description | Using hand-held dynamometer to quantify leg strength through knee extension | Description | Using the 30second sit-stand test following senior fitness test protocol | Description | Using the 30second sit-stand test following senior fitness test protocol | Description | Using the 30second sit-stand test following senior fitness test protocol | Description | Using the 30second sit-stand test following senior fitness test protocol | Description | The Geriatric Anxiety Inventory (Scale 0-20). A low score means a better outcome. | Description | The Geriatric Anxiety Inventory (Scale 0-20). A low score means a better outcome. | Description | The Geriatric Anxiety Inventory (Scale 0-20). A low score means a better outcome. | Description | The Geriatric Anxiety Inventory (Scale 0-20). A low score means a better outcome. | Description | Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome. | Description | Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome. | Description | Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome. | Description | Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome. | Description | Loneliness was measured using the UCLA Loneliness Scale (20-80). A low score indicates a better outcome | Description | Loneliness was measured using the UCLA Loneliness Scale (20-80). A low score indicates a better outcome | Description | High Density Lipoprotein (HDL) cholesterol was analyzed using the CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). A finger prick was conducted using a single use lancet and approximately 60 µL of whole blood was collected for this test. | Description | High Density Lipoprotein (HDL) cholesterol was analyzed using the CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). A finger prick was conducted using a single use lancet and approximately 60 µL of whole blood was collected for this test. | Description | Low-density lipoprotein was assessed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). | Description | Low-density lipoprotein was assessed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). | Description | Low-density lipoprotein was assessed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). | Description | Low-density lipoprotein was assessed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). | Description | Fasted blood glucose was analyzed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). | Description | Fasted blood glucose was analyzed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). | Description | Fasted blood glucose was analyzed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). | Description | Fasted blood glucose was analyzed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). |
Units | mmol/L | Units | mmol/L | Units | mmol/L | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | mmol/L | Units | mmol/L | Units | mmol/L | Units | m/s | Units | m/s | Units | m/s | Units | m/s | Units | kg | Units | kg | Units | kg | Units | kg | Units | Number of repetitions | Units | Number of repetitions | Units | Number of repetitions | Units | Number of repetitions | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | mmol/L | Units | mmol/L | Units | mmol/L | Units | mmol/L | Units | mmol/L | Units | mmol/L | Units | mmol/L | Units | mmol/L | Units | mmol/L | Units | mmol/L |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 1.47 | Param Value | 1.37 | Param Value | 1.33 | Param Value | 38.7 | Param Value | 33.8 | Param Value | 36.7 | Param Value | 31.0 | Param Value | 41.3 | Param Value | 39.0 | Param Value | 1.79 | Param Value | 1.21 | Param Value | 1.48 | Param Value | 0.34 | Param Value | 0.43 | Param Value | 0.35 | Param Value | 0.40 | Param Value | 9.48 | Param Value | 7.87 | Param Value | 9.15 | Param Value | 7.28 | Param Value | 0.74 | Param Value | 0.89 | Param Value | 0.71 | Param Value | 1.1 | Param Value | 6.1 | Param Value | 6.6 | Param Value | 6.7 | Param Value | 6.6 | Param Value | 5.1 | Param Value | 4.9 | Param Value | 5.5 | Param Value | 4.5 | Param Value | 42.3 | Param Value | 39.7 | Param Value | 1.27 | Param Value | 1.17 | Param Value | 2.40 | Param Value | 2.91 | Param Value | 2.19 | Param Value | 2.72 | Param Value | 5.96 | Param Value | 5.43 | Param Value | 6.08 | Param Value | 5.47 |
Param Value Num | 1.47 | Param Value Num | 1.37 | Param Value Num | 1.33 | Param Value Num | 38.7 | Param Value Num | 33.8 | Param Value Num | 36.7 | Param Value Num | 31.0 | Param Value Num | 41.3 | Param Value Num | 39.0 | Param Value Num | 1.79 | Param Value Num | 1.21 | Param Value Num | 1.48 | Param Value Num | 0.34 | Param Value Num | 0.43 | Param Value Num | 0.35 | Param Value Num | 0.4 | Param Value Num | 9.48 | Param Value Num | 7.87 | Param Value Num | 9.15 | Param Value Num | 7.28 | Param Value Num | 0.74 | Param Value Num | 0.89 | Param Value Num | 0.71 | Param Value Num | 1.1 | Param Value Num | 6.1 | Param Value Num | 6.6 | Param Value Num | 6.7 | Param Value Num | 6.6 | Param Value Num | 5.1 | Param Value Num | 4.9 | Param Value Num | 5.5 | Param Value Num | 4.5 | Param Value Num | 42.3 | Param Value Num | 39.7 | Param Value Num | 1.27 | Param Value Num | 1.17 | Param Value Num | 2.4 | Param Value Num | 2.91 | Param Value Num | 2.19 | Param Value Num | 2.72 | Param Value Num | 5.96 | Param Value Num | 5.43 | Param Value Num | 6.08 | Param Value Num | 5.47 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Dispersion Value | 0.82 | Dispersion Value | 1.52 | Dispersion Value | 0.51 | Dispersion Value | 12.4 | Dispersion Value | 11.2 | Dispersion Value | 13.2 | Dispersion Value | 12.8 | Dispersion Value | 17.4 | Dispersion Value | 11.8 | Dispersion Value | 1.30 | Dispersion Value | 0.45 | Dispersion Value | 0.74 | Dispersion Value | 0.17 | Dispersion Value | 0.20 | Dispersion Value | 0.20 | Dispersion Value | 0.20 | Dispersion Value | 5.95 | Dispersion Value | 5.42 | Dispersion Value | 5.25 | Dispersion Value | 4.90 | Dispersion Value | 1.84 | Dispersion Value | 2.34 | Dispersion Value | 1.81 | Dispersion Value | 2.82 | Dispersion Value | 7.2 | Dispersion Value | 6.0 | Dispersion Value | 7.1 | Dispersion Value | 6.1 | Dispersion Value | 3.2 | Dispersion Value | 3.5 | Dispersion Value | 4.0 | Dispersion Value | 2.9 | Dispersion Value | 12.0 | Dispersion Value | 12.6 | Dispersion Value | 0.44 | Dispersion Value | 0.57 | Dispersion Value | 1.63 | Dispersion Value | 1.42 | Dispersion Value | 1.21 | Dispersion Value | 1.56 | Dispersion Value | 2.38 | Dispersion Value | 1.95 | Dispersion Value | 2.29 | Dispersion Value | 1.77 |
Dispersion Value Num | 0.82 | Dispersion Value Num | 1.52 | Dispersion Value Num | 0.51 | Dispersion Value Num | 12.4 | Dispersion Value Num | 11.2 | Dispersion Value Num | 13.2 | Dispersion Value Num | 12.8 | Dispersion Value Num | 17.4 | Dispersion Value Num | 11.8 | Dispersion Value Num | 1.3 | Dispersion Value Num | 0.45 | Dispersion Value Num | 0.74 | Dispersion Value Num | 0.17 | Dispersion Value Num | 0.2 | Dispersion Value Num | 0.2 | Dispersion Value Num | 0.2 | Dispersion Value Num | 5.95 | Dispersion Value Num | 5.42 | Dispersion Value Num | 5.25 | Dispersion Value Num | 4.9 | Dispersion Value Num | 1.84 | Dispersion Value Num | 2.34 | Dispersion Value Num | 1.81 | Dispersion Value Num | 2.82 | Dispersion Value Num | 7.2 | Dispersion Value Num | 6.0 | Dispersion Value Num | 7.1 | Dispersion Value Num | 6.1 | Dispersion Value Num | 3.2 | Dispersion Value Num | 3.5 | Dispersion Value Num | 4.0 | Dispersion Value Num | 2.9 | Dispersion Value Num | 12.0 | Dispersion Value Num | 12.6 | Dispersion Value Num | 0.44 | Dispersion Value Num | 0.57 | Dispersion Value Num | 1.63 | Dispersion Value Num | 1.42 | Dispersion Value Num | 1.21 | Dispersion Value Num | 1.56 | Dispersion Value Num | 2.38 | Dispersion Value Num | 1.95 | Dispersion Value Num | 2.29 | Dispersion Value Num | 1.77 |
Baseline Counts
Sequence: | 11388510 | Sequence: | 11388511 | Sequence: | 11388512 |
Result Group Id | 56113138 | Result Group Id | 56113139 | Result Group Id | 56113140 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 50 | Count | 47 | Count | 97 |
Result Groups
Sequence: | 56113138 | Sequence: | 56113139 | Sequence: | 56113140 | Sequence: | 56113141 | Sequence: | 56113142 | Sequence: | 56113143 | Sequence: | 56113144 | Sequence: | 56113145 | Sequence: | 56113146 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Standing and Social Intervention | Title | Control Group | Title | Total | Title | Standing and Social Intervention | Title | Control Group | Title | Standing and Social Intervention | Title | Control Group | Title | Standing and Social Intervention | Title | Control Group |
Description | Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday |
Description | Control group will receive social visits, but no exposure to standing | Description | Total of all reporting groups | Description | Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday |
Description | Control group will receive social visits, but no exposure to standing | Description | Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday |
Description | Control group will receive social visits, but no exposure to standing | Description | Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday |
Description | Control group will receive social visits, but no exposure to standing |
Baseline Measurements
Sequence: | 125657415 | Sequence: | 125657416 | Sequence: | 125657417 | Sequence: | 125657418 | Sequence: | 125657419 | Sequence: | 125657420 | Sequence: | 125657421 | Sequence: | 125657422 | Sequence: | 125657423 | Sequence: | 125657424 | Sequence: | 125657425 | Sequence: | 125657426 | Sequence: | 125657427 | Sequence: | 125657428 | Sequence: | 125657429 | Sequence: | 125657430 | Sequence: | 125657431 | Sequence: | 125657432 | Sequence: | 125657433 | Sequence: | 125657434 | Sequence: | 125657435 | Sequence: | 125657436 | Sequence: | 125657437 | Sequence: | 125657438 | Sequence: | 125657439 |
Result Group Id | 56113138 | Result Group Id | 56113139 | Result Group Id | 56113140 | Result Group Id | 56113138 | Result Group Id | 56113139 | Result Group Id | 56113140 | Result Group Id | 56113138 | Result Group Id | 56113139 | Result Group Id | 56113140 | Result Group Id | 56113140 | Result Group Id | 56113138 | Result Group Id | 56113139 | Result Group Id | 56113140 | Result Group Id | 56113138 | Result Group Id | 56113139 | Result Group Id | 56113140 | Result Group Id | 56113138 | Result Group Id | 56113139 | Result Group Id | 56113140 | Result Group Id | 56113138 | Result Group Id | 56113139 | Result Group Id | 56113140 | Result Group Id | 56113138 | Result Group Id | 56113139 | Result Group Id | 56113140 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | ||||||||||||||||||||||||||||||||||||||
Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race and Ethnicity Not Collected | Title | BMI | Title | BMI | Title | BMI | Title | Frailty | Title | Frailty | Title | Frailty | Title | Transfer Status (Independent Transfer) | Title | Transfer Status (Independent Transfer) | Title | Transfer Status (Independent Transfer) | Title | Length of stay in LTC | Title | Length of stay in LTC | Title | Length of stay in LTC | Title | Cognition (MMSE) | Title | Cognition (MMSE) | Title | Cognition (MMSE) |
Description | Frailty was measured using the Clinical Frailty Scale (1-9). 1 indicates very fit, 9 indicates terminally ill. LTC staff were asked to rate participants at pre and post intervention | Description | Frailty was measured using the Clinical Frailty Scale (1-9). 1 indicates very fit, 9 indicates terminally ill. LTC staff were asked to rate participants at pre and post intervention | Description | Frailty was measured using the Clinical Frailty Scale (1-9). 1 indicates very fit, 9 indicates terminally ill. LTC staff were asked to rate participants at pre and post intervention | Description | Transfer status was assessed by LTC staff following jurisdiction regulations (Work Safe New Brunswick). It is assessed upon admission, quarterly (90 days) and when a significant change in health status occurs (e.g., fall, stroke). For our study, we used the most recent Transfer status update. Residents were categorized as requiring no assistance to transfer from sit to stand (independent), requiring staff assistance to stand (assisted transfer), or requiring staff and mechanical assistance to stand (dependent). | Description | Transfer status was assessed by LTC staff following jurisdiction regulations (Work Safe New Brunswick). It is assessed upon admission, quarterly (90 days) and when a significant change in health status occurs (e.g., fall, stroke). For our study, we used the most recent Transfer status update. Residents were categorized as requiring no assistance to transfer from sit to stand (independent), requiring staff assistance to stand (assisted transfer), or requiring staff and mechanical assistance to stand (dependent). | Description | Transfer status was assessed by LTC staff following jurisdiction regulations (Work Safe New Brunswick). It is assessed upon admission, quarterly (90 days) and when a significant change in health status occurs (e.g., fall, stroke). For our study, we used the most recent Transfer status update. Residents were categorized as requiring no assistance to transfer from sit to stand (independent), requiring staff assistance to stand (assisted transfer), or requiring staff and mechanical assistance to stand (dependent). | Description | The mini-mental state examination was administered by research assistants at baseline to assess cognition. Scored out of 30, the questionnaire categorized a person as having none, mild or severe cognitive impairment. A score of 0-17 indicates severe cognitive impairment, 18-23 as mild, and 24-30 as no cognitive impairment. | Description | The mini-mental state examination was administered by research assistants at baseline to assess cognition. Scored out of 30, the questionnaire categorized a person as having none, mild or severe cognitive impairment. A score of 0-17 indicates severe cognitive impairment, 18-23 as mild, and 24-30 as no cognitive impairment. | Description | The mini-mental state examination was administered by research assistants at baseline to assess cognition. Scored out of 30, the questionnaire categorized a person as having none, mild or severe cognitive impairment. A score of 0-17 indicates severe cognitive impairment, 18-23 as mild, and 24-30 as no cognitive impairment. | ||||||||||||||||||||||||||||||||
Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | kg/m2 | Units | kg/m2 | Units | kg/m2 | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | Participants | Units | Participants | Units | Participants | Units | years | Units | years | Units | years | Units | units on a scale | Units | units on a scale | Units | units on a scale |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 87.14 | Param Value | 85.11 | Param Value | 86 | Param Value | 37 | Param Value | 31 | Param Value | 68 | Param Value | 13 | Param Value | 16 | Param Value | 29 | Param Value | 0 | Param Value | 26.93 | Param Value | 25.56 | Param Value | 26.2 | Param Value | 6 | Param Value | 6.13 | Param Value | 6.1 | Param Value | 8 | Param Value | 25 | Param Value | 33 | Param Value | 4.6 | Param Value | 3.9 | Param Value | 4.2 | Param Value | 15.76 | Param Value | 17.7 | Param Value | 16.7 |
Param Value Num | 87.14 | Param Value Num | 85.11 | Param Value Num | 86.0 | Param Value Num | 37.0 | Param Value Num | 31.0 | Param Value Num | 68.0 | Param Value Num | 13.0 | Param Value Num | 16.0 | Param Value Num | 29.0 | Param Value Num | 0.0 | Param Value Num | 26.93 | Param Value Num | 25.56 | Param Value Num | 26.2 | Param Value Num | 6.0 | Param Value Num | 6.13 | Param Value Num | 6.1 | Param Value Num | 8.0 | Param Value Num | 25.0 | Param Value Num | 33.0 | Param Value Num | 4.6 | Param Value Num | 3.9 | Param Value Num | 4.2 | Param Value Num | 15.76 | Param Value Num | 17.7 | Param Value Num | 16.7 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||
Dispersion Value | 8.46 | Dispersion Value | 7.63 | Dispersion Value | 8 | Dispersion Value | 6.53 | Dispersion Value | 9.01 | Dispersion Value | 7.8 | Dispersion Value | 1.5 | Dispersion Value | 0.8 | Dispersion Value | 1.2 | Dispersion Value | 5.4 | Dispersion Value | 3.5 | Dispersion Value | 4.5 | Dispersion Value | 9.2 | Dispersion Value | 8.8 | Dispersion Value | 9.0 | ||||||||||||||||||||
Dispersion Value Num | 8.46 | Dispersion Value Num | 7.63 | Dispersion Value Num | 8.0 | Dispersion Value Num | 6.53 | Dispersion Value Num | 9.01 | Dispersion Value Num | 7.8 | Dispersion Value Num | 1.5 | Dispersion Value Num | 0.8 | Dispersion Value Num | 1.2 | Dispersion Value Num | 5.4 | Dispersion Value Num | 3.5 | Dispersion Value Num | 4.5 | Dispersion Value Num | 9.2 | Dispersion Value Num | 8.8 | Dispersion Value Num | 9.0 | ||||||||||||||||||||
Number Analyzed | 50 | Number Analyzed | 47 | Number Analyzed | 97 | Number Analyzed | 50 | Number Analyzed | 47 | Number Analyzed | 97 | Number Analyzed | 50 | Number Analyzed | 47 | Number Analyzed | 97 | Number Analyzed | 97 | Number Analyzed | 50 | Number Analyzed | 47 | Number Analyzed | 97 | Number Analyzed | 50 | Number Analyzed | 47 | Number Analyzed | 97 | Number Analyzed | 50 | Number Analyzed | 47 | Number Analyzed | 97 | Number Analyzed | 50 | Number Analyzed | 47 | Number Analyzed | 97 | Number Analyzed | 50 | Number Analyzed | 47 | Number Analyzed | 97 |
Population Description | Race and Ethnicity were not collected from any participant. | ||||||||||||||||||||||||||||||||||||||||||||||||
]]>
https://zephyrnet.com/NCT03796026
2019-01-04
https://zephyrnet.com/?p=NCT03796026
NCT03796026https://www.clinicaltrials.gov/study/NCT03796026?tab=tableNANANAThe purpose of this study is to evaluate the effect of multiple doses of seltorexant compared with placebo on respiration during sleep in adult participants with mild to moderate obstructive sleep apnea.
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Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-06-10 |
Start Month Year | January 4, 2019 |
Primary Completion Month Year | June 7, 2019 |
Verification Month Year | June 2022 |
Verification Date | 2022-06-30 |
Last Update Posted Date | 2022-06-10 |
Facilities
Sequence: | 198783018 | Sequence: | 198783019 | Sequence: | 198783020 | Sequence: | 198783021 |
Name | NeuroTrials Research, Inc. | Name | Clinilabs | Name | CTI Clinical Trial and Consulting Services | Name | AMR New Orleans, Formerly New Orleans Center for Clinical Research – New Orleans, an AMR company |
City | Atlanta | City | New York | City | Cincinnati | City | Knoxville |
State | Georgia | State | New York | State | Ohio | State | Tennessee |
Zip | 30342 | Zip | 10019 | Zip | 45212 | Zip | 37923 |
Country | United States | Country | United States | Country | United States | Country | United States |
Conditions
Sequence: | 51850227 |
Name | Sleep Apnea, Obstructive |
Downcase Name | sleep apnea, obstructive |
Id Information
Sequence: | 39901940 | Sequence: | 39901941 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | CR108576 | Id Value | 42847922MDD1010 |
Id Type | Other Identifier | ||
Id Type Description | Janssen Research & Development, LLC | ||
Countries
Sequence: | 42300029 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55276862 | Sequence: | 55276863 |
Group Type | Experimental | Group Type | Experimental |
Title | Seltorexant Followed by Placebo | Title | Placebo Followed by Seltorexant |
Description | Participants will receive seltorexant (40 milligram [mg] capsules) once daily for 4 consecutive days, and after a washout period of 7 to 10 days, participants will receive matching placebo orally once daily for 4 consecutive days. | Description | Participants will receive placebo once daily for 4 consecutive days, and after a washout period of 7 to 10 days, participants will receive seltorexant (40 mg capsules) orally once daily for 4 consecutive days. |
Interventions
Sequence: | 52170797 | Sequence: | 52170798 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Seltorexant 40 mg | Name | Placebo |
Description | Seltorexant 40 mg capsules (over-encapsulated tablets) will be administered orally. | Description | Matching placebo to seltorexant 40 mg capsules (over-encapsulated tablets) will be administered orally. |
Design Outcomes
Sequence: | 176338198 | Sequence: | 176338199 | Sequence: | 176338200 | Sequence: | 176338201 | Sequence: | 176338202 | Sequence: | 176338203 | Sequence: | 176338204 | Sequence: | 176338205 | Sequence: | 176338206 | Sequence: | 176338207 | Sequence: | 176338208 | Sequence: | 176338209 | Sequence: | 176338210 | Sequence: | 176338211 | Sequence: | 176338212 | Sequence: | 176338213 | Sequence: | 176338214 | Sequence: | 176338215 | Sequence: | 176338216 | Sequence: | 176338217 | Sequence: | 176338218 | Sequence: | 176338219 | Sequence: | 176338220 | Sequence: | 176338221 | Sequence: | 176338222 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Apnea-Hypopnea Index (AHI) Score as Measured by Polysomnography (PSG) | Measure | AHI Score as Measured by PSG | Measure | Mean Oxygen Saturation (SpO2) During Total Sleep Time (TST) | Measure | Mean SpO2 During Rapid Eye Movement (REM), Non-Rapid Eye Movement (NREM), and Awake Stages | Measure | Percentage of Total Sleep Time with SpO2 less than 90 percent (%), 85%, and 80% | Measure | Mean Latency to Persistent Sleep (LPS) as Assessed by PSG | Measure | Wake After Sleep Onset (WASO) by PSG | Measure | Sleep Efficiency (SE) by PSG | Measure | Total Sleep Time (TST) | Measure | Rapid Eye Movement (REM) Sleep Latency | Measure | Total Duration of Rapid Eye Movement (REM) Sleep | Measure | NREM Sleep Latency | Measure | Total Duration of NREM Sleep | Measure | Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | Measure | Percentage of Participants with all Serious Adverse Events (SAEs) and Events of Special Interest | Measure | Number of Participants with Clinically Significant Vital Signs Abnormalities | Measure | Number of Participants with Clinically Significant Physical Examination Abnormalities | Measure | Number of Participants with Clinically Significant Electrocardiogram (ECG) Abnormalities | Measure | Number of Participants with Clinically Significant Laboratory Abnormalities | Measure | Number of participants with suicidal ideation measured using Columbia Suicide Severity Rating Scale (C-SSRS) | Measure | Bond-Lader Visual Analog Scales (B-L VAS) Score | Measure | Next-Day Residual Effect Measured by the Karolinska Sleepiness Scale (KSS) Score | Measure | Residual Effect on a Cognitive Test Battery Evaluated by Symbol Digit Modalities Test (SDMT) | Measure | Performance Score on a Cognitive Test Battery Evaluated by Trail Making Test Form B (TMT-B) | Measure | Residual Effect on Cognitive Function Measured by Hopkins Verbal Learning Test-Revised (HVLT-R) |
Time Frame | Day 4 | Time Frame | Day 1 (Night) | Time Frame | Nights 1 and 4 | Time Frame | Nights 1 and 4 | Time Frame | Nights 1 and 4 | Time Frame | Nights 1 and 4 | Time Frame | Nights 1 and 4 | Time Frame | Days 1, 2, 3, and 4 | Time Frame | Nights 1 and 4 | Time Frame | Nights 1 and 4 | Time Frame | Nights 1 and 4 | Time Frame | Nights 1 and 4 | Time Frame | Nights 1 and 4 | Time Frame | Baseline up to end of study (approximately up to 9 weeks) | Time Frame | Baseline up to end of study (approximately up to 9 weeks) | Time Frame | Baseline up to end of study (approximately up to 9 weeks) | Time Frame | Baseline up to end of study (approximately up to 9 weeks) | Time Frame | Baseline up to end of study (approximately up to 9 weeks) | Time Frame | Baseline up to end of study (approximately up to 9 weeks) | Time Frame | Baseline, Days 1, 2, 4, 5, and end of study (approximately 9 weeks) | Time Frame | Baseline, Day 2, and Day 5 | Time Frame | Baseline, Day 2, and Day 5 | Time Frame | Baseline and Day 5 | Time Frame | Baseline and Day 5 | Time Frame | Baseline and Day 5 |
Description | AHI score is used to indicate the severity of sleep apnea. The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The AHI values for adults are categorized as: Normal: AHI less than (<)5, Mild sleep apnea: 5 less than or equal to (<=) AHI <15, Moderate sleep apnea: 15<= AHI <30, and Severe sleep apnea: AHI greater than or equal to (>=)30. | Description | AHI score is used to indicate the severity of sleep apnea. The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The AHI values for adults are categorized as: Normal: AHI <5, Mild sleep apnea: 5<= AHI <15, Moderate sleep apnea: 15<= AHI <30, and Severe sleep apnea: AHI >=30. | Description | The mean SpO2 during TST on Night 4 and Night 1 will be assessed by continuous finger pulse oximetry. | Description | The mean SpO2 during REM, NREM and awake stages of sleep will be assessed by continuous finger pulse oximetry. | Description | The percentage of TST with SpO2 level less than 90%, 85%, and 80% during the night, assessed by continuous finger pulse oximetry will be reported. | Description | LPS is a sleep parameter and will be measured by PSG during PSG screening. Elapsed time from the beginning of the PSG recording to the onset of the first 10 minutes of continuous sleep will be measured over 4 nights and the average time to sleep will be calculated. | Description | WASO is a sleep parameter and will be measured by PSG during PSG screening. WASO is measured during overnight sleep laboratory PSG assessment and is defined as the duration of wakefulness from the onset of persistent sleep (that is, 10 consecutive minutes of sleep) over the first 6 hours of PSG assessment. The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording. | Description | SE is a sleep parameter and will be measured by PSG during PSG screening. The total sleep time divided by the total time in bed (that is, the number of minutes from the beginning of the PSG recording to the end of the recording). | Description | TST is a sleep parameter and will be measured by PSG during PSG screening. All of the hours of non-rapid eye movement (NREM) and rapid eye movement (REM) sleep, as measured by PSG, are summed to determine the TST. | Description | REM sleep is a normal stage of sleep characterized by the rapid and random movement of the eyes. REM sleep latency is the time from sleep onset until first period of REM sleep. PSG recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep). | Description | PSG recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep). It will be calculated as number of epochs scored as REM sleep divided by 2. | Description | NREM sleep latency is the time from sleep onset until first period of NREM sleep. Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: NREM sleep). | Description | Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: NREM sleep). It will be calculated as number of epochs scored as NREM sleep divided by 2. | Description | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Description | An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. All SAEs and events of special interest including cataplexy (sudden, transient episode of muscle weakness accompanied by conscious awareness), sleep paralysis (the experience of not being able to move, react, or speak when falling asleep/awakening), and complex, sleep-related behaviors/parasomnias such as confusional arousals, somnambulism (sleep walking), sleep terrors, bruxism (teeth grinding), sleep sex, sleep related eating disorder, sleep behavior disorder, and catathrenia (Rapid Eye Movement [REM]-associated end-inspiratory apnea/breath holding) will be reported. | Description | Number of participants with clinically significant abnormalities in the vital signs including temperature, pulse/heart rate, respiratory rate, and blood pressure will be reported. | Description | Number of participants with clinically significant abnormalities in the physical examination including examination of height, body weight, and waist circumference will be reported. | Description | Number of participants with clinically significant abnormalities in the ECG will be reported. | Description | Blood samples for serum chemistry, hematology, and urinalysis will be collected for clinical laboratory testing. | Description | C-SSRS is a clinician rated assessment of suicidal behavior and / or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses are listed. Worsening of suicidal ideation indicates an increase in severity of suicidal ideation from baseline. | Description | The B-L VAS is a patient-rated scale designed to assess the current level of sedation and consists of sixteen 100-milliliter (mm) VAS anchored by antonyms (Alert-Drowsy, Lethargic-Energetic). Scores are combined to form 3 mood factors: alertness, calmness, and contentedness. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy). | Description | The KSS is a patient reported assessment of level of drowsiness at the time of scale administration. This scale is focused mainly on the propensity to fall asleep and has a high validity in measuring sleepiness. It consists of a 9-point Likert scale with response options from: 1=very alert, 3=alert, 5=neither alert nor sleepy, 7=sleepy (but not fighting sleep), 9=very sleepy (fighting sleep). | Description | The SDMT is a widely used, paper-and-pencil assessment of complex scanning and visual tracking, requiring elements of attention, visuoperceptual processing, working memory, and cognitive/psychomotor speed. The test is viewed as a robust screening test for adult neuropsychological impairment and has been used to demonstrate worse cognitive functioning in patients with MDD. The test includes a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. Following the key, the participant is presented with randomly ordered symbols and is required to write the number corresponding to each symbol as fast as possible. The number of correct substitutions within 90 seconds is recorded by examiner-administered cognitive test battery. | Description | The TMT-B measures divided attention and executive function (tracking and sequencing). The participant is instructed to draw a line to connect a set of 25 consecutively numbered and lettered circles, alternating sequentially between numbers and letters (that is, 1-A-2-B). The participant is instructed to work as quickly as possible while still maintaining accuracy. The TMT-B has acceptable reliability; reliability coefficients have typically been reported as exceeding 0.65. The TMT-B is sensitive to cognitive decline associated with MDD. | Description | The HVLT-R, a measure of verbal learning and memory, is a 12-item word list recall test. Administration includes 3 learning trials, a delayed recall (20-minute) trial, and a 24-word recognition list (including 12 target and 12 foil words). The test administrator reads instructions and word lists aloud, and records words recalled/recognized by the participant. Three learning trials are combined to calculate a total recall score learning, delayed recall, and recognition trials. |
Browse Conditions
Sequence: | 192190949 | Sequence: | 192190950 | Sequence: | 192190951 | Sequence: | 192190952 | Sequence: | 192190953 | Sequence: | 192190954 | Sequence: | 192190955 | Sequence: | 192190956 | Sequence: | 192190957 | Sequence: | 192190958 |
Mesh Term | Apnea | Mesh Term | Sleep Apnea Syndromes | Mesh Term | Sleep Apnea, Obstructive | Mesh Term | Respiration Disorders | Mesh Term | Respiratory Tract Diseases | Mesh Term | Signs and Symptoms, Respiratory | Mesh Term | Sleep Disorders, Intrinsic | Mesh Term | Dyssomnias | Mesh Term | Sleep Wake Disorders | Mesh Term | Nervous System Diseases |
Downcase Mesh Term | apnea | Downcase Mesh Term | sleep apnea syndromes | Downcase Mesh Term | sleep apnea, obstructive | Downcase Mesh Term | respiration disorders | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | signs and symptoms, respiratory | Downcase Mesh Term | sleep disorders, intrinsic | Downcase Mesh Term | dyssomnias | Downcase Mesh Term | sleep wake disorders | Downcase Mesh Term | nervous system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48022590 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Janssen Research & Development, LLC |
Overall Officials
Sequence: | 29098478 |
Role | Study Director |
Name | Janssen Research & Development, LLC Clinical Trial |
Affiliation | Janssen Research & Development, LLC |
Design Group Interventions
Sequence: | 67763580 | Sequence: | 67763581 | Sequence: | 67763582 | Sequence: | 67763583 |
Design Group Id | 55276863 | Design Group Id | 55276862 | Design Group Id | 55276863 | Design Group Id | 55276862 |
Intervention Id | 52170797 | Intervention Id | 52170797 | Intervention Id | 52170798 | Intervention Id | 52170798 |
Eligibilities
Sequence: | 30577752 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Participant must be a women of non-childbearing potential (WONCBP) or man. A WONCBP is defined as: a) Postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; b) Permanently sterile (permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy Exclusion Criteria: Has a history of, or current signs and symptoms of, severe renal insufficiency (creatinine clearance <30 milliliter per minute [mL/min]); moderate to severe hepatic insufficiency (Child-Pugh Score >=7), significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic, or endocrine disorders (including uncontrolled hypo- or hyperthyroidism or diabetes mellitus). Participants with diabetes mellitus who are under good control (hemoglobin A1c [HbA1c] <= 8.5 percent [%] and fasting glucose <=140 milligram per deciliter [mg/dL] at screening) may be eligible to participate if otherwise medically healthy, and if on a stable regimen of glucose-lowering medications for at least 2 months prior to screening |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254301447 |
Number Of Facilities | 4 |
Registered In Calendar Year | 2019 |
Actual Duration | 5 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 24 |
Designs
Sequence: | 30325943 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Investigator Masked | True |
Intervention Other Names
Sequence: | 26519137 |
Intervention Id | 52170797 |
Name | JNJ-42847922 |
Responsible Parties
Sequence: | 28704692 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03796013
2019-01-10
https://zephyrnet.com/?p=NCT03796013
NCT03796013https://www.clinicaltrials.gov/study/NCT03796013?tab=tableNANANAThis study aims to demonstrate similarities between two different forms of entrectinib (A and C) when administered under fasted conditions in healthy subjects.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-03-09 |
Start Month Year | January 10, 2019 |
Primary Completion Month Year | February 6, 2019 |
Verification Month Year | February 2020 |
Verification Date | 2020-02-29 |
Last Update Posted Date | 2020-03-09 |
Results First Posted Date | 2020-03-09 |
Facilities
Sequence: | 198555260 |
Name | Covance Research Unit – Dallas |
City | Dallas |
State | Texas |
Zip | 75247 |
Country | United States |
Browse Interventions
Sequence: | 95262862 | Sequence: | 95262863 | Sequence: | 95262864 | Sequence: | 95262865 |
Mesh Term | Entrectinib | Mesh Term | Protein Kinase Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | entrectinib | Downcase Mesh Term | protein kinase inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51768966 |
Name | Healthy Volunteers |
Downcase Name | healthy volunteers |
Id Information
Sequence: | 39838377 |
Id Source | org_study_id |
Id Value | GP41049 |
Countries
Sequence: | 42236618 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55187950 | Sequence: | 55187951 |
Group Type | Experimental | Group Type | Experimental |
Title | Form A to Form C Crossover | Title | Form C to Form A Crossover |
Description | Participants first randomized to this arm will receive a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of each Period. This dose will be followed by a minimum 14-day washout period, after which participants will receive a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days). | Description | Participants first randomized to this arm will receive a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of each Period. This dose will be followed by a minimum 14-day washout period, after which participants will receive a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days). |
Interventions
Sequence: | 52090625 | Sequence: | 52090626 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Entrectinib Form A | Name | Entrectinib Form C |
Description | Participants will receive a single oral dose of entrectinib form A under fasted conditions. | Description | Participants will receive a single oral dose of entrectinib form C under fasted conditions. |
Design Outcomes
Sequence: | 176078397 | Sequence: | 176078398 | Sequence: | 176078399 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary |
Measure | Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite | Measure | Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite | Measure | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
Time Frame | At pre-defined intervals from Hour 0 through Day 5 of each study Period (Periods 1 and 2 = 6 days) | Time Frame | At pre-defined intervals from Hour 0 through Day 5 of each study Period (Periods 1 and 2 = 6 days) | Time Frame | Baseline through the end of study (up to clinical cut-off date 06 Feb 2019 [28 days]) |
Description | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
Sponsors
Sequence: | 47944492 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Genentech, Inc. |
Overall Officials
Sequence: | 29048863 |
Role | Study Director |
Name | Clinical Trials |
Affiliation | Hoffmann-La Roche |
Design Group Interventions
Sequence: | 67660225 | Sequence: | 67660226 | Sequence: | 67660227 | Sequence: | 67660228 |
Design Group Id | 55187950 | Design Group Id | 55187951 | Design Group Id | 55187950 | Design Group Id | 55187951 |
Intervention Id | 52090625 | Intervention Id | 52090625 | Intervention Id | 52090626 | Intervention Id | 52090626 |
Eligibilities
Sequence: | 30529694 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Healthy in the opinion of the investigator. Healthy is defined by the absence of evidence of any active disease or clinically significant medical condition based on a detailed medical history and examination Exclusion Criteria: History of gastrointestinal surgery or other gastrointestinal disorder that might affect absorption of medicines from the gastrointestinal tract |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254104823 |
Number Of Facilities | 1 |
Number Of Nsae Subjects | 4 |
Registered In Calendar Year | 2019 |
Actual Duration | 0 |
Were Results Reported | True |
Months To Report Results | 11 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30278375 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Milestones
Sequence: | 40762336 | Sequence: | 40762337 | Sequence: | 40762338 | Sequence: | 40762339 | Sequence: | 40762340 | Sequence: | 40762341 | Sequence: | 40762342 | Sequence: | 40762343 | Sequence: | 40762344 | Sequence: | 40762345 | Sequence: | 40762346 | Sequence: | 40762347 |
Result Group Id | 55835860 | Result Group Id | 55835861 | Result Group Id | 55835860 | Result Group Id | 55835861 | Result Group Id | 55835860 | Result Group Id | 55835861 | Result Group Id | 55835860 | Result Group Id | 55835861 | Result Group Id | 55835860 | Result Group Id | 55835861 | Result Group Id | 55835860 | Result Group Id | 55835861 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Period 1 | Period | Period 1 | Period | Period 1 | Period | Period 1 | Period | Period 1 | Period | Period 1 | Period | Period 2 | Period | Period 2 | Period | Period 2 | Period | Period 2 | Period | Period 2 | Period | Period 2 |
Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 0 | Count | 0 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 0 | Count | 0 |
Participant Flows
Sequence: | 3898683 |
Outcome Counts
Sequence: | 73531528 | Sequence: | 73531529 | Sequence: | 73531530 | Sequence: | 73531531 | Sequence: | 73531532 | Sequence: | 73531533 |
Outcome Id | 30610058 | Outcome Id | 30610058 | Outcome Id | 30610059 | Outcome Id | 30610059 | Outcome Id | 30610060 | Outcome Id | 30610060 |
Result Group Id | 55835862 | Result Group Id | 55835863 | Result Group Id | 55835862 | Result Group Id | 55835863 | Result Group Id | 55835862 | Result Group Id | 55835863 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 28 | Count | 28 | Count | 28 | Count | 28 | Count | 28 | Count | 28 |
Provided Documents
Sequence: | 2566480 | Sequence: | 2566481 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2018-11-05 | Document Date | 2019-01-31 |
Url | https://ClinicalTrials.gov/ProvidedDocs/13/NCT03796013/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/13/NCT03796013/SAP_001.pdf |
Reported Event Totals
Sequence: | 27776965 | Sequence: | 27776966 | Sequence: | 27776967 | Sequence: | 27776968 | Sequence: | 27776969 | Sequence: | 27776970 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 28 | Subjects At Risk | 28 | Subjects At Risk | 28 | Subjects At Risk | 28 | Subjects At Risk | 28 | Subjects At Risk | 28 |
Created At | 2023-08-06 15:14:11.904880 | Created At | 2023-08-06 15:14:11.904880 | Created At | 2023-08-06 15:14:11.904880 | Created At | 2023-08-06 15:14:11.904880 | Created At | 2023-08-06 15:14:11.904880 | Created At | 2023-08-06 15:14:11.904880 |
Updated At | 2023-08-06 15:14:11.904880 | Updated At | 2023-08-06 15:14:11.904880 | Updated At | 2023-08-06 15:14:11.904880 | Updated At | 2023-08-06 15:14:11.904880 | Updated At | 2023-08-06 15:14:11.904880 | Updated At | 2023-08-06 15:14:11.904880 |
Reported Events
Sequence: | 524410874 | Sequence: | 524410875 | Sequence: | 524410876 | Sequence: | 524410877 | Sequence: | 524410878 | Sequence: | 524410879 |
Result Group Id | 55835864 | Result Group Id | 55835865 | Result Group Id | 55835864 | Result Group Id | 55835865 | Result Group Id | 55835864 | Result Group Id | 55835865 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Time Frame | Baseline through the end of study (up to clinical cut-off date 06 Feb 2019 [28 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 06 Feb 2019 [28 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 06 Feb 2019 [28 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 06 Feb 2019 [28 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 06 Feb 2019 [28 days]) | Time Frame | Baseline through the end of study (up to clinical cut-off date 06 Feb 2019 [28 days]) |
Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other |
Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 |
Subjects At Risk | 28 | Subjects At Risk | 28 | Subjects At Risk | 28 | Subjects At Risk | 28 | Subjects At Risk | 28 | Subjects At Risk | 28 |
Description | The Safety Population consisted of all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population consisted of all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population consisted of all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population consisted of all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population consisted of all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Description | The Safety Population consisted of all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. |
Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders |
Adverse Event Term | Arthropod bite | Adverse Event Term | Arthropod bite | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Nasal congestion | Adverse Event Term | Nasal congestion |
Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 |
Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 | Vocab | MedDRA 21.1 |
Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment |
Responsible Parties
Sequence: | 28657604 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3829427 |
Pi Employee | No |
Restriction Type | OTHER |
Other Details | The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights. |
Restrictive Agreement | The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights. |
Result Contacts
Sequence: | 3829392 |
Organization | Hoffmann-La Roche |
Name | Medical Communications |
Phone | 800 821-8590 |
genentech@druginfo.com | |
Outcomes
Sequence: | 30610059 | Sequence: | 30610058 | Sequence: | 30610060 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary |
Title | Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite | Title | Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite | Title | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
Description | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | ||||
Time Frame | At pre-defined intervals from Hour 0 through Day 5 of each study Period (Periods 1 and 2 = 6 days) | Time Frame | At pre-defined intervals from Hour 0 through Day 5 of each study Period (Periods 1 and 2 = 6 days) | Time Frame | Baseline through the end of study (up to clinical cut-off date 06 Feb 2019 [28 days]) |
Population | The PK Population consisted of all participants who received at least 1 dose of study drug and had at least 1 evaluable postdose PK sample. | Population | The PK Population consisted of all participants who received at least 1 dose of study drug and had at least 1 evaluable postdose pharmacokinetic (PK) sample. | Population | The Safety Population consisted of all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. |
Units | nmol/L | Units | nmol*h/L | Units | Percentage of Participants |
Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | ||
Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Number |
Outcome Measurements
Sequence: | 234085135 | Sequence: | 234085136 | Sequence: | 234085137 | Sequence: | 234085138 | Sequence: | 234085139 | Sequence: | 234085140 | Sequence: | 234085141 | Sequence: | 234085142 | Sequence: | 234085143 | Sequence: | 234085144 |
Outcome Id | 30610058 | Outcome Id | 30610058 | Outcome Id | 30610058 | Outcome Id | 30610058 | Outcome Id | 30610059 | Outcome Id | 30610059 | Outcome Id | 30610059 | Outcome Id | 30610059 | Outcome Id | 30610060 | Outcome Id | 30610060 |
Result Group Id | 55835862 | Result Group Id | 55835863 | Result Group Id | 55835862 | Result Group Id | 55835863 | Result Group Id | 55835862 | Result Group Id | 55835863 | Result Group Id | 55835862 | Result Group Id | 55835863 | Result Group Id | 55835862 | Result Group Id | 55835863 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Classification | Entrectinib | Classification | Entrectinib | Classification | M5 metabolite | Classification | M5 metabolite | Classification | Entrectinib | Classification | Entrectinib | Classification | M5 metabolite | Classification | M5 metabolite | ||||
Title | Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite | Title | Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite | Title | Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite | Title | Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite | Title | Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite | Title | Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite | Title | Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite | Title | Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite | Title | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Title | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
Description | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Description | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | ||||||||||||||||
Units | nmol*h/L | Units | nmol*h/L | Units | nmol*h/L | Units | nmol*h/L | Units | nmol/L | Units | nmol/L | Units | nmol/L | Units | nmol/L | Units | Percentage of Participants | Units | Percentage of Participants |
Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Number | Param Type | Number |
Param Value | 18500 | Param Value | 16600 | Param Value | 3610 | Param Value | 3070 | Param Value | 796 | Param Value | 726 | Param Value | 138 | Param Value | 114 | Param Value | 7.1 | Param Value | 0 |
Param Value Num | 18500.0 | Param Value Num | 16600.0 | Param Value Num | 3610.0 | Param Value Num | 3070.0 | Param Value Num | 796.0 | Param Value Num | 726.0 | Param Value Num | 138.0 | Param Value Num | 114.0 | Param Value Num | 7.1 | Param Value Num | 0.0 |
Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | ||||
Dispersion Value | 37.9 | Dispersion Value | 30.7 | Dispersion Value | 37.0 | Dispersion Value | 36.9 | Dispersion Value | 35.6 | Dispersion Value | 28.9 | Dispersion Value | 47.9 | Dispersion Value | 50.3 | ||||
Dispersion Value Num | 37.9 | Dispersion Value Num | 30.7 | Dispersion Value Num | 37.0 | Dispersion Value Num | 36.9 | Dispersion Value Num | 35.6 | Dispersion Value Num | 28.9 | Dispersion Value Num | 47.9 | Dispersion Value Num | 50.3 | ||||
Baseline Counts
Sequence: | 11317264 | Sequence: | 11317265 | Sequence: | 11317266 |
Result Group Id | 55835857 | Result Group Id | 55835858 | Result Group Id | 55835859 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 14 | Count | 14 | Count | 28 |
Result Groups
Sequence: | 55835857 | Sequence: | 55835858 | Sequence: | 55835859 | Sequence: | 55835860 | Sequence: | 55835861 | Sequence: | 55835862 | Sequence: | 55835863 | Sequence: | 55835864 | Sequence: | 55835865 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Form A to Form C Crossover | Title | Form C to Form A Crossover | Title | Total | Title | Form A to Form C Crossover | Title | Form C to Form A Crossover | Title | Form A Reference Formulation | Title | Form C Test Formulation | Title | Form A Reference Formulation | Title | Form C Test Formulation |
Description | Participants first randomized to this arm received a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of Period 1. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days). | Description | Participants first randomized to this arm received a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of Period 1. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days). | Description | Total of all reporting groups | Description | Participants first randomized to this arm received a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of Period 1. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days). | Description | Participants first randomized to this arm received a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of Period 1. This dose was followed by a minimum 14-day washout period, after which participants received a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days). | Description | Participants who received a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of Period 1 and Day 1 of Period 2 (Periods 1 and 2 = 6 days). | Description | Participants who received a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of Period 1 and Day 1 of Period 2 (Periods 1 and 2 = 6 days). | Description | Participants who received a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of Period 1 and Day 1 of Period 2 (Periods 1 and 2 = 6 days). | Description | Participants who received a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of Period 1 and Day 1 of Period 2 (Periods 1 and 2 = 6 days). |
Baseline Measurements
Sequence: | 124879624 | Sequence: | 124879625 | Sequence: | 124879626 | Sequence: | 124879627 | Sequence: | 124879628 | Sequence: | 124879629 | Sequence: | 124879630 | Sequence: | 124879631 | Sequence: | 124879632 | Sequence: | 124879633 | Sequence: | 124879634 | Sequence: | 124879635 | Sequence: | 124879636 | Sequence: | 124879637 | Sequence: | 124879638 | Sequence: | 124879639 | Sequence: | 124879640 | Sequence: | 124879641 | Sequence: | 124879642 | Sequence: | 124879643 | Sequence: | 124879644 | Sequence: | 124879645 | Sequence: | 124879646 | Sequence: | 124879647 | Sequence: | 124879648 | Sequence: | 124879649 | Sequence: | 124879650 |
Result Group Id | 55835857 | Result Group Id | 55835858 | Result Group Id | 55835859 | Result Group Id | 55835857 | Result Group Id | 55835858 | Result Group Id | 55835859 | Result Group Id | 55835857 | Result Group Id | 55835858 | Result Group Id | 55835859 | Result Group Id | 55835857 | Result Group Id | 55835858 | Result Group Id | 55835859 | Result Group Id | 55835857 | Result Group Id | 55835858 | Result Group Id | 55835859 | Result Group Id | 55835857 | Result Group Id | 55835858 | Result Group Id | 55835859 | Result Group Id | 55835857 | Result Group Id | 55835858 | Result Group Id | 55835859 | Result Group Id | 55835857 | Result Group Id | 55835858 | Result Group Id | 55835859 | Result Group Id | 55835857 | Result Group Id | 55835858 | Result Group Id | 55835859 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | White | Category | White | Category | White | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Asian | Category | Asian | Category | Asian | Category | Multiple | Category | Multiple | Category | Multiple | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | ||||||
Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized |
Units | Years | Units | Years | Units | Years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 43.9 | Param Value | 44.4 | Param Value | 44 | Param Value | 6 | Param Value | 5 | Param Value | 11 | Param Value | 8 | Param Value | 9 | Param Value | 17 | Param Value | 8 | Param Value | 8 | Param Value | 16 | Param Value | 5 | Param Value | 5 | Param Value | 10 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 5 | Param Value | 3 | Param Value | 8 | Param Value | 9 | Param Value | 11 | Param Value | 20 |
Param Value Num | 43.9 | Param Value Num | 44.4 | Param Value Num | 44.0 | Param Value Num | 6.0 | Param Value Num | 5.0 | Param Value Num | 11.0 | Param Value Num | 8.0 | Param Value Num | 9.0 | Param Value Num | 17.0 | Param Value Num | 8.0 | Param Value Num | 8.0 | Param Value Num | 16.0 | Param Value Num | 5.0 | Param Value Num | 5.0 | Param Value Num | 10.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 8.0 | Param Value Num | 9.0 | Param Value Num | 11.0 | Param Value Num | 20.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 8.4 | Dispersion Value | 11.7 | Dispersion Value | 10.4 | ||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 8.4 | Dispersion Value Num | 11.7 | Dispersion Value Num | 10.4 | ||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 28 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 28 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 28 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 28 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 28 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 28 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 28 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 28 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 28 |
]]>
https://zephyrnet.com/NCT03796000
2018-05-14
https://zephyrnet.com/?p=NCT03796000
NCT03796000https://www.clinicaltrials.gov/study/NCT03796000?tab=tableNANANAThis is a prospective, observational study aiming at improving the understanding of the pathophysiology of metabolic disease. As inflammation has been recognized as a key characteristic of metabolic disease but its starting point is still unknown, the investigators’ aim is to characterize intestinal macrophages from human gut biopsies taken in diagnostic endoscopies of the gastrointestinal tract or in bariatric surgeries for clinical reasons.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-21 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-06-23 |
Start Month Year | May 14, 2018 |
Primary Completion Month Year | April 14, 2022 |
Verification Month Year | June 2022 |
Verification Date | 2022-06-30 |
Last Update Posted Date | 2022-06-23 |
Detailed Descriptions
Sequence: | 20654972 |
Description | Metabolic disease including obesity and diabetes has reached epidemic proportions in the past years. Besides classical risk factors such as unhealthy diet and physical inactivity, smoking and air pollution have also emerged as unexpected risk factors for type 2 Diabetes.
Inflammation has been reported as key characteristic of metabolic disease and is predictive of future cardiovascular events. However, the starting point of chronic low-grade inflammation is not known. As the gastrointestinal tract first comes into contact with dietary components, but potentially also air pollution/ smoke particles ingested upon mucociliary clearance from the lung, the gut could be the starting point of inflammation in metabolic disease. The aim of this study is to characterize intestinal macrophages in obese versus lean subjects and smokers versus non-smokers to translate the principal investigator's preclinical findings to human disease and assess whether an inflammatory shift prevails in human intestinal macrophages in metabolic disease. Additionally, to assess whether intestinal macrophage subpopulations can be altered deliberately by nutritional intervention, the investigators will assess intestinal macrophages from subjects scheduled for bariatric surgery that will be on a calorie-restricted diet during the last 2 to 4 weeks prior to surgery. The macrophages originate from human gut samples. As patients will undergo diagnostic endoscopy of the gastrointestinal tract or bariatric surgery for clinical reasons and the standard of care will not be changed by the study, there will be no additional interventions to patients by their participation in the study. Additionally, three EDTA and one serum blood tube for the analysis of inflammatory cells and markers in the blood will be taken as well as a single stool sample. The investigators' goal is to recruit in total 150 patients as it will be a pilot study in a first step. |
Facilities
Sequence: | 199372664 |
Name | University Hospital Basel |
City | Basel |
State | Baselstadt |
Zip | 4031 |
Country | Switzerland |
Conditions
Sequence: | 51997951 |
Name | Metabolic Disease |
Downcase Name | metabolic disease |
Id Information
Sequence: | 40023640 | Sequence: | 40023641 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 2018-00712 | Id Value | 2018-00712 |
Id Type | Other Identifier | ||
Id Type Description | EKNZ | ||
Countries
Sequence: | 42418828 |
Name | Switzerland |
Removed | False |
Design Groups
Sequence: | 55402347 | Sequence: | 55402348 | Sequence: | 55402349 | Sequence: | 55402350 | Sequence: | 55402351 | Sequence: | 55402352 |
Title | colonoscopy: obese and smoker | Title | colonoscopy: obese and non-smoker | Title | colonoscopy: lean and smoker | Title | colonoscopy: lean and non-smoker | Title | gastroscopy: obese and non-smoker undergoing bariatric surgery | Title | gastroscopy: lean and non-smoker |
Description | 10 small tissue samples of the Colon transversum 3 EDTA blood samples and 1 Serum blood sample in some cases 1 single stool sample |
Description | 10 small tissue samples of the Colon transversum 3 EDTA blood samples and 1 Serum blood sample in some cases 1 single stool sample |
Description | 10 small tissue samples of the Colon transversum 3 EDTA blood samples and 1 Serum blood sample in some cases 1 single stool sample |
Description | 10 small tissue samples of the Colon transversum 3 EDTA blood samples and 1 Serum blood sample in some cases 1 single stool sample |
Description | 6 small tissue samples of the gastric corpus and 6 of the Duodenum 3 EDTA blood samples and 1 Serum blood sample in some cases 1 single stool sample 1cm long piece of the jejunum, which is usually disposed during bariatric surgery. |
Description | 6 small tissue samples of the gastric corpus and 6 of the Duodenum 3 EDTA blood samples and 1 Serum blood sample in some cases 1 single stool sample |
Interventions
Sequence: | 52310326 |
Intervention Type | Procedure |
Name | tissue samples, blood and stool sample |
Description | Tissue samples from gastroscopy/colonoscopy. |
Design Outcomes
Sequence: | 176771592 | Sequence: | 176771593 | Sequence: | 176771594 | Sequence: | 176771595 | Sequence: | 176771596 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Number of intestinal macrophages | Measure | Type and rate of subpopulations of intestinal macrophages | Measure | Number of other intestinal immune cells | Measure | Type and rate of subpopulations of other intestinal immune cells | Measure | Gene expression profile of intestinal macrophages |
Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years |
Description | Quantity (absolute and relative numbers) of intestinal macrophages in biopsies from the gastrointestinal tract in obese versus lean subjects and smokers versus non-smokers measured with flow cytometry. | Description | Quality (inflammatory versus non-inflammatory subpopulations) of intestinal macrophages in biopsies from the gastrointestinal tract in obese versus lean subjects and smokers versus non-smokers measured with flow cytometry. | Description | In case the investigators do not find clear differences in frequency of intestinal macrophages, they will assess other intestinal immune cells (e.g. B-, T-lymphocytes), and enteroendocrine cells (e.g. L-cells) as a secondary endpoint in an explorative manner. Additionally, the investigators aim to correlate their findings from the biopsy samples with inflammation markers and immune cells in the blood, with microbiota and immune cells in the stool and with the eating habits of the patients. | Description | In case the investigators do not find clear differences in subpopulations of intestinal macrophages, they will assess other intestinal immune cells (e.g. B-, T-lymphocytes), and enteroendocrine cells (e.g. L-cells) as a secondary endpoint in an explorative manner. Additionally, the investigators aim to correlate their findings from the biopsy samples with inflammation markers and immune cells in the blood, with microbiota and immune cells in the stool and with the eating habits of the patients. | Description | Gene expression of intestinal macrophages in biopsies from the colon in obese versus lean non-smokers by RNA sequencing. |
Browse Conditions
Sequence: | 192801405 |
Mesh Term | Metabolic Diseases |
Downcase Mesh Term | metabolic diseases |
Mesh Type | mesh-list |
Sponsors
Sequence: | 48157250 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University Hospital, Basel, Switzerland |
Overall Officials
Sequence: | 29186010 |
Role | Principal Investigator |
Name | Claudia Cavelti-Weder, PD Dr. med. |
Affiliation | University Hospital, Basel, Switzerland |
Design Group Interventions
Sequence: | 67917341 | Sequence: | 67917342 | Sequence: | 67917343 | Sequence: | 67917344 | Sequence: | 67917345 | Sequence: | 67917346 |
Design Group Id | 55402350 | Design Group Id | 55402349 | Design Group Id | 55402348 | Design Group Id | 55402347 | Design Group Id | 55402352 | Design Group Id | 55402351 |
Intervention Id | 52310326 | Intervention Id | 52310326 | Intervention Id | 52310326 | Intervention Id | 52310326 | Intervention Id | 52310326 | Intervention Id | 52310326 |
Eligibilities
Sequence: | 30663779 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 80 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | All patients planned for diagnostic endoscopy of the gastrointestinal tract or bariatric surgery at the University Hospital of Basel, the doctor's Office MagenDarm Basel or the Department of Visceral Surgery, Hospital Lindenhof of Bern will be screened for study participation, contacted and informed about the study if suitable to all inclusion and exclusion criterias. |
Criteria | Inclusion Criteria:
Patient undergoing colonoscopy: Obese (BMI > 32 kg/m2 ) and smoker (≥ 1 pack cigarettes/d) Patient undergoing gastroscopy: Obese (BMI > 35 kg/m2 ) and non-smoker planned for bariatric surgery Exclusion Criteria: Inability to provide informed consent, e.g. mental impairment or insufficient knowledge of project language |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254280730 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 47 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30410583 |
Observational Model | Cohort |
Time Perspective | Prospective |
Provided Documents
Sequence: | 2573020 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2018-11-12 |
Url | https://ClinicalTrials.gov/ProvidedDocs/00/NCT03796000/Prot_SAP_000.pdf |
Responsible Parties
Sequence: | 28777101 |
Responsible Party Type | Principal Investigator |
Name | Claudia Cavelti |
Title | private lecturer |
Affiliation | University Hospital, Basel, Switzerland |
]]>
https://zephyrnet.com/NCT03795987
2019-02-07
https://zephyrnet.com/?p=NCT03795987
NCT03795987https://www.clinicaltrials.gov/study/NCT03795987?tab=tableNANANAThis study will provide preliminary estimates of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary application) for the treatment of nightmare disorder associated with post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with the NightWare digital therapeutic system. The investigators hypothesize that the NightWare digital therapeutic system will significantly improve sleep quality in participants with PTSD-Related nightmares and poor sleep quality.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-02-26 |
Start Month Year | February 7, 2019 |
Primary Completion Month Year | August 14, 2019 |
Verification Month Year | February 2020 |
Verification Date | 2020-02-29 |
Last Update Posted Date | 2020-02-26 |
Detailed Descriptions
Sequence: | 20727223 |
Description | Nightmares are a common problem affecting 2-8% of the general population and a higher proportion of clinical populations. The negative consequences of untreated nightmares are significant and include impaired quality of life, sleep deprivation (often resulting in an increased intensity of nightmares), insomnia, daytime sleepiness, and fatigue. Untreated nightmares can also exacerbate the symptoms of underlying psychological dysfunction in people with depression and anxiety, leading to poor occupational and or social functioning. Nightmares can be idiopathic or associated with the use (or withdrawal) of certain medications or substances, or associated with disorders including PTSD.
NightWare (Minneapolis, MN) has developed a novel approach to the treatment of nightmares. Through the use of a smartwatch-based application that senses physiologic parameters, the participant is aroused from sleep (without awakening the participant) so that the nightmare is interrupted prior to reaching a threshold of severity in which the participant would awaken in distress. Seconds later the participant returns to sleep without having experienced a nightmare. This approach avoids risk from pharmacological treatment, avoids exacerbation of symptoms from image rehearsal therapy and allows for a simple method with easily achieved adherence compared to existing treatments. The NightWare digital therapeutic system consists of a proprietary software application installed on a smartwatch. The application has been effective in focus groups when used on both Apple smartwatches and Motorola smartwatches. For the purposes of this study, the investigators will be using only the Apple (Cupertino, CA) 3rd generation smartwatch and the Apple iPhone. The NightWare application uses physiological markers obtained via the smartwatch to determine by proprietary algorithm whether a participant is in the early stages of a nightmare, but has not yet awoken in distress. As directed by the algorithm, the smartwatch then applies varying degrees of vibratory stimulation to the wrist over variable lengths of time with the intention of arousing the participant from sleep without eliciting an awakening. |
Facilities
Sequence: | 200159526 |
Name | Minneapolis VA Healthcare System |
City | Minneapolis |
State | Minnesota |
Zip | 55417 |
Country | United States |
Conditions
Sequence: | 52185601 | Sequence: | 52185602 | Sequence: | 52185603 | Sequence: | 52185604 | Sequence: | 52185605 | Sequence: | 52185606 |
Name | Stress Disorders, Post-Traumatic | Name | Combat Disorders | Name | Ptsd | Name | Nightmare | Name | Nightmares, REM-Sleep Type | Name | Nightmare Disorder With Associated Non-Sleep Disorder |
Downcase Name | stress disorders, post-traumatic | Downcase Name | combat disorders | Downcase Name | ptsd | Downcase Name | nightmare | Downcase Name | nightmares, rem-sleep type | Downcase Name | nightmare disorder with associated non-sleep disorder |
Id Information
Sequence: | 40169148 |
Id Source | org_study_id |
Id Value | NW101001 |
Countries
Sequence: | 42580731 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55609245 |
Group Type | Experimental |
Title | Open Label Treatment Arm |
Description | Intervention with NightWare Therapeutic System |
Interventions
Sequence: | 52499537 |
Intervention Type | Device |
Name | NightWare Therapeutic System |
Description | A wearable digital therapeutic system that will measure physiologic data when worn during sleep to deliver a mild vibration via the watch to elicit arousal thereby disrupting nightmares. This detection and stimulation sequence will be performed according to NightWare's proprietary algorithm. |
Keywords
Sequence: | 79888930 | Sequence: | 79888931 | Sequence: | 79888932 | Sequence: | 79888933 | Sequence: | 79888934 | Sequence: | 79888935 | Sequence: | 79888936 |
Name | PTSD | Name | Nightmare | Name | Nightmare Disorder | Name | Post-traumatic stress disorder | Name | Veteran | Name | Digital therapeutic | Name | Digital medicine |
Downcase Name | ptsd | Downcase Name | nightmare | Downcase Name | nightmare disorder | Downcase Name | post-traumatic stress disorder | Downcase Name | veteran | Downcase Name | digital therapeutic | Downcase Name | digital medicine |
Design Outcomes
Sequence: | 177432398 |
Outcome Type | primary |
Measure | Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to Day 60 |
Time Frame | 0-60 days |
Description | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. This outcome is the difference between the global score on the Pittsburgh Sleep Quality Index (PSQI) score at baseline (Day 0) and average global PSQI score across the four post-treatment initiation assessments (Days 14, 30, 44 and 60). |
Browse Conditions
Sequence: | 193540575 | Sequence: | 193540576 | Sequence: | 193540577 | Sequence: | 193540578 | Sequence: | 193540579 |
Mesh Term | Stress Disorders, Traumatic | Mesh Term | Stress Disorders, Post-Traumatic | Mesh Term | Combat Disorders | Mesh Term | Trauma and Stressor Related Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | stress disorders, traumatic | Downcase Mesh Term | stress disorders, post-traumatic | Downcase Mesh Term | combat disorders | Downcase Mesh Term | trauma and stressor related disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332425 | Sequence: | 48332426 |
Agency Class | INDUSTRY | Agency Class | FED |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | NightWare | Name | Minneapolis Veterans Affairs Medical Center |
Overall Officials
Sequence: | 29293053 |
Role | Study Chair |
Name | Daniel R Karlin, MD MA |
Affiliation | NightWare |
Design Group Interventions
Sequence: | 68168319 |
Design Group Id | 55609245 |
Intervention Id | 52499537 |
Eligibilities
Sequence: | 30773641 |
Gender | All |
Minimum Age | 22 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Veteran Enrolled in the Minneapolis/St. Cloud VAHCS. Exclusion Criteria: Patient Health Questionnaire-9 (PHQ-9) score greater than or equal to 20. A score of 1 or more on the suicide ideation item of the PHQ-9 will trigger a risk assessment. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952986 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 6 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 22 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30519772 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28886073 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03795974
2017-07-23
https://zephyrnet.com/?p=NCT03795974
NCT03795974https://www.clinicaltrials.gov/study/NCT03795974?tab=tableNANANACerebral palsy(CP) consisted of a group of developmental disability in the field of motor function and is one of the major problems of pediatric neurology and at the present time there is no standard curative medical or surgical treatment for it .Stem cell therapy is one of a new and hopeful therapeutic methods of therapy for CP .This double blind study designed for the evaluation of safety and therapeutic effects of intrathecal hematopoietic and mesenchymal stem cells derived from allogenic umbilical cord in change and probable improvement of developmental functions of spastic CP participants between 4-14 years old and comparing with control group of CP participants without cell therapy . 108 cases recruited and randomly divided to 3 groups of 36 cases : hematopoietic stem cells derived from allogenic umbilical cord , Mesenchymal cells derived from allogenic umbilical cord and control group without injection and appearance simulating lumbar puncture without awareness of the patients and evaluators . Developmental functions and spasticity evaluated before intervention and will be done 1 , 3 , 6 and 12 months after injection . During this period neuro rehabilitation will be continued . Brain neuroimaging were done at the recruitment time and will be repeated after 12 months .
<![CDATA[
Studies
Study First Submitted Date | 2018-12-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | July 23, 2017 |
Primary Completion Month Year | October 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-08 |
Detailed Descriptions
Sequence: | 20716324 |
Description | CP is characterized by aberrant control of movement or posture of a patient , appearing early in life , and not the result of a recognized progressive or degenerative brain disease . CP is an umbrella term and represents a group of conditions (not a single disorder) , has a broad range of expression with a static condition originally within the developing central nervous system . CP Is a disturbance of movement and or posture . At the present time there is no standard medical or surgical treatment for it .Stem cell therapy is a new and promising treatment .
150 cases of diparetic and quadiparetic spastic CP between 4-14 years old selected among the patients referred to the pediatric neurology outpatient department of Children's Medical Center Hospital (CMC) affiliated to Tehran University of Medical Sciences and had our inclusion criteria. HLA analysis were done for these patients and 36 cases of class 6 matched cases enrolled to the hematopoietic stem cells derived from allogenic umbilical cord (MNC) because of necessity of Human Leukocyte Antigen (HLA) matching in this type of cells and 72 cases among the remaining patients randomly divided to Mesenchymal stem cells derived from allogenic umbilical cord (MSC) and control group . Therefore 108 cases enrolled in 3 divided group of 36 patients . Patients admitted to CMC hospital and intrathecal injection were done with sedation . Only one injection of stem cell was done for each patient . In the control group after insertion of the needle into the skin with an appearance of lumbar puncture simulation , no injection were done without the awareness of the patients or their parents. All of the patients admitted for one day and discharged the next day . As we wrote in the consent form for ethical consideration we are committed to perform stem cell injection for control participants free of charge after 12 months of the follow up . All of the participants will be referred for neurorehabilitation with a identical protocol .Both parents and clinical evaluators are not aware of the 3 divided groups and our study is double blind .Outcome measures will be evaluated 1, 3, 6. and 12 months after intervention . Standard brain Magnetic Resonance Imaging (MRI) with Magnetic Resonance Spectroscopy (MRS) and Diffusion Tensor Imaging (DTI) were done before injection as baseline and will be repeated after 12 months of clinical follow up . This study designed for the evaluation of therapeutic effects of intrathecal MNC and MSC derived from allogenic umbilical cord in change and probable improvement of developmental functions of spastic CP patients between 4-14 years old in comparison with control group .Different scoring systems such as Gross Motor Functional Classification System (GMFCS) , Gross Motor Function Measure Score (GMFM66) , Manual Ability Classification System (MACS) , Pediatric Evaluation of Disability Inventory (PEDI) , CP QOL , Life Habits Questionnaire and Modified Ashworth scale for spasticity were done at baseline and then will be repeated in follow ups until 12 months of final evaluation . Acute side effects and probable long term side effects will be reported and noted on our preformed questioners . |
Facilities
Sequence: | 200053421 | Sequence: | 200053422 | Sequence: | 200053423 | Sequence: | 200053424 |
Name | Tehran University of Medical Sciences , Growth and Development Research Center- Children's Medical Center | Name | Tehran University of Medical Sciences Chidren's Medical Center Radiology Department | Name | Tehran University of Medical Sciences, Department of Pediatric Neurology , Children's Medical Center | Name | ROYAN Stem Cell Technology Co |
City | Tehran | City | Tehran | City | Tehran | City | Tehran |
Zip | 1419733151 | Zip | 1419733151 | Zip | 1419733151 | Zip | 1665666311 |
Country | Iran, Islamic Republic of | Country | Iran, Islamic Republic of | Country | Iran, Islamic Republic of | Country | Iran, Islamic Republic of |
Conditions
Sequence: | 52156564 |
Name | Cerebral Palsy, Spastic |
Downcase Name | cerebral palsy, spastic |
Id Information
Sequence: | 40148253 |
Id Source | org_study_id |
Id Value | IRCT201706176907N13 |
Countries
Sequence: | 42557790 |
Name | Iran, Islamic Republic of |
Removed | False |
Design Groups
Sequence: | 55577962 | Sequence: | 55577963 |
Group Type | Active Comparator | Group Type | Experimental |
Title | MNC & MSC with Control | Title | MNC & MSC |
Description | One intrathecal injection of Hematopoietic stem cells and Mesenchymal stem cells derived from allogenic umbilical cord for each group of 36 cases of spastic CP and neurorehabilitation during the 12 months of follow up of clinical evaluation of developmental functions and spasticity | Description | Comparison of effects of intrathecal injection of MNC and MSC on improvement of developmental functions and spasticity of CP patients |
Interventions
Sequence: | 52472064 | Sequence: | 52472065 | Sequence: | 52472066 |
Intervention Type | Biological | Intervention Type | Biological | Intervention Type | Procedure |
Name | MNC | Name | MSC | Name | Control |
Description | Hematopoietic stem cells derived from allogenic umbilical cord | Description | Mesenchymal cells derived from allogenic umbilical cord | Description | control group without injection and appearance simulating lumbar puncture without awareness of the patients and evaluators , but rehabilitation continued . |
Keywords
Sequence: | 79848190 |
Name | Quadriparetic CP, Diparetic CP, Spastic |
Downcase Name | quadriparetic cp, diparetic cp, spastic |
Design Outcomes
Sequence: | 177328238 | Sequence: | 177328239 | Sequence: | 177328240 | Sequence: | 177328241 | Sequence: | 177328242 | Sequence: | 177328243 | Sequence: | 177328244 | Sequence: | 177328245 | Sequence: | 177328246 | Sequence: | 177328247 | Sequence: | 177328248 | Sequence: | 177328249 | Sequence: | 177328250 | Sequence: | 177328251 | Sequence: | 177328252 | Sequence: | 177328253 | Sequence: | 177328254 | Sequence: | 177328255 | Sequence: | 177328256 | Sequence: | 177328257 | Sequence: | 177328258 | Sequence: | 177328259 | Sequence: | 177328260 | Sequence: | 177328261 | Sequence: | 177328262 | Sequence: | 177328263 | Sequence: | 177328264 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change from baseline Gross Motor Function Classification System (GMFCS) | Measure | Change from baseline Gross Motor Function Classification System (GMFCS) | Measure | Change from baseline Gross Motor Function Classification System (GMFCS) | Measure | Change from baseline Gross Motor Function Classification System (GMFCS) | Measure | Change from baseline GROSS MOTOR FUNCTION MEASURE (GMFM66) | Measure | Change from baseline GROSS MOTOR FUNCTION MEASURE (GMFM66) | Measure | Change from baseline GROSS MOTOR FUNCTION MEASURE (GMFM66) | Measure | Change from baseline GROSS MOTOR FUNCTION MEASURE (GMFM66) | Measure | Change from baseline GROSS MOTOR FUNCTION MEASURE (GMFM66) | Measure | Change from baseline Manual Ability Classification System for Children with Cerebral Palsy (MACS) | Measure | Change from baseline Manual Ability Classification System for Children with Cerebral Palsy (MACS) | Measure | Change from baseline Manual Ability Classification System for Children with Cerebral Palsy (MACS) | Measure | Change from baseline Manual Ability Classification System for Children with Cerebral Palsy (MACS) | Measure | Change from baseline Pediatric Evaluation of Disability Inventory (PEDI) | Measure | Change from baseline Pediatric Evaluation of Disability Inventory (PEDI) | Measure | Change from baseline Pediatric Evaluation of Disability Inventory (PEDI) | Measure | Change from baseline Modified Ashworth scale | Measure | Change from baseline Modified Ashworth scale | Measure | Change from baseline Modified Ashworth scale | Measure | Change from baseline Modified Ashworth scale | Measure | Change from baseline Modified Ashworth scale | Measure | Change from baseline acquired Brain Magnetic Resonance Imaging (MRI) findings | Measure | Change from baseline acquired Brain Magnetic Resonance Imaging (MRI) findings | Measure | Change from baseline Brain Magnetic Resonance Spectroscopy (MRS) | Measure | Change from baseline Brain Magnetic Resonance Spectroscopy (MRS) | Measure | Change from baseline Diffuse Tensor Imaging (DTI) fiber count of periventricular white matter | Measure | Change from baseline Diffuse Tensor Imaging (DTI) fiber count of periventricular white matter |
Time Frame | Baseline | Time Frame | "month" 3 | Time Frame | "month" 6 | Time Frame | "month" 12 | Time Frame | Baseline | Time Frame | "month" 1 | Time Frame | "month" 3 | Time Frame | "month" 6 | Time Frame | "month" 12 | Time Frame | Baseline | Time Frame | "month" 3 | Time Frame | "month" 6 | Time Frame | "month" 12 | Time Frame | Baseline | Time Frame | "month" 6 | Time Frame | "month" 12 | Time Frame | Baseline | Time Frame | "month" 1 | Time Frame | "month" 3 | Time Frame | "month" 6 | Time Frame | "month" 12 | Time Frame | Baseline | Time Frame | "month" 12 | Time Frame | Baseline | Time Frame | "month" 12 | Time Frame | Baseline | Time Frame | "month" 12 |
Description | The Gross Motor Function Classification System (GMFCS) for cerebral palsy is based on self-initiated movement, with emphasis on sitting, transfers, and mobility. When defining a five-level classification system, our primary criterion has been that the distinctions between levels must be meaningful in daily life. Distinctions are based on functional limitations, the need for hand-held mobility devices (such as walkers, crutches, or canes) or wheeled mobility, and to a much lesser extent, quality of movement.
LEVEL I – Walks without Limitations LEVEL II – Walks with Limitations LEVEL III – Walks Using a Hand-Held Mobility Device LEVEL IV – Self-Mobility with Limitations; May Use Powered Mobility LEVEL V – Transported in a Manual Wheelchair We enrolled the patients with GMFCS more than class II and evaluate for change of this scale during the follow up period . Lower scores demonstrate better gross motor function of children . |
Description | The Gross Motor Function Classification System (GMFCS) for cerebral palsy is based on self-initiated movement, with emphasis on sitting, transfers, and mobility. When defining a five-level classification system, our primary criterion has been that the distinctions between levels must be meaningful in daily life. Distinctions are based on functional limitations, the need for hand-held mobility devices (such as walkers, crutches, or canes) or wheeled mobility, and to a much lesser extent, quality of movement.
LEVEL I – Walks without Limitations LEVEL II – Walks with Limitations LEVEL III – Walks Using a Hand-Held Mobility Device LEVEL IV – Self-Mobility with Limitations; May Use Powered Mobility LEVEL V – Transported in a Manual Wheelchair We enrolled the patients with GMFCS more than class II and evaluate for change of this scale during the follow up period . Lower scores demonstrate better gross motor function of children . |
Description | The Gross Motor Function Classification System (GMFCS) for cerebral palsy is based on self-initiated movement, with emphasis on sitting, transfers, and mobility. When defining a five-level classification system, our primary criterion has been that the distinctions between levels must be meaningful in daily life. Distinctions are based on functional limitations, the need for hand-held mobility devices (such as walkers, crutches, or canes) or wheeled mobility, and to a much lesser extent, quality of movement.
LEVEL I – Walks without Limitations LEVEL II – Walks with Limitations LEVEL III – Walks Using a Hand-Held Mobility Device LEVEL IV – Self-Mobility with Limitations; May Use Powered Mobility LEVEL V – Transported in a Manual Wheelchair We enrolled the patients with GMFCS more than class II and evaluate for change of this scale during the follow up period . Lower scores demonstrate better gross motor function of children . |
Description | The Gross Motor Function Classification System (GMFCS) for cerebral palsy is based on self-initiated movement, with emphasis on sitting, transfers, and mobility. When defining a five-level classification system, our primary criterion has been that the distinctions between levels must be meaningful in daily life. Distinctions are based on functional limitations, the need for hand-held mobility devices (such as walkers, crutches, or canes) or wheeled mobility, and to a much lesser extent, quality of movement.
LEVEL I – Walks without Limitations LEVEL II – Walks with Limitations LEVEL III – Walks Using a Hand-Held Mobility Device LEVEL IV – Self-Mobility with Limitations; May Use Powered Mobility LEVEL V – Transported in a Manual Wheelchair We enrolled the patients with GMFCS more than class II and evaluate for change of this scale during the follow up period . Lower scores demonstrate better gross motor function of children . |
Description | The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy.
GMFM 66 contained 66 item and each item include 4 score (0-3) SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes We are using validated Persian version of GMFM 66 in this research. Higher scores demonstrate better gross motor function of children. |
Description | The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy.
GMFM 66 contained 66 item and each item include 4 score (0-3) SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes We are using validated Persian version of GMFM 66 in this research. Higher scores demonstrate better gross motor function of children. |
Description | The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy.
GMFM 66 contained 66 item and each item include 4 score (0-3) SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes We are using validated Persian version of GMFM 66 in this research. Higher scores demonstrate better gross motor function of children. |
Description | The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy.
GMFM 66 contained 66 item and each item include 4 score (0-3) SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes We are using validated Persian version of GMFM 66 in this research. Higher scores demonstrate better gross motor function of children. |
Description | The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy.
GMFM 66 contained 66 item and each item include 4 score (0-3) SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes We are using validated Persian version of GMFM 66 in this research. Higher scores demonstrate better gross motor function of children. |
Description | The Manual Ability Classification System (MACS)describes how children with cerebral palsy (CP)use their hands to handle objects in daily activities.
MACS describes five levels. The levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. Handle objects easily and successfully We are using validated Persian classification system. |
Description | The Manual Ability Classification System (MACS)describes how children with cerebral palsy (CP)use their hands to handle objects in daily activities.
MACS describes five levels. The levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. Handle objects easily and successfully We are using validated Persian classification system. |
Description | The Manual Ability Classification System (MACS)describes how children with cerebral palsy (CP)use their hands to handle objects in daily activities.
MACS describes five levels. The levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. Handle objects easily and successfully We are using validated Persian classification system. |
Description | The Manual Ability Classification System (MACS)describes how children with cerebral palsy (CP)use their hands to handle objects in daily activities.
MACS describes five levels. The levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. Handle objects easily and successfully We are using validated Persian classification system. |
Description | The PEDI contains items to measure functional capability, and also items to measure the performance in three content domains: Self Care (SC), Mobility (M) and Social Function (SF), Capability is measured by the assessment of the functional skills of which the child has shown mastery.
The items in the FSS are discrete and are accompanied by scoring criteria and sometimes examples of behavior to help clarify scoring decisions. The items can be scored 0 or 1. 0 = unable or limited in capability to perform item in most situations 1 = capable of performing item in most situations, or item has been previously mastered and functional skills have progressed beyond this level. We are using validated Persian version of this Questionnaire. Higher scores demonstrate better functional capability. |
Description | The PEDI contains items to measure functional capability, and also items to measure the performance in three content domains: Self Care (SC), Mobility (M) and Social Function (SF), Capability is measured by the assessment of the functional skills of which the child has shown mastery.
The items in the FSS are discrete and are accompanied by scoring criteria and sometimes examples of behavior to help clarify scoring decisions. The items can be scored 0 or 1. 0 = unable or limited in capability to perform item in most situations 1 = capable of performing item in most situations, or item has been previously mastered and functional skills have progressed beyond this level. We are using validated Persian version of this Questionnaire. Higher scores demonstrate better functional capability. |
Description | The PEDI contains items to measure functional capability, and also items to measure the performance in three content domains: Self Care (SC), Mobility (M) and Social Function (SF), Capability is measured by the assessment of the functional skills of which the child has shown mastery.
The items in the FSS are discrete and are accompanied by scoring criteria and sometimes examples of behavior to help clarify scoring decisions. The items can be scored 0 or 1. 0 = unable or limited in capability to perform item in most situations 1 = capable of performing item in most situations, or item has been previously mastered and functional skills have progressed beyond this level. We are using validated Persian version of this Questionnaire. Higher scores demonstrate better functional capability. |
Description | Scoring (taken from Bohannon and Smith, 1987):
0 No increase in muscle tone Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM ankle plantar flexion,knee flexion,hip flexion,wrist flexion,elbow flexion,Spasticity improvement of patients according to Modified Ashworth scale |
Description | Scoring (taken from Bohannon and Smith, 1987):
0 No increase in muscle tone Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM ankle plantar flexion,knee flexion,hip flexion,wrist flexion,elbow flexion,Spasticity improvement of patients according to Modified Ashworth scale |
Description | Scoring (taken from Bohannon and Smith, 1987):
0 No increase in muscle tone Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM ankle plantar flexion,knee flexion,hip flexion,wrist flexion,elbow flexion,Spasticity improvement of patients according to Modified Ashworth scale |
Description | Scoring (taken from Bohannon and Smith, 1987):
0 No increase in muscle tone Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM ankle plantar flexion,knee flexion,hip flexion,wrist flexion,elbow flexion,Spasticity improvement of patients according to Modified Ashworth scale |
Description | Scoring (taken from Bohannon and Smith, 1987):
0 No increase in muscle tone Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM ankle plantar flexion,knee flexion,hip flexion,wrist flexion,elbow flexion,Spasticity improvement of patients according to Modified Ashworth scale |
Description | One of our inclusion criteria for enrollment of the cases was evidence of definite acquired abnormal imaging findings compatible with CP such as periventricular leukomalacia (PVL) , cystic encephalomalacia ,periventricular gliosis , porencephalic cyst , basal ganglia involvement and brain atrophy . Decrements in size or improvement of Brain imaging findings would be expected due to Stem Cell therapy and will be followed 12 months after injection . | Description | One of our inclusion criteria for enrollment of the cases was evidence of definite acquired abnormal imaging findings compatible with CP such as periventricular leukomalacia (PVL) , cystic encephalomalacia ,periventricular gliosis , porencephalic cyst , basal ganglia involvement and brain atrophy . Decrements in size or improvement of Brain imaging findings would be expected due to Stem Cell therapy and will be followed 12 months after injection . | Description | MRS allows noninvasive detection and measurement of normal and abnormal metabolites and biochemical changes in the brain . The frequency of different metabolites is measured in units called parts per million (PPM) and plotted on a graph as peaks of varying height . The metabolites normally detected in the brain, regardless of the adopted echo time, include Nacetyl aspartate (NAA),a neuronal marker, choline (Cho), a membrane marker, and creatine (Cr), an energy metabolism marker. Increase in NAA /Cr and NAA/Cho ratios expected as baseline and would be expected to have a change after Stem Cell therapy in favor of neuroglia cells load or number increase at the site of previous brain damage. | Description | MRS allows noninvasive detection and measurement of normal and abnormal metabolites and biochemical changes in the brain . The frequency of different metabolites is measured in units called parts per million (PPM) and plotted on a graph as peaks of varying height . The metabolites normally detected in the brain, regardless of the adopted echo time, include Nacetyl aspartate (NAA),a neuronal marker, choline (Cho), a membrane marker, and creatine (Cr), an energy metabolism marker. Increase in NAA /Cr and NAA/Cho ratios expected as baseline and would be expected to have a change after Stem Cell therapy in favor of neuroglia cells load or number increase at the site of previous brain damage. | Description | DTI is a modification of the MRI technique that is sensitive to the Brownian motion of water molecules in biological tissues and is a new clinical method that can demonstrate the orientation and integrity of white matter fibers . Periventricular white matter injury is a major form of brain injury observed in CP . Significant reduction in DTI fiber count on the periventricular or other regions of cerebral white matter injury involving corticospinal tract , corticobulbar tract and superior thalamic radiation expected as baseline . Increase in DTI fiber count would be expected due to Stem Cell therapy and will be followed 12 months after injection . | Description | DTI is a modification of the MRI technique that is sensitive to the Brownian motion of water molecules in biological tissues and is a new clinical method that can demonstrate the orientation and integrity of white matter fibers . Periventricular white matter injury is a major form of brain injury observed in CP . Significant reduction in DTI fiber count on the periventricular or other regions of cerebral white matter injury involving corticospinal tract , corticobulbar tract and superior thalamic radiation expected as baseline . Increase in DTI fiber count would be expected due to Stem Cell therapy and will be followed 12 months after injection . |
Browse Conditions
Sequence: | 193432282 | Sequence: | 193432283 | Sequence: | 193432284 | Sequence: | 193432285 | Sequence: | 193432286 | Sequence: | 193432287 | Sequence: | 193432288 | Sequence: | 193432289 | Sequence: | 193432290 | Sequence: | 193432291 | Sequence: | 193432292 |
Mesh Term | Muscle Spasticity | Mesh Term | Cerebral Palsy | Mesh Term | Neurologic Manifestations | Mesh Term | Nervous System Diseases | Mesh Term | Brain Damage, Chronic | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Muscular Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Muscle Hypertonia | Mesh Term | Neuromuscular Manifestations |
Downcase Mesh Term | muscle spasticity | Downcase Mesh Term | cerebral palsy | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | brain damage, chronic | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | muscular diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | muscle hypertonia | Downcase Mesh Term | neuromuscular manifestations |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306149 | Sequence: | 48306150 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Tehran University of Medical Sciences | Name | Hormozgan University of Medical Sciences |
Overall Officials
Sequence: | 29277967 | Sequence: | 29277968 | Sequence: | 29277969 | Sequence: | 29277970 | Sequence: | 29277971 | Sequence: | 29277972 |
Role | Principal Investigator | Role | Study Director | Role | Study Director | Role | Study Director | Role | Study Director | Role | Study Director |
Name | Mahmoudreza Ashrafi, MD | Name | Amirali Hamidieh, MD | Name | Hadi Montazerlotfelahi, MD | Name | Anahita Majma, MD | Name | Masood Ghahvechi akbari, MD | Name | Ali Reza Moaeidi, MD |
Affiliation | Tehran University of Medical Sciences, Children's Medical Center | Affiliation | Tehran University of Medical Sciences , Children's Medical Center | Affiliation | Alborz University of Medical Sciences | Affiliation | Tehran University of Medical Sciences Children's Medical Center | Affiliation | Tehran University of Medical Sciences ,Children's Medical Center | Affiliation | Hormozgan University of Medical Sciences |
Design Group Interventions
Sequence: | 68130927 | Sequence: | 68130928 | Sequence: | 68130929 | Sequence: | 68130930 | Sequence: | 68130931 |
Design Group Id | 55577963 | Design Group Id | 55577962 | Design Group Id | 55577963 | Design Group Id | 55577962 | Design Group Id | 55577962 |
Intervention Id | 52472064 | Intervention Id | 52472064 | Intervention Id | 52472065 | Intervention Id | 52472065 | Intervention Id | 52472066 |
Eligibilities
Sequence: | 30757394 |
Gender | All |
Minimum Age | 4 Years |
Maximum Age | 14 Years |
Healthy Volunteers | No |
Criteria | Inclusion criteria :
Spastic cerebral palsy (Diparetic , Quadriparetic) Exclusion criteria: Normal brain MRI |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254228608 |
Number Of Facilities | 4 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 4 |
Maximum Age Num | 14 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 21 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30503619 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Masking Description | only one of the investigators knows the type of cell therapy for intervention group and simulation of intrathecal injection for control group . |
Intervention Model Description | HLA typing were done for 150 cases of spastic CP with our inclusion criteria and 36 cases of class 6 matching of HLA selected for hematopoietic stem cells derived from allogenic umbilical cord and 72 cases were randomly divided to Mesenchymal cells derived from allogenic umbilical cord and control group . |
Subject Masked | True |
Caregiver Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26665944 | Sequence: | 26665945 |
Intervention Id | 52472064 | Intervention Id | 52472065 |
Name | Hematopoietic stem cells | Name | Mesenchymal stem cells |
Provided Documents
Sequence: | 2578358 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2017-01-18 |
Url | https://ClinicalTrials.gov/ProvidedDocs/74/NCT03795974/Prot_SAP_000.pdf |
Responsible Parties
Sequence: | 28869897 |
Responsible Party Type | Principal Investigator |
Name | Mahmoud Reza Ashrafi |
Title | Professor of Pediatric Neurology |
Affiliation | Tehran University of Medical Sciences |
Study References
Sequence: | 52049439 | Sequence: | 52049440 | Sequence: | 52049441 | Sequence: | 52049442 | Sequence: | 52049443 | Sequence: | 52049444 | Sequence: | 52049445 | Sequence: | 52049446 | Sequence: | 52049447 | Sequence: | 52049448 | Sequence: | 52049449 | Sequence: | 52049450 |
Pmid | 21335665 | Pmid | 26236347 | Pmid | 16049045 | Pmid | 25593079 | Pmid | 16108461 | Pmid | 19416339 | Pmid | 15037681 | Pmid | 24100132 | Pmid | 12529557 | Pmid | 24909743 | Pmid | 35351020 | Pmid | 34362453 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | derived | Reference Type | derived |
Citation | Papadopoulos KI, Low SS, Aw TC, Chantarojanasiri T. Safety and feasibility of autologous umbilical cord blood transfusion in 2 toddlers with cerebral palsy and the role of low dose granulocyte-colony stimulating factor injections. Restor Neurol Neurosci. 2011;29(1):17-22. doi: 10.3233/RNN-2011-0572. | Citation | Feng M, Lu A, Gao H, Qian C, Zhang J, Lin T, Zhao Y. Safety of Allogeneic Umbilical Cord Blood Stem Cells Therapy in Patients with Severe Cerebral Palsy: A Retrospective Study. Stem Cells Int. 2015;2015:325652. doi: 10.1155/2015/325652. Epub 2015 Jul 8. | Citation | Thomas B, Eyssen M, Peeters R, Molenaers G, Van Hecke P, De Cock P, Sunaert S. Quantitative diffusion tensor imaging in cerebral palsy due to periventricular white matter injury. Brain. 2005 Nov;128(Pt 11):2562-77. doi: 10.1093/brain/awh600. Epub 2005 Jul 27. | Citation | Zali A, Arab L, Ashrafi F, Mardpour S, Niknejhadi M, Hedayati-Asl AA, Halimi-Asl A, Ommi D, Hosseini SE, Baharvand H, Aghdami N. Intrathecal injection of CD133-positive enriched bone marrow progenitor cells in children with cerebral palsy: feasibility and safety. Cytotherapy. 2015 Feb;17(2):232-41. doi: 10.1016/j.jcyt.2014.10.011. Epub 2014 Nov 1. | Citation | Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x. | Citation | Shevell MI, Dagenais L, Hall N; REPACQ CONSORTIUM*. The relationship of cerebral palsy subtype and functional motor impairment: a population-based study. Dev Med Child Neurol. 2009 Nov;51(11):872-7. doi: 10.1111/j.1469-8749.2009.03269.x. Epub 2009 Mar 11. | Citation | Ashwal S, Russman BS, Blasco PA, Miller G, Sandler A, Shevell M, Stevenson R; Quality Standards Subcommittee of the American Academy of Neurology; Practice Committee of the Child Neurology Society. Practice parameter: diagnostic assessment of the child with cerebral palsy: report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2004 Mar 23;62(6):851-63. doi: 10.1212/01.wnl.0000117981.35364.1b. | Citation | Wang X, Cheng H, Hua R, Yang J, Dai G, Zhang Z, Wang R, Qin C, An Y. Effects of bone marrow mesenchymal stromal cells on gross motor function measure scores of children with cerebral palsy: a preliminary clinical study. Cytotherapy. 2013 Dec;15(12):1549-62. doi: 10.1016/j.jcyt.2013.06.001. Epub 2013 Oct 5. | Citation | Romanov YA, Svintsitskaya VA, Smirnov VN. Searching for alternative sources of postnatal human mesenchymal stem cells: candidate MSC-like cells from umbilical cord. Stem Cells. 2003;21(1):105-10. doi: 10.1634/stemcells.21-1-105. | Citation | Crompton KE, Elwood N, Kirkland M, Clark P, Novak I, Reddihough D. Feasibility of trialling cord blood stem cell treatments for cerebral palsy in Australia. J Paediatr Child Health. 2014 Jul;50(7):540-4. doi: 10.1111/jpc.12618. Epub 2014 Jun 9. | Citation | Zarrabi M, Akbari MG, Amanat M, Majmaa A, Moaiedi AR, Montazerlotfelahi H, Nouri M, Hamidieh AA, Badv RS, Karimi H, Rabbani A, Mohebbi A, Rahimi-Dehgolan S, Rahimi R, Dehghan E, Vosough M, Abroun S, Shamsabadi FM, Tavasoli AR, Alizadeh H, Pak N, Zamani GR, Mohammadi M, Javadzadeh M, Ghofrani M, Hassanpour SH, Heidari M, Taghdiri MM, Mohseni MJ, Noparast Z, Masoomi S, Goudarzi M, Mohamadpour M, Shodjaee R, Samimi S, Mohammad M, Gholami M, Vafaei N, Koochakzadeh L, Valizadeh A, Malamiri RA, Ashrafi MR. The safety and efficacy of umbilical cord blood mononuclear cells in individuals with spastic cerebral palsy: a randomized double-blind sham-controlled clinical trial. BMC Neurol. 2022 Mar 29;22(1):123. doi: 10.1186/s12883-022-02636-y. | Citation | Amanat M, Majmaa A, Zarrabi M, Nouri M, Akbari MG, Moaiedi AR, Ghaemi O, Zamani F, Najafi S, Badv RS, Vosough M, Hamidieh AA, Salehi M, Montazerlotfelahi H, Tavasoli AR, Heidari M, Mohebi H, Fatemi A, Garakani A, Ashrafi MR. Clinical and imaging outcomes after intrathecal injection of umbilical cord tissue mesenchymal stem cells in cerebral palsy: a randomized double-blind sham-controlled clinical trial. Stem Cell Res Ther. 2021 Aug 6;12(1):439. doi: 10.1186/s13287-021-02513-4. |
]]>
https://zephyrnet.com/NCT03795961
2018-12-16
https://zephyrnet.com/?p=NCT03795961
NCT03795961https://www.clinicaltrials.gov/study/NCT03795961?tab=tableAhmed Maatyaimaaty@hotmail.com+201027089991This is a double blinded randomized clinical trial to study the neuromodulatory effect of tDCS in patients with CTS, the study subject will be randomly into two groups; active and sham group , the active group will receive five sessions of active TDCS over the M1 while the Sham group will receive sham tDCS in which the device will be turned off after 30 seconds. The patient will be assessed by VAS score, Boston carpal tunnel questionnaire , central sensetization inventory , pressure pain threshold, sensory and pain threshold for electerical stimulation before , after the end of the sessions and 4 weeks later.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | December 16, 2018 |
Primary Completion Month Year | January 2020 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-08 |
Detailed Descriptions
Sequence: | 20735726 |
Description | The study will be carried out on patients attending the Physical Medicine, Rheumatology and Rehabilitation outpatient clinic in Suez Canal University Hospital, Ismailia, EGYPT and diagnosed with CTS according to clinical examination and to the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) practice recommendations for CTS.
Study subjects will be divided into two groups: Group (1): (active group) will include 42 patients with CTS and will receive anodal tDCS of M1 for 20 minutes, at 2 mA for 5 sessions and less than 72 hrs. may be allowed between experimental sessions for each participant to avoid any interference. Group (2): (sham group) will include 42 patients with CTS and will receive sham tDCS M1 (the set will be turned off after 30 seconds) for 20 minutes, at 2 mA for 5 sessions. The study sample will be collected from all patients with CTS attending to the Physical medicine, Rheumatology and Rehabilitation outpatient clinic in Suez Canal University Hospital fulfilling the eligibility criteria, will be eligible to join the study (either referred for electrophysiological study or presented to the clinic for primary assessment). To make sure that no bias should enter the assessment of the results, neither the patient nor the clinicians will be aware whether active tDCS will be applicated to a particular case. To ensure this result, two symbols (Square and Triangle) will be applicated to the physiotherapy sheet and only the physiotherapist knew the key for each symbol. The triangle may represent the cases of CTS for active tDCS and the square may represent the sham group or vice versa. At the end of the study the two groups will be revealed in order to analyze the results according to proper statistical measures. |
Facilities
Sequence: | 200244000 |
Status | Recruiting |
Name | Suez Canal University Hospital |
City | Ismailia |
Zip | 41522 |
Country | Egypt |
Facility Contacts
Sequence: | 28127922 | Sequence: | 28127923 |
Facility Id | 200244000 | Facility Id | 200244000 |
Contact Type | primary | Contact Type | backup |
Name | Gehad Swilam, MSc | Name | Ahmed Maaty, MD |
gsa237@gmail.com | aimaaty@hotmail.com | ||
Phone | +201027089991 | Phone | +201004978451 |
Conditions
Sequence: | 52207934 |
Name | Carpal Tunnel Syndrome |
Downcase Name | carpal tunnel syndrome |
Id Information
Sequence: | 40186059 |
Id Source | org_study_id |
Id Value | GSMGAEAM |
Countries
Sequence: | 42599563 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55634534 | Sequence: | 55634535 |
Group Type | Experimental | Group Type | Sham Comparator |
Title | Active tDCS group | Title | Sham tDCS group |
Description | This group will include 42 patients with CTS Intervention (active transcranial direct current electrical stimulation) Stimulation site (M1) Stimulation mode (anodal) Duration of session (20 minutes) Stimulation intensity (2 mA) Number of sessions (5 sessions) Intervals (every another day) | Description | This group will include 42 patients with CTS Intervention (sham or inactive transcranial direct current electrical stimulation) Stimulation site (M1) Stimulation mode (anodal) Duration of session (20 minutes) Stimulation intensity (2 mA) Number of sessions (5 sessions) Intervals (every another day) |
Interventions
Sequence: | 52521950 |
Intervention Type | Device |
Name | transcranial direct current electrical stimulation |
Description | anodal tDCS of M1 for 20 minutes, at 2 mA for 5 sessions (day after day) |
Design Outcomes
Sequence: | 177510762 | Sequence: | 177510763 | Sequence: | 177510764 | Sequence: | 177510765 | Sequence: | 177510766 | Sequence: | 177510767 | Sequence: | 177510768 | Sequence: | 177510769 | Sequence: | 177510770 | Sequence: | 177510771 | Sequence: | 177510772 | Sequence: | 177510773 | Sequence: | 177510774 | Sequence: | 177510775 | Sequence: | 177510776 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Visual analogue scale | Measure | Visual analogue scale (VAS) | Measure | Visual analogue scale (VAS) | Measure | Sensory threshold and pain threshold for electrical stimulation | Measure | Sensory threshold and pain threshold for electrical stimulation | Measure | Sensory threshold and pain threshold for electrical stimulation | Measure | Pressure pain threshold assessment | Measure | Pressure pain threshold assessment | Measure | Pressure pain threshold assessment | Measure | Boston carpal tunnel syndrome questionnaire | Measure | Boston carpal tunnel syndrome questionnaire | Measure | Boston carpal tunnel syndrome questionnaire | Measure | Central sensitization inventory | Measure | Central sensitization inventory (CSI) | Measure | Central sensitization inventory (CSI) |
Time Frame | before sessions (baseline assessment) | Time Frame | immediately after the ending of sessions | Time Frame | four weeks after the ending of sessions | Time Frame | before sessions (baseline assessment) | Time Frame | immediately after the ending of sessions | Time Frame | four weeks after the ending of sessions | Time Frame | before sessions (baseline assessment) | Time Frame | immediately after the ending of sessions | Time Frame | four weeks after the ending of sessions | Time Frame | before sessions (baseline assessment) | Time Frame | immediately after the ending of sessions | Time Frame | four weeks after the ending of sessions | Time Frame | before sessions (baseline assessment) | Time Frame | immediately after the ending of sessions | Time Frame | four weeks after the ending of sessions |
Description | Visual analogue scale is a measurement instrument that measure the pain across a continuum of values. Visual analogue scale is measured in millimeters and ranged from minimum (0 millimeter) to maximum (100 millimeters), where, score 0 indicates no pain and 100 indicates worst pain ever. | Description | Visual analogue scale is a measurement instrument that measure the pain across a continuum of values. Visual analogue scale is measured in millimeters and ranged from minimum (0 millimeter) to maximum (100 millimeters), where, score 0 indicates no pain and 100 indicates worst pain ever. | Description | Visual analogue scale is a measurement instrument that measure the pain across a continuum of values. Visual analogue scale is measured in millimeters and ranged from minimum (0 millimeter) to maximum (100 millimeters), where, score 0 indicates no pain and 100 indicates worst pain ever. | Description | Electrical stimulation will be applied by a pen electrode (model: 2762CC; Chattanooga) to the median nerve (pulse duration – 200 microseconds) at wrist level. Current supply start at 0 milli-ampere and will be increased in steps of 0.1 milli-ampere, until the participant report sensation and pain. The intensity of current (in milli-ampere) at which perception of the electrical stimulus first reported will be taken as sensory threshold; the intensity of current (in milli-ampere) at which participants first reported pain will be taken as pain threshold. These measurements will be averaged for analysis. Both sides will be assessed and compared. The lower the intensity of current (in milli-ampere) perceived, the worse the threshold, while the higher the intensity of current (in milli-ampere) perceived, the better the threshold. | Description | Electrical stimulation will be applied by a pen electrode (model: 2762CC; Chattanooga) to the median nerve (pulse duration – 200 microseconds) at wrist level. Current supply start at 0 milli-ampere and will be increased in steps of 0.1 milli-ampere, until the participant report sensation and pain. The intensity of current (in milli-ampere) at which perception of the electrical stimulus first reported will be taken as sensory threshold; the intensity of current (in milli-ampere) at which participants first reported pain will be taken as pain threshold. These measurements will be averaged for analysis. Both sides will be assessed and compared. The lower the intensity of current (in milli-ampere) perceived, the worse the threshold, while the higher the intensity of current (in milli-ampere) perceived, the better the threshold. | Description | Electrical stimulation will be applied by a pen electrode (model: 2762CC; Chattanooga) to the median nerve (pulse duration – 200 microseconds) at wrist level. Current supply start at 0 milli-ampere and will be increased in steps of 0.1 milli-ampere, until the participant report sensation and pain. The intensity of current (in milli-ampere) at which perception of the electrical stimulus first reported will be taken as sensory threshold; the intensity of current (in milli-ampere) at which participants first reported pain will be taken as pain threshold. These measurements will be averaged for analysis. Both sides will be assessed and compared. The lower the intensity of current (in milli-ampere) perceived, the worse the threshold, while the higher the intensity of current (in milli-ampere) perceived, the better the threshold. | Description | Pressure will be induced using a pressure algometer (PainTest™ FPN 100 Algometer (Wagner Instruments, Greenwich, USA)) with a flat circular metal probe dressed in a rubber cover with a surface area of 1 cm2 applied to median, ulnar, radial, and c5-6 zygoapophyseal joint, The algometer will be mounted vertically and the pressure will be increased. Patients are asked to notify the investigator when they start to feel pain (pain threshold). For each measurement the algometer will be calibrated to enable force to be applied at a controlled and steady rate, the mean of three trials (intra-examiner reliability) will be calculated and used for main analysis. A 30 seconds resting period will be allowed between each measure. Both sides will be assessed and compared. Abnormal pressure pain threshold is at least 2 kg/cm2 different than that of the opposite site. The lower the value perceived, the worse the threshold, while the higher the value perceived, the better the threshold. | Description | Pressure will be induced using a pressure algometer (PainTest™ FPN 100 Algometer (Wagner Instruments, Greenwich, USA)) with a flat circular metal probe dressed in a rubber cover with a surface area of 1 cm2 applied to median, ulnar, radial, and c5-6 zygoapophyseal joint, The algometer will be mounted vertically and the pressure will be increased. Patients are asked to notify the investigator when they start to feel pain (pain threshold). For each measurement the algometer will be calibrated to enable force to be applied at a controlled and steady rate, the mean of three trials (intra-examiner reliability) will be calculated and used for main analysis. A 30 seconds resting period will be allowed between each measure. Both sides will be assessed and compared. Abnormal pressure pain threshold is at least 2 kg/cm2 different than that of the opposite site. The lower the value perceived, the worse the threshold, while the higher the value perceived, the better the threshold. | Description | Pressure will be induced using a pressure algometer (PainTest™ FPN 100 Algometer (Wagner Instruments, Greenwich, USA)) with a flat circular metal probe dressed in a rubber cover with a surface area of 1 cm2 applied to median, ulnar, radial, and c5-6 zygoapophyseal joint, The algometer will be mounted vertically and the pressure will be increased. Patients are asked to notify the investigator when they start to feel pain (pain threshold). For each measurement the algometer will be calibrated to enable force to be applied at a controlled and steady rate, the mean of three trials (intra-examiner reliability) will be calculated and used for main analysis. A 30 seconds resting period will be allowed between each measure. Both sides will be assessed and compared. Abnormal pressure pain threshold is at least 2 kg/cm2 different than that of the opposite site. The lower the value perceived, the worse the threshold, while the higher the value perceived, the better the threshold. | Description | Boston carpal tunnel syndrome questionnaire is a disease-specific measure of self-reported symptom severity and functional status. It is frequently used in the reporting of outcomes from trials into interventions for carpal tunnel syndrome. Boston carpal tunnel syndrome questionnaire contains two sub-scales: symptom severity scale (11 items) and functional status scale (8 items). Scoring instructions: add the numbers corresponding to all answers and divide by the number of questions answered. Composite score (round to nearest 1/100th). The scores of symptom severity scale is ranged from 1-5, where, score 1 indicates no pain and score 5 indicates very severe pain. The scores of functional status scale is ranged from 1-5, where, score 1 indicates no difficulty and score 5 indicates cannot do at all due to hand or wrist. | Description | Boston carpal tunnel syndrome questionnaire is a disease-specific measure of self-reported symptom severity and functional status. It is frequently used in the reporting of outcomes from trials into interventions for carpal tunnel syndrome. Boston carpal tunnel syndrome questionnaire contains two sub-scales: symptom severity scale (11 items) and functional status scale (8 items). Scoring instructions: add the numbers corresponding to all answers and divide by the number of questions answered. Composite score (round to nearest 1/100th). The scores of symptom severity scale is ranged from 1-5, where, score 1 indicates no pain and score 5 indicates very severe pain. The scores of functional status scale is ranged from 1-5, where, score 1 indicates no difficulty and score 5 indicates cannot do at all due to hand or wrist. | Description | Boston carpal tunnel syndrome questionnaire is a disease-specific measure of self-reported symptom severity and functional status. It is frequently used in the reporting of outcomes from trials into interventions for carpal tunnel syndrome. Boston carpal tunnel syndrome questionnaire contains two sub-scales: symptom severity scale (11 items) and functional status scale (8 items). Scoring instructions: add the numbers corresponding to all answers and divide by the number of questions answered. Composite score (round to nearest 1/100th). The scores of symptom severity scale is ranged from 1-5, where, score 1 indicates no pain and score 5 indicates very severe pain. The scores of functional status scale is ranged from 1-5, where, score 1 indicates no difficulty and score 5 indicates cannot do at all due to hand or wrist. | Description | Central sensitization inventory is a screening instrument for clinicians to help identify patients with central sensitivity syndrome. Central sensitization inventory consists of two parts. Part A, one is asked how often he/she experiences each symptom ("never, rarely, sometimes, often, or always"). Individual items are scored from "0" (never) to "4" (always), resulting in a total score range for all 25 items from "0" to "100." A score of 40 or higher indicates the presence of central sensitivity syndrome. Part B asked if one has been previously diagnosed with seven common central sensitivity syndrome diagnoses (tension headaches/migraines, fibromyalgia, irritable bowel syndrome, restless leg syndrome, temporomandibular joint disorder, chronic fatigue syndrome, and multiple chemical sensitivities) and three central sensitization-related diagnoses (depression, anxiety/panic attacks, and neck injury). Central sensitization inventory B is for information only and is not scored. | Description | Central sensitization inventory is a screening instrument for clinicians to help identify patients with central sensitivity syndrome. Central sensitization inventory consists of two parts. Part A, one is asked how often he/she experiences each symptom ("never, rarely, sometimes, often, or always"). Individual items are scored from "0" (never) to "4" (always), resulting in a total score range for all 25 items from "0" to "100." A score of 40 or higher indicates the presence of central sensitivity syndrome. Part B asked if one has been previously diagnosed with seven common central sensitivity syndrome diagnoses (tension headaches/migraines, fibromyalgia, irritable bowel syndrome, restless leg syndrome, temporomandibular joint disorder, chronic fatigue syndrome, and multiple chemical sensitivities) and three central sensitization-related diagnoses (depression, anxiety/panic attacks, and neck injury). Central sensitization inventory B is for information only and is not scored. | Description | Central sensitization inventory is a screening instrument for clinicians to help identify patients with central sensitivity syndrome. Central sensitization inventory consists of two parts. Part A, one is asked how often he/she experiences each symptom ("never, rarely, sometimes, often, or always"). Individual items are scored from "0" (never) to "4" (always), resulting in a total score range for all 25 items from "0" to "100." A score of 40 or higher indicates the presence of central sensitivity syndrome. Part B asked if one has been previously diagnosed with seven common central sensitivity syndrome diagnoses (tension headaches/migraines, fibromyalgia, irritable bowel syndrome, restless leg syndrome, temporomandibular joint disorder, chronic fatigue syndrome, and multiple chemical sensitivities) and three central sensitization-related diagnoses (depression, anxiety/panic attacks, and neck injury). Central sensitization inventory B is for information only and is not scored. |
Browse Conditions
Sequence: | 193626444 | Sequence: | 193626445 | Sequence: | 193626446 | Sequence: | 193626447 | Sequence: | 193626448 | Sequence: | 193626449 | Sequence: | 193626450 | Sequence: | 193626451 | Sequence: | 193626452 | Sequence: | 193626453 | Sequence: | 193626454 | Sequence: | 193626455 | Sequence: | 193626456 |
Mesh Term | Carpal Tunnel Syndrome | Mesh Term | Syndrome | Mesh Term | Disease | Mesh Term | Pathologic Processes | Mesh Term | Median Neuropathy | Mesh Term | Mononeuropathies | Mesh Term | Peripheral Nervous System Diseases | Mesh Term | Neuromuscular Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Nerve Compression Syndromes | Mesh Term | Cumulative Trauma Disorders | Mesh Term | Sprains and Strains | Mesh Term | Wounds and Injuries |
Downcase Mesh Term | carpal tunnel syndrome | Downcase Mesh Term | syndrome | Downcase Mesh Term | disease | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | median neuropathy | Downcase Mesh Term | mononeuropathies | Downcase Mesh Term | peripheral nervous system diseases | Downcase Mesh Term | neuromuscular diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | nerve compression syndromes | Downcase Mesh Term | cumulative trauma disorders | Downcase Mesh Term | sprains and strains | Downcase Mesh Term | wounds and injuries |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48353575 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Suez Canal University |
Overall Officials
Sequence: | 29305920 |
Role | Study Director |
Name | Mona S Ghaly, MD |
Affiliation | Suez Canal University |
Central Contacts
Sequence: | 12017167 | Sequence: | 12017168 |
Contact Type | primary | Contact Type | backup |
Name | Gehad Swilam | Name | Ahmed Maaty |
Phone | +201027089991 | Phone | +201027089991 |
gsa237@gmail.com | aimaaty@hotmail.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68199028 | Sequence: | 68199029 |
Design Group Id | 55634534 | Design Group Id | 55634535 |
Intervention Id | 52521950 | Intervention Id | 52521950 |
Eligibilities
Sequence: | 30786799 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patient diagnosed as CTS by history, clinical examination and NCS for more than 3 months. Both genders. Adult of aged 18 years and above. Able to understand the informed consent. Exclusion Criteria: Patients with diabetes mellitus, collagen disorders, thyroid disease, peripheral neuropathy, traumatic nerve injury, cervical radiculopathy, fibromyalgia. Pregnancy. Malignant. Patients with any clinically significant or unstable medical or psychiatric disorder. |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253989475 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 9 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30532869 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Masking Description | To make sure that no bias should enter the assessment of the results, neither the patient nor the clinicians will be aware whether active tDCS will be applicated to a particular case. To ensure this result, two symbols (Square and Triangle) will be applicated to the physiotherapy sheet and only the physiotherapist knew the key for each symbol. The triangle may represent the cases of CTS for active tDCS and the square may represent the sham group or vice versa. At the end of the study the two groups will be revealed in order to analyze the results according to proper statistical measures. |
Intervention Model Description | the study subject will be allocated into two group ; active and sham group |
Subject Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28899163 |
Responsible Party Type | Principal Investigator |
Name | Gehad Swilam Abdelmonem Swilam |
Title | Assistant Lecturer |
Affiliation | Suez Canal University |
]]>
https://zephyrnet.com/NCT03795948
2017-07-01
https://zephyrnet.com/?p=NCT03795948
NCT03795948https://www.clinicaltrials.gov/study/NCT03795948?tab=tableNANANAThe presented study is an explorative prospective study. First, it focusses on the longitudinal analysis of outcome quality in stroke treatment (12 months). Particularly, it addresses patient reported quality of life after inpatient stroke treatment and influencing factors. Second, it focusses on the feasibility and acceptance of a standard set of measures capturing outcome quality of medical care in stroke patients.
<![CDATA[
Studies
Study First Submitted Date | 2018-01-19 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-04-10 |
Start Month Year | July 1, 2017 |
Primary Completion Month Year | June 30, 2019 |
Verification Month Year | April 2020 |
Verification Date | 2020-04-30 |
Last Update Posted Date | 2020-04-10 |
Detailed Descriptions
Sequence: | 20721567 |
Description | With a shift in focus to patient-centered health care and a constant effort to improve the quality of treatment, the role of the patient's perception of his/her medical care becomes essential. Patient reported outcome measures (PROMs) are among the most adequate instruments for assessing the patient's perspective on symptom load, functional status, and quality of life. After stroke, patients not only suffer from objectively scaled and measurable symptoms and impairments but also experience dramatic changes in everyday routine and quality of life.
In this project, a standardized outcome measurement, including PROMs, for stroke patients is used. This stoke standard set was developed by the International Consortium for Health Outcomes Measurement (ICHOM; www.ICHOM.org); an international, interdisciplinary and inter-professional expert group with the contribution of patient representatives, aiming to create a comprehensive tool for measuring the most important outcomes and risk factors applicable to a broad variety of diseases. Main objective of this study is the analysis of quality of life 90 and 360 days after stroke and its association with stroke specific risk factors and complications, also measured within the scope of the ICHOM tool. Furthermore, the process and success of the implementation of the ICHOM stroke standard set within the stroke unit of the University Medical Centre Hamburg- Eppendorf (UKE) will be studied and evaluated. |
Facilities
Sequence: | 200107784 |
Name | Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE) |
City | Hamburg |
Zip | 20246 |
Country | Germany |
Conditions
Sequence: | 52171072 |
Name | Stroke |
Downcase Name | stroke |
Id Information
Sequence: | 40158516 |
Id Source | org_study_id |
Id Value | 0977_114 |
Countries
Sequence: | 42568825 |
Name | Germany |
Removed | False |
Design Groups
Sequence: | 55593007 |
Group Type | Other |
Title | PROM Evaluation for stroke patients |
Description | Patient will be enrolled and PROMs will be collected. |
Interventions
Sequence: | 52485317 |
Intervention Type | Other |
Name | PROMs |
Description | Introduction and assessment of the ICHOM standard set consisting of demographic and medical data as well as questionnaires filled in by patients, shortly after admission to the stroke unit, at discharge, and at 90 and 360 days after stroke.
Specifically the intervention includes an assembly of clinical records, in particular records of complications, recurrence of disease and mortality. Further patients will be required to complete a questionnaire assessing their situation in terms of housing and symptom burden as well as their self-perceived autonomy and quality of life. Telephone assessments will be administered to support patients if necessary and validate their responses. |
Keywords
Sequence: | 79868247 | Sequence: | 79868248 | Sequence: | 79868249 | Sequence: | 79868250 | Sequence: | 79868251 | Sequence: | 79868252 | Sequence: | 79868253 | Sequence: | 79868254 | Sequence: | 79868255 |
Name | Stoke | Name | Patient-reported outcomes (PROs) | Name | Quality of life | Name | Morbidity | Name | Mortality | Name | Functional status | Name | Patient-centered care | Name | ICHOM | Name | Treatment quality |
Downcase Name | stoke | Downcase Name | patient-reported outcomes (pros) | Downcase Name | quality of life | Downcase Name | morbidity | Downcase Name | mortality | Downcase Name | functional status | Downcase Name | patient-centered care | Downcase Name | ichom | Downcase Name | treatment quality |
Design Outcomes
Sequence: | 177378205 | Sequence: | 177378203 | Sequence: | 177378204 | Sequence: | 177378206 | Sequence: | 177378207 | Sequence: | 177378208 | Sequence: | 177378209 | Sequence: | 177378210 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Recurrence of disease | Measure | Global patient reported health-related quality of life | Measure | Patient reported mental health status | Measure | Acute complications of treatment | Measure | Use of healthcare services after stroke | Measure | Quantitative process evaluation of the implementation of the ICHOM stroke standard set in routine care | Measure | Psychometric evaluation of the patient-reported outcome measures | Measure | Qualitative process evaluation of the implementation of the ICHOM stroke standard set in routine care |
Time Frame | 90 days | Time Frame | 90 days | Time Frame | 90 days | Time Frame | at discharge from inpatient care, on average 6 days after admission | Time Frame | 90 days | Time Frame | after study completion (2 years) | Time Frame | after study completion (2 years) | Time Frame | after study completion (2 years) |
Description | patient-reported measures | Description | PROMIS-10 | Description | PHQ-4 (depression, anxiety) | Description | clinical assessment of symptomatic intracranial hemorrhage | Description | Patient-reported measures about the patient's level of care and use of specific rehabilitation measures as part of the ICHOM stroke standard set, specifically two questions ranging from 0 to 5 and 0 to 4 with 0 denoting self-containment and no use of rehabilitation services respec-tively and 5 and 4 denoting high level care-dependency and admission in longterm care facilities respectively. | Description | Quantitative indicators on feasibility of the intervention (i.e. recruitente and respective response rate) | Description | Psychometric evaluation of the patient-reported outcome measueres of the ICHOM stroke standard set in the study population | Description | qualitative interviews with the staff and patients on acceptability, feasibility, barriers, and facilitators of the intervention |
Browse Conditions
Sequence: | 193486038 | Sequence: | 193486039 | Sequence: | 193486040 | Sequence: | 193486041 | Sequence: | 193486042 | Sequence: | 193486043 | Sequence: | 193486044 |
Mesh Term | Stroke | Mesh Term | Cerebrovascular Disorders | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases |
Downcase Mesh Term | stroke | Downcase Mesh Term | cerebrovascular disorders | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319127 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Universitätsklinikum Hamburg-Eppendorf |
Overall Officials
Sequence: | 29285254 |
Role | Principal Investigator |
Name | Thomalla Götz, MD, Prof. |
Affiliation | Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany |
Design Group Interventions
Sequence: | 68148941 |
Design Group Id | 55593007 |
Intervention Id | 52485317 |
Eligibilities
Sequence: | 30765253 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients in inpatient care in the stroke unit of the UKE with the following diagnoses (ICD-10): Ischemic attack (I63), Exclusion Criteria: Substantially impaired communication capacity due to aphasia or dementia |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253875413 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 24 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 7 |
Designs
Sequence: | 30511420 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28877714 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52063104 | Sequence: | 52063105 | Sequence: | 52063106 | Sequence: | 52063107 |
Pmid | 35292028 | Pmid | 34420516 | Pmid | 33324894 | Pmid | 32810906 |
Reference Type | derived | Reference Type | derived | Reference Type | derived | Reference Type | derived |
Citation | Lebherz L, Fraune E, Thomalla G, Frese M, Appelbohm H, Rimmele DL, Harter M, Kriston L. Implementability of collecting patient-reported outcome data in stroke unit care – a qualitative study. BMC Health Serv Res. 2022 Mar 16;22(1):346. doi: 10.1186/s12913-022-07722-y. | Citation | Rimmele DL, Schrage T, Lebherz L, Kriston L, Gerloff C, Harter M, Thomalla G. Profiles of patients' self-reported health after acute stroke. Neurol Res Pract. 2021 Aug 23;3(1):43. doi: 10.1186/s42466-021-00146-9. | Citation | Rimmele DL, Lebherz L, Frese M, Appelbohm H, Bartz HJ, Kriston L, Gerloff C, Harter M, Thomalla G. Outcome evaluation by patient reported outcome measures in stroke clinical practice (EPOS) protocol for a prospective observation and implementation study. Neurol Res Pract. 2019 Nov 1;1:28. doi: 10.1186/s42466-019-0034-0. eCollection 2019. | Citation | Rimmele DL, Lebherz L, Frese M, Appelbohm H, Bartz HJ, Kriston L, Gerloff C, Harter M, Thomalla G. Health-related quality of life 90 days after stroke assessed by the International Consortium for Health Outcome Measurement standard set. Eur J Neurol. 2020 Dec;27(12):2508-2516. doi: 10.1111/ene.14479. Epub 2020 Sep 7. |
]]>
https://zephyrnet.com/NCT03795935
2018-09-17
https://zephyrnet.com/?p=NCT03795935
NCT03795935https://www.clinicaltrials.gov/study/NCT03795935?tab=tableNatasha Sarai, BSNnatasha.sarai@vch.ca6048754111Deep Brain Stimulation (DBS) uses electrical pulses sent through a lead (insulated wire) to help stop unwanted symptoms in a variety of brain diseases, including the tremor seen in patients with Essential Tremor (ET). The current standard lead allows this stimulation to spread out uniformly in all directions. As these diseases progress, however, the amount of electrical stimulation required to stop the symptom usually increases. This may become problematic because the increased electrical stimulation required for advanced symptoms may spread outside the desired targeted area, and effect other parts of the brain and causing unwanted side effects. A new type of DBS lead has been developed which can steer, or focus, the electrical stimulation in a given direction toward the desired target area and away from areas that would cause side effects. We would like to quantify the benefit seen in patients who have been switched from the traditional lead to this new directional lead.
<![CDATA[
Studies
Study First Submitted Date | 2018-09-17 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | September 17, 2018 |
Primary Completion Month Year | July 1, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-08 |
Detailed Descriptions
Sequence: | 20741070 |
Description | Patients implanted with a DBS may experience unwanted side effects such as motor contractures, paresthesia, or dysarthria. This occurs when the electrical field of the stimulation spreads out beyond the targeted area. This is especially common in patients whose disease has progressed, and must use increasingly higher currents in order to regain control of their tremor. Unfortunately, because the electrical field affects neurons in a symmetrical sphere around the DBS, it is often impossible to reach the additional desired neuronal elements without simultaneously affecting equidistant brain regions responsible for side effects. For many of our advanced patients, this means choosing between a debilitating tremor or disabling side effects.The directional lead is a FDA and Health Canada approved DBS lead which features radially segmented electrodes which can selectively steer the electrical field in a predefined direction, orthogonal to the lead trajectory. This will allow DBS clinicians to steer current towards desired structural areas, while avoiding locations, which produce negative side effects. |
Facilities
Sequence: | 200280070 |
Status | Recruiting |
Name | The Vancouver General Hospital |
City | Vancouver |
State | British Columbia |
Zip | V5Z 4E3 |
Country | Canada |
Facility Contacts
Sequence: | 28132783 |
Facility Id | 200280070 |
Contact Type | primary |
Name | Christopher R Honey, MD, DPhil |
chris.honey@telus.net | |
Phone | 604.875.5894 |
Conditions
Sequence: | 52221268 | Sequence: | 52221269 | Sequence: | 52221270 |
Name | Deep Brain Stimulation | Name | Directional Lead | Name | Essential Tremor |
Downcase Name | deep brain stimulation | Downcase Name | directional lead | Downcase Name | essential tremor |
Id Information
Sequence: | 40195459 |
Id Source | org_study_id |
Id Value | H17-00672 |
Countries
Sequence: | 42609463 |
Name | Canada |
Removed | False |
Design Groups
Sequence: | 55649527 |
Group Type | Experimental |
Title | Treatment |
Description | Patients who were previously implanted with a traditional DBS lead and have subsequently developed stimulation induced side effects will gain significantly more tremor control without side effects when re-implanted with a directional DBS lead. We expect these patients' quality of life will improve. These patients typically will have had significant tremor relief (greater than 75% reduction from preoperative tremor rating scale) without side effects at their one year post operative follow-up. With the expected disease progression they will have had to increase their DBS stimulation to the degree that their DBS now causes side effects in order to block their tremor |
Interventions
Sequence: | 52535051 |
Intervention Type | Other |
Name | No side-effect stimulator settings with directional lead |
Description | Individuals in this arm will have their stimulator settings programmed to the point in which they have maximum tremor control with no side effects. |
Keywords
Sequence: | 79941459 | Sequence: | 79941460 | Sequence: | 79941461 |
Name | Deep Brain Stimulation | Name | Directional Lead | Name | Essential Tremor |
Downcase Name | deep brain stimulation | Downcase Name | directional lead | Downcase Name | essential tremor |
Design Outcomes
Sequence: | 177560482 | Sequence: | 177560483 | Sequence: | 177560484 | Sequence: | 177560485 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Tremor Control | Measure | Quality of life based on participant's best real life setting | Measure | Quality of life based on tremor management participant's best real life setting | Measure | Quality of life based on voice handicap with participant's best real life setting |
Time Frame | Assessed once all tests performed – 1 to 2 months post-operatively | Time Frame | Assessed during study visits – The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured | Time Frame | Assessed during study visits – The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured | Time Frame | Assessed during study visits – The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured |
Description | Maximum percentage change in tremor (as measured by the Tremor Rating Scale) without side-effects (comparing DBS "on" versus "off") in each patient using the standard lead compared to the directional lead. | Description | Quality of life will be based on each participant's subjective opinion using the Short Form 36 (SF36) (a patient-reported survey focusing on health and quality of life) assessment form. | Description | Quality of life will be based on each participant's subjective opinion using the Quality of Life in Essential Tremor Questionare. | Description | Quality of life will be based on each participant's subjective opinion using the Vocal handicap Index scale. |
Browse Conditions
Sequence: | 193677586 | Sequence: | 193677587 | Sequence: | 193677588 | Sequence: | 193677589 | Sequence: | 193677590 | Sequence: | 193677591 | Sequence: | 193677585 |
Mesh Term | Essential Tremor | Mesh Term | Dyskinesias | Mesh Term | Neurologic Manifestations | Mesh Term | Nervous System Diseases | Mesh Term | Movement Disorders | Mesh Term | Central Nervous System Diseases | Mesh Term | Tremor |
Downcase Mesh Term | essential tremor | Downcase Mesh Term | dyskinesias | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | movement disorders | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | tremor |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list |
Sponsors
Sequence: | 48366177 | Sequence: | 48366178 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of British Columbia | Name | Boston Scientific Corporation |
Central Contacts
Sequence: | 12020528 | Sequence: | 12020529 |
Contact Type | primary | Contact Type | backup |
Name | Christopher Honey, DPhil | Name | Natasha Sarai, BSN |
Phone | 6048755894 | Phone | 6048754111 |
chris.honey@telus.net | natasha.sarai@vch.ca | ||
Phone Extension | 69584 | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68217006 |
Design Group Id | 55649527 |
Intervention Id | 52535051 |
Eligibilities
Sequence: | 30794565 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 80 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Participants must have been implanted with the DBS Exclusion Criteria: All individuals who meet criteria outlined in "inclusion criteria" may be eligible for this study |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004070 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30540605 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Pending Results
Sequence: | 1502290 | Sequence: | 1502291 | Sequence: | 1502292 | Sequence: | 1502293 | Sequence: | 1502294 | Sequence: | 1502295 | Sequence: | 1502296 | Sequence: | 1502297 |
Event | Release | Event | Reset | Event | Release | Event | Reset | Event | Release | Event | Reset | Event | Release | Event | Reset |
Event Date Description | October 26, 2020 | Event Date Description | November 19, 2020 | Event Date Description | November 20, 2020 | Event Date Description | December 18, 2020 | Event Date Description | January 8, 2021 | Event Date Description | January 28, 2021 | Event Date Description | April 26, 2021 | Event Date Description | May 21, 2021 |
Event Date | 2020-10-26 | Event Date | 2020-11-19 | Event Date | 2020-11-20 | Event Date | 2020-12-18 | Event Date | 2021-01-08 | Event Date | 2021-01-28 | Event Date | 2021-04-26 | Event Date | 2021-05-21 |
Responsible Parties
Sequence: | 28906924 |
Responsible Party Type | Principal Investigator |
Name | Christopher Honey |
Title | Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders |
Affiliation | University of British Columbia |
Study References
Sequence: | 52117979 | Sequence: | 52117980 |
Pmid | 21096152 | Pmid | 28385887 |
Reference Type | background | Reference Type | background |
Citation | Toader E, Decre MM, Martens HC. Steering deep brain stimulation fields using a high resolution electrode array. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:2061-4. doi: 10.1109/IEMBS.2010.5626472. | Citation | Reinacher PC, Kruger MT, Coenen VA, Shah M, Roelz R, Jenkner C, Egger K. Determining the Orientation of Directional Deep Brain Stimulation Electrodes Using 3D Rotational Fluoroscopy. AJNR Am J Neuroradiol. 2017 Jun;38(6):1111-1116. doi: 10.3174/ajnr.A5153. Epub 2017 Apr 6. |
]]>
https://zephyrnet.com/NCT03795922
2018-12-24
https://zephyrnet.com/?p=NCT03795922
NCT03795922https://www.clinicaltrials.gov/study/NCT03795922?tab=tableNANANATo evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in participants with moderate to severe GL.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-20 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-07-27 |
Start Month Year | December 24, 2018 |
Primary Completion Month Year | March 13, 2020 |
Verification Month Year | July 2023 |
Verification Date | 2023-07-31 |
Last Update Posted Date | 2023-07-27 |
Results First Posted Date | 2023-06-27 |
Facilities
Sequence: | 198680615 | Sequence: | 198680616 | Sequence: | 198680617 | Sequence: | 198680618 | Sequence: | 198680619 | Sequence: | 198680620 | Sequence: | 198680621 | Sequence: | 198680622 | Sequence: | 198680623 | Sequence: | 198680624 | Sequence: | 198680625 | Sequence: | 198680626 | Sequence: | 198680627 | Sequence: | 198680628 | Sequence: | 198680629 |
Name | Investigate MD | Name | Art of Skin MD | Name | Weinkle Dermatology | Name | Etre, Cosmetic Dermatology and Laser Center | Name | Dermatology and Laser Surgery Center of New York | Name | SkinSearch of Rochester, Inc. | Name | M3 Wake Research, Inc. | Name | Aventiv Research, Inc. | Name | Westlake Dermatology & Cosmetic Surgery | Name | Centre de la Fontaine | Name | Medical Skin Care | Name | Universitair Ziekenhuis Brussel | Name | CHU Liege | Name | Kazan State Medical University | Name | Medical Centre Capital-Zdorovie |
City | Scottsdale | City | Solana Beach | City | Bradenton | City | New Orleans | City | New York | City | Rochester | City | Raleigh | City | Dublin | City | Austin | City | Loverval | City | Sint-Truiden | City | Brussels | City | Liege | City | Kazan | City | Moscow |
State | Arizona | State | California | State | Florida | State | Louisiana | State | New York | State | New York | State | North Carolina | State | Ohio | State | Texas | State | Hainaut | State | Limburg | State | Tatarstan Republic | ||||||
Zip | 85255 | Zip | 92075 | Zip | 34209 | Zip | 70130 | Zip | 10028 | Zip | 14623 | Zip | 27612 | Zip | 43016 | Zip | 78746 | Zip | 6280 | Zip | 3800 | Zip | 1090 | Zip | 4000 | Zip | 420105 | Zip | 109369 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | Belgium | Country | Belgium | Country | Belgium | Country | Belgium | Country | Russian Federation | Country | Russian Federation |
Conditions
Sequence: | 51805991 |
Name | Glabellar Lines |
Downcase Name | glabellar lines |
Id Information
Sequence: | 39867741 | Sequence: | 39867742 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | MT10109L-001 | Id Value | 2018-004384-31 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42266302 | Sequence: | 42266303 | Sequence: | 42266304 |
Name | United States | Name | Belgium | Name | Russian Federation |
Removed | False | Removed | False | Removed | False |
Design Groups
Sequence: | 55226133 | Sequence: | 55226134 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | MT10109L | Title | Placebo |
Description | MT10109L will be injected into the GL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. | Description | Placebo will be injected into the GL: initial double-blind treatment on Day 1. |
Interventions
Sequence: | 52127684 | Sequence: | 52127683 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Placebo | Name | MT10109L |
Description | Placebo will be injected into the GL. | Description | MT10109L will be injected into the GL. |
Design Outcomes
Sequence: | 176201931 | Sequence: | 176201932 | Sequence: | 176201933 | Sequence: | 176201934 | Sequence: | 176201935 | Sequence: | 176201936 | Sequence: | 176201937 | Sequence: | 176201938 | Sequence: | 176201939 | Sequence: | 176201940 | Sequence: | 176201941 | Sequence: | 176201942 | Sequence: | 176201943 | Sequence: | 176201944 | Sequence: | 176201945 | Sequence: | 176201946 | Sequence: | 176201947 | Sequence: | 176201948 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 30 | Measure | The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS) | Measure | The Duration of Glabellar Lines (GL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in GL Severity at Maximum Frown at Day 30 According to Investigator Assessments Using the Facial Wrinkle Scale (FWS) | Measure | The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Glabellar Lines (GL) | Measure | The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS). | Measure | Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration | Measure | Mean Change From Baseline in Vital Signs – Systolic Blood Pressure (BP) | Measure | Mean Change From Baseline in Vital Signs – Diastolic Blood Pressure (BP) | Measure | Mean Change From Baseline in Vital Signs – Pulse Rate | Measure | Mean Change From Baseline in Vital Signs – Respiratory Rate | Measure | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – Heart Rate | Measure | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – PR Interval | Measure | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – QRS Duration | Measure | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – QT Interval | Measure | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – QTcB Interval | Measure | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – QTcF Interval | Measure | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – RR Interval | Measure | Number of Participants With Binding and Neutralizing Antibodies |
Time Frame | Day 30 | Time Frame | Day 30 | Time Frame | Day 1 (first treatment) to Day 180 | Time Frame | Day 60 | Time Frame | Day 30 | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | Baseline to Study exit (Day 360 or early exit) | Time Frame | Baseline to Study exit (Day 360 or early exit) | Time Frame | Baseline to Study exit (Day 360 or early exit) | Time Frame | Baseline to Study exit (Day 360 or early exit) | Time Frame | Baseline to Study Exit (Day 360 or early exit) | Time Frame | Baseline to Study Exit (Day 360 or early exit) | Time Frame | Baseline to Study Exit (Day 360 or early exit) | Time Frame | Baseline to Study Exit (Day 360 or early exit) | Time Frame | Baseline to Study Exit (Day 360 or early exit) | Time Frame | Baseline to Study Exit (Day 360 or early exit) | Time Frame | Baseline to Study Exit (Day 360 or early exit) | Time Frame | Up to Study Exit (Day 360 or early exit) |
Description | The primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 0=none and 3=severe.
The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline. |
Description | The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a ≥2-grade Improvement from Baseline at Maximum Frown at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe | Description | The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (i.e., return to moderate or severe GL severity at maximum frown using the FWS). | Description | The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied. | Description | The outcome was measured among participants who Were rated at least mild at rest at baseline, where a Responder was defined as achieving a ≥1-grade improvement from Baseline at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. | Description | This section focuses primarily on Treatment Emergent Adverse Events (TEAEs), i.e., AEs that started or worsened after the first dose of study intervention (Day 1) until up to 30 days after their last visit or study exit. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown. |
Sponsors
Sequence: | 47978755 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Medy-Tox |
Overall Officials
Sequence: | 29069668 |
Role | Study Director |
Name | SangMi Park |
Affiliation | Medytox Inc. |
Design Group Interventions
Sequence: | 67707419 | Sequence: | 67707420 |
Design Group Id | 55226133 | Design Group Id | 55226134 |
Intervention Id | 52127683 | Intervention Id | 52127684 |
Eligibilities
Sequence: | 30550793 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria
• Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Exclusion Criteria Known immunization or hypersensitivity to any botulinum toxin serotype. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254231768 |
Number Of Facilities | 15 |
Number Of Nsae Subjects | 46 |
Number Of Sae Subjects | 11 |
Registered In Calendar Year | 2018 |
Actual Duration | 14 |
Were Results Reported | True |
Months To Report Results | 39 |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 17 |
Designs
Sequence: | 30299162 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Drop Withdrawals
Sequence: | 28781919 | Sequence: | 28781920 | Sequence: | 28781921 | Sequence: | 28781922 | Sequence: | 28781923 | Sequence: | 28781924 | Sequence: | 28781925 | Sequence: | 28781926 | Sequence: | 28781927 | Sequence: | 28781928 | Sequence: | 28781929 | Sequence: | 28781930 | Sequence: | 28781931 | Sequence: | 28781932 |
Result Group Id | 55884677 | Result Group Id | 55884678 | Result Group Id | 55884677 | Result Group Id | 55884678 | Result Group Id | 55884677 | Result Group Id | 55884678 | Result Group Id | 55884677 | Result Group Id | 55884678 | Result Group Id | 55884677 | Result Group Id | 55884678 | Result Group Id | 55884677 | Result Group Id | 55884678 | Result Group Id | 55884677 | Result Group Id | 55884678 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Adverse Event | Reason | Adverse Event | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Pregnancy | Reason | Pregnancy | Reason | Physician Decision | Reason | Physician Decision | Reason | Protocol Violation | Reason | Protocol Violation | Reason | Other (Early termination, COVID, Family issue) | Reason | Other (Early termination, COVID, Family issue) |
Count | 2 | Count | 1 | Count | 5 | Count | 13 | Count | 2 | Count | 3 | Count | 0 | Count | 1 | Count | 1 | Count | 2 | Count | 0 | Count | 1 | Count | 3 | Count | 4 |
Intervention Other Names
Sequence: | 26497657 |
Intervention Id | 52127683 |
Name | NivobotulinumtoxinA |
Milestones
Sequence: | 40803746 | Sequence: | 40803747 | Sequence: | 40803748 | Sequence: | 40803749 | Sequence: | 40803750 | Sequence: | 40803751 |
Result Group Id | 55884677 | Result Group Id | 55884678 | Result Group Id | 55884677 | Result Group Id | 55884678 | Result Group Id | 55884677 | Result Group Id | 55884678 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 80 | Count | 154 | Count | 67 | Count | 129 | Count | 13 | Count | 25 |
Participant Flows
Sequence: | 3903280 |
Pre Assignment Details | 234 met the inclusion/exclusion criteria and were randomized. |
Outcome Counts
Sequence: | 73600980 | Sequence: | 73600981 | Sequence: | 73600982 | Sequence: | 73600983 | Sequence: | 73600984 | Sequence: | 73600985 | Sequence: | 73600986 | Sequence: | 73600987 | Sequence: | 73600988 | Sequence: | 73600989 | Sequence: | 73600990 | Sequence: | 73600991 | Sequence: | 73600992 | Sequence: | 73600993 | Sequence: | 73600994 | Sequence: | 73600995 | Sequence: | 73600996 | Sequence: | 73600997 | Sequence: | 73600998 | Sequence: | 73600999 | Sequence: | 73601000 | Sequence: | 73601001 | Sequence: | 73601002 | Sequence: | 73601003 | Sequence: | 73601004 | Sequence: | 73601005 | Sequence: | 73601006 | Sequence: | 73601007 | Sequence: | 73601008 | Sequence: | 73601009 | Sequence: | 73601010 | Sequence: | 73601011 | Sequence: | 73601012 | Sequence: | 73601013 | Sequence: | 73601014 | Sequence: | 73601015 |
Outcome Id | 30640031 | Outcome Id | 30640031 | Outcome Id | 30640032 | Outcome Id | 30640032 | Outcome Id | 30640033 | Outcome Id | 30640033 | Outcome Id | 30640034 | Outcome Id | 30640034 | Outcome Id | 30640035 | Outcome Id | 30640035 | Outcome Id | 30640036 | Outcome Id | 30640036 | Outcome Id | 30640037 | Outcome Id | 30640037 | Outcome Id | 30640038 | Outcome Id | 30640038 | Outcome Id | 30640039 | Outcome Id | 30640039 | Outcome Id | 30640040 | Outcome Id | 30640040 | Outcome Id | 30640041 | Outcome Id | 30640041 | Outcome Id | 30640042 | Outcome Id | 30640042 | Outcome Id | 30640043 | Outcome Id | 30640043 | Outcome Id | 30640044 | Outcome Id | 30640044 | Outcome Id | 30640045 | Outcome Id | 30640045 | Outcome Id | 30640046 | Outcome Id | 30640046 | Outcome Id | 30640047 | Outcome Id | 30640047 | Outcome Id | 30640048 | Outcome Id | 30640048 |
Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884681 | Result Group Id | 55884682 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 80 | Count | 154 | Count | 77 | Count | 153 | Count | 1 | Count | 94 | Count | 72 | Count | 145 | Count | 73 | Count | 140 | Count | 80 | Count | 223 | Count | 73 | Count | 133 | Count | 73 | Count | 133 | Count | 73 | Count | 133 | Count | 73 | Count | 133 | Count | 70 | Count | 130 | Count | 70 | Count | 130 | Count | 70 | Count | 130 | Count | 70 | Count | 130 | Count | 70 | Count | 130 | Count | 70 | Count | 130 | Count | 70 | Count | 130 | Count | 80 | Count | 154 |
Provided Documents
Sequence: | 2569044 | Sequence: | 2569045 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2020-09-30 | Document Date | 2020-11-18 |
Url | https://ClinicalTrials.gov/ProvidedDocs/22/NCT03795922/Prot_002.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/22/NCT03795922/SAP_003.pdf |
Reported Event Totals
Sequence: | 27808474 | Sequence: | 27808475 | Sequence: | 27808476 | Sequence: | 27808477 | Sequence: | 27808478 | Sequence: | 27808479 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 3 | Subjects Affected | 8 | Subjects Affected | 0 | Subjects Affected | 5 | Subjects Affected | 32 | Subjects Affected | 0 |
Subjects At Risk | 80 | Subjects At Risk | 80 | Subjects At Risk | 80 | Subjects At Risk | 223 | Subjects At Risk | 223 | Subjects At Risk | 223 |
Created At | 2023-08-06 20:07:19.130372 | Created At | 2023-08-06 20:07:19.130372 | Created At | 2023-08-06 20:07:19.130372 | Created At | 2023-08-06 20:07:19.130372 | Created At | 2023-08-06 20:07:19.130372 | Created At | 2023-08-06 20:07:19.130372 |
Updated At | 2023-08-06 20:07:19.130372 | Updated At | 2023-08-06 20:07:19.130372 | Updated At | 2023-08-06 20:07:19.130372 | Updated At | 2023-08-06 20:07:19.130372 | Updated At | 2023-08-06 20:07:19.130372 | Updated At | 2023-08-06 20:07:19.130372 |
Reported Events
Sequence: | 524858577 | Sequence: | 524858578 | Sequence: | 524858579 | Sequence: | 524858580 | Sequence: | 524858581 | Sequence: | 524858582 | Sequence: | 524858583 | Sequence: | 524858584 | Sequence: | 524858585 | Sequence: | 524858586 | Sequence: | 524858587 | Sequence: | 524858588 | Sequence: | 524858589 | Sequence: | 524858590 | Sequence: | 524858591 | Sequence: | 524858592 | Sequence: | 524858593 | Sequence: | 524858594 | Sequence: | 524858595 | Sequence: | 524858596 | Sequence: | 524858597 | Sequence: | 524858598 | Sequence: | 524858599 | Sequence: | 524858600 | Sequence: | 524858601 | Sequence: | 524858602 |
Result Group Id | 55884683 | Result Group Id | 55884684 | Result Group Id | 55884683 | Result Group Id | 55884684 | Result Group Id | 55884683 | Result Group Id | 55884684 | Result Group Id | 55884683 | Result Group Id | 55884684 | Result Group Id | 55884683 | Result Group Id | 55884684 | Result Group Id | 55884683 | Result Group Id | 55884684 | Result Group Id | 55884683 | Result Group Id | 55884684 | Result Group Id | 55884683 | Result Group Id | 55884684 | Result Group Id | 55884683 | Result Group Id | 55884684 | Result Group Id | 55884683 | Result Group Id | 55884684 | Result Group Id | 55884683 | Result Group Id | 55884684 | Result Group Id | 55884683 | Result Group Id | 55884684 | Result Group Id | 55884683 | Result Group Id | 55884684 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). |
Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | other | Event Type | other | Event Type | other | Event Type | other |
Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 4 | Subjects Affected | 22 | Subjects Affected | 4 | Subjects Affected | 16 |
Subjects At Risk | 80 | Subjects At Risk | 223 | Subjects At Risk | 80 | Subjects At Risk | 223 | Subjects At Risk | 80 | Subjects At Risk | 223 | Subjects At Risk | 80 | Subjects At Risk | 223 | Subjects At Risk | 80 | Subjects At Risk | 223 | Subjects At Risk | 80 | Subjects At Risk | 223 | Subjects At Risk | 80 | Subjects At Risk | 223 | Subjects At Risk | 80 | Subjects At Risk | 223 | Subjects At Risk | 80 | Subjects At Risk | 223 | Subjects At Risk | 80 | Subjects At Risk | 223 | Subjects At Risk | 80 | Subjects At Risk | 223 | Subjects At Risk | 80 | Subjects At Risk | 223 | Subjects At Risk | 80 | Subjects At Risk | 223 |
Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Description | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. |
Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 4 | Event Count | 22 | Event Count | 4 | Event Count | 16 |
Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | General disorders | Organ System | General disorders |
Adverse Event Term | COVID-19 pneumonia | Adverse Event Term | COVID-19 pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Rectal prolapse | Adverse Event Term | Rectal prolapse | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Hip fracture | Adverse Event Term | Hip fracture | Adverse Event Term | Radius fracture | Adverse Event Term | Radius fracture | Adverse Event Term | Road traffic accident | Adverse Event Term | Road traffic accident | Adverse Event Term | Breast Cancer | Adverse Event Term | Breast Cancer | Adverse Event Term | Breast Cancer Stage II | Adverse Event Term | Breast Cancer Stage II | Adverse Event Term | Malignant Melanoma in situ | Adverse Event Term | Malignant Melanoma in situ | Adverse Event Term | Intentional Overdose | Adverse Event Term | Intentional Overdose | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Injection site pain | Adverse Event Term | Injection site pain |
Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 |
Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 | Vocab | MedDRA, Version 23.1 |
Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment |
Responsible Parties
Sequence: | 28677730 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3834024 |
Pi Employee | No |
Restriction Type | OTHER |
Other Details | General research agreement between the sponsor and PI's that includes a confidentiality section that includes a statement that the sponsor is and shall remain the exclusive owner of 'Information'. 'Information' shall include, but shall not be limited to, protocols, trade secrets, know-how, formulations, inventions, techniques, equipment, data and results. |
Restrictive Agreement | General research agreement between the sponsor and PI's that includes a confidentiality section that includes a statement that the sponsor is and shall remain the exclusive owner of 'Information'. 'Information' shall include, but shall not be limited to, protocols, trade secrets, know-how, formulations, inventions, techniques, equipment, data and results. |
Result Contacts
Sequence: | 3833989 |
Organization | Medytox Inc. |
Name | Young Ryu |
Phone | +82-2-6901-5424 |
aab005@medytox.com | |
Outcomes
Sequence: | 30640031 | Sequence: | 30640038 | Sequence: | 30640032 | Sequence: | 30640033 | Sequence: | 30640034 | Sequence: | 30640035 | Sequence: | 30640036 | Sequence: | 30640037 | Sequence: | 30640039 | Sequence: | 30640040 | Sequence: | 30640041 | Sequence: | 30640042 | Sequence: | 30640043 | Sequence: | 30640044 | Sequence: | 30640045 | Sequence: | 30640046 | Sequence: | 30640047 | Sequence: | 30640048 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 30 | Title | Mean Change From Baseline in Vital Signs – Diastolic Blood Pressure (BP) | Title | The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS) | Title | The Duration of Glabellar Lines (GL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in GL Severity at Maximum Frown at Day 30 According to Investigator Assessments Using the Facial Wrinkle Scale (FWS) | Title | The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Glabellar Lines (GL) | Title | The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS). | Title | Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration | Title | Mean Change From Baseline in Vital Signs – Systolic Blood Pressure (BP) | Title | Mean Change From Baseline in Vital Signs – Pulse Rate | Title | Mean Change From Baseline in Vital Signs – Respiratory Rate | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – Heart Rate | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – PR Interval | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – QRS Duration | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – QT Interval | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – QTcB Interval | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – QTcF Interval | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – RR Interval | Title | Number of Participants With Binding and Neutralizing Antibodies |
Description | The primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 0=none and 3=severe.
The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline. |
Description | Change from baseline at study exit. | Description | The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a ≥2-grade Improvement from Baseline at Maximum Frown at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe | Description | The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (i.e., return to moderate or severe GL severity at maximum frown using the FWS). | Description | The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied. | Description | The outcome was measured among participants who Were rated at least mild at rest at baseline, where a Responder was defined as achieving a ≥1-grade improvement from Baseline at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. | Description | This section focuses primarily on Treatment Emergent Adverse Events (TEAEs), i.e., AEs that started or worsened after the first dose of study intervention (Day 1) until up to 30 days after their last visit or study exit. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown. |
Time Frame | Day 30 | Time Frame | Baseline to Study exit (Day 360 or early exit) | Time Frame | Day 30 | Time Frame | Day 1 (first treatment) to Day 180 | Time Frame | Day 60 | Time Frame | Day 30 | Time Frame | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). | Time Frame | Baseline to Study exit (Day 360 or early exit) | Time Frame | Baseline to Study exit (Day 360 or early exit) | Time Frame | Baseline to Study exit (Day 360 or early exit) | Time Frame | Baseline to Study Exit (Day 360 or early exit) | Time Frame | Baseline to Study Exit (Day 360 or early exit) | Time Frame | Baseline to Study Exit (Day 360 or early exit) | Time Frame | Baseline to Study Exit (Day 360 or early exit) | Time Frame | Baseline to Study Exit (Day 360 or early exit) | Time Frame | Baseline to Study Exit (Day 360 or early exit) | Time Frame | Baseline to Study Exit (Day 360 or early exit) | Time Frame | Up to Study Exit (Day 360 or early exit) |
Population | All primary and secondary efficacy analyses endpoints were carried out using the Intent-To-Treat (ITT) analysis set, which was defined as all participants who were randomized. Multiple imputation method was used for missing variables in primary efficacy endpoint. Analyses of the secondary efficacy variables were performed using observed data. | Population | All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Population | All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data. | Population | The analysis population for this outcome includes the participants who achieved a rating of ≥ 2-gradeimprovement from baseline in GL severity at maximum frown at Day 30 of double-blind period according to investigator assessments using the Facial Wrinkle Scale (FWS). This corresponds to the responders for Outcome 2. Note: Analyses of the secondary efficacy variables were performed using observed data. | Population | All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which wasdefined as all participants who were randomized. Analyses of the secondary efficacy variables wereperformed using observed data | Population | All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data. | Population | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Population | All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Population | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Population | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Population | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Population | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Population | All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Population | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Population | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Population | All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Population | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Population | All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. |
Units | Participants | Units | mmHg | Units | Participants | Units | Days | Units | Participants | Units | Participants | Units | Participants | Units | mmHg | Units | beats/min | Units | breaths/min | Units | beats/min | Units | milliseconds | Units | milliseconds | Units | milliseconds | Units | milliseconds | Units | milliseconds | Units | milliseconds | Units | Participants |
Dispersion Type | Standard Deviation | Dispersion Type | 95% Confidence Interval | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||
Param Type | Count of Participants | Param Type | Mean | Param Type | Count of Participants | Param Type | Median | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants |
Outcome Measurements
Sequence: | 234260165 | Sequence: | 234260166 | Sequence: | 234260167 | Sequence: | 234260168 | Sequence: | 234260169 | Sequence: | 234260170 | Sequence: | 234260177 | Sequence: | 234260178 | Sequence: | 234260171 | Sequence: | 234260172 | Sequence: | 234260173 | Sequence: | 234260174 | Sequence: | 234260175 | Sequence: | 234260176 | Sequence: | 234260179 | Sequence: | 234260180 | Sequence: | 234260181 | Sequence: | 234260182 | Sequence: | 234260183 | Sequence: | 234260184 | Sequence: | 234260185 | Sequence: | 234260186 | Sequence: | 234260187 | Sequence: | 234260188 | Sequence: | 234260189 | Sequence: | 234260190 | Sequence: | 234260191 | Sequence: | 234260192 | Sequence: | 234260193 | Sequence: | 234260194 | Sequence: | 234260195 | Sequence: | 234260196 | Sequence: | 234260197 | Sequence: | 234260198 | Sequence: | 234260199 | Sequence: | 234260200 |
Outcome Id | 30640031 | Outcome Id | 30640031 | Outcome Id | 30640032 | Outcome Id | 30640032 | Outcome Id | 30640033 | Outcome Id | 30640033 | Outcome Id | 30640037 | Outcome Id | 30640037 | Outcome Id | 30640034 | Outcome Id | 30640034 | Outcome Id | 30640035 | Outcome Id | 30640035 | Outcome Id | 30640036 | Outcome Id | 30640036 | Outcome Id | 30640038 | Outcome Id | 30640038 | Outcome Id | 30640039 | Outcome Id | 30640039 | Outcome Id | 30640040 | Outcome Id | 30640040 | Outcome Id | 30640041 | Outcome Id | 30640041 | Outcome Id | 30640042 | Outcome Id | 30640042 | Outcome Id | 30640043 | Outcome Id | 30640043 | Outcome Id | 30640044 | Outcome Id | 30640044 | Outcome Id | 30640045 | Outcome Id | 30640045 | Outcome Id | 30640046 | Outcome Id | 30640046 | Outcome Id | 30640047 | Outcome Id | 30640047 | Outcome Id | 30640048 | Outcome Id | 30640048 |
Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884681 | Result Group Id | 55884682 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 | Result Group Id | 55884679 | Result Group Id | 55884680 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Title | The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 30 | Title | The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 30 | Title | The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS) | Title | The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS) | Title | The Duration of Glabellar Lines (GL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in GL Severity at Maximum Frown at Day 30 According to Investigator Assessments Using the Facial Wrinkle Scale (FWS) | Title | The Duration of Glabellar Lines (GL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in GL Severity at Maximum Frown at Day 30 According to Investigator Assessments Using the Facial Wrinkle Scale (FWS) | Title | Mean Change From Baseline in Vital Signs – Systolic Blood Pressure (BP) | Title | Mean Change From Baseline in Vital Signs – Systolic Blood Pressure (BP) | Title | The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Glabellar Lines (GL) | Title | The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Glabellar Lines (GL) | Title | The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS). | Title | The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS). | Title | Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration | Title | Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration | Title | Mean Change From Baseline in Vital Signs – Diastolic Blood Pressure (BP) | Title | Mean Change From Baseline in Vital Signs – Diastolic Blood Pressure (BP) | Title | Mean Change From Baseline in Vital Signs – Pulse Rate | Title | Mean Change From Baseline in Vital Signs – Pulse Rate | Title | Mean Change From Baseline in Vital Signs – Respiratory Rate | Title | Mean Change From Baseline in Vital Signs – Respiratory Rate | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – Heart Rate | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – Heart Rate | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – PR Interval | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – PR Interval | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – QRS Duration | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – QRS Duration | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – QT Interval | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – QT Interval | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – QTcB Interval | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – QTcB Interval | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – QTcF Interval | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – QTcF Interval | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – RR Interval | Title | Mean Change From Baseline in Electrocardiogram (ECG) Parameters – RR Interval | Title | Number of Participants With Binding and Neutralizing Antibodies | Title | Number of Participants With Binding and Neutralizing Antibodies |
Description | The primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 0=none and 3=severe.
The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline. |
Description | The primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 0=none and 3=severe.
The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline. |
Description | The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a ≥2-grade Improvement from Baseline at Maximum Frown at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe | Description | The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a ≥2-grade Improvement from Baseline at Maximum Frown at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe | Description | The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (i.e., return to moderate or severe GL severity at maximum frown using the FWS). | Description | The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (i.e., return to moderate or severe GL severity at maximum frown using the FWS). | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied. | Description | The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied. | Description | The outcome was measured among participants who Were rated at least mild at rest at baseline, where a Responder was defined as achieving a ≥1-grade improvement from Baseline at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. | Description | The outcome was measured among participants who Were rated at least mild at rest at baseline, where a Responder was defined as achieving a ≥1-grade improvement from Baseline at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. | Description | This section focuses primarily on Treatment Emergent Adverse Events (TEAEs), i.e., AEs that started or worsened after the first dose of study intervention (Day 1) until up to 30 days after their last visit or study exit. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs. | Description | This section focuses primarily on Treatment Emergent Adverse Events (TEAEs), i.e., AEs that started or worsened after the first dose of study intervention (Day 1) until up to 30 days after their last visit or study exit. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Change from baseline at study exit. | Description | Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown. | Description | Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown. |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Days | Units | Days | Units | mmHg | Units | mmHg | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | mmHg | Units | mmHg | Units | beats/min | Units | beats/min | Units | breaths/min | Units | breaths/min | Units | beats/min | Units | beats/min | Units | milliseconds | Units | milliseconds | Units | milliseconds | Units | milliseconds | Units | milliseconds | Units | milliseconds | Units | milliseconds | Units | milliseconds | Units | milliseconds | Units | milliseconds | Units | milliseconds | Units | milliseconds | Units | Participants | Units | Participants |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Median | Param Type | Median | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 0 | Param Value | 71 | Param Value | 1 | Param Value | 94 | Param Value | 64 | Param Value | 121 | Param Value | 0.3 | Param Value | -0.6 | Param Value | 7 | Param Value | 121 | Param Value | 23 | Param Value | 95 | Param Value | 35 | Param Value | 118 | Param Value | 0.5 | Param Value | -1.9 | Param Value | 2.5 | Param Value | 0.4 | Param Value | -0.3 | Param Value | -0.3 | Param Value | 4.8 | Param Value | 2.8 | Param Value | -1.2 | Param Value | -1.2 | Param Value | 0.4 | Param Value | 1.2 | Param Value | -11.7 | Param Value | -8.4 | Param Value | 2.7 | Param Value | 0.0 | Param Value | -2.4 | Param Value | -2.9 | Param Value | -64.6 | Param Value | -39.3 | Param Value | 1 | Param Value | 0 |
Param Value Num | 0.0 | Param Value Num | 71.0 | Param Value Num | 1.0 | Param Value Num | 94.0 | Param Value Num | 64.0 | Param Value Num | 121.0 | Param Value Num | 0.3 | Param Value Num | -0.6 | Param Value Num | 7.0 | Param Value Num | 121.0 | Param Value Num | 23.0 | Param Value Num | 95.0 | Param Value Num | 35.0 | Param Value Num | 118.0 | Param Value Num | 0.5 | Param Value Num | -1.9 | Param Value Num | 2.5 | Param Value Num | 0.4 | Param Value Num | -0.3 | Param Value Num | -0.3 | Param Value Num | 4.8 | Param Value Num | 2.8 | Param Value Num | -1.2 | Param Value Num | -1.2 | Param Value Num | 0.4 | Param Value Num | 1.2 | Param Value Num | -11.7 | Param Value Num | -8.4 | Param Value Num | 2.7 | Param Value Num | 0.0 | Param Value Num | -2.4 | Param Value Num | -2.9 | Param Value Num | -64.6 | Param Value Num | -39.3 | Param Value Num | 1.0 | Param Value Num | 0.0 |
Dispersion Type | 95% Confidence Interval | Dispersion Type | 95% Confidence Interval | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||
Dispersion Value | 13.26 | Dispersion Value | 15.28 | Dispersion Value | 10.04 | Dispersion Value | 10.64 | Dispersion Value | 10.35 | Dispersion Value | 10.54 | Dispersion Value | 2.44 | Dispersion Value | 2.18 | Dispersion Value | 10.38 | Dispersion Value | 8.52 | Dispersion Value | 11.67 | Dispersion Value | 11.91 | Dispersion Value | 6.65 | Dispersion Value | 6.41 | Dispersion Value | 23.87 | Dispersion Value | 19.71 | Dispersion Value | 18.69 | Dispersion Value | 17.14 | Dispersion Value | 15.43 | Dispersion Value | 14.06 | Dispersion Value | 127.1 | Dispersion Value | 106.19 | ||||||||||||||||||||||||||||
Dispersion Value Num | 13.26 | Dispersion Value Num | 15.28 | Dispersion Value Num | 10.04 | Dispersion Value Num | 10.64 | Dispersion Value Num | 10.35 | Dispersion Value Num | 10.54 | Dispersion Value Num | 2.44 | Dispersion Value Num | 2.18 | Dispersion Value Num | 10.38 | Dispersion Value Num | 8.52 | Dispersion Value Num | 11.67 | Dispersion Value Num | 11.91 | Dispersion Value Num | 6.65 | Dispersion Value Num | 6.41 | Dispersion Value Num | 23.87 | Dispersion Value Num | 19.71 | Dispersion Value Num | 18.69 | Dispersion Value Num | 17.14 | Dispersion Value Num | 15.43 | Dispersion Value Num | 14.06 | Dispersion Value Num | 127.1 | Dispersion Value Num | 106.19 | ||||||||||||||||||||||||||||
Dispersion Lower Limit | 113.0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Upper Limit | 145.0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Explanation Of Na | 95% Confidence Interval cannot be calculated as there was only 1 responder. |
Baseline Counts
Sequence: | 11330055 | Sequence: | 11330056 | Sequence: | 11330057 |
Result Group Id | 55884674 | Result Group Id | 55884675 | Result Group Id | 55884676 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 80 | Count | 154 | Count | 234 |
Result Groups
Sequence: | 55884674 | Sequence: | 55884675 | Sequence: | 55884676 | Sequence: | 55884677 | Sequence: | 55884678 | Sequence: | 55884679 | Sequence: | 55884680 | Sequence: | 55884681 | Sequence: | 55884682 | Sequence: | 55884683 | Sequence: | 55884684 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Placebo/MT10109L | Title | MT10109L/MT10109L | Title | Total | Title | Placebo/MT10109L | Title | MT10109L/MT10109L | Title | Placebo/MT10109L | Title | MT10109L/MT10109L | Title | Placebo | Title | MT10109L | Title | Placebo | Title | MT10109L |
Description | Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments. | Description | MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. | Description | Total of all reporting groups | Description | Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments. | Description | MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. | Description | Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments. | Description | MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. | Description | Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. Placebo participants were allowed to enter open-label phase for retreatment but the TEAEs with onset date after the retreatment were not counted here. | Description | MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. Placebo participants who experienced TEAE after receiving MT10109L during open-label phase were counted here. | Description | Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part post day 180, up to 2 open-label study interventions during the retreatment period. Placebo participants were allowed to enter open-label phase for retreatment but the TEAEs with onset date after the retreatment were not counted here. | Description | MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. Placebo participants who experienced TEAE after receiving MT10109L during open-label phase were counted here. |
Baseline Measurements
Sequence: | 125010995 | Sequence: | 125010996 | Sequence: | 125010997 | Sequence: | 125010998 | Sequence: | 125010985 | Sequence: | 125010986 | Sequence: | 125010987 | Sequence: | 125010988 | Sequence: | 125010989 | Sequence: | 125010990 | Sequence: | 125010991 | Sequence: | 125010992 | Sequence: | 125010993 | Sequence: | 125010994 | Sequence: | 125010999 | Sequence: | 125011000 | Sequence: | 125011001 | Sequence: | 125011002 | Sequence: | 125011003 | Sequence: | 125011004 | Sequence: | 125011005 | Sequence: | 125011006 | Sequence: | 125011007 | Sequence: | 125011008 | Sequence: | 125011009 | Sequence: | 125011010 | Sequence: | 125011011 | Sequence: | 125011012 | Sequence: | 125011013 | Sequence: | 125011014 | Sequence: | 125011015 | Sequence: | 125011016 | Sequence: | 125011017 | Sequence: | 125011018 | Sequence: | 125011019 | Sequence: | 125011020 | Sequence: | 125011021 | Sequence: | 125011022 | Sequence: | 125011023 | Sequence: | 125011024 | Sequence: | 125011025 | Sequence: | 125011026 | Sequence: | 125011027 | Sequence: | 125011028 | Sequence: | 125011029 | Sequence: | 125011030 | Sequence: | 125011031 | Sequence: | 125011032 |
Result Group Id | 55884675 | Result Group Id | 55884676 | Result Group Id | 55884674 | Result Group Id | 55884675 | Result Group Id | 55884674 | Result Group Id | 55884675 | Result Group Id | 55884676 | Result Group Id | 55884674 | Result Group Id | 55884675 | Result Group Id | 55884676 | Result Group Id | 55884674 | Result Group Id | 55884675 | Result Group Id | 55884676 | Result Group Id | 55884674 | Result Group Id | 55884676 | Result Group Id | 55884674 | Result Group Id | 55884675 | Result Group Id | 55884676 | Result Group Id | 55884674 | Result Group Id | 55884675 | Result Group Id | 55884676 | Result Group Id | 55884674 | Result Group Id | 55884675 | Result Group Id | 55884676 | Result Group Id | 55884674 | Result Group Id | 55884675 | Result Group Id | 55884676 | Result Group Id | 55884674 | Result Group Id | 55884675 | Result Group Id | 55884676 | Result Group Id | 55884674 | Result Group Id | 55884675 | Result Group Id | 55884676 | Result Group Id | 55884674 | Result Group Id | 55884675 | Result Group Id | 55884676 | Result Group Id | 55884674 | Result Group Id | 55884675 | Result Group Id | 55884676 | Result Group Id | 55884674 | Result Group Id | 55884675 | Result Group Id | 55884676 | Result Group Id | 55884674 | Result Group Id | 55884675 | Result Group Id | 55884676 | Result Group Id | 55884674 | Result Group Id | 55884675 | Result Group Id | 55884676 |
Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Category | Female | Category | Female | Category | <=18 years | Category | <=18 years | Category | <=18 years | Category | Between 18 and 65 years | Category | Between 18 and 65 years | Category | Between 18 and 65 years | Category | >=65 years | Category | >=65 years | Category | >=65 years | Category | Female | Category | Male | Category | Male | Category | Male | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Asian | Category | Asian | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | White | Category | White | Category | White | Category | More than one race | Category | More than one race | Category | More than one race | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | ||||||
Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) |
Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 47.3 | Param Value | 47.0 | Param Value | 76 | Param Value | 140 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 77 | Param Value | 141 | Param Value | 218 | Param Value | 3 | Param Value | 13 | Param Value | 16 | Param Value | 46.4 | Param Value | 216 | Param Value | 4 | Param Value | 14 | Param Value | 18 | Param Value | 3 | Param Value | 10 | Param Value | 13 | Param Value | 77 | Param Value | 144 | Param Value | 221 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 2 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 6 | Param Value | 8 | Param Value | 76 | Param Value | 146 | Param Value | 222 | Param Value | 1 | Param Value | 1 | Param Value | 2 | Param Value | 0 | Param Value | 0 | Param Value | 0 |
Param Value Num | 47.3 | Param Value Num | 47.0 | Param Value Num | 76.0 | Param Value Num | 140.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 77.0 | Param Value Num | 141.0 | Param Value Num | 218.0 | Param Value Num | 3.0 | Param Value Num | 13.0 | Param Value Num | 16.0 | Param Value Num | 46.4 | Param Value Num | 216.0 | Param Value Num | 4.0 | Param Value Num | 14.0 | Param Value Num | 18.0 | Param Value Num | 3.0 | Param Value Num | 10.0 | Param Value Num | 13.0 | Param Value Num | 77.0 | Param Value Num | 144.0 | Param Value Num | 221.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 6.0 | Param Value Num | 8.0 | Param Value Num | 76.0 | Param Value Num | 146.0 | Param Value Num | 222.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 12.64 | Dispersion Value | 12.27 | Dispersion Value | 11.57 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 12.64 | Dispersion Value Num | 12.27 | Dispersion Value Num | 11.57 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 154 | Number Analyzed | 234 | Number Analyzed | 80 | Number Analyzed | 154 | Number Analyzed | 80 | Number Analyzed | 154 | Number Analyzed | 234 | Number Analyzed | 80 | Number Analyzed | 154 | Number Analyzed | 234 | Number Analyzed | 80 | Number Analyzed | 154 | Number Analyzed | 234 | Number Analyzed | 80 | Number Analyzed | 234 | Number Analyzed | 80 | Number Analyzed | 154 | Number Analyzed | 234 | Number Analyzed | 80 | Number Analyzed | 154 | Number Analyzed | 234 | Number Analyzed | 80 | Number Analyzed | 154 | Number Analyzed | 234 | Number Analyzed | 80 | Number Analyzed | 154 | Number Analyzed | 234 | Number Analyzed | 80 | Number Analyzed | 154 | Number Analyzed | 234 | Number Analyzed | 80 | Number Analyzed | 154 | Number Analyzed | 234 | Number Analyzed | 80 | Number Analyzed | 154 | Number Analyzed | 234 | Number Analyzed | 80 | Number Analyzed | 154 | Number Analyzed | 234 | Number Analyzed | 80 | Number Analyzed | 154 | Number Analyzed | 234 | Number Analyzed | 80 | Number Analyzed | 154 | Number Analyzed | 234 | Number Analyzed | 80 | Number Analyzed | 154 | Number Analyzed | 234 |
]]>
https://zephyrnet.com/NCT03795909
2017-03-01
https://zephyrnet.com/?p=NCT03795909
NCT03795909https://www.clinicaltrials.gov/study/NCT03795909?tab=tablexiaodong d Shi, MD18611196921@163.com8613911601076A protocol named as “HLH-DR” for patients with refractory and secondary hemophagocytic lymphohistiocytosismay.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | March 1, 2017 |
Primary Completion Month Year | March 1, 2020 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-08 |
Detailed Descriptions
Sequence: | 20727226 |
Description | A modified protocol about ruxolitinib combined with dexamethasone which includes oral ruxolitinib (2.5 mg twice daily for patients if the age<14 years and the weight <25kg,5 mg twice daily for patients if the age<14 years and the weight≥25kg, 10mg twice daily for patients if the age ≥14 years and<18 years). Dexamethasone (10mg/m2.d) delayes for the first 2 weeks (form week 1 to 2),(5mg/m2.d) from week 3 to 4,(2.5mg/m2.d) from week 5 to 6),1.25mg/m2.d for week 7,and dropped off on week 8. Every 2 weeks, patients can be evaluated based the diagnosed index |
Facilities
Sequence: | 200159531 | Sequence: | 200159532 |
Status | Recruiting | Status | Recruiting |
Name | Yan Yue | Name | Yan Yue |
City | Beijing | City | Beijing |
State | Chaoyang District | ||
Zip | 100020 | ||
Country | China | Country | China |
Facility Contacts
Sequence: | 28113755 | Sequence: | 28113756 | Sequence: | 28113757 | Sequence: | 28113758 |
Facility Id | 200159531 | Facility Id | 200159531 | Facility Id | 200159532 | Facility Id | 200159532 |
Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup |
Name | Yan Yue, MD | Name | Yan Yue, MD | Name | xiaodong Shi, MD | Name | Yan Yue, MD |
18611196921@163.com | adaile123@sina.com | adaile123@sina.com | adaile123@sina.com | ||||
Phone | 8618515238169 | Phone | 8618515238169 | Phone | 008613911601076 | Phone | 8618515238169 |
Phone Extension | 8618515238169 | Phone Extension | 8618515238169 | Phone Extension | 8618515238169 | Phone Extension | 8618515238169 |
Facility Investigators
Sequence: | 18336506 |
Facility Id | 200159531 |
Role | Principal Investigator |
Name | Jia Y Qin, MD |
Browse Interventions
Sequence: | 96074360 | Sequence: | 96074361 | Sequence: | 96074362 | Sequence: | 96074363 | Sequence: | 96074364 | Sequence: | 96074365 | Sequence: | 96074366 | Sequence: | 96074367 | Sequence: | 96074368 | Sequence: | 96074369 | Sequence: | 96074370 | Sequence: | 96074371 |
Mesh Term | Dexamethasone | Mesh Term | Anti-Inflammatory Agents | Mesh Term | Antiemetics | Mesh Term | Autonomic Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Gastrointestinal Agents | Mesh Term | Glucocorticoids | Mesh Term | Hormones | Mesh Term | Hormones, Hormone Substitutes, and Hormone Antagonists | Mesh Term | Antineoplastic Agents, Hormonal | Mesh Term | Antineoplastic Agents |
Downcase Mesh Term | dexamethasone | Downcase Mesh Term | anti-inflammatory agents | Downcase Mesh Term | antiemetics | Downcase Mesh Term | autonomic agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | gastrointestinal agents | Downcase Mesh Term | glucocorticoids | Downcase Mesh Term | hormones | Downcase Mesh Term | hormones, hormone substitutes, and hormone antagonists | Downcase Mesh Term | antineoplastic agents, hormonal | Downcase Mesh Term | antineoplastic agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52185611 |
Name | Hemophagocytic Lymphohistiocytosis |
Downcase Name | hemophagocytic lymphohistiocytosis |
Id Information
Sequence: | 40169152 |
Id Source | org_study_id |
Id Value | HLH-DR |
Countries
Sequence: | 42580735 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55609252 | Sequence: | 55609253 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Ruxolitinib and Placebo | Title | Placebo and Ruxolitinib |
Description | Ruxolitinib 2.5 mg twice daily by oral | Description | Sugar pill 2.5 mg twice daily by oral |
Interventions
Sequence: | 52499543 | Sequence: | 52499544 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Ruxolitinib | Name | Dexamethasone |
Description | Ruxolitinib (2.5 mg twice daily for patients if the age<14 years and the weight <25kg,5 mg twice daily for patients if the age<14 years and the weight≥25kg, 10mg twice daily for patients if the age ≥14 years and<18 years) | Description | Dexamethasone (10mg/m2.d) delayes for the first 2 weeks(form week 1 to 2),(5mg/m2.d) from week 3 to 4,(2.5mg/m2.d) from week 5 to 6),1.25mg/m2.d for week 7,and dropped off on week 8. |
Design Outcomes
Sequence: | 177432418 | Sequence: | 177432419 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Severity of disease | Measure | Axillary temperature |
Time Frame | 2 weeks | Time Frame | 2 weeks |
Description | Serum ferritin>2000ng/ml, disease actvie; serum ferritin<2000ng/ml, disease control; | Description | 36<Axillary temperature<37.2, disease control; 37.2<Axillary temperature<38.2, disease partly control; Axillary temperature>38.2, disease active |
Browse Conditions
Sequence: | 193540588 | Sequence: | 193540589 | Sequence: | 193540590 | Sequence: | 193540591 |
Mesh Term | Lymphohistiocytosis, Hemophagocytic | Mesh Term | Histiocytosis, Non-Langerhans-Cell | Mesh Term | Histiocytosis | Mesh Term | Lymphatic Diseases |
Downcase Mesh Term | lymphohistiocytosis, hemophagocytic | Downcase Mesh Term | histiocytosis, non-langerhans-cell | Downcase Mesh Term | histiocytosis | Downcase Mesh Term | lymphatic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332433 |
Agency Class | OTHER_GOV |
Lead Or Collaborator | lead |
Name | Capital Research Institute of Pediatrics |
Overall Officials
Sequence: | 29293058 |
Role | Principal Investigator |
Name | Yan Yue, MD |
Affiliation | Capital Institute of Pediatrics, China |
Central Contacts
Sequence: | 12012330 | Sequence: | 12012331 |
Contact Type | primary | Contact Type | backup |
Name | Yan Yue, MD | Name | xiaodong d Shi, MD |
Phone | 8618515238169 | Phone | 8613911601076 |
adaile123@sina.com | 18611196921@163.com | ||
Phone Extension | 8618515238169 | Phone Extension | 8618515238169 |
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68168326 | Sequence: | 68168327 | Sequence: | 68168328 | Sequence: | 68168329 |
Design Group Id | 55609253 | Design Group Id | 55609252 | Design Group Id | 55609253 | Design Group Id | 55609252 |
Intervention Id | 52499543 | Intervention Id | 52499543 | Intervention Id | 52499544 | Intervention Id | 52499544 |
Eligibilities
Sequence: | 30773645 |
Gender | All |
Minimum Age | 1 Year |
Maximum Age | 18 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Secondary and refractory HLH. Exclusion Criteria: Family HLH. |
Gender Based | True |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253952997 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 1 |
Maximum Age Num | 18 |
Minimum Age Unit | Year |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30519776 |
Allocation | Randomized |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Subject Masked | True |
Intervention Other Names
Sequence: | 26680465 | Sequence: | 26680466 |
Intervention Id | 52499543 | Intervention Id | 52499544 |
Name | Jakafi | Name | Hormone |
Responsible Parties
Sequence: | 28886077 |
Responsible Party Type | Principal Investigator |
Name | Yan Yue |
Title | Principal Investigator |
Affiliation | Capital Research Institute of Pediatrics |
]]>
https://zephyrnet.com/NCT03795896
2018-09-01
https://zephyrnet.com/?p=NCT03795896
NCT03795896https://www.clinicaltrials.gov/study/NCT03795896?tab=tableNANANARaised intracranial pressure (ICP) is a common and life threatening condition especially in patients with traumatic brain injury.There are many methods for monitoring the increased (ICP) either invasive or non- invasive ,but the gold standard is invasive method. Optic nerve sheath ultrasonography provides a very promising bedside tool for detection of increased ICP. This study will monitor the dynamic changes of intracranial pressure by optic nerve sheath diameter (ONSD) in response to mannitol osmotherapy
<![CDATA[
Studies
Study First Submitted Date | 2019-01-01 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | September 1, 2018 |
Primary Completion Month Year | June 1, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-08 |
Detailed Descriptions
Sequence: | 20716328 |
Description | Traumatic brain injury is the main cause of increased intracranial pressure (ICP) in the intensive care .
There are multiple methods for monitoring the raised ICP either invasive or non-invasive.The gold standard is the invasive devices because it is more accurate and reliable .However ,it requires a surgical intervention which has many hazards such as (infection ,hemorrhage,malfunction ). Optic nerve sheath ultrasonography is a promising bedside tool for detection of increased ICP. The optic nerve is surrounded by cerebro-spinal fluid ,thus if the circulation of cerebro-spinal fluid not blocked ,an increase in ICP will be transmitted through the subarachnoid space around the optic nerve within the nerve sheath especially the retro-bulbar segment. The study will be conducted to monitor the dynamic changes of intracranial pressure by optic nerve sheath diameter (ONSD) in response to mannitol osmotherapy as a primary outcome and secondary to evaluate the efficacy of ONSD in assessing the severity of the disease |
Facilities
Sequence: | 200053457 |
Name | Reem Abdelraouf Elsharkawy |
City | Mansourah |
State | Dakahlia |
Zip | 35516 |
Country | Egypt |
Conditions
Sequence: | 52156576 |
Name | Traumatic Brain Injury |
Downcase Name | traumatic brain injury |
Id Information
Sequence: | 40148260 |
Id Source | org_study_id |
Id Value | Ms/15.05.88 |
Countries
Sequence: | 42557796 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55577979 |
Group Type | Experimental |
Title | Optic nerve sheath diameter |
Description | The intracranial pressure will be measured by optic nerve sheath diameter while the patient in supine position with 30 -degree bed position .The linear probe in the two -dimensional mode will be placed gently on the upper eyelid without pressure .In linear horizontal orientation for both right and left optic nerve sheath will be measured |
Interventions
Sequence: | 52472081 |
Intervention Type | Diagnostic Test |
Name | Optic nerve sheath diameter |
Description | The intracranial pressure will be measured by the optic nerve sheath diameter and after giving the mannitol osmotherapy the intracranial pressure will be monitored by the optic nerve sheath diameter |
Design Outcomes
Sequence: | 177328349 | Sequence: | 177328350 | Sequence: | 177328351 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Assessing the changes in the intracranial pressure | Measure | Assessing the changes in the heart rate | Measure | Assessing the changes in the mean arterial pressure |
Time Frame | from 20 minutes before mannitol therapy (basal reading) till 48 hours after the end of mannitol infusion | Time Frame | from 20 minutes before mannitol therapy (basal reading ) till 48 hours after the end of mannitol infusion | Time Frame | from 20 minutes before mannitol therapy(basal reading) till 48 hours after the end of mannitol infusion |
Description | It will be monitored and recorded the changes in intracranial pressure to the mannitol therapy .Basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion | Description | It will be recorded basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion | Description | It will be calculated according to the formula systolic blood pressure+2(diastolic blood pressure)recorded basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion |
Browse Conditions
Sequence: | 193432319 | Sequence: | 193432320 | Sequence: | 193432321 | Sequence: | 193432322 | Sequence: | 193432323 | Sequence: | 193432324 | Sequence: | 193432325 | Sequence: | 193432326 |
Mesh Term | Brain Injuries | Mesh Term | Brain Injuries, Traumatic | Mesh Term | Wounds and Injuries | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Craniocerebral Trauma | Mesh Term | Trauma, Nervous System |
Downcase Mesh Term | brain injuries | Downcase Mesh Term | brain injuries, traumatic | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | craniocerebral trauma | Downcase Mesh Term | trauma, nervous system |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306161 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mansoura University Hospital |
Design Group Interventions
Sequence: | 68130952 |
Design Group Id | 55577979 |
Intervention Id | 52472081 |
Eligibilities
Sequence: | 30757400 |
Gender | All |
Minimum Age | 21 Years |
Maximum Age | 60 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients with traumatic brain injury Exclusion Criteria: Patients with history of optic neuritis |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254228969 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 21 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30503625 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Diagnostic |
Time Perspective | |
Masking | None (Open Label) |
Masking Description | No masking |
Intervention Model Description | prospective observational study |
Intervention Other Names
Sequence: | 26665947 |
Intervention Id | 52472081 |
Name | ONSD |
Responsible Parties
Sequence: | 28869903 |
Responsible Party Type | Principal Investigator |
Name | Abdelraouf Elsharkawy |
Title | Lecturer of anesthesia and surgical intensive care |
Affiliation | Mansoura University Hospital |
]]>
https://zephyrnet.com/NCT03795883
2019-02-01
https://zephyrnet.com/?p=NCT03795883
NCT03795883https://www.clinicaltrials.gov/study/NCT03795883?tab=tableNANANAThe investigators aim to test the thrombotic potential of various heart chambers including left atrium, left atrial appendage, right atrium and peripheral veins. Blood samples will be taken from the different chambers in 50 patients admitted for standard pulmonary vein ablation and compared to patients without atrial fibrillation admitted for left sided supra ventricular tachycardia or mitral clip. Thrombin generation parameters will be assessed by the calibrated automated thrombogram.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-30 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-03-10 |
Start Month Year | February 1, 2019 |
Primary Completion Month Year | December 31, 2021 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-03-10 |
Detailed Descriptions
Sequence: | 20576912 |
Description | Atrial fibrillation is the most common arrhythmia, there is a strong correlation between atrial fibrillation and embolic stroke. In order to lower the risk for embolic stroke anticoagulation is recommended for patients with CHADS-VASC score equal or above 2. The mechanism for thrombus formation in the left atrium is thought to be caused by various factors 1. blood stasis due to the loss of atrial kick 2. endothelial dysfunction 3. blood hemostatic alteration leading to procoagulant state.
Previous studies demonstrated increased thrombin generation in the left atrium in patients with atrial fibrillation, when compared to other heart chambers and when compared to control group in patients with structurally normal heart. In recent years calibrated automated thrombogram (CAT) is considered a good indicator for total thrombotic activity in hypercoagulable states. In the current study the investigators aim to test the thrombotic potential of various heart chambers including left atrium, left atrial appendage, right atrium and peripheral veins. Blood samples will be taken from the different chambers in 50 patients admitted for standard pulmonary vein ablation without changing the course of the procedure. Thrombin generation parameters will be assessed by the calibrated automated thrombogram. A control group composed of 50 patients admitted for standard left sided supra ventricular tachycardia ablation or patients admitted to mitral clip procedure without the presence of atrial fibrillation. In addition demographic data,CHADS-VASC score, atrial fibrillation burden, echocardiographic and cardiac CT parameters will be collected. |
Facilities
Sequence: | 198653047 |
Name | Rambam Health Care Campus |
City | Haifa |
Zip | 31999 |
Country | Israel |
Conditions
Sequence: | 51797601 | Sequence: | 51797602 | Sequence: | 51797603 |
Name | Atrial Fibrillation | Name | Thrombosis Cardiac | Name | Left Atrial Thrombosis |
Downcase Name | atrial fibrillation | Downcase Name | thrombosis cardiac | Downcase Name | left atrial thrombosis |
Id Information
Sequence: | 39861468 |
Id Source | org_study_id |
Id Value | RMB CTIL-0216-18 |
Countries
Sequence: | 42259144 |
Name | Israel |
Removed | False |
Design Groups
Sequence: | 55217087 | Sequence: | 55217088 |
Title | Participants with atrial fibrillation | Title | Participants without atrial fibrillation |
Description | Patients with atrial fibrillation admitted for standard pulmonary vein ablation. | Description | Patients without atrial fibrillation admitted for standard left sided supra ventricular tachycardia ablation or patients admitted to mitral clip procedure. |
Keywords
Sequence: | 79254891 | Sequence: | 79254892 | Sequence: | 79254893 |
Name | Thrombin generation | Name | Calibrated automated thrombogram | Name | Atrial fibrillation |
Downcase Name | thrombin generation | Downcase Name | calibrated automated thrombogram | Downcase Name | atrial fibrillation |
Design Outcomes
Sequence: | 176174172 | Sequence: | 176174173 | Sequence: | 176174174 | Sequence: | 176174175 | Sequence: | 176174176 | Sequence: | 176174177 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | ETP of various heart chambers measured by the calibrated automated thrombogram (CAT) | Measure | Peak height of various heart chambers measured by the calibrated automated thrombogram (CAT) | Measure | Lag time of various heart chambers measured by the calibrated automated thrombogram (CAT) | Measure | Time to peak of various heart chambers measured by the calibrated automated thrombogram (CAT) | Measure | The 1 year incidence of thromboembolic events | Measure | The number of participants with spontaneous echocardiographic contrast demonstrated in trans-esophageal echocardiogram (TEE) |
Time Frame | 1 Day | Time Frame | 1 Day | Time Frame | 1 Day | Time Frame | 1 Day | Time Frame | 1 Year | Time Frame | 1 Days |
Description | ETP (endogenous thrombotic potential) nM*min | Description | Peak height nM | Description | Lag time in minutes | Description | Time to peak in minutes |
Browse Conditions
Sequence: | 191981780 | Sequence: | 191981781 | Sequence: | 191981782 | Sequence: | 191981783 | Sequence: | 191981784 | Sequence: | 191981785 | Sequence: | 191981786 | Sequence: | 191981779 |
Mesh Term | Thrombosis | Mesh Term | Arrhythmias, Cardiac | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Pathologic Processes | Mesh Term | Embolism and Thrombosis | Mesh Term | Vascular Diseases | Mesh Term | Atrial Fibrillation |
Downcase Mesh Term | thrombosis | Downcase Mesh Term | arrhythmias, cardiac | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | embolism and thrombosis | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | atrial fibrillation |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list |
Sponsors
Sequence: | 47970754 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Rambam Health Care Campus |
Eligibilities
Sequence: | 30545893 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Study group:Participants with atrial fibrillation admitted to pulmonary vein ablation Control group: Participant without atrial fibrillation admitted to left sided SVT ablation or Mitral clip. |
Criteria | Inclusion Criteria:
Age above 18 Exclusion Criteria: Left atrial thrombus |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254224132 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 35 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30294296 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28672848 |
Responsible Party Type | Principal Investigator |
Name | Adi Elias MD |
Title | Resident Physician at Cardiology Department, Principal Investigator |
Affiliation | Rambam Health Care Campus |
]]>
https://zephyrnet.com/NCT03795870
2018-07-07
https://zephyrnet.com/?p=NCT03795870
NCT03795870https://www.clinicaltrials.gov/study/NCT03795870?tab=tableVishakantha (Vishu) Murthy, PhDMurthy.Vishakantha@mayo.edu507-255-8112The current study will enroll patients who are going to require enteral nutrition support for at least 4 weeks and randomize them to standard polymeric formulas or blenderized tube feeding. They will be asked to fill out a questionnaire about their tolerance of enteral feeds. They will also be asked to provide stool samples before enrollment and after 4-6 weeks.
The study is trying to assess whether the use of whole food in blenderized tube feeding will be better tolerated and also lead to greater diversity of microbiome.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-10 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-02-08 |
Start Month Year | July 7, 2018 |
Primary Completion Month Year | December 2023 |
Verification Month Year | February 2023 |
Verification Date | 2023-02-28 |
Last Update Posted Date | 2023-02-08 |
Detailed Descriptions
Sequence: | 20601528 |
Description | Malnutrition remains highly prevalent in both acute and chronic diseases, leading to longer hospital length of stay, greater risk of hospital readmission, and overall increase in morbidity and mortality. Over the last few decades, studies have continued to reveal significant clinical benefit from nutrition support, including reduction in complications and length of stay, maintenance of gastrointestinal integrity, and overall improvement in clinical outcomes and mortality. Despite high prevalence of Home Enteral Nutrition(HEN), patients continue to struggle with intolerance of tube feeds leading to chronic underfeeding and weight loss. Current guidelines recommend using standard polymeric formula or high-protein standard formula in the hospitalized patient requiring EN and also recommend against routine use of formulas designed to be immune-modulatory, elemental/semi-elemental, disease-specific (diabetes), and organ-specific (hepatic, renal, pulmonary).
Blenderized Tube Feeding(BTF) offers a number of advantages to standard polymeric formula including being able to modify the macro-nutrient and fiber content based on patient preference. BTF use has also been increasing significantly in the past few years. The gut microbiome, or gut host environment, consists of approximately 10 thousand cells and has been the subject of much interest as it relates to gastrointestinal homeostasis. Our aim therefore is to (1) characterize the structure and dynamics of complex microbial communities using 16S rRNA- encoding gene sequences; (2) determine how they change with EN and; (3) how they may be correlated with tolerance of EN. A total of fifty subjects who are willing to participate in current trial and who meet eligibility will be recruited from the Mayo Clinic HEN program. Suitable subjects will be identified when they present at the initial HEN visit prior to undergoing enteral tube placement. Written informed consent will be obtained from all individuals who participate in the study. The principal investigator or member of study team meet with each participant, review the consent form in detail and confirm the subject's understanding of the study. The study team will answer all questions posed by the participants and when convinced that the subject verbally demonstrates understanding of the protocol, they will obtain a signed consent. Only designated staff members are authorized to obtain informed consent. At the pre-enteral tube visit, subjects will complete a gastrointestinal quality of life (QoL) questionnaire which will form the baseline assessment for symptoms and functional status. Body composition will be measured using Bio-impedance analysis (BIA; InBody™). A stool specimen will be obtained for analysis of the gut microbiome at baseline. Baseline clinical data such as current medical problems will be recorded. |
Facilities
Sequence: | 198874317 |
Status | Recruiting |
Name | Mayo Clinic in Rochester |
City | Rochester |
State | Minnesota |
Zip | 55905 |
Country | United States |
Facility Contacts
Sequence: | 27978798 |
Facility Id | 198874317 |
Contact Type | primary |
Name | Manpreet Mundi, MD |
Conditions
Sequence: | 51864456 |
Name | Enteral Feeding Intolerance |
Downcase Name | enteral feeding intolerance |
Id Information
Sequence: | 39912689 |
Id Source | org_study_id |
Id Value | 18-004416 |
Countries
Sequence: | 42311136 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55291922 | Sequence: | 55291923 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | Polymeric Tube Feeds | Title | Blenderized Tube Feeds |
Description | This arm will be receiving Polymeric Tube Feeds as a part of the regular HEN Protocol. | Description | This arm will be receiving Blenderized tube feeds as a part of the regular HEN Protocol. |
Interventions
Sequence: | 52184096 | Sequence: | 52184097 |
Intervention Type | Dietary Supplement | Intervention Type | Dietary Supplement |
Name | Polymeric Tube Feeds | Name | Blenderized Tube Feeds |
Description | Polymeric tube feeds will be given to HEN patients to assess the percentage of goal calories provided in comparison with blenderized tube feeds | Description | Blenderized tube feeds will be given to HEN patients to assess the percentage of goal calories provided in comparison with polymeric tube feeds |
Keywords
Sequence: | 79367746 | Sequence: | 79367747 | Sequence: | 79367748 |
Name | Home Enteral Nutrition | Name | Gut Microbiome | Name | Blenderized Tube Feeds |
Downcase Name | home enteral nutrition | Downcase Name | gut microbiome | Downcase Name | blenderized tube feeds |
Design Outcomes
Sequence: | 176382087 | Sequence: | 176382088 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Percentage of goal calories provided | Measure | Gut microbiome |
Time Frame | 4-6 weeks | Time Frame | 1 week, 4-6 weeks |
Description | A stool specimen will be collected to assess the composition of the gut microbiome at baseline and at the follow-up visit. |
Sponsors
Sequence: | 48034673 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mayo Clinic |
Overall Officials
Sequence: | 29106355 |
Role | Principal Investigator |
Name | Manpreet S Mundi, MD |
Affiliation | Mayo Clinic |
Central Contacts
Sequence: | 11945683 | Sequence: | 11945684 |
Contact Type | primary | Contact Type | backup |
Name | Manpreet S Mundi, MD | Name | Vishakantha (Vishu) Murthy, PhD |
Phone | 507-284-0106 | Phone | 507-255-8112 |
Mundi.Manpreet@mayo.edu | Murthy.Vishakantha@mayo.edu | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 67782512 | Sequence: | 67782513 |
Design Group Id | 55291922 | Design Group Id | 55291923 |
Intervention Id | 52184096 | Intervention Id | 52184097 |
Eligibilities
Sequence: | 30585519 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
All subjects who are above 18 years of age, who present to Mayo Clinic HEN program for initial evaluation prior to enteral tube placement Exclusion Criteria: Patients with type 1 or 2 diabetes will be excluded due to the known pre-existing changes in the gut microbiome in this population. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253864035 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30333669 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | Triple |
Masking Description | The randomization list will be generated using http://www.randomization.com and the investigator team will be blinded at enrollment using supplement codes. A designated study coordinator will hold the randomization codes and the codes will be revealed to the investigators only after the statistical analysis is complete. |
Intervention Model Description | Prospective Randomized Controlled |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Links
Sequence: | 4361438 |
Url | http://www.mayo.edu/research/clinical-trials/ |
Description | Mayo Clinic Clinical Trials |
Responsible Parties
Sequence: | 28712445 |
Responsible Party Type | Principal Investigator |
Name | Manpreet S. Mundi |
Title | Principal Investigator |
Affiliation | Mayo Clinic |
]]>
https://zephyrnet.com/NCT03795857
2019-01-14
https://zephyrnet.com/?p=NCT03795857
NCT03795857https://www.clinicaltrials.gov/study/NCT03795857?tab=tableNANANAIn France, according to current legislation, termination of pregnancy could be performed without any upper gestational age limit, if there is a strong probability that the fetus will be affected by a particularly severe and incurable disease. When there is a lethal fetal diagnosis most of parents wish to terminate their pregnancy. However, and despite some medical resistance a few of them do wish to continue pregnancy. In these situations, palliative care seems to be a good way to prepare to welcome the child and surround him until death.
The aim of the study is to describe parents’ experience for a better understanding and a better care.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-08-29 |
Start Month Year | January 14, 2019 |
Primary Completion Month Year | April 11, 2019 |
Verification Month Year | August 2019 |
Verification Date | 2019-08-31 |
Last Update Posted Date | 2019-08-29 |
Facilities
Sequence: | 200618371 | Sequence: | 200618372 | Sequence: | 200618373 |
Name | Équipe de psychopathologie périnatale – Service de psychopathologie du développement – Centre Hospitalier Femme-Mère-Enfant – Hospices Civils de Lyon | Name | Service de gynécologie obstétrique – Hôpital de la Croix Rousse | Name | Service de gynécologie-obstétrique – Centre hospitalier Lyon sud |
City | Bron | City | Lyon | City | Pierre-Bénite |
Zip | 69677 | Zip | 69004 | Zip | 69495 |
Country | France | Country | France | Country | France |
Conditions
Sequence: | 52328329 | Sequence: | 52328330 |
Name | Fetal Death | Name | Fetal Anomaly |
Downcase Name | fetal death | Downcase Name | fetal anomaly |
Id Information
Sequence: | 40271109 |
Id Source | org_study_id |
Id Value | 69HCL18_0371 |
Countries
Sequence: | 42691178 |
Name | France |
Removed | False |
Interventions
Sequence: | 52639324 |
Intervention Type | Behavioral |
Name | Semi-structured interviews |
Description | The purpose of this study is to describe the experience of pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis. Therefore, semi-structured interviews will be conducted to explore the links between context, feeling, involvement, decision and actions during pregnancy, whether within the couple or in its environment. |
Design Outcomes
Sequence: | 177960025 |
Outcome Type | primary |
Measure | Description of the pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis |
Time Frame | About 1 hour and 30 minutes |
Description | The purpose of this study is to describe the experience of pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis. Therefore, semi-structured interviews will be conducted to explore the links between context, feeling, involvement, decision and actions during pregnancy, whether within the couple or in its environment. |
Browse Conditions
Sequence: | 194085249 | Sequence: | 194085250 | Sequence: | 194085251 | Sequence: | 194085252 | Sequence: | 194085253 | Sequence: | 194085254 | Sequence: | 194085255 |
Mesh Term | Fetal Death | Mesh Term | Congenital Abnormalities | Mesh Term | Pregnancy Complications | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Death | Mesh Term | Pathologic Processes |
Downcase Mesh Term | fetal death | Downcase Mesh Term | congenital abnormalities | Downcase Mesh Term | pregnancy complications | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | death | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48466455 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Hospices Civils de Lyon |
Eligibilities
Sequence: | 30856349 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | This study will focus on couples who have been diagnosed with lethal fetal pathology and who have chosen to continue the pregnancy for a birth in palliative care.
The death of the child may have occurred in utero or after birth. |
Criteria | Inclusion Criteria:
The woman must be between the ages of 18 and 50 and the adult, Exclusion Criteria: Non-mastery of the French language, |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254313069 |
Number Of Facilities | 3 |
Registered In Calendar Year | 2019 |
Actual Duration | 2 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30602187 |
Observational Model | Other |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28968703 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03795844
2019-11-01
https://zephyrnet.com/?p=NCT03795844
NCT03795844https://www.clinicaltrials.gov/study/NCT03795844?tab=tableNANANAThe frequency of laparoscopic bariatric surgery is increasing day by day. In these surgeries, the liver masses are also found to be significantly larger due to the high Body Mass Index scores. It is known that the application of a diet called liver shrinkage protein diet which is applied preoperatively is a method that contributes to the comfort of the surgeon during surgery by reducing the size of the liver. The large size of the liver narrows the field of view of the surgeon in operation and decreases the comfort of surgery. One of the most important points that the surgeon must solve during surgery is the exclusion of the left lobe of the liver. The most commonly used types of liver retractors today; Nathanson retractor, Snowden-Window retractor, Snake retractor, Fan retractor, LIvac retractor and many other retractors. Some of these retractors require an additional incision under xiphoid, which may lead to an injury risk. The installation of these retractors also increases the operation time and requires additional time. Numerous studies have shown that retractors, which are used to rule out liver left lobe during surgery, cause liver damage. However, in order to reveal His angle in the esophageal-gastric composition, hepatic left lobe exclusion is mandatory. Therefore, it is necessary to determine and use the retractor type which causes the least damage between the liver retractors. In our study, it was aimed to reveal three types of liver retractors in our hospital in different cases and to reveal the type of trocar that causes the least amount of liver damage.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-03-23 |
Start Month Year | November 1, 2019 |
Primary Completion Month Year | January 1, 2020 |
Verification Month Year | March 2021 |
Verification Date | 2021-03-31 |
Last Update Posted Date | 2021-03-23 |
Detailed Descriptions
Sequence: | 20709984 |
Description | During laparoscopic upper abdominal surgery, the operative view is usually blocked by the left lobe of the liver. An effective liver retraction is important for good vision and safety during operation. In this study, 120 patients who are over 18 years old with laparoscopic sleeve gastrectomy will be included. 4 groups will be formed and each group will be planned to include 30 patients. In group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved. In the second group, a snake retractor with a 5 mm incision under the xiphoid will be used. In the 3rd group, liver retraction will be provided by using a 5 mm trocar from the intersection of the right midclavicular line. In the group, liver retraction through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools. In these patients, aspartate aminotransferase, alanine aminotransferase and Bilirubin levels will be examined on the postoperative 1st, 2nd and 3rd days and the patients will be examined with postoperative first day abdominal abdomen magnetic resonance imaging and the liver injury will be evaluated by the radiologist. Patients will not know which liver excision method is used during surgery. The radiologist who will perform damage assessment on imaging will not know which type of liver dislocation is used. Therefore, the study will be planned as double blind. The liver excision method will be applied sequentially. Randomization will be done in this way. |
Facilities
Sequence: | 199965061 |
Name | Fatih Sultan Mehmet Research and Training Hospital |
City | Istanbul |
Zip | 34734 |
Country | Turkey |
Browse Interventions
Sequence: | 95996886 | Sequence: | 95996887 |
Mesh Term | Liver Extracts | Mesh Term | Hematinics |
Downcase Mesh Term | liver extracts | Downcase Mesh Term | hematinics |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52138990 |
Name | Liver Damage |
Downcase Name | liver damage |
Id Information
Sequence: | 40135055 |
Id Source | org_study_id |
Id Value | ANIL ERGIN……. |
Countries
Sequence: | 42542680 |
Name | Turkey |
Removed | False |
Design Groups
Sequence: | 55559328 | Sequence: | 55559329 | Sequence: | 55559330 | Sequence: | 55559331 |
Group Type | Active Comparator | Group Type | Active Comparator | Group Type | Active Comparator | Group Type | Active Comparator |
Title | Nathanson retractor | Title | snake retractor | Title | fan retractor | Title | CONTROL GROUP |
Description | Liver retraction in group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved. | Description | Liver retraction in group 2 ; 5 mm incision under the xiphoid will be used. Snake retractor was placed and liver left lobe retraction would be achieved. | Description | Liver retraction in group 3 ; through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus | Description | Liver retraction in group 4 ; through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools |
Interventions
Sequence: | 52454897 | Sequence: | 52454898 | Sequence: | 52454899 | Sequence: | 52454900 |
Intervention Type | Procedure | Intervention Type | Procedure | Intervention Type | Procedure | Intervention Type | Procedure |
Name | liver retraction Nathanson retractor | Name | liver retraction snake retractor | Name | liver retraction fan retractor | Name | liver retraction laparoscopic grasper |
Description | liver retractor will be used for the retraction of left lobe of liver | Description | liver retractor will be used for the retraction of left lobe of liver | Description | liver retractor will be used for the retraction of left lobe of liver | Description | laparoscopic grasper without any special tools |
Design Outcomes
Sequence: | 177263604 |
Outcome Type | primary |
Measure | Liver damage of liver retractors by measurement of AST(Aspartate Aminotransferase), ALT (alanine aminotransferase) , GGT (Gamma-Glutamyl Transferase) , Bilirubin (Total , direct , indirect ) levels. |
Time Frame | 72 hours |
Description | measurement of AST(Aspartate Aminotransferase), ALT (alanine aminotransferase) , GGT (Gamma-Glutamyl Transferase) , Bilirubin (Total , direct , indirect ) levels will be measured preoperatively and postoperative 0 , 1 , 2 , 3 days and record. |
Browse Conditions
Sequence: | 193366474 | Sequence: | 193366475 |
Mesh Term | Liver Diseases | Mesh Term | Digestive System Diseases |
Downcase Mesh Term | liver diseases | Downcase Mesh Term | digestive system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290699 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Fatih Sultan Mehmet Training and Research Hospital |
Design Group Interventions
Sequence: | 68107437 | Sequence: | 68107438 | Sequence: | 68107439 | Sequence: | 68107440 |
Design Group Id | 55559328 | Design Group Id | 55559329 | Design Group Id | 55559330 | Design Group Id | 55559331 |
Intervention Id | 52454897 | Intervention Id | 52454898 | Intervention Id | 52454899 | Intervention Id | 52454900 |
Eligibilities
Sequence: | 30747715 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
The patients older than 18 years planned for Laparoscopic Sleeve Gastrectomy Exclusion Criteria: The patients with liver failure |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121843 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 2 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30493998 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | In this study, 120 patients who are over 18 years old with laparoscopic sleeve gastrectomy will be included. 4 groups will be formed and each group will be planned to include 30 patients. In group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved. In the second group, a snake retractor with a 5 mm incision under the xiphoid will be used. In the 3rd group, liver retraction will be provided by using a 5 mm trocar from the intersection of the right midclavicular line. In the control group, liver retraction through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools. |
Intervention Other Names
Sequence: | 26655412 |
Intervention Id | 52454897 |
Name | nathanson retractor |
Responsible Parties
Sequence: | 28860278 |
Responsible Party Type | Principal Investigator |
Name | ANIL ERGIN |
Title | Dr Anil ERGIN , General Surgery , Asistant doctor |
Affiliation | Fatih Sultan Mehmet Training and Research Hospital |
]]>
https://zephyrnet.com/NCT03795831
2017-03-01
https://zephyrnet.com/?p=NCT03795831
NCT03795831https://www.clinicaltrials.gov/study/NCT03795831?tab=tableD.P. Veelo, Drd.p.veelo@amc.uva.nl0031205662533Collecting all available data (waveforms, beat to beat data, status data) generated by a non invasive blood pressure monitor on each hand and compare this to the actual data obtained by intra arterial (radial) monitoring.
This to see if the non invasive bloodpressure monitor can be validated for intraoperative use.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | March 1, 2017 |
Primary Completion Month Year | December 30, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20727262 |
Description | Although a blood pressure monitoring device could be evaluated by the comparing systolic, diastolic and mean arterial pressure to a reference pressure, it is the specific aim to collect all available data (waveforms, beat to beat data, status data) generated by the blood pressure monitor.
After data analysis and comparison to patient's actual intra-arterial waveform, the outcome will be evaluated by Association for the Advancement of Medical Instrumentation (AAMI) standards to see if the non invasive bloodpressure monitor can be validated for intraoperative use. The study is targeted at patients already monitored with a system that accurately measures and stores the intra-arterial waveform, such as the FloTrac system in the EV1000 monitor. This study is a substudy of a feasability protocol evaluating a new algorithm for the Clearsight system. |
Facilities
Sequence: | 200159743 |
Status | Recruiting |
Name | Academic Medical Center |
City | Amsterdam |
Zip | 1105AZ |
Country | Netherlands |
Facility Contacts
Sequence: | 28113776 |
Facility Id | 200159743 |
Contact Type | primary |
Name | D.P. Veelo, Dr. |
d.p.veelo@amc.uva.nl | |
Phone | 0031205662533 |
Conditions
Sequence: | 52185702 |
Name | Intraoperative Hypotension |
Downcase Name | intraoperative hypotension |
Id Information
Sequence: | 40169220 |
Id Source | org_study_id |
Id Value | 2017-14 |
Countries
Sequence: | 42580805 |
Name | Netherlands |
Removed | False |
Design Groups
Sequence: | 55609364 |
Title | Cohort |
Description | Adult patients, undergoing surgery requiring general anesthesia, planned to be monitored with a system that accurately measures and stores the intra-arterial waveform. |
Interventions
Sequence: | 52499643 |
Intervention Type | Device |
Name | ClearSight feasibility testing |
Description | A cuff is placed on a finger of the patient. The ClearSight system uses a volume clamp technology allowing measuring of continuous blood pressure waveform. Note: There will only be observational recordings, no interventions |
Design Outcomes
Sequence: | 177432851 | Sequence: | 177432852 |
Outcome Type | primary | Outcome Type | primary |
Measure | validation systole, diastole, mean ABP and pulse pressure | Measure | implementation of software alterations to improve systole, diastole, mean ABP accuracy and pulse pressure |
Time Frame | within 1 hour | Time Frame | time during surgery |
Description | accuracy and precision of invasive blood pressure curve vs non-invasive blood pressure curves(ipsilateral and contralateral) | Description | Comparison of the non-invasive blood pressure curve after software alterations to the reference and invasive arterial blood pressure curve |
Browse Conditions
Sequence: | 193540935 | Sequence: | 193540936 | Sequence: | 193540937 |
Mesh Term | Hypotension | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases |
Downcase Mesh Term | hypotension | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332529 | Sequence: | 48332530 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA) | Name | Edwards Lifesciences |
Overall Officials
Sequence: | 29293110 |
Role | Principal Investigator |
Name | D.P. Veelo, Dr |
Affiliation | inverstigator |
Central Contacts
Sequence: | 12012351 |
Contact Type | primary |
Name | D.P. Veelo, Dr |
Phone | 0031205662533 |
d.p.veelo@amc.uva.nl | |
Role | Contact |
Design Group Interventions
Sequence: | 68168457 |
Design Group Id | 55609364 |
Intervention Id | 52499643 |
Eligibilities
Sequence: | 30773703 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | Patients in a perioperative setting already monitored with a system that accurately measures and stores the intra-arterial waveform, such as the FloTrac system in the EV1000 monitor. |
Criteria | Inclusion Criteria:
Patients whose arterial blood pressure is measured invasively with technology that allows for the storage of the intra-arterial waveform with sufficient quality and resolution (Flotrac). Exclusion Criteria: – Patient conditions that are expected to potentially and significantly affect the transfer of pressure between radial artery and the finger, e.g. due to recent finger fractures |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253953224 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Designs
Sequence: | 30519833 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28886135 |
Responsible Party Type | Principal Investigator |
Name | D.P.Veelo |
Title | Principal investigator |
Affiliation | Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA) |
Study References
Sequence: | 52079252 |
Pmid | 36174389 |
Reference Type | derived |
Citation | Kho E, van der Ster BJP, van der Ven WH, Vlaar APJ, Immink RV, Veelo DP. Clinical agreement of a novel algorithm to estimate radial artery blood pressure from the non-invasive finger blood pressure. J Clin Anesth. 2022 Dec;83:110976. doi: 10.1016/j.jclinane.2022.110976. Epub 2022 Sep 26. |
]]>
https://zephyrnet.com/NCT03795818
2019-08-01
https://zephyrnet.com/?p=NCT03795818
NCT03795818https://www.clinicaltrials.gov/study/NCT03795818?tab=tableLaura Mufson, Ph.D.Laura.Mufson@nyspi.columbia.edu646-774-5791In the present study, the investigators propose to 1) adapt Interpersonal Psychotherapy for Adolescents (IPT-A) as an intervention for adolescents who report elevated symptoms of posttraumatic stress disorder (PTSD) and/or meet Diagnostic and Statistical Manual of Mental Disorders – Fifth Edition (DSM-5) criteria for PTSD; and 2) conduct a small open pilot study of IPT-A for PTSD. Ten adolescents ages 13 to 18 who meet DSM-5 criteria for a PTSD diagnosis or have elevated symptoms of PTSD (Child PTSD Symptom Scale [CPSS-5] ≥ 31) will be treated with 14-16 weeks of an adapted version of IPT-A. If participants have evidenced a decrease in PTSD symptoms (CPSS-5 < 31) they will also receive 3 months of once a month maintenance treatment and be assessed by a clinician evaluator at the conclusion of the 3 monthly sessions. If participants have not evidenced a decrease in PTSD symptoms (CPSS-5 ≥ 31), they will be referred for alternative treatments in the community and be assessed by a clinician evaluator 3 months following the completion of IPT-A. All evaluations and therapy sessions will be done over telehealth platform until able to be done in person.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-24 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-09-30 |
Start Month Year | August 1, 2019 |
Primary Completion Month Year | June 30, 2023 |
Verification Month Year | September 2022 |
Verification Date | 2022-09-30 |
Last Update Posted Date | 2022-09-30 |
Detailed Descriptions
Sequence: | 20618027 |
Description | Please see the brief summary for study description. |
Facilities
Sequence: | 199044753 |
Status | Recruiting |
Name | New York State Psychiatric Institute |
City | New York |
State | New York |
Zip | 10032 |
Country | United States |
Facility Contacts
Sequence: | 27990130 | Sequence: | 27990131 |
Facility Id | 199044753 | Facility Id | 199044753 |
Contact Type | primary | Contact Type | backup |
Name | Hannah Ishimuro, MA | Name | Laura Mufson, Ph.D. |
Hannah.Ishimuro@nyspi.columbia.edu | Laura.Mufson@nyspi.columbia.edu | ||
Phone | 646-774-5793 | Phone | 6467745791 |
Conditions
Sequence: | 51906595 |
Name | PTSD |
Downcase Name | ptsd |
Id Information
Sequence: | 39951185 |
Id Source | org_study_id |
Id Value | 7717 |
Countries
Sequence: | 42343624 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55314802 |
Group Type | Other |
Title | IPT-A |
Description | Interpersonal psychotherapy for adolescents (IPT-A) is a psychosocial treatment for adolescents. It has been shown to be effective for adolescents with depression. It is now being studied as to its benefit for adolescents who meet criteria for PTSD or have subthreshold PTSD symptoms. |
Interventions
Sequence: | 52221420 |
Intervention Type | Behavioral |
Name | Interpersonal Psychotherapy for Adolescents |
Description | IPT-A is a psychosocial intervention for adolescents that focuses on improving interpersonal relationships that seem to be associated with the psychiatric symptoms. |
Design Outcomes
Sequence: | 176471167 | Sequence: | 176471168 | Sequence: | 176471169 | Sequence: | 176471170 | Sequence: | 176471171 | Sequence: | 176471172 | Sequence: | 176471173 | Sequence: | 176471174 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in Child PTSD Symptom Scale (CPSS-5) | Measure | Change in Clinician-Administered PTSD Scale for DSM-5, Child/Adolescent Version (CAPS-CA-5) | Measure | Change in Clinical Global Scale of Illness – Improvement/Severity (CGI-I/S) | Measure | Change in Mood and Feelings Questionnaire (MFQ) | Measure | Change in Social Adjustment Scale-Self Report (SAS-SR) | Measure | Change in Columbia-Suicide Severity Rating Scale (C-SSRS) | Measure | Change in Children's Global Assessment Scale (CGAS) | Measure | Change in Conflict Behavior Questionnaire (CBQ) |
Time Frame | baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 4 weeks prior to the assessment date. | Time Frame | baseline, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 4 weeks prior to the assessment date. | Time Frame | baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 2 weeks prior to the assessment date | Time Frame | baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 2 weeks prior to the assessment date | Time Frame | baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 2 weeks prior to the assessment date | Time Frame | lifetime from birth to baseline time period, the month (4 weeks) prior to the initial baseline assessement prior to treatment, and at weeks 7, 14-16 (post intervention) and 3 month follow-up ratings on behavior since prior assessment up to 36 weeks. | Time Frame | baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the past 4 weeks prior to the assessment date | Time Frame | baseline, week 7, between weeks 14-16(post-intervention), and at the 3 month follow-up, each time rating the past 2 weeks prior to the assessment date. |
Description | The Child Post-Traumatic Stress Disorder (PTSD) Symptom Scale (CPSS-5) is a self-report scale designed to assess PTSD symptoms in children and adolescents ages 8-18. The measure screens for stressful life events and asks about the emotional impact of these events in the 4 weeks prior to the assessment. Items are rated on a 5-point scale from 0 (not at all) to 4 (almost always) for how often the problem bothers the youth in the prior 4 weeks. A total symptom severity rating is calculated by summing the ratings of all 20 items and ranges from 0-80, with a higher score indicating greater symptom severity. The CPSS-5 will be used to assess change in PTSD symptoms through study completion at the 3-month follow-up assessment. The scale will be completed at baseline about the prior 4 weeks, at week 7 about the prior 4 weeks, between weeks 14-16 (post-intervention) about the prior 4 weeks, and at the 3-month follow-up assessment about the prior 4 weeks. | Description | The Clinician-Administered Post-Traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DMS-5) – Child/Adolescent Version (CAPS-CA-5) is a 30-item scale that assesses PTSD in children and adolescents ages 7 and older based on the 20 DSM-5 PTSD symptoms. Each item is given a severity rating based on symptom frequency and intensity. Ratings are given for the 4 weeks prior to each assessment timepoint. A total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms and ranges from 0-80, with a higher score indicating greater symptom severity. The CAPS-CA-5 will be used to assess change in symptoms through study completion at the 3-month follow-up assessment. The measure will be administered at baseline rating the prior 4 weeks, between weeks 14-16 (post-intervention) rating the prior 4 weeks, and at the 3-month follow-up assessment rating the prior 4 weeks. | Description | The Clinical Global Scale of Illness – Improvement/Severity (CGI-I/S) is a 2-item clinician-rated instrument that assesses change in global illness severity and global improvement from baseline prior to treatment to study completion at the 3-month follow-up assessment. The improvement item is scored on a 7-point scale and ranges from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). The severity item is scored on a 7-point scale and ranges from 1 (normal) to 7 (among the most extremely ill patients). It will be administered at baseline rating the prior 2 weeks, at week 7 rating the prior 2 weeks, between weeks 14-16 (post-intervention) rating the prior 2 weeks, and at the 3-month follow-up assessment rating the prior 2 weeks. | Description | The Mood and Feelings Questionnaire (MFQ) is a 33-item self-report measure completed by the parent and adolescent to identify symptoms of depression in children and adolescents ages 6-17. Items are scored from 0 (not true) to 2 (true). A total score is calculated by summing the point values of all items and ranges from 0 to 66, with higher scores indicating more severe depressive symptoms. The measure will be completed at baseline about the prior 2 weeks, at week 7 about the prior 2 weeks, between weeks 14-16 (post-intervention) about the prior 2 weeks, and at the 3-month follow-up assessment about the prior 2 weeks. Scores at these timepoints will enable assessment of change in symptoms through completion of the study at the 3-month follow-up assessment. | Description | The Social Adjustment Scale-Self Report (SAS-SR) is a 23-item scale that assesses social adjustment/functioning for the past 2 weeks in 5 areas: overall adjustment, school behavior, relationships with friends, relationships with family, and dating. Items are scored on a Likert scale from 1 to 5. A total score is calculated by averaging all items. Subscale scores are calculated by averaging all items within each subscale. The total and subscale scores range from 1-5, with higher scores indicating more impaired social adjustment. The SAS-SR will be completed at baseline about the prior 2 weeks, at week 7 about the prior 2 weeks, between weeks 14-16 (post-intervention) about the prior 2 weeks, and at the 3-month follow-up assessment about the prior 2 weeks. Ratings will provide information regarding change in social adjustment through study completion at the 3-month follow-up assessment. | Description | The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician-administered measure that collects information on suicidal behavior, suicide attempts, and presence and intensity of suicidal ideation. The majority of the items are scored as yes or no for being present, severity items for suicidal ideation are scored regarding frequency and intensity. A numerical Suicidal Ideation Score is equivalent to the maximum category of items 1-5 that is present at the assessment, where 0 is no suicidal ideation and 5 is active suicidal ideation with specific plan or intent. The baseline version will assess lifetime of the adolescent and past 4 weeks of suicidal ideation and behavior. At week 7, between 14-16 weeks (post-intervention), and at the 3-month follow-up timepoint, it will be administered and assess suicidal ideation and behavior for the past 7 weeks at weeks 7 and 14-16 (post-intervention), and the past 36 weeks at the 3-month follow-up assessment. | Description | The Children's Global Assessment Scale (CGAS) is a clinician-rated scale that assesses overall/global impairment across aspects of the child's life for the 4 weeks prior to the assessment. It has been found to be a reliable instrument for assessing impairment in children with psychiatric disorders. Based on clinical interview, the evaluator assigns a single score for the person's level of impairment in various domains of his/her life including relationships, school, work, and symptomatology in the 4 weeks prior to the assessment. A single global rating is provided on a scale of 1-100, with 100 being no impairment. It will be completed at baseline, week 7, between weeks 14-16 (post-intervention), and at the 3-month follow-up assessment, rating the 4 weeks prior to each of these timepoints. The repeated timepoints will allow assessment of change from baseline through the study completion at the 3-month follow-up assessment. | Description | The Conflict Behavior Questionnaire is a self-report that assesses the parent-child relationship for the 2 weeks prior to the assessment. It has been found to be a reliable measure of the quality of the relationship between mother and adolescent and father and adolescent. It is completed both by the adolescent about the parents and the parent about the adolescent. It is a 20-item scale scored on a true/false scale. The total score is calculated by summing the point values of all of the items and ranges from 0-20. Higher scores indicate greater conflict in the relationship. The CBQ will be completed at baseline, week 7, between weeks 14-16 (post-intervention), and at the 3-month follow-up assessment, rating the 2 weeks prior to each of these timepoints. The repeated timepoints will allow assessment of the change from baseline through the study completion at 3-month follow-up assessment. |
Sponsors
Sequence: | 48069783 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | New York State Psychiatric Institute |
Overall Officials
Sequence: | 29129571 |
Role | Principal Investigator |
Name | Laura Mufson, Ph.D. |
Affiliation | Columbia University/NYSPI |
Central Contacts
Sequence: | 11951026 |
Contact Type | primary |
Name | Laura Mufson, Ph.D. |
Phone | 646-774-5791 |
Laura.Mufson@nyspi.columbia.edu | |
Role | Contact |
Design Group Interventions
Sequence: | 67812962 |
Design Group Id | 55314802 |
Intervention Id | 52221420 |
Eligibilities
Sequence: | 30608050 |
Gender | All |
Minimum Age | 13 Years |
Maximum Age | 18 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Adolescents who meet criteria for DSM-5 diagnosis of PTSD or have elevated PTSD symptoms Exclusion Criteria: Severe impairment in functioning |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253939197 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 13 |
Maximum Age Num | 18 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30355314 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | This is an open clinical trial of an psychosocial intervention for adolescents |
Intervention Other Names
Sequence: | 26545263 |
Intervention Id | 52221420 |
Name | IPT-A |
Responsible Parties
Sequence: | 28727663 |
Responsible Party Type | Principal Investigator |
Name | Laura Mufson |
Title | Professor of Medical Psychology (in Psychiatry) |
Affiliation | New York State Psychiatric Institute |
]]>
https://zephyrnet.com/NCT03795805
2018-03-15
https://zephyrnet.com/?p=NCT03795805
NCT03795805https://www.clinicaltrials.gov/study/NCT03795805?tab=tableNANANAThis study analize the incidence of acute renal failure after performing total knee arthroplasty with or without use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial
<![CDATA[
Studies
Study First Submitted Date | 2018-12-26 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | March 15, 2018 |
Primary Completion Month Year | November 20, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Detailed Descriptions
Sequence: | 20735755 |
Description | This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without (using local intraarticular anesthesia) use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial |
Facilities
Sequence: | 200244151 |
Name | UMAE Dr. Victorio de La Fuente Narvaez |
City | Ciudad de México |
Zip | 07020 |
Country | Mexico |
Browse Interventions
Sequence: | 96113032 | Sequence: | 96113033 | Sequence: | 96113034 | Sequence: | 96113035 | Sequence: | 96113036 | Sequence: | 96113037 | Sequence: | 96113038 | Sequence: | 96113039 | Sequence: | 96113040 | Sequence: | 96113041 | Sequence: | 96113042 | Sequence: | 96113043 |
Mesh Term | Lidocaine | Mesh Term | Anesthetics, Local | Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Anti-Arrhythmia Agents | Mesh Term | Voltage-Gated Sodium Channel Blockers | Mesh Term | Sodium Channel Blockers | Mesh Term | Membrane Transport Modulators | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | lidocaine | Downcase Mesh Term | anesthetics, local | Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | anti-arrhythmia agents | Downcase Mesh Term | voltage-gated sodium channel blockers | Downcase Mesh Term | sodium channel blockers | Downcase Mesh Term | membrane transport modulators | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52208067 | Sequence: | 52208068 | Sequence: | 52208069 | Sequence: | 52208070 |
Name | Arthroplasty, Replacement, Knee | Name | Acute Kidney Injury | Name | Tourniquets | Name | Knee Osteoarthritis |
Downcase Name | arthroplasty, replacement, knee | Downcase Name | acute kidney injury | Downcase Name | tourniquets | Downcase Name | knee osteoarthritis |
Id Information
Sequence: | 40186118 |
Id Source | org_study_id |
Id Value | R-2018-3401-053 |
Countries
Sequence: | 42599610 |
Name | Mexico |
Removed | False |
Design Groups
Sequence: | 55634624 | Sequence: | 55634625 |
Group Type | Other | Group Type | Experimental |
Title | TKA and Tourniquet | Title | Intraarticular lidocain |
Description | Total knee arthroplasty and use of tourniquet limb cuff at 270 mmHg | Description | Total knee arthroplasty with Intaarticular lidocain |
Interventions
Sequence: | 52522040 | Sequence: | 52522041 | Sequence: | 52522042 |
Intervention Type | Procedure | Intervention Type | Procedure | Intervention Type | Drug |
Name | total knee arthroplasty | Name | Tourniquet limb cuff | Name | Intaarticular lidocain |
Description | Total knee arhroplasty | Description | Tourniquet limb cuff and regular anesthesia | Description | 20 ml of 2% lidocain application intraarticular before surgery (intraarticular lidocain) |
Design Outcomes
Sequence: | 177511059 | Sequence: | 177511060 | Sequence: | 177511061 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Creatinin before surgery | Measure | Creatinin after surgery 1 | Measure | Creatinin after surgery 2 |
Time Frame | Creatinin before surgery | Time Frame | Creatinin after surgery 1 at 24 hours | Time Frame | Creatinin after surgery 2 at 48 hours |
Description | Blood Creatinin meassure in mg/dl before surgery | Description | Blood Creatinin meassure in mg/dl at 24 hours | Description | Blood Creatinin meassure in mg/dl at 48 hours |
Browse Conditions
Sequence: | 193626857 | Sequence: | 193626858 | Sequence: | 193626859 | Sequence: | 193626860 | Sequence: | 193626861 | Sequence: | 193626862 | Sequence: | 193626863 | Sequence: | 193626864 |
Mesh Term | Acute Kidney Injury | Mesh Term | Renal Insufficiency | Mesh Term | Kidney Diseases | Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Male Urogenital Diseases |
Downcase Mesh Term | acute kidney injury | Downcase Mesh Term | renal insufficiency | Downcase Mesh Term | kidney diseases | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | male urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48353651 |
Agency Class | OTHER_GOV |
Lead Or Collaborator | lead |
Name | Instituto Mexicano del Seguro Social |
Overall Officials
Sequence: | 29305958 |
Role | Principal Investigator |
Name | Avelino Colin Vázquez, MD |
Affiliation | IMSS |
Design Group Interventions
Sequence: | 68199148 | Sequence: | 68199149 | Sequence: | 68199150 | Sequence: | 68199151 |
Design Group Id | 55634625 | Design Group Id | 55634624 | Design Group Id | 55634624 | Design Group Id | 55634625 |
Intervention Id | 52522040 | Intervention Id | 52522040 | Intervention Id | 52522041 | Intervention Id | 52522042 |
Eligibilities
Sequence: | 30786846 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 99 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Patients knee arthrosis Exclusion Criteria: Not accept to be in the study |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989588 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 8 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 99 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Designs
Sequence: | 30532916 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Double |
Intervention Model Description | Randomized Clinical Trial |
Subject Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26692025 | Sequence: | 26692026 |
Intervention Id | 52522040 | Intervention Id | 52522042 |
Name | TKA | Name | lidocaine |
Responsible Parties
Sequence: | 28899210 |
Responsible Party Type | Principal Investigator |
Name | JUAN LOPEZ VALENCIA |
Title | Principal Investigator |
Affiliation | Instituto Mexicano del Seguro Social |
]]>
https://zephyrnet.com/NCT03795792
2018-05-06
https://zephyrnet.com/?p=NCT03795792
NCT03795792https://www.clinicaltrials.gov/study/NCT03795792?tab=tableNANANAThe metabolic syndrome consists of a set of risk factors that increases the probability to develop heart diseases and type 2 diabetes, two of the principal chronic diseases that affect Mexican population. The curcumin is a compound that is extracted from the root of a plant called Cúrcuma longa. There exists information that curcumin helps to diminish weight and the levels of blood glucose and blood fats. The hypothesis of this study is: that curcumin administration combined with diet and exercise remits the metabolic syndrome.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-04-17 |
Start Month Year | May 6, 2018 |
Primary Completion Month Year | August 6, 2019 |
Verification Month Year | April 2020 |
Verification Date | 2020-04-30 |
Last Update Posted Date | 2020-04-17 |
Detailed Descriptions
Sequence: | 20721569 |
Description | Objective: The aim of this study is to determinate the efficacy of oral administration of curcumin in the remission of metabolic syndrome.
Design: clinical trial, randomized, double blind, placebo controlled. Study population: Men and women from 20 to 55 years old with metabolic syndrome according to the ATP III criteria, will be included. Study groups: intervention and control group. Sample size: It was calculated using a statistical power of 80%, an alpha value of 0.05. A 50% of the difference in the mean of remission of metabolic syndrome between control group and intervention groups was considered. The estimated sample size was 220 subjects for each group. Process: All eligible participants according to inclusion and exclusion criteria, will be randomized to one of the study groups. The intervention group will receive a total dose of curcumin 1.2 g / black pepper 10 mg a day; and control group will receive a total dose of hydrolyzed collagen 1.2 g / black pepper 10 mg a day; plus dietary and exercise recommendations for both groups during three months. The blood concentrations of glucose, triglycerides, and HDL cholesterol will be measured, as well as the abdominal perimeter and blood pressure, at baseline conditions, at one month and three months after treatment. Statistical analysis: Numerical values will be expressed as mean ± standard deviation; categorical variables will be expressed as proportions. Differences between the groups were estimated by unpaired Student t test for numerical variables (Mann-Whitney U test for skewed data) or Chi-square and Fisher´s exact test for categorical variables. Intragroup differences were estimated by paired Student t-test. |
Facilities
Sequence: | 200107790 |
Name | Biomedical Research Unit. IMSS. Durango |
City | Durango |
State | Dgo |
Zip | 34067 |
Country | Mexico |
Browse Interventions
Sequence: | 96049985 | Sequence: | 96049986 | Sequence: | 96049987 | Sequence: | 96049988 | Sequence: | 96049989 | Sequence: | 96049990 | Sequence: | 96049991 | Sequence: | 96049992 | Sequence: | 96049993 | Sequence: | 96049994 | Sequence: | 96049995 | Sequence: | 96049996 |
Mesh Term | Curcumin | Mesh Term | Anti-Inflammatory Agents, Non-Steroidal | Mesh Term | Analgesics, Non-Narcotic | Mesh Term | Analgesics | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Anti-Inflammatory Agents | Mesh Term | Antirheumatic Agents | Mesh Term | Antineoplastic Agents | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | curcumin | Downcase Mesh Term | anti-inflammatory agents, non-steroidal | Downcase Mesh Term | analgesics, non-narcotic | Downcase Mesh Term | analgesics | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | anti-inflammatory agents | Downcase Mesh Term | antirheumatic agents | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52171076 |
Name | Metabolic Syndrome |
Downcase Name | metabolic syndrome |
Id Information
Sequence: | 40158520 |
Id Source | org_study_id |
Id Value | R-2017-785-132 |
Countries
Sequence: | 42568828 |
Name | Mexico |
Removed | False |
Design Groups
Sequence: | 55593011 | Sequence: | 55593012 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Curcumin | Title | Hydrollased collagen |
Description | Curcumin 1.2 g / black pepper 10 mg a day for 3 months, plus recommendations to decrease calories intake and do exercise. | Description | Hydrolyzed collagen 1.2 g / black pepper 10 mg a day for 3 months, plus recommendations to decrease calories intake and do exercise. |
Interventions
Sequence: | 52485321 | Sequence: | 52485322 |
Intervention Type | Dietary Supplement | Intervention Type | Dietary Supplement |
Name | Curcumin | Name | Hydrolyzed collagen |
Description | Will be provided in capsules | Description | Will be provided in capsules. |
Design Outcomes
Sequence: | 177378218 |
Outcome Type | primary |
Measure | Remission of metabolic syndrome. |
Time Frame | Three months. |
Description | Presence of two or less metabolic syndrome criteria, according to the ATP III criteria. |
Browse Conditions
Sequence: | 193486064 | Sequence: | 193486065 | Sequence: | 193486066 | Sequence: | 193486067 | Sequence: | 193486068 | Sequence: | 193486069 | Sequence: | 193486070 | Sequence: | 193486071 |
Mesh Term | Metabolic Syndrome | Mesh Term | Syndrome | Mesh Term | Disease | Mesh Term | Pathologic Processes | Mesh Term | Insulin Resistance | Mesh Term | Hyperinsulinism | Mesh Term | Glucose Metabolism Disorders | Mesh Term | Metabolic Diseases |
Downcase Mesh Term | metabolic syndrome | Downcase Mesh Term | syndrome | Downcase Mesh Term | disease | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | insulin resistance | Downcase Mesh Term | hyperinsulinism | Downcase Mesh Term | glucose metabolism disorders | Downcase Mesh Term | metabolic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319134 |
Agency Class | OTHER_GOV |
Lead Or Collaborator | lead |
Name | Coordinación de Investigación en Salud, Mexico |
Overall Officials
Sequence: | 29285257 | Sequence: | 29285258 | Sequence: | 29285259 | Sequence: | 29285260 |
Role | Principal Investigator | Role | Study Chair | Role | Study Chair | Role | Study Chair |
Name | Fernando Guerrero, PhD | Name | Luis Simental, PhD | Name | Gerardo Martínez, PhD | Name | Claudia Gamboa, PhD |
Affiliation | Instituto Mexicano del Seguro Social | Affiliation | Instituto Mexicano del Seguro Social | Affiliation | Instituto Mexicano del Seguro Social | Affiliation | Instituto Mexicano del Seguro Social |
Design Group Interventions
Sequence: | 68148945 | Sequence: | 68148946 |
Design Group Id | 55593011 | Design Group Id | 55593012 |
Intervention Id | 52485321 | Intervention Id | 52485322 |
Eligibilities
Sequence: | 30765256 |
Gender | All |
Minimum Age | 20 Years |
Maximum Age | 55 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Women and men. Exclusion Criteria: Diabetes or hypoglycaemic therapy. |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253876615 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 15 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 20 |
Maximum Age Num | 55 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30511423 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Masking Description | Neither the patient nor the treating doctor will know the study group the participant was randomized. |
Intervention Model Description | Study groups:
Intervention group: curcumin 1.2 g / black pepper 10 mg a day for 3 months, plus recommendations to decrease calories intake and do exercise. Control group: hydrolyzed collagen 1.2 g / black pepper 10 mg a day for 3 months, plus recommendations to decrease calories intake and do exercise. |
Subject Masked | True |
Caregiver Masked | True |
Intervention Other Names
Sequence: | 26673662 |
Intervention Id | 52485321 |
Name | Turmeric |
Responsible Parties
Sequence: | 28877717 |
Responsible Party Type | Principal Investigator |
Name | Fernando Guerrero Romero MD |
Title | Head of the research unit |
Affiliation | Coordinación de Investigación en Salud, Mexico |
Study References
Sequence: | 52063109 | Sequence: | 52063110 | Sequence: | 52063111 | Sequence: | 52063112 | Sequence: | 52063113 | Sequence: | 52063114 | Sequence: | 52063115 | Sequence: | 52063116 | Sequence: | 52063117 | Sequence: | 52063118 | Sequence: | 52063119 | Sequence: | 52063120 | Sequence: | 52063121 | Sequence: | 52063122 | Sequence: | 52063123 | Sequence: | 52063124 | Sequence: | 52063125 |
Pmid | 27980598 | Pmid | 28538842 | Pmid | 26592847 | Pmid | 27325504 | Pmid | 20607063 | Pmid | 22996406 | Pmid | 22610853 | Pmid | 25374024 | Pmid | 22930403 | Pmid | 24260564 | Pmid | 27761427 | Pmid | 17437639 | Pmid | 28639538 | Pmid | 22253696 | Pmid | 22386732 | Pmid | 22058071 | Pmid | 25131839 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Azhar Y, Parmar A, Miller CN, Samuels JS, Rayalam S. Phytochemicals as novel agents for the induction of browning in white adipose tissue. Nutr Metab (Lond). 2016 Dec 3;13:89. doi: 10.1186/s12986-016-0150-6. eCollection 2016. | Citation | Cabrera-Rode E, Stusser B, Calix W, Orlandi N, Rodriguez J, Cubas-Duenas I, Echevarria R, Alvarez A. [Diagnostic concordance between seven definitions of metabolic syndrome in overweight and obese adults]. Rev Peru Med Exp Salud Publica. 2017 Jan-Mar;34(1):19-27. doi: 10.17843/rpmesp.2017.341.2763. Spanish. | Citation | Di Pierro F, Bressan A, Ranaldi D, Rapacioli G, Giacomelli L, Bertuccioli A. Potential role of bioavailable curcumin in weight loss and omental adipose tissue decrease: preliminary data of a randomized, controlled trial in overweight people with metabolic syndrome. Preliminary study. Eur Rev Med Pharmacol Sci. 2015 Nov;19(21):4195-202. | Citation | Jimenez-Osorio AS, Monroy A, Alavez S. Curcumin and insulin resistance-Molecular targets and clinical evidences. Biofactors. 2016 Nov 12;42(6):561-580. doi: 10.1002/biof.1302. Epub 2016 Jun 21. | Citation | Kim M, Kim Y. Hypocholesterolemic effects of curcumin via up-regulation of cholesterol 7a-hydroxylase in rats fed a high fat diet. Nutr Res Pract. 2010 Jun;4(3):191-5. doi: 10.4162/nrp.2010.4.3.191. Epub 2010 Jun 28. | Citation | Metzler M, Pfeiffer E, Schulz SI, Dempe JS. Curcumin uptake and metabolism. Biofactors. 2013 Jan-Feb;39(1):14-20. doi: 10.1002/biof.1042. Epub 2012 Sep 20. | Citation | Mohammadi A, Sahebkar A, Iranshahi M, Amini M, Khojasteh R, Ghayour-Mobarhan M, Ferns GA. Effects of supplementation with curcuminoids on dyslipidemia in obese patients: a randomized crossover trial. Phytother Res. 2013 Mar;27(3):374-9. doi: 10.1002/ptr.4715. Epub 2012 May 21. | Citation | Na LX, Yan BL, Jiang S, Cui HL, Li Y, Sun CH. Curcuminoids Target Decreasing Serum Adipocyte-fatty Acid Binding Protein Levels in Their Glucose-lowering Effect in Patients with Type 2 Diabetes. Biomed Environ Sci. 2014 Nov;27(11):902-6. doi: 10.3967/bes2014.127. | Citation | Na LX, Li Y, Pan HZ, Zhou XL, Sun DJ, Meng M, Li XX, Sun CH. Curcuminoids exert glucose-lowering effect in type 2 diabetes by decreasing serum free fatty acids: a double-blind, placebo-controlled trial. Mol Nutr Food Res. 2013 Sep;57(9):1569-77. doi: 10.1002/mnfr.201200131. Epub 2012 Aug 29. | Citation | Neyrinck AM, Alligier M, Memvanga PB, Nevraumont E, Larondelle Y, Preat V, Cani PD, Delzenne NM. Curcuma longa extract associated with white pepper lessens high fat diet-induced inflammation in subcutaneous adipose tissue. PLoS One. 2013 Nov 19;8(11):e81252. doi: 10.1371/journal.pone.0081252. eCollection 2013. | Citation | Rahimi HR, Mohammadpour AH, Dastani M, Jaafari MR, Abnous K, Ghayour Mobarhan M, Kazemi Oskuee R. The effect of nano-curcumin on HbA1c, fasting blood glucose, and lipid profile in diabetic subjects: a randomized clinical trial. Avicenna J Phytomed. 2016 Sep-Oct;6(5):567-577. | Citation | Kowluru RA, Kanwar M. Effects of curcumin on retinal oxidative stress and inflammation in diabetes. Nutr Metab (Lond). 2007 Apr 16;4:8. doi: 10.1186/1743-7075-4-8. | Citation | Rochlani Y, Pothineni NV, Kovelamudi S, Mehta JL. Metabolic syndrome: pathophysiology, management, and modulation by natural compounds. Ther Adv Cardiovasc Dis. 2017 Aug;11(8):215-225. doi: 10.1177/1753944717711379. Epub 2017 Jun 22. | Citation | Shao W, Yu Z, Chiang Y, Yang Y, Chai T, Foltz W, Lu H, Fantus IG, Jin T. Curcumin prevents high fat diet induced insulin resistance and obesity via attenuating lipogenesis in liver and inflammatory pathway in adipocytes. PLoS One. 2012;7(1):e28784. doi: 10.1371/journal.pone.0028784. Epub 2012 Jan 9. | Citation | Shen L, Ji HF. The pharmacology of curcumin: is it the degradation products? Trends Mol Med. 2012 Mar;18(3):138-44. doi: 10.1016/j.molmed.2012.01.004. Epub 2012 Mar 1. | Citation | Shin SK, Ha TY, McGregor RA, Choi MS. Long-term curcumin administration protects against atherosclerosis via hepatic regulation of lipoprotein cholesterol metabolism. Mol Nutr Food Res. 2011 Dec;55(12):1829-40. doi: 10.1002/mnfr.201100440. Epub 2011 Nov 7. | Citation | Yang YS, Su YF, Yang HW, Lee YH, Chou JI, Ueng KC. Lipid-lowering effects of curcumin in patients with metabolic syndrome: a randomized, double-blind, placebo-controlled trial. Phytother Res. 2014 Dec;28(12):1770-7. doi: 10.1002/ptr.5197. Epub 2014 Aug 6. |
]]>
https://zephyrnet.com/NCT03795779
2018-03-01
https://zephyrnet.com/?p=NCT03795779
NCT03795779https://www.clinicaltrials.gov/study/NCT03795779?tab=tableKevin Pinzkevin.pinz@icellgene.com6315386218Phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CLL1-CD33 cCAR in patients with relapsed and/or refractory, high risk hematologic malignancies.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-05-19 |
Start Month Year | March 1, 2018 |
Primary Completion Month Year | September 30, 2022 |
Verification Month Year | May 2021 |
Verification Date | 2021-05-31 |
Last Update Posted Date | 2021-05-19 |
Detailed Descriptions
Sequence: | 20741098 |
Description | AML bears heterogeneous cells that can consequently offset killing by single-CAR-based therapy, which results in disease relapse. Leukemic stem cells (LSCs) associated with CLL1 expression comprise a rare population that also plays an important role in disease progression and relapse for myeloid malignancies. CD33 is widely expressed in AML, high risk myelodysplastic syndromes (MDS) and myeloproliferative neoplasms. Targeting both CD33 and CLL1 surface antigens together may offer two distinct benefits. First, targeting both bulk disease and leukemic stem cells together allows for a more comprehensive ablation of the disease. Second, dual targeting of myeloid malignancies by both CD33 and CLL1 directed therapy overcomes the pitfalls of single-antigen therapy by preventing relapse due to antigen loss. While loss of a single antigen under antigen-specific selection pressure is possible, loss of two antigens simultaneously is much less likely.
CLL1-CD33 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins CLL1 and CD33. cCAR intends to target the mechanisms of single-CAR relapse, specifically antigen escape and leukemic stem cells. |
Facilities
Sequence: | 200280127 | Sequence: | 200280128 |
Status | Recruiting | Status | Not yet recruiting |
Name | The General Hospital of Western Theater Command | Name | Peking University Shenzhen Hospital |
City | Chengdu | City | Shenzhen |
Country | China | Country | China |
Facility Contacts
Sequence: | 28132819 | Sequence: | 28132820 | Sequence: | 28132821 | Sequence: | 28132822 |
Facility Id | 200280127 | Facility Id | 200280127 | Facility Id | 200280128 | Facility Id | 200280128 |
Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup |
Name | Fang Liu, MD, PhD | Name | Hongyu Zhang, MD, PhD | ||||
lfyh2006@yahoo.com | HongyuZhang@pkuszh.com | ||||||
Conditions
Sequence: | 52221341 | Sequence: | 52221342 | Sequence: | 52221343 | Sequence: | 52221344 | Sequence: | 52221345 |
Name | Hematologic Malignancy | Name | Acute Myeloid Leukemia | Name | Myelodysplastic Syndromes | Name | Myeloproliferative Neoplasm | Name | Chronic Myeloid Leukemia |
Downcase Name | hematologic malignancy | Downcase Name | acute myeloid leukemia | Downcase Name | myelodysplastic syndromes | Downcase Name | myeloproliferative neoplasm | Downcase Name | chronic myeloid leukemia |
Id Information
Sequence: | 40195497 |
Id Source | org_study_id |
Id Value | ICG141-001 |
Countries
Sequence: | 42609490 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55649586 |
Group Type | Experimental |
Title | CLL1-CD33 cCAR T cells |
Description | CLL1-CD33cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-CLL1 and CD33 CARs |
Interventions
Sequence: | 52535110 |
Intervention Type | Biological |
Name | CLL1-CD33 cCAR T cells |
Description | CLL1-CD33 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-CLL1 and CD33 CARs. |
Keywords
Sequence: | 79941515 | Sequence: | 79941516 | Sequence: | 79941517 | Sequence: | 79941518 | Sequence: | 79941519 |
Name | CLL1 | Name | CD33 | Name | CLL1-CD33 cCAR | Name | Leukemia | Name | Hematologic Malignancies |
Downcase Name | cll1 | Downcase Name | cd33 | Downcase Name | cll1-cd33 ccar | Downcase Name | leukemia | Downcase Name | hematologic malignancies |
Design Outcomes
Sequence: | 177560695 | Sequence: | 177560696 | Sequence: | 177560697 | Sequence: | 177560698 | Sequence: | 177560699 | Sequence: | 177560700 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Measure | Type of dose-limiting toxicity (DLT) | Measure | Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Measure | Overall Response Rate (ORR) | Measure | Progression-free survival (PFS) | Measure | Overall survival |
Time Frame | 28 days | Time Frame | 28 days | Time Frame | 2 years | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year |
Description | Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies |
Browse Conditions
Sequence: | 193677780 | Sequence: | 193677781 | Sequence: | 193677782 | Sequence: | 193677783 | Sequence: | 193677784 | Sequence: | 193677785 | Sequence: | 193677786 | Sequence: | 193677787 | Sequence: | 193677788 | Sequence: | 193677789 | Sequence: | 193677790 | Sequence: | 193677791 | Sequence: | 193677792 | Sequence: | 193677793 |
Mesh Term | Leukemia | Mesh Term | Leukemia, Myeloid | Mesh Term | Neoplasms | Mesh Term | Hematologic Neoplasms | Mesh Term | Leukemia, Myelogenous, Chronic, BCR-ABL Positive | Mesh Term | Myelodysplastic Syndromes | Mesh Term | Myeloproliferative Disorders | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Bone Marrow Diseases | Mesh Term | Hematologic Diseases | Mesh Term | Neoplasms by Site | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | leukemia | Downcase Mesh Term | leukemia, myeloid | Downcase Mesh Term | neoplasms | Downcase Mesh Term | hematologic neoplasms | Downcase Mesh Term | leukemia, myelogenous, chronic, bcr-abl positive | Downcase Mesh Term | myelodysplastic syndromes | Downcase Mesh Term | myeloproliferative disorders | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | bone marrow diseases | Downcase Mesh Term | hematologic diseases | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366240 | Sequence: | 48366241 | Sequence: | 48366242 | Sequence: | 48366243 |
Agency Class | INDUSTRY | Agency Class | OTHER | Agency Class | INDUSTRY | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | iCell Gene Therapeutics | Name | The General Hospital of Western Theater Command | Name | iCAR Bio Therapeutics Ltd. | Name | Peking University Shenzhen Hospital |
Overall Officials
Sequence: | 29312821 | Sequence: | 29312822 |
Role | Principal Investigator | Role | Principal Investigator |
Name | Hongyu Zhang, MD, PhD | Name | Fang Liu, MD, PhD |
Affiliation | Peking University Shenzhen Hospital | Affiliation | The General Hospital of Western Theater Command |
Central Contacts
Sequence: | 12020545 |
Contact Type | primary |
Name | Kevin Pinz |
Phone | 6315386218 |
kevin.pinz@icellgene.com | |
Role | Contact |
Design Group Interventions
Sequence: | 68217097 |
Design Group Id | 55649586 |
Intervention Id | 52535110 |
Eligibilities
Sequence: | 30794596 |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Prior HSCT relapse beyond 6 months without active GVHD; systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks Exclusion Criteria: Prior solid organ transplantation |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254004113 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30540636 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28906955 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03795766
2019-01-01
https://zephyrnet.com/?p=NCT03795766
NCT03795766https://www.clinicaltrials.gov/study/NCT03795766?tab=tableLei Lilileigh@163.com+8613911988831In this cross-section study, all patients in the gynecologic ward of Peking Union Medical College Hospital will accepted a survey about the prevalence and severity of nausea and vomiting according to visual analogue scale and WHO classification. Epidemiological, surgical, anaesthetic characteristics and post-operative treatment are considered as predictors for the post-operative nausea and vomiting. The primary objective is the incidence of nausea and vomiting. The secondary objective is the possible predictors of nausea and vomiting.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | January 1, 2019 |
Primary Completion Month Year | January 1, 2020 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-08 |
Facilities
Sequence: | 199965076 |
Status | Recruiting |
Name | Lei Li |
City | Beijing |
State | Beijing |
Zip | 100730 |
Country | China |
Facility Contacts
Sequence: | 28086649 |
Facility Id | 199965076 |
Contact Type | primary |
Name | Lei Li, MD |
lileigh@163.com | |
Phone | 008613911988831 |
Conditions
Sequence: | 52139006 | Sequence: | 52139007 |
Name | Postoperative Nausea and Vomiting | Name | Gynecologic Surgery |
Downcase Name | postoperative nausea and vomiting | Downcase Name | gynecologic surgery |
Id Information
Sequence: | 40135064 |
Id Source | org_study_id |
Id Value | GY-PONV |
Countries
Sequence: | 42542689 |
Name | China |
Removed | False |
Interventions
Sequence: | 52454911 |
Intervention Type | Procedure |
Name | Surgeries for gynecologic disease |
Description | All patients accept surgeries for gynecologic disease. |
Design Outcomes
Sequence: | 177263644 | Sequence: | 177263645 | Sequence: | 177263646 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Incidence of post-operative nausea and vomiting | Measure | Severity of post-operative nausea and vomiting by visual analogue scale | Measure | Severity of post-operative nausea and vomiting by World Health Organization classification |
Time Frame | 72 hours post-operative | Time Frame | 72 hours post-operative | Time Frame | 72 hours post-operative |
Description | Incidence of post-operative nausea and vomiting | Description | Severity of post-operative nausea and vomiting according to the visual analogue scale. In th scale, 0 denotes none, 10 denotes the most severe conditions. The scale will be judged by the patients. | Description | Severity of post-operative nausea and vomiting according to World Health Organization (WHO) classification. In WHO classfication, I denotes none, II, III and IV denote mild, moderate and severe conditions. |
Browse Conditions
Sequence: | 193366532 | Sequence: | 193366533 | Sequence: | 193366534 | Sequence: | 193366535 | Sequence: | 193366536 | Sequence: | 193366537 |
Mesh Term | Nausea | Mesh Term | Vomiting | Mesh Term | Postoperative Nausea and Vomiting | Mesh Term | Signs and Symptoms, Digestive | Mesh Term | Postoperative Complications | Mesh Term | Pathologic Processes |
Downcase Mesh Term | nausea | Downcase Mesh Term | vomiting | Downcase Mesh Term | postoperative nausea and vomiting | Downcase Mesh Term | signs and symptoms, digestive | Downcase Mesh Term | postoperative complications | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290710 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Peking Union Medical College Hospital |
Overall Officials
Sequence: | 29268532 |
Role | Principal Investigator |
Name | Lei Li, M.D. |
Affiliation | Peking Union Medical College Hospital |
Central Contacts
Sequence: | 12000488 |
Contact Type | primary |
Name | Lei Li |
Phone | +8613911988831 |
lileigh@163.com | |
Role | Contact |
Eligibilities
Sequence: | 30747724 |
Sampling Method | Non-Probability Sample |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | All patients accept elective surgeries for gynecologic disease with good performance status. |
Criteria | Inclusion Criteria:
Aged 18 years or older Exclusion Criteria: Emergency surgeries |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121855 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30494007 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28860287 |
Responsible Party Type | Principal Investigator |
Name | Lei Li |
Title | Professor |
Affiliation | Peking Union Medical College Hospital |
]]>
https://zephyrnet.com/NCT03795753
2019-03-22
https://zephyrnet.com/?p=NCT03795753
NCT03795753https://www.clinicaltrials.gov/study/NCT03795753?tab=tableNANANAThe purpose of this study is to determine the effectiveness of a non-invasive communication aid for BPAP/CPAP masks. This study also looks to determine the potential impact of the device on patients with obstructive sleep apnea (OSA) and the individuals that interact with the device.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-28 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-09-18 |
Start Month Year | March 22, 2019 |
Primary Completion Month Year | July 8, 2019 |
Verification Month Year | August 2020 |
Verification Date | 2020-08-31 |
Last Update Posted Date | 2020-09-18 |
Results First Posted Date | 2020-09-18 |
Detailed Descriptions
Sequence: | 20554144 |
Description | Noninvasive positive pressure ventilation (NIPPV) is a crucial tool used to treat respiratory distress and failure, especially when patients have acute worsening (also called exacerbations) of emphysema or chronic obstructive pulmonary disease (COPD). This study will randomize patients who use Noninvasive positive pressure ventilation (NIPPV) to a control (non-functioning) and intervention (functioning) device to determine how well speech can be understood while wearing the device.
The purpose of this study is to determine the effectiveness of a non-invasive communication aid for BPAP/CPAP masks. This study also looks to determine the potential impact of the device on patients with obstructive sleep apnea (OSA) and the individuals that interact with the device. |
Facilities
Sequence: | 198449409 | Sequence: | 198449410 | Sequence: | 198449411 |
Name | Emory Clinic | Name | Emory University Hospital | Name | Grady Health System |
City | Atlanta | City | Atlanta | City | Atlanta |
State | Georgia | State | Georgia | State | Georgia |
Zip | 30322 | Zip | 30322 | Zip | 30322 |
Country | United States | Country | United States | Country | United States |
Conditions
Sequence: | 51740957 | Sequence: | 51740958 |
Name | Positive-Pressure Respiration | Name | Communication |
Downcase Name | positive-pressure respiration | Downcase Name | communication |
Id Information
Sequence: | 39815706 |
Id Source | org_study_id |
Id Value | IRB00097529 |
Countries
Sequence: | 42215022 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55162111 | Sequence: | 55162112 |
Group Type | Experimental | Group Type | Sham Comparator |
Title | F2S Communicator | Title | Non-functioning Communicator |
Description | The F2S Communication System is a communication aid for use with a noninvasive ventilation (NIV) mask covering at least the mouth. It is a two-component system consisting of (1) a disposable, single patient use patch and signal cable and (2) a reusable communicator with power cable.The non-invasive aid for patients receiving BPAP/CPAP therapy delivers communication between the patient and medical personnel. | Description | Non-functioning study communication device is used. |
Interventions
Sequence: | 52062608 | Sequence: | 52062609 |
Intervention Type | Device | Intervention Type | Other |
Name | F2S Communicator | Name | Non-functioning Communicator |
Description | The communicator will be attached to the BPAP/CPAP mask. The study coordinator will ENABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the "mask on, communicator on" period. | Description | The communicator will be attached to the BPAP/CPAP mask. The study coordinator will DISABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the "mask on, communicator on" period. |
Keywords
Sequence: | 79164427 | Sequence: | 79164428 | Sequence: | 79164429 |
Name | Emphysema | Name | Chronic obstructive pulmonary disease | Name | Obstructive sleep apnea |
Downcase Name | emphysema | Downcase Name | chronic obstructive pulmonary disease | Downcase Name | obstructive sleep apnea |
Design Outcomes
Sequence: | 175985123 | Sequence: | 175985124 | Sequence: | 175985125 | Sequence: | 175985126 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Accuracy of Single Word Selection (Proportion of Right Words From Total) | Measure | Accuracy of Sentence Selection (Proportion of Right Sentences From Total) | Measure | Speech Transmission Index (STI) | Measure | Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort |
Time Frame | Mask on-communicator on-20 minutes | Time Frame | Mask on-communicator on-20 minutes | Time Frame | Mask on with communicator on (20 min) | Time Frame | Mask on-communicator on-20 minutes |
Description | Data will be collected using audio recording – accuracy of single word selection (spoken by patient -> selected by partner). The communicator will be attached to the BPAP/CPAP mask. A list of single words will be provided to the patient. Each single word may be read aloud by patient up to two times. The partner must then select the read word out of a list of twelve possible words. | Description | Data will be collected using audio recording – accuracy of sentence selection (spoken by patient -> transcribed by partner). The communicator will be attached to the BPAP/CPAP mask. A list of 5-word through 15-word sentences will be provided to the patient. Each sentence may be read aloud by patient up to two times. The partner must transcribe each sentence on a standardized form. | Description | STI is a numeric representation measure of communication channel characteristics whose value varies from 0 = bad to 1 = excellent.On this scale, an STI of at least 0.5 is desirable for most applications. | Description | Number of subjects that found that the device significantly improved noninvasive ventilation (NIV) comfort was calculated and reported. Assessment of noninvasive ventilation (NIV) comfort was conducted using Likert Scale Score on clarity of communication on a symmetric seven-level agree-disagree scale. |
Sponsors
Sequence: | 47919613 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Emory University |
Overall Officials
Sequence: | 29034567 |
Role | Principal Investigator |
Name | Nancy Collop, MD |
Affiliation | Emory University |
Design Group Interventions
Sequence: | 67626741 | Sequence: | 67626742 |
Design Group Id | 55162111 | Design Group Id | 55162112 |
Intervention Id | 52062608 | Intervention Id | 52062609 |
Eligibilities
Sequence: | 30514363 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients must be receiving BPAP/CPAP therapy in the outpatient setting (e.g. clinics, sleep centers). Exclusion Criteria: Intubated or have a tracheostomy. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254064853 |
Number Of Facilities | 3 |
Registered In Calendar Year | 2018 |
Actual Duration | 3 |
Were Results Reported | True |
Months To Report Results | 11 |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30263427 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26464041 |
Intervention Id | 52062608 |
Name | BPAP/CPAP communicator |
Milestones
Sequence: | 40721694 | Sequence: | 40721695 | Sequence: | 40721696 | Sequence: | 40721697 | Sequence: | 40721698 | Sequence: | 40721699 |
Result Group Id | 55787774 | Result Group Id | 55787775 | Result Group Id | 55787774 | Result Group Id | 55787775 | Result Group Id | 55787774 | Result Group Id | 55787775 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 23 | Count | 13 | Count | 23 | Count | 13 | Count | 0 | Count | 0 |
Participant Flows
Sequence: | 3894040 |
Outcome Counts
Sequence: | 73462179 | Sequence: | 73462180 | Sequence: | 73462181 | Sequence: | 73462182 | Sequence: | 73462183 | Sequence: | 73462184 | Sequence: | 73462185 | Sequence: | 73462186 |
Outcome Id | 30579292 | Outcome Id | 30579292 | Outcome Id | 30579293 | Outcome Id | 30579293 | Outcome Id | 30579294 | Outcome Id | 30579294 | Outcome Id | 30579295 | Outcome Id | 30579295 |
Result Group Id | 55787776 | Result Group Id | 55787777 | Result Group Id | 55787776 | Result Group Id | 55787777 | Result Group Id | 55787776 | Result Group Id | 55787777 | Result Group Id | 55787776 | Result Group Id | 55787777 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 23 | Count | 13 | Count | 23 | Count | 13 | Count | 0 | Count | 0 | Count | 23 | Count | 13 |
Provided Documents
Sequence: | 2562479 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2019-03-27 |
Url | https://ClinicalTrials.gov/ProvidedDocs/53/NCT03795753/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27745774 | Sequence: | 27745775 | Sequence: | 27745776 | Sequence: | 27745777 | Sequence: | 27745778 | Sequence: | 27745779 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 23 | Subjects At Risk | 23 | Subjects At Risk | 23 | Subjects At Risk | 13 | Subjects At Risk | 13 | Subjects At Risk | 13 |
Created At | 2023-08-06 11:22:12.610978 | Created At | 2023-08-06 11:22:12.610978 | Created At | 2023-08-06 11:22:12.610978 | Created At | 2023-08-06 11:22:12.610978 | Created At | 2023-08-06 11:22:12.610978 | Created At | 2023-08-06 11:22:12.610978 |
Updated At | 2023-08-06 11:22:12.610978 | Updated At | 2023-08-06 11:22:12.610978 | Updated At | 2023-08-06 11:22:12.610978 | Updated At | 2023-08-06 11:22:12.610978 | Updated At | 2023-08-06 11:22:12.610978 | Updated At | 2023-08-06 11:22:12.610978 |
Responsible Parties
Sequence: | 28643876 |
Responsible Party Type | Principal Investigator |
Name | Nancy Abbey Collop, MD |
Title | Professor |
Affiliation | Emory University |
Result Agreements
Sequence: | 3824784 |
Pi Employee | Yes |
Result Contacts
Sequence: | 3824749 |
Organization | Emory University |
Name | Dr. Nancy Collop |
Phone | 404-712-7533 |
nancy.collop@emory.edu | |
Outcomes
Sequence: | 30579292 | Sequence: | 30579293 | Sequence: | 30579294 | Sequence: | 30579295 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Accuracy of Single Word Selection (Proportion of Right Words From Total) | Title | Accuracy of Sentence Selection (Proportion of Right Sentences From Total) | Title | Speech Transmission Index (STI) | Title | Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort |
Description | Data will be collected using audio recording – accuracy of single word selection (spoken by patient -> selected by partner). The communicator will be attached to the BPAP/CPAP mask. A list of single words will be provided to the patient. Each single word may be read aloud by patient up to two times. The partner must then select the read word out of a list of twelve possible words. | Description | Data will be collected using audio recording – accuracy of sentence selection (spoken by patient -> transcribed by partner). The communicator will be attached to the BPAP/CPAP mask. A list of 5-word through 15-word sentences will be provided to the patient. Each sentence may be read aloud by patient up to two times. The partner must transcribe each sentence on a standardized form. | Description | STI is a numeric representation measure of communication channel characteristics whose value varies from 0 = bad to 1 = excellent.On this scale, an STI of at least 0.5 is desirable for most applications. | Description | Number of subjects that found that the device significantly improved noninvasive ventilation (NIV) comfort was calculated and reported. Assessment of noninvasive ventilation (NIV) comfort was conducted using Likert Scale Score on clarity of communication on a symmetric seven-level agree-disagree scale. |
Time Frame | Mask on-communicator on-20 minutes | Time Frame | Mask on-communicator on-20 minutes | Time Frame | Mask on with communicator on (20 min) | Time Frame | Mask on-communicator on-20 minutes |
Population | A validated conversion for word/sentence accuracy and STI was not predetermined and the intent was to record at both the mask and the speaker. However, the conversion was not able to be determined and recording at the mask level was limited by the device. Thus, there is no effective comparator to calculate STI and this information is unavailable. | ||||||
Units | proportion of right words | Units | proportion of sentence intelligibility | Units | Participants | ||
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||
Param Type | Mean | Param Type | Mean | Param Type | Count of Participants |
Outcome Measurements
Sequence: | 233916452 | Sequence: | 233916453 | Sequence: | 233916454 | Sequence: | 233916455 | Sequence: | 233916456 | Sequence: | 233916457 |
Outcome Id | 30579292 | Outcome Id | 30579292 | Outcome Id | 30579293 | Outcome Id | 30579293 | Outcome Id | 30579295 | Outcome Id | 30579295 |
Result Group Id | 55787776 | Result Group Id | 55787777 | Result Group Id | 55787776 | Result Group Id | 55787777 | Result Group Id | 55787776 | Result Group Id | 55787777 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Title | Accuracy of Single Word Selection (Proportion of Right Words From Total) | Title | Accuracy of Single Word Selection (Proportion of Right Words From Total) | Title | Accuracy of Sentence Selection (Proportion of Right Sentences From Total) | Title | Accuracy of Sentence Selection (Proportion of Right Sentences From Total) | Title | Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort | Title | Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort |
Description | Data will be collected using audio recording – accuracy of single word selection (spoken by patient -> selected by partner). The communicator will be attached to the BPAP/CPAP mask. A list of single words will be provided to the patient. Each single word may be read aloud by patient up to two times. The partner must then select the read word out of a list of twelve possible words. | Description | Data will be collected using audio recording – accuracy of single word selection (spoken by patient -> selected by partner). The communicator will be attached to the BPAP/CPAP mask. A list of single words will be provided to the patient. Each single word may be read aloud by patient up to two times. The partner must then select the read word out of a list of twelve possible words. | Description | Data will be collected using audio recording – accuracy of sentence selection (spoken by patient -> transcribed by partner). The communicator will be attached to the BPAP/CPAP mask. A list of 5-word through 15-word sentences will be provided to the patient. Each sentence may be read aloud by patient up to two times. The partner must transcribe each sentence on a standardized form. | Description | Data will be collected using audio recording – accuracy of sentence selection (spoken by patient -> transcribed by partner). The communicator will be attached to the BPAP/CPAP mask. A list of 5-word through 15-word sentences will be provided to the patient. Each sentence may be read aloud by patient up to two times. The partner must transcribe each sentence on a standardized form. | Description | Number of subjects that found that the device significantly improved noninvasive ventilation (NIV) comfort was calculated and reported. Assessment of noninvasive ventilation (NIV) comfort was conducted using Likert Scale Score on clarity of communication on a symmetric seven-level agree-disagree scale. | Description | Number of subjects that found that the device significantly improved noninvasive ventilation (NIV) comfort was calculated and reported. Assessment of noninvasive ventilation (NIV) comfort was conducted using Likert Scale Score on clarity of communication on a symmetric seven-level agree-disagree scale. |
Units | proportion of right words | Units | proportion of right words | Units | proportion of sentence intelligibility | Units | proportion of sentence intelligibility | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 0.61 | Param Value | 0.35 | Param Value | 0.76 | Param Value | 0.33 | Param Value | 11 | Param Value | 2 |
Param Value Num | 0.61 | Param Value Num | 0.35 | Param Value Num | 0.76 | Param Value Num | 0.33 | Param Value Num | 11.0 | Param Value Num | 2.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||
Dispersion Value | 0.13 | Dispersion Value | 0.17 | Dispersion Value | 0.22 | Dispersion Value | 0.25 | ||||
Dispersion Value Num | 0.13 | Dispersion Value Num | 0.17 | Dispersion Value Num | 0.22 | Dispersion Value Num | 0.25 | ||||
Study References
Sequence: | 51633089 |
Pmid | 33011202 |
Reference Type | derived |
Citation | Wong AI, Cheung PC, Zhang J, Cotsonis G, Kutner M, Gay PC, Collop NA. Randomized Controlled Trial of a Novel Communication Device Assessed During Noninvasive Ventilation Therapy. Chest. 2021 Apr;159(4):1531-1539. doi: 10.1016/j.chest.2020.09.250. Epub 2020 Oct 1. |
Baseline Counts
Sequence: | 11304609 | Sequence: | 11304610 | Sequence: | 11304611 |
Result Group Id | 55787771 | Result Group Id | 55787772 | Result Group Id | 55787773 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 23 | Count | 13 | Count | 36 |
Result Groups
Sequence: | 55787771 | Sequence: | 55787772 | Sequence: | 55787773 | Sequence: | 55787774 | Sequence: | 55787775 | Sequence: | 55787776 | Sequence: | 55787777 | Sequence: | 55787778 | Sequence: | 55787779 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | F2S Communicator | Title | Non-functioning Communicator | Title | Total | Title | F2S Communicator | Title | Non-functioning Communicator | Title | F2S Communicator | Title | Non-functioning Communicator | Title | F2S Communicator | Title | Non-functioning Communicator |
Description | The F2S Communication System is a communication aid for use with a noninvasive ventilation (NIV) mask covering at least the mouth. It is a two-component system consisting of (1) a disposable, single patient use patch and signal cable and (2) a reusable communicator with power cable.The non-invasive aid for patients receiving BPAP/CPAP therapy delivers communication between the patient and medical personnel.
F2S Communicator: The communicator will be attached to the BPAP/CPAP mask. The study coordinator will ENABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the "mask on, communicator on" period. |
Description | Non-functioning study communication device is used.
Non-functioning Communicator: The communicator will be attached to the BPAP/CPAP mask. The study coordinator will DISABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the "mask on, communicator on" period. |
Description | Total of all reporting groups | Description | The F2S Communication System is a communication aid for use with a noninvasive ventilation (NIV) mask covering at least the mouth. It is a two-component system consisting of (1) a disposable, single patient use patch and signal cable and (2) a reusable communicator with power cable.The non-invasive aid for patients receiving BPAP/CPAP therapy delivers communication between the patient and medical personnel.
F2S Communicator: The communicator will be attached to the BPAP/CPAP mask. The study coordinator will ENABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the "mask on, communicator on" period. |
Description | Non-functioning study communication device is used.
Non-functioning Communicator: The communicator will be attached to the BPAP/CPAP mask. The study coordinator will DISABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the "mask on, communicator on" period. |
Description | The F2S Communication System is a communication aid for use with a noninvasive ventilation (NIV) mask covering at least the mouth. It is a two-component system consisting of (1) a disposable, single patient use patch and signal cable and (2) a reusable communicator with power cable.The non-invasive aid for patients receiving BPAP/CPAP therapy delivers communication between the patient and medical personnel.
F2S Communicator: The communicator will be attached to the BPAP/CPAP mask. The study coordinator will ENABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the "mask on, communicator on" period. |
Description | Non-functioning study communication device is used.
Non-functioning Communicator: The communicator will be attached to the BPAP/CPAP mask. The study coordinator will DISABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the "mask on, communicator on" period. |
Description | The F2S Communication System is a communication aid for use with a noninvasive ventilation (NIV) mask covering at least the mouth. It is a two-component system consisting of (1) a disposable, single patient use patch and signal cable and (2) a reusable communicator with power cable.The non-invasive aid for patients receiving BPAP/CPAP therapy delivers communication between the patient and medical personnel.
F2S Communicator: The communicator will be attached to the BPAP/CPAP mask. The study coordinator will ENABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the "mask on, communicator on" period. |
Description | Non-functioning study communication device is used.
Non-functioning Communicator: The communicator will be attached to the BPAP/CPAP mask. The study coordinator will DISABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the "mask on, communicator on" period. |
Baseline Measurements
Sequence: | 124738140 | Sequence: | 124738128 | Sequence: | 124738129 | Sequence: | 124738130 | Sequence: | 124738131 | Sequence: | 124738132 | Sequence: | 124738133 | Sequence: | 124738134 | Sequence: | 124738135 | Sequence: | 124738136 | Sequence: | 124738137 | Sequence: | 124738138 | Sequence: | 124738139 | Sequence: | 124738141 | Sequence: | 124738142 | Sequence: | 124738143 | Sequence: | 124738144 | Sequence: | 124738145 | Sequence: | 124738146 | Sequence: | 124738147 | Sequence: | 124738148 | Sequence: | 124738149 | Sequence: | 124738150 | Sequence: | 124738151 | Sequence: | 124738152 | Sequence: | 124738153 | Sequence: | 124738154 | Sequence: | 124738155 | Sequence: | 124738156 | Sequence: | 124738157 | Sequence: | 124738158 | Sequence: | 124738159 | Sequence: | 124738160 |
Result Group Id | 55787771 | Result Group Id | 55787771 | Result Group Id | 55787772 | Result Group Id | 55787773 | Result Group Id | 55787771 | Result Group Id | 55787772 | Result Group Id | 55787773 | Result Group Id | 55787771 | Result Group Id | 55787772 | Result Group Id | 55787773 | Result Group Id | 55787771 | Result Group Id | 55787772 | Result Group Id | 55787773 | Result Group Id | 55787772 | Result Group Id | 55787773 | Result Group Id | 55787771 | Result Group Id | 55787772 | Result Group Id | 55787773 | Result Group Id | 55787771 | Result Group Id | 55787772 | Result Group Id | 55787773 | Result Group Id | 55787771 | Result Group Id | 55787772 | Result Group Id | 55787773 | Result Group Id | 55787771 | Result Group Id | 55787772 | Result Group Id | 55787773 | Result Group Id | 55787771 | Result Group Id | 55787772 | Result Group Id | 55787773 | Result Group Id | 55787771 | Result Group Id | 55787772 | Result Group Id | 55787773 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Classification | United States | Classification | United States | Classification | United States | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Category | Asian | Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Asian | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | White | Category | White | Category | White | Category | More than one race | Category | More than one race | Category | More than one race | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | ||||||||||||
Title | Race (NIH/OMB) | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Region of Enrollment | Title | Region of Enrollment | Title | Region of Enrollment |
Units | Participants | Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | participants | Units | participants |
Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number |
Param Value | 0 | Param Value | 55.4 | Param Value | 59.9 | Param Value | 57.03 | Param Value | 13 | Param Value | 6 | Param Value | 19 | Param Value | 10 | Param Value | 7 | Param Value | 17 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 13 | Param Value | 4 | Param Value | 17 | Param Value | 10 | Param Value | 9 | Param Value | 19 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 23 | Param Value | 13 | Param Value | 36 |
Param Value Num | 0.0 | Param Value Num | 55.4 | Param Value Num | 59.9 | Param Value Num | 57.03 | Param Value Num | 13.0 | Param Value Num | 6.0 | Param Value Num | 19.0 | Param Value Num | 10.0 | Param Value Num | 7.0 | Param Value Num | 17.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 13.0 | Param Value Num | 4.0 | Param Value Num | 17.0 | Param Value Num | 10.0 | Param Value Num | 9.0 | Param Value Num | 19.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 23.0 | Param Value Num | 13.0 | Param Value Num | 36.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 13.3 | Dispersion Value | 17.1 | Dispersion Value | 14.7 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 13.3 | Dispersion Value Num | 17.1 | Dispersion Value Num | 14.7 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 23 | Number Analyzed | 23 | Number Analyzed | 13 | Number Analyzed | 36 | Number Analyzed | 23 | Number Analyzed | 13 | Number Analyzed | 36 | Number Analyzed | 23 | Number Analyzed | 13 | Number Analyzed | 36 | Number Analyzed | 23 | Number Analyzed | 13 | Number Analyzed | 36 | Number Analyzed | 13 | Number Analyzed | 36 | Number Analyzed | 23 | Number Analyzed | 13 | Number Analyzed | 36 | Number Analyzed | 23 | Number Analyzed | 13 | Number Analyzed | 36 | Number Analyzed | 23 | Number Analyzed | 13 | Number Analyzed | 36 | Number Analyzed | 23 | Number Analyzed | 13 | Number Analyzed | 36 | Number Analyzed | 23 | Number Analyzed | 13 | Number Analyzed | 36 | Number Analyzed | 23 | Number Analyzed | 13 | Number Analyzed | 36 |
]]>
https://zephyrnet.com/NCT03795740
2017-02-01
https://zephyrnet.com/?p=NCT03795740
NCT03795740https://www.clinicaltrials.gov/study/NCT03795740?tab=tableJiade Zhu, MD15801204824@163.com86-15801204824This study is a effectiveness study of the application of high-definition enhanced computed-tomography for patients with chronic thromboembolic pulmonary hypertension(CTEPH).The patients with CTEPH was randomized into 2 groups,precise pulmonary endarterectomy group(guided by enhanced CT scanning) and traditional pulmonary endarterectomy group,the hemodynamic changes tested with right sided heart catherization from baseline to post-operative period and end-point including peri-operative deaths,follow-up mortality,follow-up parameters of ultrasonic cardiogram(UCG),right-sided heart catherization(RHC),nuclear magnetic resonance imaging(MRI),cardiac pulmonary exercise test(CPET) are documented,so as to compare the prognosis between these 2 groups.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-19 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | February 1, 2017 |
Primary Completion Month Year | May 31, 2020 |
Verification Month Year | December 2018 |
Verification Date | 2018-12-31 |
Last Update Posted Date | 2019-01-08 |
Facilities
Sequence: | 200053473 |
Status | Recruiting |
Name | Fuwai Hospital,Chinese Academy of Medical Sciences |
City | Beijing |
State | Beijing |
Zip | 100044 |
Country | China |
Facility Contacts
Sequence: | 28097585 |
Facility Id | 200053473 |
Contact Type | primary |
Name | Sheng Liu, MD |
liusheng@fuwai.com | |
Phone | 86-13501331366 |
Conditions
Sequence: | 52156591 | Sequence: | 52156592 |
Name | Chronic Thromboembolic Pulmonary Hypertension | Name | Pulmonary Embolism |
Downcase Name | chronic thromboembolic pulmonary hypertension | Downcase Name | pulmonary embolism |
Id Information
Sequence: | 40148274 |
Id Source | org_study_id |
Id Value | liusheng-1999 |
Countries
Sequence: | 42557808 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55578002 | Sequence: | 55578003 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Precise | Title | Placebo |
Description | precise PEA therapy with the guide of 3-D imaging techniques | Description | traditional PEA therapy solely by surgical probe and traditional CT scanning/pulmonary angiography method |
Interventions
Sequence: | 52472100 |
Intervention Type | Diagnostic Test |
Name | 3-D CT scanning |
Description | For patients in Group 1,precisely analyzed CT scanning and/or pulmonary angiography will be done,and the patients in Group 1 will receive PEA procedure with the guide of precise 3-D imaging techniques |
Keywords
Sequence: | 79848233 | Sequence: | 79848234 | Sequence: | 79848235 | Sequence: | 79848236 | Sequence: | 79848237 |
Name | computed tomography | Name | chronic thromboembolic pulmonary hypertension | Name | pulmonary endarterectomy | Name | result | Name | randomized controlled trial |
Downcase Name | computed tomography | Downcase Name | chronic thromboembolic pulmonary hypertension | Downcase Name | pulmonary endarterectomy | Downcase Name | result | Downcase Name | randomized controlled trial |
Design Outcomes
Sequence: | 177328448 | Sequence: | 177328449 | Sequence: | 177328450 | Sequence: | 177328451 | Sequence: | 177328452 | Sequence: | 177328453 | Sequence: | 177328454 | Sequence: | 177328455 | Sequence: | 177328456 | Sequence: | 177328457 | Sequence: | 177328458 | Sequence: | 177328459 | Sequence: | 177328460 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change from Baseline pulmonary systolic pressure within 1 month | Measure | Change from Baseline pulmonary mean pressure within 1 month | Measure | Change from Baseline pulmonary vascular resistance within 1 month | Measure | Change from Baseline cardiac output within 1 month | Measure | mortality rate after surgery | Measure | Follow-up right ventricular ejection fraction | Measure | Follow-up tricuspid annular plane systolic excursion | Measure | Follow-up right ventricular anterior-posterior diameter | Measure | Follow-up tricuspid insufficiency level | Measure | Follow-up peak oxygen consumption (Peak O2) result | Measure | Follow-up Peak O2% | Measure | Follow-up 6-minutes walking distance | Measure | follow-up NYHA classes |
Time Frame | within 1 month before and after pulmonary endarterectomy surgery | Time Frame | within 1 month before and after pulmonary endarterectomy surgery | Time Frame | within 1 month before and after pulmonary endarterectomy surgery | Time Frame | within 1 month before and after pulmonary endarterectomy surgery | Time Frame | immediately after the surgery to the longest 48 months follow-up period | Time Frame | 3-24 months after the surgeries | Time Frame | 3-24 months after the surgeries | Time Frame | 3-24 months after the surgeries | Time Frame | 3-24 months after the surgeries | Time Frame | 6-24 months after the surgeries | Time Frame | 6-24 months after the surgeries | Time Frame | 6-24 months after the surgeries | Time Frame | 6-24 months after surgeries |
Description | Systolic pulmonary pressure result tested by right-sided heart | Description | Mean pulmonary pressure result tested by right-sided heart | Description | Pulmonary vascular resistance result tested by right-sided heart | Description | Cardiac output result tested by right-sided heart | Description | mortality rate after surgery | Description | Assessed by UCG | Description | Assessed by UCG | Description | Assessed by UCG | Description | Assessed by UCG | Description | Assessed by cardio-pulmonary exercise test (CPET) | Description | Assessed by CPET | Description | Assessed by CPET | Description | NYHA classes in the follow up period,either with telephone follow-up or out-patient follow up |
Browse Conditions
Sequence: | 193432390 | Sequence: | 193432385 | Sequence: | 193432386 | Sequence: | 193432387 | Sequence: | 193432388 | Sequence: | 193432389 | Sequence: | 193432391 | Sequence: | 193432392 | Sequence: | 193432393 |
Mesh Term | Cardiovascular Diseases | Mesh Term | Hypertension, Pulmonary | Mesh Term | Pulmonary Embolism | Mesh Term | Hypertension | Mesh Term | Embolism | Mesh Term | Vascular Diseases | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Embolism and Thrombosis |
Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | hypertension, pulmonary | Downcase Mesh Term | pulmonary embolism | Downcase Mesh Term | hypertension | Downcase Mesh Term | embolism | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | embolism and thrombosis |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306181 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Sheng Liu |
Central Contacts
Sequence: | 12004767 | Sequence: | 12004768 |
Contact Type | primary | Contact Type | backup |
Name | Sheng Liu, MD | Name | Jiade Zhu, MD |
Phone | 13501331366 | Phone | 86-15801204824 |
liusheng@fuwai.com | 15801204824@163.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68130982 | Sequence: | 68130983 |
Design Group Id | 55578003 | Design Group Id | 55578002 |
Intervention Id | 52472100 | Intervention Id | 52472100 |
Eligibilities
Sequence: | 30757411 |
Gender | All |
Minimum Age | N/A |
Maximum Age | 85 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Definite diagnosed with chronic thromboembolic pulmonary hypertension with the right-sided cathrization and pulmonary angiography; Exclusion Criteria: Beyond the age limit described above,or combined with other severe conditions such as severe organ dysfunction and considered contraindicated for surgical therapy by the cardiac surgeons; |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254229066 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Maximum Age Num | 85 |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 5 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30503636 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Links
Sequence: | 4387000 |
Url | https://www.ncbi.nlm.nih.gov/pubmed |
Description | a website could find all the citation above,enter the website of "https://www.ncbi.nlm.nih.gov/pubmed",input the PubMed ID of corresponding citation,and the citation will be shown in the webpage. |
Provided Documents
Sequence: | 2578359 | Sequence: | 2578360 |
Document Type | Study Protocol and Statistical Analysis Plan | Document Type | Informed Consent Form |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | True |
Has Sap | True | Has Sap | False |
Document Date | 2018-12-19 | Document Date | 2018-12-19 |
Url | https://ClinicalTrials.gov/ProvidedDocs/40/NCT03795740/Prot_SAP_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/40/NCT03795740/ICF_001.pdf |
Responsible Parties
Sequence: | 28869914 |
Responsible Party Type | Sponsor-Investigator |
Name | Sheng Liu |
Title | Adult Cardiac Surgery Center |
Affiliation | Chinese Academy of Medical Sciences, Fuwai Hospital |
Study References
Sequence: | 52049466 | Sequence: | 52049467 | Sequence: | 52049468 | Sequence: | 52049469 | Sequence: | 52049470 | Sequence: | 52049471 | Sequence: | 52049472 |
Pmid | 14602267 | Pmid | 15163775 | Pmid | 29563171 | Pmid | 21793646 | Pmid | 26826181 | Pmid | 24728482 | Pmid | 21969018 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Jamieson SW, Kapelanski DP, Sakakibara N, Manecke GR, Thistlethwaite PA, Kerr KM, Channick RN, Fedullo PF, Auger WR. Pulmonary endarterectomy: experience and lessons learned in 1,500 cases. Ann Thorac Surg. 2003 Nov;76(5):1457-62; discussion 1462-4. doi: 10.1016/s0003-4975(03)00828-2. | Citation | Pengo V, Lensing AW, Prins MH, Marchiori A, Davidson BL, Tiozzo F, Albanese P, Biasiolo A, Pegoraro C, Iliceto S, Prandoni P; Thromboembolic Pulmonary Hypertension Study Group. Incidence of chronic thromboembolic pulmonary hypertension after pulmonary embolism. N Engl J Med. 2004 May 27;350(22):2257-64. doi: 10.1056/NEJMoa032274. | Citation | Coquoz N, Weilenmann D, Stolz D, Popov V, Azzola A, Fellrath JM, Stricker H, Pagnamenta A, Ott S, Ulrich S, Gyorik S, Pasquier J, Aubert JD. Multicentre observational screening survey for the detection of CTEPH following pulmonary embolism. Eur Respir J. 2018 Apr 4;51(4):1702505. doi: 10.1183/13993003.02505-2017. Print 2018 Apr. | Citation | Kirson NY, Birnbaum HG, Ivanova JI, Waldman T, Joish V, Williamson T. Prevalence of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension in the United States. Curr Med Res Opin. 2011 Sep;27(9):1763-8. doi: 10.1185/03007995.2011.604310. Epub 2011 Jul 27. | Citation | Delcroix M, Lang I, Pepke-Zaba J, Jansa P, D'Armini AM, Snijder R, Bresser P, Torbicki A, Mellemkjaer S, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Jais X, Ambroz D, Treacy C, Morsolini M, Jenkins D, Lindner J, Dartevelle P, Mayer E, Simonneau G. Long-Term Outcome of Patients With Chronic Thromboembolic Pulmonary Hypertension: Results From an International Prospective Registry. Circulation. 2016 Mar 1;133(9):859-71. doi: 10.1161/CIRCULATIONAHA.115.016522. Epub 2016 Jan 29. | Citation | Inami T, Kataoka M, Ando M, Fukuda K, Yoshino H, Satoh T. A new era of therapeutic strategies for chronic thromboembolic pulmonary hypertension by two different interventional therapies; pulmonary endarterectomy and percutaneous transluminal pulmonary angioplasty. PLoS One. 2014 Apr 11;9(4):e94587. doi: 10.1371/journal.pone.0094587. eCollection 2014. | Citation | Pepke-Zaba J, Delcroix M, Lang I, Mayer E, Jansa P, Ambroz D, Treacy C, D'Armini AM, Morsolini M, Snijder R, Bresser P, Torbicki A, Kristensen B, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Hamid AM, Jais X, Simonneau G. Chronic thromboembolic pulmonary hypertension (CTEPH): results from an international prospective registry. Circulation. 2011 Nov 1;124(18):1973-81. doi: 10.1161/CIRCULATIONAHA.110.015008. Epub 2011 Oct 3. |
]]>
https://zephyrnet.com/NCT03795727
2020-01-20
https://zephyrnet.com/?p=NCT03795727
NCT03795727https://www.clinicaltrials.gov/study/NCT03795727?tab=tableNANANAThe aim of this study is to evaluate the effects of different matricing techniques either sectional matrix or circumferential matrix on reproduction of optimum proximal contacts and contours during restoration of class II cavities with resin composite by undergraduate students or postgraduate dentists.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-04-21 |
Start Month Year | January 20, 2020 |
Primary Completion Month Year | February 12, 2020 |
Verification Month Year | April 2020 |
Verification Date | 2020-04-30 |
Last Update Posted Date | 2020-04-21 |
Facilities
Sequence: | 200244227 |
Name | Faculty of Dentistry, Cairo University |
City | Cairo |
State | El Manial |
Zip | 11553 |
Country | Egypt |
Conditions
Sequence: | 52208105 |
Name | Proximal Contact |
Downcase Name | proximal contact |
Id Information
Sequence: | 40186148 |
Id Source | org_study_id |
Id Value | circumferential vs sectional |
Countries
Sequence: | 42599642 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55634665 | Sequence: | 55634666 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Sectional matrix | Title | Circumferential matrix |
Description | precontoured sectional matrix band | Description | Circumferential matrix band applied by tofflemire retainer |
Interventions
Sequence: | 52522075 | Sequence: | 52522076 |
Intervention Type | Device | Intervention Type | Device |
Name | MD ring and precontoured sectional matrix by TOR VM | Name | Circumferential matrix and tofflemire retainer by Kerr |
Description | MD ring (separation ring) and precontoured sectional matrix (thickness 0.035mm hard) and a wedge was used to secure matrix in place | Description | Circumferential matrix (thickness 0.038mm) applied by tofflemire retainer and secured in place with wedge |
Design Outcomes
Sequence: | 177511222 |
Outcome Type | primary |
Measure | Proximal contact |
Time Frame | Up to 3 hours from randomization till contact is restored |
Description | Reproduction of proximal contact either optimum, tight or loose (Categorical) |
Sponsors
Sequence: | 48353696 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Cairo University |
Design Group Interventions
Sequence: | 68199188 | Sequence: | 68199189 |
Design Group Id | 55634665 | Design Group Id | 55634666 |
Intervention Id | 52522075 | Intervention Id | 52522076 |
Eligibilities
Sequence: | 30786871 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 40 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Compound class II cavities Exclusion Criteria: Complex class II cavities |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253989626 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 0 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 40 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30532941 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28899235 |
Responsible Party Type | Principal Investigator |
Name | Omar Osama Shaalan |
Title | Lecturer of conservative dentistry, Faculty of Dentistry |
Affiliation | Cairo University |
]]>
https://zephyrnet.com/NCT03795714
2017-11-17
https://zephyrnet.com/?p=NCT03795714
NCT03795714https://www.clinicaltrials.gov/study/NCT03795714?tab=tableKi Hong Choi, MDcardiokh@gmail.com82-10-8875-1648to evaluate diagnostic accuracy and performance of IVUS and OCT-derived quantitative parameters to predict functional significance of stenosis defined using all the available physiologic indices.
to explores the association between intravascular imaging-derived plaque characteristics and invasive physiologic indices.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-28 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-22 |
Start Month Year | November 17, 2017 |
Primary Completion Month Year | January 31, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-22 |
Detailed Descriptions
Sequence: | 20721572 |
Description | Given the inherent limitations of coronary angiography to depict the presence of functionally significant epicardial coronary stenosis and discrepancy between angiographic stenosis severity and the presence of myocardial ischemia, invasive physiologic indices such as fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) has been a standard method to guide decision of revascularization.
Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are an intracoronary imaging method able to provide information about lumen area, vessel area, plaque burden, and plaque characteristics that can be used for the guidance of revascularization procedure. Several previous studies explored the diagnostic performance of intravascular imaging-defined quantitative parameters to predict functional significance defined by FFR, however, quantitative parameter derived from intravascular imaging showed only moderate diagnostic accuracy and the optimal cut-off value of intravascular imaging-derived minimal lumen area (MLA) or minimal lumen diameter (MLD) were varied according to the patient population, interrogated vessels, and the location of target lesions, suggesting limited clinical relevance of judging functional significance of target stenosis using intravascular imaging alone. Nevertheless, the adoption rate of FFR-guided decision has been limited due to various reasons and intravascular image-guided decision has been still used in substantial proportion of the patients. Recently, new resting pressure-derived indices including resting full-cycle ratio (RFR) or diastolic pressure ratio (dPR) have been introduced as other substitutes for iFR, which does not require administration of hyperemic agents, therefore, possess more convenient in daily practice. Recent study with the largest sample size demonstrated identical diagnostic property and prognostic implication among iFR, RFR, and dPR. As those resting pressure-derived indices might have more generalizability for daily practice, it is expected to raise the adoption rate of physiologic interrogation. Therefore, understanding the association between all the available physiologic indices and intravascular imaging-derived quantitative and qualitative parameters might be important in clinical decision for patient who underwent invasive coronary angiography. In this regard, the investigators sought to evaluate diagnostic accuracy and performance of intravascular imaging-derived quantitative parameters to predict functional significance of stenosis defined using all the available physiologic indices and further explores the association between IVUS and OCT-derived plaque characteristics and invasive physiologic indices. |
Facilities
Sequence: | 200107794 | Sequence: | 200107795 |
Status | Recruiting | Status | Recruiting |
Name | Samsung Medical Center | Name | Seoul national university hospital |
City | Seoul | City | Seoul |
Zip | 06351 | Zip | 110-744 |
Country | Korea, Republic of | Country | Korea, Republic of |
Facility Contacts
Sequence: | 28106374 | Sequence: | 28106375 | Sequence: | 28106376 |
Facility Id | 200107794 | Facility Id | 200107794 | Facility Id | 200107795 |
Contact Type | primary | Contact Type | backup | Contact Type | primary |
Name | Joo Myung Lee, MD, MPH, PhD | Name | Ki Hong Choi, MD | Name | Bon-kown Koo, MD/PhD |
drone80@hanmail.net | cardiokh@gmail.com | bkkoo@snu.ac.kr | |||
Phone | 82-2-2072-2062 | ||||
Facility Investigators
Sequence: | 18332477 | Sequence: | 18332478 | Sequence: | 18332479 |
Facility Id | 200107794 | Facility Id | 200107794 | Facility Id | 200107795 |
Role | Principal Investigator | Role | Sub-Investigator | Role | Principal Investigator |
Name | Joo Myung Lee, MD, MPH, PhD | Name | Ki Hong Choi, MD | Name | Bon-kwon Koo, MD/PhD |
Conditions
Sequence: | 52171082 |
Name | Ischemic Heart Disease |
Downcase Name | ischemic heart disease |
Id Information
Sequence: | 40158527 |
Id Source | org_study_id |
Id Value | IVUS2017-11-056-001 |
Countries
Sequence: | 42568832 |
Name | Korea, Republic of |
Removed | False |
Design Groups
Sequence: | 55593020 |
Title | Intravascular Imaging and Physiologic Assessment |
Description | 330 patients with suspected ischemic heart disease and who underwent IVUS or OCT assessment and invasive physiologic assessment. |
Interventions
Sequence: | 52485330 |
Intervention Type | Diagnostic Test |
Name | IVUS or OCT and Invasive physiologic indices |
Description | IVUS or OCT measurement in order to evaluate the lesion morphology and stent optimization, and invasive physiologic measurement in order to functional significance of epicardial stenosis |
Keywords
Sequence: | 79868276 | Sequence: | 79868277 | Sequence: | 79868278 | Sequence: | 79868279 | Sequence: | 79868280 | Sequence: | 79868281 | Sequence: | 79868282 |
Name | Intravascular Ultrasound | Name | Optical Coherence Tomography | Name | Fractional Flow Reserve | Name | Diastolic Pressure Ratio | Name | Resting Full-Cycle Ratio | Name | Ischemic Heart Disease | Name | Instantaneous Wave-free Ratio |
Downcase Name | intravascular ultrasound | Downcase Name | optical coherence tomography | Downcase Name | fractional flow reserve | Downcase Name | diastolic pressure ratio | Downcase Name | resting full-cycle ratio | Downcase Name | ischemic heart disease | Downcase Name | instantaneous wave-free ratio |
Design Outcomes
Sequence: | 177378246 | Sequence: | 177378247 | Sequence: | 177378248 | Sequence: | 177378249 | Sequence: | 177378250 | Sequence: | 177378251 | Sequence: | 177378252 | Sequence: | 177378253 | Sequence: | 177378254 | Sequence: | 177378255 | Sequence: | 177378256 | Sequence: | 177378257 | Sequence: | 177378258 | Sequence: | 177378259 | Sequence: | 177378260 | Sequence: | 177378261 | Sequence: | 177378262 | Sequence: | 177378263 | Sequence: | 177378264 | Sequence: | 177378265 | Sequence: | 177378266 | Sequence: | 177378267 | Sequence: | 177378268 | Sequence: | 177378269 | Sequence: | 177378270 | Sequence: | 177378271 | Sequence: | 177378272 | Sequence: | 177378273 | Sequence: | 177378274 | Sequence: | 177378275 | Sequence: | 177378276 | Sequence: | 177378277 | Sequence: | 177378278 | Sequence: | 177378279 | Sequence: | 177378280 | Sequence: | 177378281 | Sequence: | 177378282 | Sequence: | 177378283 | Sequence: | 177378284 | Sequence: | 177378285 | Sequence: | 177378286 | Sequence: | 177378287 | Sequence: | 177378288 | Sequence: | 177378289 | Sequence: | 177378290 | Sequence: | 177378291 | Sequence: | 177378292 | Sequence: | 177378293 | Sequence: | 177378294 | Sequence: | 177378295 | Sequence: | 177378296 | Sequence: | 177378297 | Sequence: | 177378298 | Sequence: | 177378299 | Sequence: | 177378300 | Sequence: | 177378301 | Sequence: | 177378302 | Sequence: | 177378303 | Sequence: | 177378304 | Sequence: | 177378305 | Sequence: | 177378306 | Sequence: | 177378307 | Sequence: | 177378308 | Sequence: | 177378309 | Sequence: | 177378310 | Sequence: | 177378311 | Sequence: | 177378312 | Sequence: | 177378313 | Sequence: | 177378314 | Sequence: | 177378315 | Sequence: | 177378316 | Sequence: | 177378317 | Sequence: | 177378318 | Sequence: | 177378319 | Sequence: | 177378320 | Sequence: | 177378321 | Sequence: | 177378322 | Sequence: | 177378323 | Sequence: | 177378324 | Sequence: | 177378325 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by fractional flow reserve (FFR) | Measure | Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by instantaneous wave-free ratio (iFR) | Measure | Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by diastolic pressure ratio (dPR) | Measure | Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by resting full-cycle ratio (RFR) | Measure | Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR | Measure | Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR | Measure | Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR | Measure | Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR | Measure | Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR | Measure | Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR | Measure | Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR | Measure | Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR | Measure | Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR | Measure | Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance assessed by iFR | Measure | Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance assessed by dPR | Measure | Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR | Measure | Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR | Measure | Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR | Measure | Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR | Measure | Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR | Measure | Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR | Measure | Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR | Measure | Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR | Measure | Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR | Measure | Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR | Measure | Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR | Measure | Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR | Measure | Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR | Measure | Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR | Measure | Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by iFR | Measure | Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by dPR | Measure | Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR | Measure | Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR | Measure | Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR | Measure | Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR | Measure | Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR | Measure | Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR | Measure | Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR | Measure | Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR | Measure | Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR | Measure | Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR | Measure | Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR | Measure | Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR | Measure | Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR | Measure | Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR | Measure | Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by iFR | Measure | Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by dPR | Measure | Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR | Measure | Linear correlation between percent diameter stenosis and FFR | Measure | Linear correlation between percent diameter stenosis and iFR | Measure | Linear correlation between percent diameter stenosis and dPR | Measure | Linear correlation between percent diameter stenosis and RFR | Measure | Linear correlation between minimal lumen diameter and FFR | Measure | Linear correlation between minimal lumen diameter and iFR | Measure | Linear correlation between minimal lumen diameter and dPR | Measure | Linear correlation between minimal lumen diameter and RFR | Measure | Linear correlation between minimal lumen area and FFR | Measure | Linear correlation between minimal lumen area and iFR | Measure | Linear correlation between minimal lumen area and dPR | Measure | Linear correlation between minimal lumen area and RFR | Measure | Linear correlation between plaque burden and FFR | Measure | Linear correlation between plaque burden and iFR | Measure | Linear correlation between plaque burden and dPR | Measure | Linear correlation between plaque burden and RFR | Measure | Discriminatory function of percent diameter stenosis to predict functional significance assessed by FFR | Measure | Discriminatory function of percent diameter stenosis to predict functional significance assessed by iFR | Measure | Discriminatory function of percent diameter stenosis to predict functional significance assessed by dPR | Measure | Discriminatory function of percent diameter stenosis to predict functional significance assessed by RFR | Measure | Discriminatory function of minimal lumen diameter to predict functional significance assessed by FFR | Measure | Discriminatory function of minimal lumen diameter to predict functional significance assessed by iFR | Measure | Discriminatory function of minimal lumen diameter to predict functional significance assessed by dPR | Measure | Discriminatory function of minimal lumen diameter to predict functional significance assessed by RFR | Measure | Discriminatory function of minimal lumen area to predict functional significance assessed by FFR | Measure | Discriminatory function of minimal lumen area to predict functional significance assessed by iFR | Measure | Discriminatory function of minimal lumen area to predict functional significance assessed by dPR | Measure | Discriminatory function of minimal lumen area to predict functional significance assessed by RFR | Measure | Discriminatory function of plaque burden to predict functional significance assessed by FFR | Measure | Discriminatory function of plaque burden to predict functional significance assessed by iFR | Measure | Discriminatory function of plaque burden to predict functional significance assessed by dPR | Measure | Discriminatory function of plaque burden to predict functional significance assessed by RFR |
Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath | Time Frame | During Cardiac Cath |
Description | Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80 | Description | Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89 | Description | Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89 | Description | Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89 | Description | Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80 | Description | Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89 | Description | Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89 | Description | Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89 | Description | Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80 | Description | Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89 | Description | Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89 | Description | Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89 | Description | Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80 | Description | Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance defined by iFR ≤0.89 | Description | Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance defined by dPR ≤0.89 | Description | Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89 | Description | Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80 | Description | Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89 | Description | Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89 | Description | Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89 | Description | Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80 | Description | Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89 | Description | Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89 | Description | Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89 | Description | Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80 | Description | Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89 | Description | Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89 | Description | Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89 | Description | Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80 | Description | Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89 | Description | Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89 | Description | Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89 | Description | Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80 | Description | Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89 | Description | Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89 | Description | Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89 | Description | Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80 | Description | Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89 | Description | Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89 | Description | Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89 | Description | Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80 | Description | Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89 | Description | Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89 | Description | Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89 | Description | Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80 | Description | Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89 | Description | Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89 | Description | Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89 | Description | Linear regression analysis between percent diameter stenosis and FFR | Description | Linear regression analysis between percent diameter stenosis and iFR | Description | Linear regression analysis between percent diameter stenosis and dPR | Description | Linear regression analysis between percent diameter stenosis and RFR | Description | Linear regression analysis between minimal lumen diameter and FFR | Description | Linear regression analysis between minimal lumen diameter and iFR | Description | Linear regression analysis between minimal lumen diameter and dPR | Description | Linear regression analysis between minimal lumen diameter and RFR | Description | Linear regression analysis between minimal lumen area and FFR | Description | Linear regression analysis between minimal lumen area and iFR | Description | Linear regression analysis between minimal lumen area and dPR | Description | Linear regression analysis between minimal lumen area and RFR | Description | Linear regression analysis between plaque burden and FFR | Description | Linear regression analysis between plaque burden and iFR | Description | Linear regression analysis between plaque burden and dPR | Description | Linear regression analysis between plaque burden and RFR | Description | Discriminatory function of percent diameter stenosis to predict functional significance defined by FFR≤0.80 | Description | Discriminatory function of percent diameter stenosis to predict functional significance defined by iFR≤0.89 | Description | Discriminatory function of percent diameter stenosis to predict functional significance defined by dPR≤0.89 | Description | Discriminatory function of percent diameter stenosis to predict functional significance defined by RFR≤0.89 | Description | Discriminatory function of minimal lumen diameter to predict functional significance defined by FFR≤0.80 | Description | Discriminatory function of minimal lumen diameter to predict functional significance defined by iFR≤0.89 | Description | Discriminatory function of minimal lumen diameter to predict functional significance defined by dPR≤0.89 | Description | Discriminatory function of minimal lumen diameter to predict functional significance defined by RFR≤0.89 | Description | Discriminatory function of minimal lumen area to predict functional significance defined by FFR≤0.80 | Description | Discriminatory function of minimal lumen area to predict functional significance defined by iFR≤0.89 | Description | Discriminatory function of minimal lumen area to predict functional significance defined by dPR≤0.89 | Description | Discriminatory function of minimal lumen area to predict functional significance defined by RFR≤0.89 | Description | Discriminatory function of plaque burden to predict functional significance defined by FFR≤0.80 | Description | Discriminatory function of plaque burden to predict functional significance defined by iFR≤0.89 | Description | Discriminatory function of plaque burden to predict functional significance defined by dPR≤0.89 | Description | Discriminatory function of plaque burden to predict functional significance defined by RFR≤0.89 |
Browse Conditions
Sequence: | 193486075 | Sequence: | 193486076 | Sequence: | 193486077 | Sequence: | 193486078 | Sequence: | 193486079 | Sequence: | 193486080 | Sequence: | 193486081 | Sequence: | 193486082 |
Mesh Term | Heart Diseases | Mesh Term | Myocardial Ischemia | Mesh Term | Coronary Artery Disease | Mesh Term | Cardiovascular Diseases | Mesh Term | Vascular Diseases | Mesh Term | Coronary Disease | Mesh Term | Arteriosclerosis | Mesh Term | Arterial Occlusive Diseases |
Downcase Mesh Term | heart diseases | Downcase Mesh Term | myocardial ischemia | Downcase Mesh Term | coronary artery disease | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | coronary disease | Downcase Mesh Term | arteriosclerosis | Downcase Mesh Term | arterial occlusive diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319142 | Sequence: | 48319143 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Seoul National University Hospital | Name | Samsung Medical Center |
Overall Officials
Sequence: | 29285269 | Sequence: | 29285270 |
Role | Study Chair | Role | Principal Investigator |
Name | Bon-Kwon Koo, MD, PhD | Name | Joo Myung Lee, MD, MPH, PhD |
Affiliation | Professor | Affiliation | Assistant Professor |
Central Contacts
Sequence: | 12008836 | Sequence: | 12008837 |
Contact Type | primary | Contact Type | backup |
Name | Joo Myung Lee, MD, MPH, PhD | Name | Ki Hong Choi, MD |
Phone | 82-10-8884-8439 | Phone | 82-10-8875-1648 |
drone80@hanmail.net | cardiokh@gmail.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68148954 |
Design Group Id | 55593020 |
Intervention Id | 52485330 |
Eligibilities
Sequence: | 30765262 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | 330 patients with suspected ischemic heart disease and who underwent IVUS or OCT assessment and invasive physiologic assessment. |
Criteria | Inclusion Criteria:
Patients who suspected ischemic heart disease, and underwent invasive physiologic assessment and intravascular ultrasound Exclusion Criteria: Cardiogenic shock |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 253876967 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Number Of Primary Outcomes To Measure | 16 |
Number Of Secondary Outcomes To Measure | 64 |
Designs
Sequence: | 30511429 |
Observational Model | Case-Only |
Time Perspective | Retrospective |
Responsible Parties
Sequence: | 28877723 |
Responsible Party Type | Principal Investigator |
Name | Bon-Kwon Koo |
Title | Professor |
Affiliation | Seoul National University Hospital |
Study References
Sequence: | 52063128 |
Pmid | 31812517 |
Reference Type | derived |
Citation | Lee JM, Choi KH, Koo BK, Zhang J, Han JK, Yang HM, Park KW, Song YB, Hahn JY, Choi SH, Gwon HC, Kim HS. Intravascular ultrasound or optical coherence tomography-defined anatomic severity and hemodynamic severity assessed by coronary physiologic indices. Rev Esp Cardiol (Engl Ed). 2020 Oct;73(10):812-821. doi: 10.1016/j.rec.2019.11.001. Epub 2019 Dec 4. English, Spanish. |
]]>
https://zephyrnet.com/NCT03795701
2019-01-08
https://zephyrnet.com/?p=NCT03795701
NCT03795701https://www.clinicaltrials.gov/study/NCT03795701?tab=tableNANANAThe study is a single center, randomized, double blind, placebo controlled; parallel-group repeated measures design. Subjects will be randomly assigned to either Saxenda® or placebo group after baseline assessments. The study will consist of a 4-week partial dose period (Liraglutide 0.6mg, 1.2mg, 1.8mg, 2.4 mg) and a 12-week full-dose (Liraglutide 3.0 mg) period. The placebo group will administer equivalent volumes of the pre-filled solutions from pen-injector at the same time, using the same method during this period. The study proposes to identify factors contributing to early weight loss response in a Saxenda® treatment program. Specifically, the proposed experiments will help determine if Saxenda® changes brain functional Magnetic Resonance Imaging Food Cue Reactivity (fMRI-FCR) and whether the magnitude of that change is associated with changes in behavioral and physiological variables (hunger, satiety, cravings and weight loss).
<![CDATA[
Studies
Study First Submitted Date | 2018-12-17 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2022-11-03 |
Start Month Year | January 8, 2019 |
Primary Completion Month Year | January 1, 2024 |
Verification Month Year | November 2022 |
Verification Date | 2022-11-30 |
Last Update Posted Date | 2022-11-03 |
Facilities
Sequence: | 199179138 | Sequence: | 199179139 |
Name | Texas Tech Neuroimaging Institute | Name | Nutrition & Metabolic Health Initiative |
City | Lubbock | City | Lubbock |
State | Texas | State | Texas |
Zip | 79409 | Zip | 79410 |
Country | United States | Country | United States |
Browse Interventions
Sequence: | 95633581 | Sequence: | 95633578 | Sequence: | 95633579 | Sequence: | 95633580 | Sequence: | 95633582 | Sequence: | 95633583 |
Mesh Term | Incretins | Mesh Term | Liraglutide | Mesh Term | Hypoglycemic Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Hormones | Mesh Term | Hormones, Hormone Substitutes, and Hormone Antagonists |
Downcase Mesh Term | incretins | Downcase Mesh Term | liraglutide | Downcase Mesh Term | hypoglycemic agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | hormones | Downcase Mesh Term | hormones, hormone substitutes, and hormone antagonists |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51951359 |
Name | Obesity |
Downcase Name | obesity |
Id Information
Sequence: | 39988107 |
Id Source | org_study_id |
Id Value | TTUIRB2018-824 |
Countries
Sequence: | 42378848 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55351059 | Sequence: | 55351060 |
Group Type | Placebo Comparator | Group Type | Experimental |
Title | Placebo | Title | Liraglutide 3.0 |
Description | Subjects in placebo group will receive placebo plus behavioral weight loss counselling to portion control to achieve 500 kcal daily deficit based on MedGem required maintenance calories (not to be reduced below 1000 kcal per day for any subject). Subjects will also be asked to maintain physical activity. | Description | Subjects in Liraglutide 3.0 group will receive Saxenda® plus behavioral weight loss counselling to portion control to achieve 500 kcal daily deficit based on MedGem required maintenance calories (not to be reduced below 1000 kcal per day for any subject). Subjects will be asked to maintain physical activity. The dose of Saxenda® will be increased weekly in the first 4 weeks (.6; 1.2; 1.8; 2.4 mg) and maintained on 3 mg for 12 weeks. |
Interventions
Sequence: | 52263460 | Sequence: | 52263461 |
Intervention Type | Drug | Intervention Type | Other |
Name | Saxenda® | Name | Placebo |
Description | Receiving escalating dose of Saxenda® for the first 4 weeks (0.6mg, 1.2mg, 1.8mg, 2.4 mg) and receiving full-dose (3.0 mg) for 12 weeks. | Description | Receiving equivalent volumes of the pre-filled solutions from pen-injector as Liraglutide 3.0 group . |
Keywords
Sequence: | 79525927 | Sequence: | 79525928 |
Name | Neuroimaging | Name | Hormones |
Downcase Name | neuroimaging | Downcase Name | hormones |
Design Outcomes
Sequence: | 176598563 | Sequence: | 176598564 | Sequence: | 176598565 | Sequence: | 176598566 | Sequence: | 176598567 | Sequence: | 176598568 | Sequence: | 176598569 | Sequence: | 176598570 | Sequence: | 176598571 | Sequence: | 176598572 | Sequence: | 176598573 | Sequence: | 176598574 | Sequence: | 176598575 | Sequence: | 176598576 | Sequence: | 176598577 | Sequence: | 176598578 | Sequence: | 176598579 | Sequence: | 176598580 | Sequence: | 176598581 | Sequence: | 176598582 | Sequence: | 176598583 | Sequence: | 176598584 | Sequence: | 176598585 | Sequence: | 176598586 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Compare the changes of pre-prandial fMRI-FCR in Liraglutide 3.0 vs. Placebo Group | Measure | Compare the changes of post-prandial fMRI-FCR in Liraglutide 3.0 vs. Placebo Group | Measure | Compare the changes of energy intake in Liraglutide 3.0 vs. Placebo Group | Measure | Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group | Measure | Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group | Measure | Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group | Measure | Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group | Measure | Prediction of weight loss in Liraglutide 3.0 group by examine early change in pre-prandial fMRI-FCR | Measure | Prediction of weight loss in Liraglutide 3.0 group by examine early change in post-prandial fMRI-FCR | Measure | Correlation between changes in post-prandial fMRI-FCR and changes in energy intake | Measure | Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety | Measure | Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety | Measure | Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety | Measure | Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety | Measure | Examine if the correlations described in outcome 10 differ in Liraglutide 3.0 vs. Placebo Group | Measure | Examine if the correlations described in outcome 11 differ in Liraglutide 3.0 vs. Placebo Group | Measure | Examine if the correlations described in outcome 12 differ in Liraglutide 3.0 vs. Placebo Group | Measure | Examine if the correlations described in outcome 13 differ in Liraglutide 3.0 vs. Placebo Group | Measure | Examine if the correlations described in outcome 14 differ in Liraglutide 3.0 vs. Placebo Group | Measure | Prediction of weight loss after 16 weeks intervention by assessing early changes in energy intake | Measure | Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety | Measure | Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety | Measure | Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety | Measure | Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety |
Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 | Time Frame | Baseline, Week 4, and Week 16 |
Description | Pre-prandial fMRI-FCR will be measured via fMRI | Description | Post-prandial fMRI-FCR will be measured via fMRI | Description | Energy intake will be assessed via ad libitum feeding | Description | Hunger/satiety will be assessed via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation is paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry' or 'Not at all satiated' and 'extremely satiated'). | Description | Hunger/satiety will be assessed via glucagon-like peptide-1 (GLP-1) | Description | Hunger/satiety will be assessed via Peptide YY (PYY) | Description | Hunger/satiety will be assessed via ghrelin | Description | Pre-prandial fMRI-FCR will be measured via fMRI | Description | Post-prandial fMRI-FCR will be measured via fMRI | Description | Post-prandial fMRI-FCR measured via fMRI. Energy intake will be assessed via ad libitum feeding. | Description | Post-prandial fMRI-FCR measured via fMRI. Hunger/satiety will be measured via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation was paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry'). | Description | Post-prandial fMRI-FCR measured via fMRI. Hunger/satiety will be measured via glucagon-like peptide-1 (GLP-1). | Description | Post-prandial fMRI-FCR measured via fMRI. Hunger/satiety will be measured via peptide YY (PYY). | Description | Post-prandial fMRI-FCR measured via fMRI. Hunger/satiety will be measured via ghrelin. | Description | Energy intake will be assessed via ad libitum feeding. | Description | Hunger/satiety will be measured via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation was paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry'). | Description | Hunger/satiety will be measured via glucagon-like peptide-1 (GLP-1) | Description | Hunger/satiety will be measured via peptide YY (PYY) | Description | Hunger/satiety will be measured via ghrelin | Description | Energy intake will be assessed via ad libitum feeding | Description | Hunger/satiety will be measured via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation was paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry' or 'Not at all satiated' and 'extremely satiated'). | Description | Hunger/satiety will be measured via glucagon-like peptide-1 (GLP-1) | Description | Hunger/satiety will be measured via peptide YY (PYY) | Description | Hunger/satiety will be measured via ghrelin |
Browse Conditions
Sequence: | 192614778 | Sequence: | 192614779 | Sequence: | 192614780 |
Mesh Term | Weight Loss | Mesh Term | Body Weight Changes | Mesh Term | Body Weight |
Downcase Mesh Term | weight loss | Downcase Mesh Term | body weight changes | Downcase Mesh Term | body weight |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48113598 | Sequence: | 48113599 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Texas Tech University | Name | Novo Nordisk A/S |
Overall Officials
Sequence: | 29159763 |
Role | Principal Investigator |
Name | Nikhil V Dhurandhar, PhD |
Affiliation | Texas Tech University |
Design Group Interventions
Sequence: | 67854775 | Sequence: | 67854776 |
Design Group Id | 55351060 | Design Group Id | 55351059 |
Intervention Id | 52263460 | Intervention Id | 52263461 |
Eligibilities
Sequence: | 30635850 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Age 18-60 years Exclusion Criteria: Participants unable or unwilling to provide informed consent. Participants with contraindications for MRI scanning. aneurism clips Contraindications to study medications, Subject with a personal or family history of medullary thyroid carcinoma (MTC). |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254115092 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 9 |
Number Of Secondary Outcomes To Measure | 15 |
Designs
Sequence: | 30382789 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26559211 |
Intervention Id | 52263460 |
Name | Liraglutide 3.0 |
Responsible Parties
Sequence: | 28749582 |
Responsible Party Type | Principal Investigator |
Name | Martin Binks |
Title | Associate Professor |
Affiliation | Texas Tech University |
]]>
https://zephyrnet.com/NCT03795688
2019-01-24
https://zephyrnet.com/?p=NCT03795688
NCT03795688https://www.clinicaltrials.gov/study/NCT03795688?tab=tableNANANAHormonal transitions such as across pregnancy and postpartum may trigger depressive episodes in some women. It is not known why, but estrogen sensitivity may play a critical role. A preclinical human risk model showed that depressive symptoms induced by pharmacological sex-hormone manipulation is linked to increases in serotonin transporter (SERT) brain binding, which lowers serotonergic brain tone. It is currently unknown if these findings translates to women across pre- to postpartum transitions.
This longitudinal project studies a group of women who will deliver by planned caesarian, thus permitting the collection of cerebrospinal fluid (csf) containing central markers of serotonergic signaling, at the latest point in pregnancy. The women are followed across late pregnancy, delivery and 6 months postpartum to illuminate relations between sex-hormones, stress-regulation, estradiol sensitivity, csf markers of neurotransmission, serotonin transporter genotype variance, and potential development of subclinical or manifest depressive symptoms. Further, markers of relevance for the infant brain development and stress-regulation will be obtained from placenta tissue and umbilical cord blood. A subgroup of 70 women will participate in a brain imaging program early postpartum (week 3-5), which includes an evaluation of brain activity and structure and in vivo molecular brain imaging serotonergic markers. Thus, serotonergic markers in csf can be combined with postpartum molecular brain imaging of key features of serotonin signaling. Women in the imaging program are selected based on variation in their level of mental distress immediately postpartum (day 2-5).
The study’s main hypothesis is that women with high-expressing SERT genotypes are more sensitive to peripartum hormonal transition in terms of changes in serotonergic tone and emergence of depressive symptoms and that such an association will be stronger in the presence of candidate gene transcript biomarkers of oestrogen sensitivity. A further hypothesis is that in vivo molecular brain imaging and csf based serotonergic markers will be associated with depressive symptoms both early and later postpartum.
Ideally, this project will provide a rationale for future targeted prevention and/or treatment of perinatal depression in women at high risk, which holds grand potential to protect not only mother but also infant brain health long-term.
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Studies
Study First Submitted Date | 2018-12-18 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-12-17 |
Start Month Year | January 24, 2019 |
Primary Completion Month Year | December 1, 2020 |
Verification Month Year | December 2020 |
Verification Date | 2020-12-31 |
Last Update Posted Date | 2020-12-17 |
Detailed Descriptions
Sequence: | 20709989 |
Description | Motivation:
Major depressive disorder (MDD) affects twice as many women as men and women are at an increased risk during hormonal transition phases such as pregnancy and birth. A highly relevant subpopulation within the mixed MDD diagnostic category comprises women who develop perinatal depression (PND). PND is defined as a depressive episode with onset during pregnancy or up to 4 weeks postpartum, however epidemiological studies show that the risk of developing depression is heightened for 6 months postpartum. PND affects 10-15% of mothers postpartum. Why certain women are at high risk of developing perinatal depression (PND) remains unclear but recent studies suggest that these women might be particularly sensitive to the transition from high levels of placenta-produced sex-steroids in pregnancy to the hormone withdrawal phase postpartum. Further, pharmacologically induced changes in ovarian sex-hormones can produce depressive symptoms in a subgroup of otherwise healthy women and that the emergence of depressive symptoms is linked to both estrogen fluctuations and increases in serotonin transporter (SERT) brain binding (which putatively lowers serotonergic brain tone). Intriguingly, common gene variants that index SERT expression levels show "gene BY environment" associations with risk for depression, such that high-expressing SERT genotypes render women more vulnerable to depressive symptoms early – but not late – postpartum in a "gene-dose" dependent manner. Further, DNA methylation and gene expression markers of estradiol sensitivity predispose to PND and are linked to the estradiol stimulation phase in the pharmacological manipulation of sex-steroids risk model, thus constituting a candidate biomarker for PND. It is currently unknown if estradiol sensitivity during pregnancy confers to PND risk through mechanism that (transiently) affect serotonergic tone in susceptible women. Changes in brain function late in pregnancy may extend to the early postpartum and shape how the brain integrates additional neurobiological changes that are associated with the postpartum hormonal withdrawal phase. This study will examine these mechanisms in a group of pregnant women that are followed from late pregnancy across early to late postpartum up to 6 month. Natural variation in SERT-genotypes provides a unique opportunity to specifically address the interaction between SERT-gene expression-capacity and estradiol exposure through pregnancy in processes driving changes in serotonergic tone, brain structure and activity, and mental health from late pregnancy to 6 months postpartum. The time-points comprise: basic program: 2-5 days postpartum, 6 weeks postpartum and 6 months postpartum for all participants and for the imaging program participants: 2-5 days postpartum, 3-5 weeks postpartum, 12 weeks postpartum, 6 months postpartum. By including women who undergo planned caesarean section, cerebrospinal fluid (CSF) can be obtained and thus, for the first time combine CSF markers of serotonergic tone and other transmitter systems (serotonin, 5-hydroxyindolacetic acid, other monoamines, γ-aminobutyric acid) with molecular brain imaging methods that index serotonergic tone (i.e. serotonin 4 receptor binding) Aims: Determine if depressive symptoms from late pregnancy to 6 months postpartum map onto molecular brain imaging markers of serotonin signaling early postpartum (week 3-5), and evaluate if such markers and/or symptoms are dependent on serotonin transporter genotype and/or predicted by candidate gene transcription biomarkers for estrogen sensitivity. Hypotheses: Women with high-expressing SERT genotypes are more sensitive to estradiol exposure in late pregnancy in terms of changes in proxies for serotonergic tone (PET imaging or csf based) and emergence of depressive symptoms in late pregnancy and/or postpartum and such an association will be stronger in the presence of candidate gene transcript PND biomarkers. Study design: 150 pregnant women between 18-40 years of age who deliver by planned caesarean section, due to breech presentation of the fetus or previous caesarean section, will be included in a longitudinal study. Participants will be recruited at the midwife clinic of Rigshospitalet, Copenhagen, Denmark. Based on natural variation in European populations the expected distribution of high vs. low expressing SERT genotypes is 40/60, respectively, thus genotype status can be included in the analysis structure. Self-reported psychometrics and questionnaires will be collected online at inclusion, across the pre- to postpartum transition and up to 6 months postpartum (basic program: 2-5 days postpartum, 6 weeks postpartum and 6 months postpartum; imaging program: 2-5 days postpartum, 3-5 weeks postpartum, 12 weeks postpartum, 6 months postpartum). CSF will be collected as part of the anesthetic procedures for a planned caesarean section, thus avoiding any additional invasive procedures. CSF markers of serotonergic tone (serotonin and its main metabolite, 5-HIAA) will be measured by HPLC techniques. Corresponding blood samples for determining relevant biomarkers (sex-steroids, DNA, mRNA and microRNA) and saliva for hypothalamic-pituitary-adrenal axis dynamics, will be taken just before the planned caesarean section. Hair from mother and infant will be collected around delivery for further cortisol analyses. Placenta tissue and umbilical cord blood will also be collected for determining relevant markers of serotonergic and hypothalamic-pituitary-adrenal axis functioning. A subgroup of the study cohort selected towards high (N=35) or low risk for later manifest PND (N=35), based on symptoms of mental distress 2-5 days postpartum (in-house interview, high-risk scores correspond to at least 12 on the Kennerley Maternity Blues Questionnaire and at least 8 on Stein's Maternity Blues Scale), will participate in an extended brain imaging program. This program will include 5-HT4R ([11C]SB207145) PET, structural MRI, functional MRI (including emotional processing, reward processing and resting state fMRI), neuropsychological testing and face to face rating of mental state with a semi-structured interview (HAM-D17). The study includes long-term follow-up at six months. Collected data will enter the Center for Integrated Molecular Brain Imaging database, thus providing a basis for longitudinal follow-up, data sharing and crossvalidation. Statistics: Power calculations based on inter-subject variability of the 5-HT4R show that an imaging group size of 35 is required to detect a 15% difference with a power of 0.8 for the brain regions of interest. With the full cohort number of 150 and due to oversampling of high and low risk women, about 25 women are expected to develop manifest PND episodes and more will display subclinical depressive symptoms, which will allow for correlation analyses with relevant outcome parameters including the candidate gene transcript based biomarker of estrogen sensitivity. Highly correlated self-reported psychometric outcomes will be included in a latent variable construct of self-reported mental state (composite measure) using structural equation modelling. Ethics: The PET scans convey no known risk for adults. Infants will not be exposed to radiation and will be nursed by special staff or a close relative while the mother is scanned. Participants who develop levels of mental distress or depressive symptoms that approach clinical thresholds will be referred to relevant and timely psychiatric care. The study has been approved by the local ethics committee. |
Facilities
Sequence: | 199965079 |
Name | Rigshospitalet |
City | Copenhagen |
Zip | 2100 |
Country | Denmark |
Conditions
Sequence: | 52139010 | Sequence: | 52139011 |
Name | Major Depressive Disorder | Name | Perinatal Depression |
Downcase Name | major depressive disorder | Downcase Name | perinatal depression |
Id Information
Sequence: | 40135067 | Sequence: | 40135068 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | PND1 | Id Value | H-18029563 |
Id Type | Other Identifier | ||
Id Type Description | Regional ethics committee | ||
Countries
Sequence: | 42542692 |
Name | Denmark |
Removed | False |
Design Groups
Sequence: | 55559360 | Sequence: | 55559361 |
Title | Basic, non-imaging group | Title | Extended, imaging group |
Description | Pregnant women who will deliver by planned caesarian. Participants enrolled in the study that are not eligible for the imaging subgroup.
All participants start in the basic program. Includes collection of blood, cerebrospinal fluid, saliva, hair, placenta tissues, umbilical cord blood and psychometrics. |
Description | A subgroup of 70 pregnant women who will deliver by planned caesarian selected towards either high (N=35) or low (N=35) risk for perinatal depression will undergo brain imaging in addition to the elements of the basic program. The extended imaging program includes functional and structural magnetic resonance imaging, positron emission tomography (PET) and a semistructured interview for depression symptoms (HAM-D17). |
Interventions
Sequence: | 52454915 |
Intervention Type | Other |
Name | Pregnancy |
Description | Peripartum transition from pregnant to postpartum state |
Design Outcomes
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Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Depressive symptoms | Measure | Depressive symptoms | Measure | Gene transcript and DNA methylation markers of estrogen sensitivity | Measure | Cerebral serotonin 4 receptor binding postpartum | Measure | CSF levels of GABA | Measure | CSF levels of serotonin metabolite (5-HIAA) | Measure | Cortisol awakening response | Measure | Hair cortisol level mothers | Measure | Hair cortisol level newborns | Measure | Hippocampal volumes | Measure | functional MRI response to reward | Measure | Change in DNA methylation of the FK506-binding protein 51 (FKBP5) gene | Measure | Resting state functional connectivity MRI | Measure | Change in epigenetic SERT status | Measure | Concentration of inflammatory markers, i.e hsCRP and immunoactive cytokines, in peripheral blood | Measure | functional MRI response to emotional faces | Measure | Depressive symptoms | Measure | Depressive symptoms | Measure | Depressive symptoms | Measure | Depressive symptoms | Measure | CSF levels of serotonin | Measure | CSF levels of dopamine metabolites | Measure | CSF levels of noradrenaline metabolites | Measure | CSF levels of inflammatory markers | Measure | Estradiol level | Measure | Estradiol level | Measure | Change in estradiol level | Measure | DNA methylation of the glucocorticoid receptor gene | Measure | Progesterone level | Measure | Progesterone level | Measure | Change in progesterone level | Measure | Allopregnanolone level | Measure | Allopregnanolone level | Measure | Change in allopregnanolone level | Measure | Change in cortisol level | Measure | Cortisol awakening response | Measure | Cortisol awakening response | Measure | Change in cortisol awakening response | Measure | DNA methylation of the SERT gene | Measure | DNA methylation of the SERT gene | Measure | DNA methylation of the FK506-binding protein 51 (FKBP5) gene | Measure | DNA methylation of the FK506-binding protein 51 (FKBP5) gene | Measure | DNA methylation of the glucocorticoid receptor gene | Measure | Change in DNA methylation of the glucocorticoid receptor gene | Measure | DNA methylation of the COMT gene | Measure | DNA methylation of the COMT gene | Measure | Change in DNA methylation of the COMT gene | Measure | DNA methylation of the MAO-A gene | Measure | Change in DNA methylation of the MAO-A gene | Measure | DNA methylation of the MAO-A gene | Measure | DNA methylation of the oxytocin receptor gene | Measure | DNA methylation of the oxytocin receptor gene | Measure | Change in DNA methylation of the oxytocin receptor gene | Measure | DNA methylation of the oxytocin gene | Measure | DNA methylation of the oxytocin gene | Measure | Change in DNA methylation of the oxytocin gene | Measure | Systemic inflammation peripheral blood hsCRP and immunoactive cytokines | Measure | Change in systemic inflammation peripheral blood hsCRP and immunoactive cytokines | Measure | Self reported family history of mood disorders | Measure | Self reported impulsiveness score | Measure | Self reported Neuroticism score from NEO personality questionnaire | Measure | Self reported parental bonding quality | Measure | Self-reported perceived stress | Measure | Change in self-reported mood | Measure | Self-reported perceived stress | Measure | Change in self-reported perceived stress | Measure | Self-reported anhedonia | Measure | Self-reported anhedonia | Measure | Change in self-reported anhedonia | Measure | Self-reported rumination | Measure | Self-reported rumination | Measure | Change in elf-reported rumination | Measure | Self-reported mood | Measure | Self-reported mood | Measure | Self-reported sleep quality | Measure | Self-reported sleep quality | Measure | Change in self-reported sleep quality | Measure | Self-reported psychiatric symptoms | Measure | Self-reported psychiatric symptoms | Measure | Change in self-reported psychiatric symptoms | Measure | Self-reported well-being | Measure | Self-reported well-being | Measure | Change in self-reported well-being | Measure | Self-reported anxiety | Measure | Self-reported anxiety | Measure | Change in self-reported anxiety | Measure | Self-reported obsessive and compulsive symptoms | Measure | Self-reported obsessive and compulsive symptoms | Measure | Change in self-reported obsessive and compulsive symptoms | Measure | Performance on Simple Reaction Time | Measure | Gray matter brain volume prefrontal cortex and anterior cingulate cortex | Measure | Serotonergic turnover in placenta | Measure | 11-beta-hydroxysteroid dehydrogenase type 2 activity in placenta | Measure | Methylation status of genes relevant for stress-hormone regulation in placenta | Measure | Methylation status of genes related to serotonergic signaling in placenta | Measure | Methylation status and gene transcript profiles of relevance for early brain development and stress regulation in newborn infants | Measure | COMT-genotype (rs4680) variant, i.e met/met vs other polymorphisms | Measure | BDNF genotype (rs6265) status, i.e. val/val versus met-carrier variants | Measure | 5-HTT genotype status, i.e LALA vs low-expressing (S or LG) variants | Measure | Postpartum blues symptoms | Measure | Postpartum blues symptoms |
Time Frame | Week 3-6 postpartum | Time Frame | Week 3-6 postpartum | Time Frame | Prior to caesarean section | Time Frame | Week 3-6 postpartum | Time Frame | On day of caesarean section | Time Frame | On day of caesarean section | Time Frame | Week 3-6 postpartum | Time Frame | On day of caesarean section. | Time Frame | Day 0-5 postpartum. | Time Frame | Week 3-6 postpartum. | Time Frame | Week 3-6 postpartum. | Time Frame | From baseline (caesarean section to week 3-6 postpartum) | Time Frame | Week 3-6 postpartum | Time Frame | From just before delivery to 3-6 weeks postpartum | Time Frame | At week 3-6 | Time Frame | Week 3-6 postpartum. | Time Frame | Day 3-5 postpartum | Time Frame | Week 12 postpartum | Time Frame | Day 3-5 postpartum | Time Frame | 6 months postpartum | Time Frame | On day of caesarean section | Time Frame | On day of caesarean section | Time Frame | On day of caesarean section | Time Frame | On day of caesarean section | Time Frame | Prior to caesarean section. | Time Frame | At week 3-6 postpartum. | Time Frame | From baseline (caesarean section to week 3-6 postpartum) | Time Frame | Prior to caesarean section. | Time Frame | Prior to caesarean section. | Time Frame | At week 3-6 postpartum. | Time Frame | From baseline (caesarean section to week 3-6 postpartum) | Time Frame | Prior to caesarean section. | Time Frame | At week 3-6 postpartum. | Time Frame | From baseline (caesarean section to week 3-6 postpartum) | Time Frame | From baseline (caesarean section to week 3-6 postpartum) | Time Frame | Week 12 postpartum | Time Frame | Prior to caesarean section | Time Frame | ´From baseline (caesarean section to week 3-6 postpartum) | Time Frame | Prior to caesarean section | Time Frame | Week 3-6 postpartum | Time Frame | Prior to caesarean section. | Time Frame | Week 3-6 postpartum | Time Frame | Week 3-6 postpartum | Time Frame | From baseline (caesarean section to week 3-6 postpartum) | Time Frame | Prior to caesarean section. | Time Frame | Week 3-6 postpartum | Time Frame | From baseline (caesarean section to week 3-6 postpartum) | Time Frame | Prior to caesarean section. | Time Frame | From baseline (caesarean section to week 3-6 postpartum) | Time Frame | Week 3-6 postpartum | Time Frame | Prior to caesarean section. | Time Frame | Week 3-6 postpartum | Time Frame | From baseline (caesarean section to week 3-6 postpartum) | Time Frame | Prior to caesarean section. | Time Frame | Week 3-6 postpartum | Time Frame | From baseline (caesarean section to week 3-6 postpartum) | Time Frame | Prior to caesarean section. | Time Frame | From baseline (caesarean section to week 3-6 postpartum | Time Frame | Day 3-5 postpartum or before | Time Frame | Day 3-5 postpartum or before | Time Frame | Day 3-5 postpartum or before | Time Frame | Day 3-5 postpartum or before | Time Frame | Day 3-5 postpartum | Time Frame | Change from day 3-5 to week 3-6 postpartum | Time Frame | Week 3-6 postpartum | Time Frame | Change from day 3-5 to week 3-6 postpartum | Time Frame | Day 3-5 postpartum | Time Frame | Week 3-6 postpartum | Time Frame | Change from day 3-5 to week 3-6 postpartum | Time Frame | Day 3-5 postpartum | Time Frame | Week 3-6 postpartum | Time Frame | Change from day 3-5 to week 3-6 postpartum | Time Frame | Day 3-5 postpartum | Time Frame | Week 3-6 postpartum | Time Frame | Day 3-5 postpartum | Time Frame | Week 3-6 postpartum | Time Frame | Change from day 3-5 to week 3-6 postpartum | Time Frame | Day 3-5 postpartum | Time Frame | Week 3-6 postpartum | Time Frame | Change from day 3-5 to week 3-6 postpartum | Time Frame | Day 3-5 postpartum | Time Frame | Week 3-6 postpartum | Time Frame | Change from day 3-5 to week 3-6 postpartum | Time Frame | Day 3-5 postpartum | Time Frame | Week 3-6 postpartum | Time Frame | Change from day 3-5 to week 3-6 postpartum | Time Frame | Day 3-5 | Time Frame | Week 3-6 postpartum | Time Frame | Change from day 3-5 to week 3-6 postpartum | Time Frame | Week 3-6 postpartum | Time Frame | At week 3-6 postpartum | Time Frame | At delivery. | Time Frame | At delivery | Time Frame | At delivery | Time Frame | At delivery | Time Frame | At delivery. | Time Frame | Prior to caesarean section. | Time Frame | Prior to caesarean section. | Time Frame | Prior to caesarean section. | Time Frame | Day 3-5 postpartum. | Time Frame | Day 3-5 postpartum. |
Description | Edinburgh Postnatal Depression Scale. Score range: 0-30. Higher scores indicate more symptoms of postpartum depression. Total group | Description | Score on the Hamilton 17-item depression scale. Score range: 0-52. Higher scores indicate more depressive symptoms. Assessed in imaging group | Description | 116 a priori defined gene transcripts, which where differentially expressed in third trimester of women who later developed perinatal depression with postpartum onset relative to pregnant women who did not and to other depressed (reference Mehta et al, 2014, Psychological Medicine) and confirmed to be coupled to estrogen fluctuations (Mehtaet al. 2018 British Journal of Psychiatry) will be evaluated in the total group.
Also DNA methylation of the genes of these transcripts will be determined and analysed in terms of their predictive value (above chance) for perinatal depression. |
Description | Latent variable construct of brain 5-HT4R level based on quantification of 5-HT4R binding from 11C-SB207145 positron emission tomography in primary volumes of interest; neocortex, nucleus caudatus, putamen and hippocampus. Assessed in imaging group. | Description | Assessed in total group | Description | Assessed in total group | Description | Cortisol awakening response, area under the curve with respect to baseline from 0 to 60 minutes from awakening. | Description | Provides an estimate of cortisol exposure up to 6 months prior to delivery, total group | Description | Provides an estimate of fetal cortisol exposure, infants from total group | Description | Hippocampal brain volume (including hippocampus) from structural MRI, imaging group. | Description | fMRI (BOLD response) based assessment of brain activity in response to reward, relative to non-reward, stimuli. Assessed in imaging cohort | Description | Change in methylation status for the FK506-binding protein 51 (FKBP5) gene from late pregnancy to postpartum week 3-6. | Description | rsfMRI based spontaneous co-fluctuations in low frequency BOLD signal, (functional connectivity). Assessed with rsfMRI scan in the resting state, i.e. non-goal oriented spontaneous thought and awake. Assessed in imaging group. | Description | Change in epigenetic SERT status from late pregnancy to postpartum week 3-6. | Description | Composite measure of hsCRP, TNF-α, IL-6, IL-18 and IL-10 levels, total group | Description | fMRI (BOLD response) based assessment of brain activity to emotionally salient, relative to neutral, stimuli. Assessed in imaging cohort. | Description | Score on the Hamilton 17-item depression scale. Score range: 0-52. Higher scores indicate more depressive symptoms. Assessed in imaging group | Description | Score on the Hamilton 17-item depression scale. Score range: 0-52. Higher scores indicate more depressive symptoms. Assessed in imaging group | Description | Edinburgh Postnatal Depression Scale. Score range: 0-30. Higher scores indicate more symptoms of postpartum depression. Assessed in total group | Description | Edinburgh Postnatal Depression Scale. Score range: 0-30. Higher scores indicate more symptoms of postpartum depression. Assessed in all | Description | Assessed in total group | Description | Assessed in total group | Description | Assessed in total group | Description | Composite measure of IFN-c, IFN-alfa TNF-alfa og IL-6, in total group | Description | Estradiol level in peripheral blood, total group | Description | Estradiol level peripheral blood, total group | Description | Estradiol change pre- to postpartum, peripheral blood total group | Description | Methylation status for the glucocorticoid receptor gene, total group | Description | Progesterone level in peripheral blood | Description | Progesterone level in peripheral blood | Description | Progesterone change pre- to postpartum, peripheral blood total group | Description | Allopregnanolone level in peripheral blood | Description | Allopregnanolone level in peripheral blood | Description | Change in allopregnanolone level in peripheral blood | Description | Cortisol change pre- to postpartum, peripheral blood total group | Description | Cortisol awakening response, area under the curve with respect to baseline from 0 to 60 minutes from awakening. | Description | Cortisol awakening response, area under the curve with respect to baseline from 0 to 60 minutes from awakening. | Description | Change in cortisol awakening response, from caesarean section to 3-6 weeks postpartum. | Description | Methylation status for the SERT gene, total group | Description | DNA Methylation status for the SERT gene, total group | Description | Methylation status for the FK506-binding protein 51 (FKBP5) gene, total group | Description | Methylation status for the FK506-binding protein 51 (FKBP5) gene, total group | Description | Methylation status for the glucocorticoid receptor gene, total group | Description | Change in methylation status for the glucocorticoid receptor gene from late pregnancy to postpartum week 3-6. | Description | Methylation status for the COMT gene, total group | Description | Methylation status for the COMT gene, total group | Description | Change in methylation status for the COMT gene from just before delivery to 3-6 weeks postpartum | Description | Methylation status for the MAO-A gene, total group | Description | Change in methylation status for the MAO-A gene, total group | Description | Methylation status for the MAO-A gene, total group | Description | Methylation status for the oxytocin receptor gene, total group | Description | Methylation status for the oxytocin receptor gene, total group | Description | Change in methylation status for the oxytocin receptor gene, total group | Description | Methylation status for the oxytocin gene, total group | Description | Methylation status for the oxytocin gene, total group | Description | Change methylation status for the oxytocin gene, total group | Description | Composite measure of hsCRP, TNF-α, IL-6, IL-18 and IL-10 levels, total group | Description | Change in composite measure of hsCRP, TNF-α, IL-6, IL-18 and IL-10 levels, total group | Description | Family History Assessment Module (OS-FHAM). Number of first degree relatives with a history of depressive episodes or bipolar disorder. Total group. | Description | Barratt Impulsiveness Scale (BIS-11), self-reported. Range: 30-120. Total group. | Description | NEO-PI-R – Revised NEO Personality Inventory, self-reported. Participants may score 20-80 for each of the personality traits: openness, conscientiousness, extraversion, agreeableness, and neuroticism. The higher the score, the more prominent is the personality trait. Total group. | Description | Parental bonding instrument (PBI), both parents, self-reported. Total group. | Description | Perceived Stress Scale (PSS), range 0-40, a score of 0 indicates no perceived stress. Total group. | Description | Change in Profile of Mood States (POMS) score, range 0-260, a score of 0 indicates no mood disturbance. Total group. | Description | Perceived Stress Scale (PSS), range 0-40, a score of 0 indicates no perceived stress. Total group. | Description | Change in Perceived Stress Scale (PSS), range 0-40, a score of 0 indicates no perceived stress. Total group. | Description | Snaith-Hamilton Pleasure Scale (SHAPS), range 0-14, a score of 0 indicates no self-reported anhedonia. Total group. | Description | Snaith-Hamilton Pleasure Scale (SHAPS), range 0-14, a score of 0 indicates no self-reported anhedonia. Total group. | Description | Change in Snaith-Hamilton Pleasure Scale (SHAPS) score, range 0-14, a score of 0 indicates no self-reported anhedonia. Total group. | Description | Rumination Response Scale (RRS), range 22-88, a score of 22 indicates no ruminative symptoms. Total group. | Description | Rumination Response Scale (RRS), range 22-88, a score of 22 indicates no ruminative symptoms. Total group. | Description | Change in Rumination Response Scale (RRS) score, range 22-88, a score of 22 indicates no ruminative symptoms. Total group. | Description | Profile of Mood States (POMS), range 0-260, a score of 0 indicates no mood disturbance. Total group. | Description | Profile of Mood States (POMS), range 0-260, a score of 0 indicates no mood disturbance. Total group. | Description | Pittsburgh Sleep Quality Index (PSQI), range 0-21, a score of 0 indicates a healthy sleep quality. Total group. | Description | Pittsburgh Sleep Quality Index (PSQI), range 0-21, a score of 0 indicates a healthy sleep quality. Total group. | Description | Change in Pittsburgh Sleep Quality Index (PSQI), range 0-21, a score of 0 indicates a healthy sleep quality. Total group. | Description | Brief symptom Inventory-53 item (BSI-53), range 0-212, increasing score means worsening of symptoms.Total group. | Description | Brief symptom Inventory-53 item (BSI-53), range 0-212, increasing score means worsening of symptoms.Total group. | Description | Change in Brief symptom Inventory-53 item (BSI-53) score, range 0-212, increasing score means worsening of symptoms.Total group. | Description | WHO-5 well-being index, range 0-100, low score means less well-being. Total group. | Description | WHO-5 well-being index, range 0-100, low score means less well-being. Total group. | Description | Change in WHO-5 well-being index, range 0-100, low score means less well-being. Total group. | Description | State Trait Anxiety Inventory (STAI-AD-D), state and trait subscales each have a range of 20-80, 20 means no anxiety. Total group. | Description | State Trait Anxiety Inventory (STAI-AD-D), state subscale range 20-80, 20 means no anxiety. Total group. | Description | Change in State Trait Anxiety Inventory (STAI-AD-D) score, state subscale range 20-80, 20 means no anxiety. Total group. | Description | Obsessive-Compulsive Inventory (OCI) score, self-reported, range 0-72, higher scores indicate more symptoms. Total group. | Description | Obsessive-Compulsive Inventory (OCI) score, self-reported, range 0-72, higher scores indicate more symptoms. Total group. | Description | Change in Obsessive-Compulsive Inventory (OCI) score, self-reported, range 0-72, higher scores indicate more symptoms. Total group. | Description | Performance on Simple Reaction Time, in imaging cohort. | Description | Gray matter brain volume prefrontal cortex and anterior cingulate cortex | Description | Composite measure of serotonin, tryptophan og tryptofan hydroxylase levels relative to 5-HIAA, in placenta sample. Infants from total group | Description | 11-beta-hydroxysteroid dehydrogenase type 2 activity in placenta. Infants from total group | Description | Composite measure of methylation status for the FKBP5, glucocorticoid receptor, 11-beta hydroxysteroid dehydrogenase type 2 genes. Infants from total group | Description | Composite measure of the methylation status for monoamine oxidase, serotonin receptor and serotonin transporter genes. Infants from total group | Description | Composite measure of methylation status and gene transcript profiles of Glucocorticoid receptor, FKBP5, oxytocin and oxytocin receptors, Brain-derived neurotrophic factor (BDNF) genes. Assessed in blood from umbilical cord blood sample from infants, total group. | Description | val158met (rs4680) status, binary variable, i.e. "val/val, val/met" vs "met/met" variants | Description | BDNF val66met (rs6265) status, binary variable, i.e. "val/val" versus "met-carrier" status | Description | 5-HTTLPR genotype status (binary), i.e. high-expressing LALA vs low-expressing (S or LG) variants, based on SLC6A4, i.e. L or S variants, and further subtyping on rs25531 haplotype L(A)L(A) vs LGLA, LGLG or variants containing as S as specified above. | Description | In house interview based on Kennerley Maternity Blues Questionnaire, range: 0-28, higher score indicates more severe postpartum blues symptoms. High blues score is associated with greater risk for perinatal depression at week 3-6. | Description | In house interview based on Stein's Maternity Blues Scale, range 0-26. High blues score is associated with greater risk for perinatal depression at week 3-6. |
Browse Conditions
Sequence: | 193366552 | Sequence: | 193366553 | Sequence: | 193366554 | Sequence: | 193366555 |
Mesh Term | Depressive Disorder | Mesh Term | Depressive Disorder, Major | Mesh Term | Mood Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | depressive disorder | Downcase Mesh Term | depressive disorder, major | Downcase Mesh Term | mood disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290713 | Sequence: | 48290714 | Sequence: | 48290715 | Sequence: | 48290716 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Vibe G Frøkjær, MD, PhD | Name | Center for Integrated Molecular Brain Imaging, Copenhagen, Denmak | Name | Mental Health Centre Copenhagen | Name | University of Copenhagen |
Overall Officials
Sequence: | 29268534 |
Role | Principal Investigator |
Name | Vibe Frokjaer, MD, PhD |
Affiliation | Rigshospitalet, Denmark |
Design Group Interventions
Sequence: | 68107470 | Sequence: | 68107471 |
Design Group Id | 55559360 | Design Group Id | 55559361 |
Intervention Id | 52454915 | Intervention Id | 52454915 |
Eligibilities
Sequence: | 30747727 |
Sampling Method | Non-Probability Sample |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 40 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | Participants will be recruited from the midwife clinic at Rigshospitalet, Copenhagen, i.e., included women will be residents of the central Copenhagen area. |
Criteria | Inclusion Criteria:
Age 18-40 years Exclusion Criteria: Current or previous severe psychiatric disorder such as psychotic disorders, eating disorder and bipolar disorder or current or previous psychiatric disorder requiring hospitalization. |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254121879 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 22 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 40 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 15 |
Number Of Secondary Outcomes To Measure | 81 |
Number Of Other Outcomes To Measure | 5 |
Designs
Sequence: | 30494010 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28860290 |
Responsible Party Type | Sponsor-Investigator |
Name | Vibe G Frøkjær, MD, PhD |
Title | Senior researcher, Principal investigator |
Affiliation | Rigshospitalet, Denmark |
Study References
Sequence: | 52032732 | Sequence: | 52032733 | Sequence: | 52032734 | Sequence: | 52032735 | Sequence: | 52032736 | Sequence: | 52032737 | Sequence: | 52032738 | Sequence: | 52032739 | Sequence: | 52032740 | Sequence: | 52032741 | Sequence: | 52032742 |
Pmid | 12589387 | Pmid | 20231323 | Pmid | 23689534 | Pmid | 24189342 | Pmid | 23442893 | Pmid | 25891375 | Pmid | 20096787 | Pmid | 24495551 | Pmid | 30457060 | Pmid | 17148723 | Pmid | 18978318 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Carpenter LL, Anderson GM, Siniscalchi JM, Chappell PB, Price LH. Acute changes in cerebrospinal fluid 5-HIAA following oral paroxetine challenge in healthy humans. Neuropsychopharmacology. 2003 Feb;28(2):339-47. doi: 10.1038/sj.npp.1300025. | Citation | Caspi A, Hariri AR, Holmes A, Uher R, Moffitt TE. Genetic sensitivity to the environment: the case of the serotonin transporter gene and its implications for studying complex diseases and traits. Am J Psychiatry. 2010 May;167(5):509-27. doi: 10.1176/appi.ajp.2010.09101452. Epub 2010 Mar 15. | Citation | Guintivano J, Arad M, Gould TD, Payne JL, Kaminsky ZA. Antenatal prediction of postpartum depression with blood DNA methylation biomarkers. Mol Psychiatry. 2014 May;19(5):560-7. doi: 10.1038/mp.2013.62. Epub 2013 May 21. Erratum In: Mol Psychiatry. 2014 May; 19(5):633. | Citation | Haahr ME, Fisher PM, Jensen CG, Frokjaer VG, Mahon BM, Madsen K, Baare WF, Lehel S, Norremolle A, Rabiner EA, Knudsen GM. Central 5-HT4 receptor binding as biomarker of serotonergic tonus in humans: a [11C]SB207145 PET study. Mol Psychiatry. 2014 Apr;19(4):427-32. doi: 10.1038/mp.2013.147. Epub 2013 Nov 5. | Citation | Klengel T, Binder EB. Gene-environment interactions in major depressive disorder. Can J Psychiatry. 2013 Feb;58(2):76-83. doi: 10.1177/070674371305800203. | Citation | Knudsen GM, Jensen PS, Erritzoe D, Baare WFC, Ettrup A, Fisher PM, Gillings N, Hansen HD, Hansen LK, Hasselbalch SG, Henningsson S, Herth MM, Holst KK, Iversen P, Kessing LV, Macoveanu J, Madsen KS, Mortensen EL, Nielsen FA, Paulson OB, Siebner HR, Stenbaek DS, Svarer C, Jernigan TL, Strother SC, Frokjaer VG. The Center for Integrated Molecular Brain Imaging (Cimbi) database. Neuroimage. 2016 Jan 1;124(Pt B):1213-1219. doi: 10.1016/j.neuroimage.2015.04.025. Epub 2015 Apr 17. | Citation | Marner L, Gillings N, Madsen K, Erritzoe D, Baare WF, Svarer C, Hasselbalch SG, Knudsen GM. Brain imaging of serotonin 4 receptors in humans with [11C]SB207145-PET. Neuroimage. 2010 Apr 15;50(3):855-61. doi: 10.1016/j.neuroimage.2010.01.054. Epub 2010 Jan 22. | Citation | Mehta D, Newport DJ, Frishman G, Kraus L, Rex-Haffner M, Ritchie JC, Lori A, Knight BT, Stagnaro E, Ruepp A, Stowe ZN, Binder EB. Early predictive biomarkers for postpartum depression point to a role for estrogen receptor signaling. Psychol Med. 2014 Aug;44(11):2309-22. doi: 10.1017/S0033291713003231. Epub 2014 Feb 5. | Citation | Mehta D, Rex-Haffner M, Sondergaard HB, Pinborg A, Binder EB, Frokjaer VG. Evidence for oestrogen sensitivity in perinatal depression: pharmacological sex hormone manipulation study. Br J Psychiatry. 2019 Sep;215(3):519-527. doi: 10.1192/bjp.2018.234. | Citation | Munk-Olsen T, Laursen TM, Pedersen CB, Mors O, Mortensen PB. New parents and mental disorders: a population-based register study. JAMA. 2006 Dec 6;296(21):2582-9. doi: 10.1001/jama.296.21.2582. | Citation | Sanjuan J, Martin-Santos R, Garcia-Esteve L, Carot JM, Guillamat R, Gutierrez-Zotes A, Gornemann I, Canellas F, Baca-Garcia E, Jover M, Navines R, Valles V, Vilella E, de Diego Y, Castro JA, Ivorra JL, Gelabert E, Guitart M, Labad A, Mayoral F, Roca M, Gratacos M, Costas J, van Os J, de Frutos R. Mood changes after delivery: role of the serotonin transporter gene. Br J Psychiatry. 2008 Nov;193(5):383-8. doi: 10.1192/bjp.bp.107.045427. |
Ipd Information Types
Sequence: | 3331370 |
Name | Study Protocol |
]]>
https://zephyrnet.com/NCT03795675
2019-01-14
https://zephyrnet.com/?p=NCT03795675
NCT03795675https://www.clinicaltrials.gov/study/NCT03795675?tab=tableWilliam Riggs, AuDWilliam.Riggs@osumc.edu614-293-9750This study is a prospective, clinical study to determine if it is safe and effective to use a cochlear implant over time in individuals undergoing removal of a vestibular schwannoma (VS), benign tumor of the hearing and balance nerve or undergoing a labyrinthectomy for treatment of Meniere’s disease. Individuals undergoing these surgeries will be deaf on the surgical side after the procedure. Currently, cochlear implants are approved for use and not considered investigational in individuals with hearing loss on both sides. However, use of a cochlear implant for these patient populations (single-sided hearing loss) will be considered a new use of an approved device. Participants undergoing surgery to remove a VS or having a labyrinthectomy will have a cochlear implant inserted after the surgical procedure for clinical care. Approximately 4 weeks after surgery, participants will be fitted with an external speech processor on the surgical side that will stimulate the internal cochlear implant. Participants will return at the following intervals after the initial processor fitting: 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months. At each interval, participants will complete questionnaires on how they are hearing with the implant and their quality of life with the implant and be tested on their ability to hear sounds and understand speech. Potential risks are those associated with all cochlear implant surgeries, and include device failure resulting in removal of device, irritation or redness in surgical area and/or area where processor is attached, increased ringing in the ear, facial nerve stimulation and a change in the way speech and other sounds sound through the implant. Potential benefits to individual participants in this study include improvement in detection and speech understanding of the surgical ear. Participants may also experience improved abilities to locate sound and understand speech in noise as the result of having hearing on both sides.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-07 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-04-06 |
Start Month Year | January 14, 2019 |
Primary Completion Month Year | December 2024 |
Verification Month Year | April 2023 |
Verification Date | 2023-04-30 |
Last Update Posted Date | 2023-04-06 |
Facilities
Sequence: | 198439366 |
Status | Recruiting |
Name | The Ohio State University |
City | Columbus |
State | Ohio |
Zip | 43210 |
Country | United States |
Conditions
Sequence: | 51737149 | Sequence: | 51737150 |
Name | Vestibular Schwannoma | Name | Meniere Disease |
Downcase Name | vestibular schwannoma | Downcase Name | meniere disease |
Id Information
Sequence: | 39812883 |
Id Source | org_study_id |
Id Value | 2017H0273 |
Countries
Sequence: | 42212129 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55157763 |
Group Type | Experimental |
Title | Meniere's Disease/Vestibular Schwannoma |
Description | Individuals diagnosed with Meniere's disease and undergoing labyrinthectomy or diagnosed with vestibular schwannoma and undergoing surgical excision via translabyrinthine approach for treatment will receive cochlear implant at the time of surgery. |
Interventions
Sequence: | 52058574 |
Intervention Type | Device |
Name | Cochlear Implant |
Description | Cochlear implant device to be implanted at time of surgical intervention. |
Keywords
Sequence: | 79158994 |
Name | Cochlear implants |
Downcase Name | cochlear implants |
Design Outcomes
Sequence: | 175969873 | Sequence: | 175969874 | Sequence: | 175969875 | Sequence: | 175969876 | Sequence: | 175969877 | Sequence: | 175969878 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in Sound Detection Testing | Measure | Change in Speech Perception Testing | Measure | Change in Sound Localization Testing | Measure | Change in Speech, Spatial and Qualities of Hearing Scale (SSQ) Scores | Measure | Change in Nijmegen Cochlear Implant Questionnaire (NCIQ) Scores | Measure | Change in Tinnitus Handicap Inventory (THI) Scores |
Time Frame | Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation. | Time Frame | Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation. | Time Frame | Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation. | Time Frame | Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation. | Time Frame | Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation. | Time Frame | Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation. |
Description | Sounds that vary in pitch (frequency) will be presented in a sound field to identify hearing thresholds in decibels (dB). Participant indicates when a sound is detected/perceived when listening with the cochlear implant. The softest sound at each specific frequency (125, 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 Hertz (Hz)) will be recorded in dB hearing level. | Description | Arizona (AZ) Bio sentences (speech perception test comprised of 660 unique sentences, presented in 33 independent lists of 20 sentences each) and the Maryland consonant-vowel nucleus-consonant (CNC) (10 phonetically balanced 50-word lists) word lists will be presented through a sound field speaker, and participant will be asked to repeat back the sentences and/or word that was heard. Background noise will be presented in conjunction with the sentences/words at various signals to noise levels (quiet [no noise], +0 dB and +5 dB signal to noise ratio). The percentage of sentences/words correctly repeated will be calculated for each test (AZ Bio, CNC) at each signal to noise level. Higher percentages indicate better word and sentence recognition ability. | Description | Participant listens to bursts of sounds (100 trials of pink noise [random noise having equal energy per octave and having more low-frequency components than white noise; the power per hertz decreases as the frequency increases] presented randomly from seven speakers in a half-moon orientation and identifies which speaker presented the sounds. Two testing conditions will be evaluated (implant on, implant off). Total percentage of sounds correctly identified for each condition (0-100%) will be calculated, with a larger percentage indicating higher accuracy. Additionally, root mean square error (average of total degree of error when localizing) will be calculated for each trial. | Description | Subjective questionnaire designed to study the relationship of disability and handicap across many listening domains using 49 questions in a clinician/patient interview format. The scale is sub-divided into three domains: 14 items on speech hearing, 17 items on spatial hearing (direction and distance judgments), and 18 items on "other" functions and qualities of hearing. The "other" qualities section contains items related to recognition and segregation of sounds, clarity, naturalness, and listening effort. Items are scored with ratings of 0 to 10, with 0 representing complete inability with regard to the item in question and 10 representing perfect ability. The average score (0-10) for each subscale/domain is reported individually. | Description | Questionnaire encompassing hearing and speech, psychological, and social domains and is used to evaluate quality of life. This questionnaire contains six subdomains of hearing that are rated categorically (1-5 (never-always) and "not applicable"). The subdomains are 1. Basic sound perception, 2. Advanced sound perception (in difficult daily listening situations or background noise), 3. Speech production, 4. Self-esteem, 5. Activity limitations, 6. Social interaction. The answer categories must first be transformed (1=0, 2=25, 3=50, 4=75 and 5=100). Afterwards, the final subdomain score is computed by adding together all the item scores and dividing by the number of completed items, resulting in a range of scores from 0 to 100. A higher score reflects a greater ability. | Description | Subjective questionnaire that identifies, qualifies, and evaluates the difficulties that may be experienced due to tinnitus. It is a 25-item questionnaire grouped into three subscales: functional, emotional and catastrophic responses. The functional subscale items reflect the effect of tinnitus on mental, social, occupational and physical functioning. The emotional subscale items probe the individual's emotional reactions to tinnitus, and the catastrophic response items address whether tinnitus makes the respondent feel desperate, trapped, hopeless or out of control. A "yes" response is given 4 points, a "sometimes" response 2 points and a "no" response 0 points. The questionnaire yields scores for each subscale and a total score that ranges from 0 and 100, with high scores indicating a greater handicap. The total score of this questionnaire represents the overall severity of tinnitus: slight (0-16), mild (18-36), moderate (38-56), severe (58-76) or catastrophic (78-100). |
Browse Conditions
Sequence: | 191738829 | Sequence: | 191738816 | Sequence: | 191738817 | Sequence: | 191738818 | Sequence: | 191738819 | Sequence: | 191738820 | Sequence: | 191738821 | Sequence: | 191738822 | Sequence: | 191738823 | Sequence: | 191738824 | Sequence: | 191738825 | Sequence: | 191738826 | Sequence: | 191738827 | Sequence: | 191738828 | Sequence: | 191738830 | Sequence: | 191738831 | Sequence: | 191738832 | Sequence: | 191738833 | Sequence: | 191738834 | Sequence: | 191738835 | Sequence: | 191738836 | Sequence: | 191738837 | Sequence: | 191738838 | Sequence: | 191738839 |
Mesh Term | Ear Diseases | Mesh Term | Neurilemmoma | Mesh Term | Neuroma, Acoustic | Mesh Term | Meniere Disease | Mesh Term | Neuroendocrine Tumors | Mesh Term | Neuroectodermal Tumors | Mesh Term | Neoplasms, Germ Cell and Embryonal | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Neuroma | Mesh Term | Nerve Sheath Neoplasms | Mesh Term | Neoplasms, Nerve Tissue | Mesh Term | Endolymphatic Hydrops | Mesh Term | Labyrinth Diseases | Mesh Term | Otorhinolaryngologic Diseases | Mesh Term | Cranial Nerve Neoplasms | Mesh Term | Nervous System Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Peripheral Nervous System Neoplasms | Mesh Term | Vestibulocochlear Nerve Diseases | Mesh Term | Retrocochlear Diseases | Mesh Term | Otorhinolaryngologic Neoplasms | Mesh Term | Cranial Nerve Diseases | Mesh Term | Nervous System Diseases |
Downcase Mesh Term | ear diseases | Downcase Mesh Term | neurilemmoma | Downcase Mesh Term | neuroma, acoustic | Downcase Mesh Term | meniere disease | Downcase Mesh Term | neuroendocrine tumors | Downcase Mesh Term | neuroectodermal tumors | Downcase Mesh Term | neoplasms, germ cell and embryonal | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | neuroma | Downcase Mesh Term | nerve sheath neoplasms | Downcase Mesh Term | neoplasms, nerve tissue | Downcase Mesh Term | endolymphatic hydrops | Downcase Mesh Term | labyrinth diseases | Downcase Mesh Term | otorhinolaryngologic diseases | Downcase Mesh Term | cranial nerve neoplasms | Downcase Mesh Term | nervous system neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | peripheral nervous system neoplasms | Downcase Mesh Term | vestibulocochlear nerve diseases | Downcase Mesh Term | retrocochlear diseases | Downcase Mesh Term | otorhinolaryngologic neoplasms | Downcase Mesh Term | cranial nerve diseases | Downcase Mesh Term | nervous system diseases |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47915944 | Sequence: | 47915945 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Ohio State University | Name | Advanced Bionics |
Overall Officials
Sequence: | 29032350 |
Role | Principal Investigator |
Name | Oliver Adunka, MD |
Affiliation | Ohio State University |
Central Contacts
Sequence: | 11921154 | Sequence: | 11921155 |
Contact Type | primary | Contact Type | backup |
Name | Meghan Hiss, AuD | Name | William Riggs, AuD |
Phone | 614-366-1549 | Phone | 614-293-9750 |
Meghan.Hiss@osumc.edu | William.Riggs@osumc.edu | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 67621315 |
Design Group Id | 55157763 |
Intervention Id | 52058574 |
Eligibilities
Sequence: | 30512115 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Have a diagnosis of a vestibular schwannoma confirmed by a physician with an MRI and/or CT scan; Or have a diagnosis of Meniere's disease by a physician Exclusion Criteria: Subjects with bilateral Meniere's disease or bilateral vestibular schwannomas |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254061437 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30261184 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Provided Documents
Sequence: | 2561517 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2018-05-02 |
Url | https://ClinicalTrials.gov/ProvidedDocs/75/NCT03795675/Prot_SAP_000.pdf |
Responsible Parties
Sequence: | 28641657 |
Responsible Party Type | Principal Investigator |
Name | Oliver Adunka |
Title | Professor-Clinical Otolaryngology |
Affiliation | Ohio State University |
]]>
https://zephyrnet.com/NCT03795662
2019-01-07
https://zephyrnet.com/?p=NCT03795662
NCT03795662https://www.clinicaltrials.gov/study/NCT03795662?tab=tableMaria Hegelund, MScmaria.hein.hegelund.01@regionh.dk+4548293250The study aims to explore risk factors for poor prognosis among patients admitted with community-acquired pneumonia (CAP). During a 5-year study period, all patients (aged ≥ 18 years) admitted with CAP at North Zealand Hospital will be invited for inclusion. Questionnaires, anthropometric measures, laboratory tests, and biomaterials will be collected at admission, daily during admission, at discharge and at follow-up. The main clinical outcomes of the study consist of deaths and development of diabetes.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-09 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-04-29 |
Start Month Year | January 7, 2019 |
Primary Completion Month Year | December 31, 2023 |
Verification Month Year | April 2021 |
Verification Date | 2021-04-30 |
Last Update Posted Date | 2021-04-29 |
Facilities
Sequence: | 200053468 |
Status | Recruiting |
Name | Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital |
City | Hillerød |
Zip | 3400 |
Country | Denmark |
Facility Contacts
Sequence: | 28097584 |
Facility Id | 200053468 |
Contact Type | primary |
Name | Birgitte Lindegaard, MD, PhD |
birgitte.lindegaard.madsen@regionh.dk | |
Conditions
Sequence: | 52156586 |
Name | Community-acquired Pneumonia |
Downcase Name | community-acquired pneumonia |
Id Information
Sequence: | 40148268 |
Id Source | org_study_id |
Id Value | Surviving Pneumonia |
Countries
Sequence: | 42557803 |
Name | Denmark |
Removed | False |
Design Groups
Sequence: | 55577990 |
Title | Community-acquired pneumonia |
Description | Adults over 18 years old admitted with confirmed community-acquired pneumonia. |
Interventions
Sequence: | 52472090 |
Intervention Type | Other |
Name | No intervention |
Description | Obervational |
Keywords
Sequence: | 79848207 | Sequence: | 79848208 | Sequence: | 79848209 | Sequence: | 79848210 | Sequence: | 79848211 | Sequence: | 79848212 |
Name | Community-acquired pneumonia | Name | Diabetes | Name | Immune status | Name | Nutritional status | Name | Physical inactivity | Name | Risk factors |
Downcase Name | community-acquired pneumonia | Downcase Name | diabetes | Downcase Name | immune status | Downcase Name | nutritional status | Downcase Name | physical inactivity | Downcase Name | risk factors |
Design Outcomes
Sequence: | 177328376 | Sequence: | 177328377 | Sequence: | 177328378 | Sequence: | 177328379 | Sequence: | 177328380 | Sequence: | 177328381 | Sequence: | 177328382 | Sequence: | 177328383 | Sequence: | 177328384 | Sequence: | 177328385 | Sequence: | 177328386 | Sequence: | 177328387 | Sequence: | 177328388 | Sequence: | 177328389 | Sequence: | 177328390 | Sequence: | 177328391 | Sequence: | 177328392 | Sequence: | 177328393 | Sequence: | 177328394 | Sequence: | 177328395 | Sequence: | 177328396 | Sequence: | 177328397 | Sequence: | 177328398 | Sequence: | 177328399 | Sequence: | 177328400 | Sequence: | 177328401 | Sequence: | 177328402 | Sequence: | 177328403 | Sequence: | 177328404 | Sequence: | 177328405 | Sequence: | 177328406 | Sequence: | 177328407 | Sequence: | 177328408 | Sequence: | 177328409 | Sequence: | 177328410 | Sequence: | 177328411 | Sequence: | 177328412 | Sequence: | 177328413 | Sequence: | 177328414 | Sequence: | 177328415 | Sequence: | 177328416 | Sequence: | 177328417 | Sequence: | 177328418 | Sequence: | 177328419 | Sequence: | 177328420 | Sequence: | 177328421 | Sequence: | 177328422 | Sequence: | 177328423 | Sequence: | 177328424 | Sequence: | 177328425 | Sequence: | 177328426 | Sequence: | 177328427 | Sequence: | 177328428 | Sequence: | 177328429 | Sequence: | 177328430 | Sequence: | 177328431 | Sequence: | 177328432 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Number of death from any causes | Measure | Number of participants who develop diabetes | Measure | Length of hospital stay | Measure | Oral glucose tolerance test | Measure | Number of participants who are readmitted | Measure | Facal sample to assess changes in microbiome | Measure | Urine samples to assess metabolomics | Measure | Physical activity monitoring (measured by the AX3 accelerometers) | Measure | Self-reported physical activity by scoring of the international physical activity questionnaire (IPAQ) | Measure | Muscle strength (measured by hand grip test) | Measure | Muscle strength (measured by 30-sec chair stand test) | Measure | Functional capacity (measured by 6-minutes walking test) | Measure | Activities of daily living (measured by Barthel100) | Measure | BMI | Measure | Waist circumference (measured in cm) | Measure | Body composition analysis (measured by DEXA scans) | Measure | Body composition analysis (measured by bioimpedance) | Measure | Nutritional status (measured by NRS2002) | Measure | Concentration of p-phosphate (mmol/l), p-sodium (mmol/l), p-carbamide (mmol/l), p-potassium (mmol/l) | Measure | Concentration of pro- and anti-inflammatory cytokines (IL-6, Il-1ra, IL-18, IL-10, TNF-alpha) | Measure | Immune cell phenotyping to identify cell counts various T-cells, B-cells, NK-cells and monocytes | Measure | Concentration of blood lipids | Measure | Scoring of the Charlson Comorbidity Index to predict 10-year survival | Measure | Oral status (determined by revised oral assessment guide) | Measure | Dysphagia screening (eating assessment tool 10) | Measure | Quality of life (EQ-5D-5L) | Measure | Glycemic control during oral glucose tolerance test | Measure | Glucagon concentration during oral glucose tolerance test | Measure | Insulin concentration during oral glucose tolerance test | Measure | C-peptide concentration during oral glucose tolerance test | Measure | GLP-1 concentration during oral glucose tolerance test | Measure | GLP-2 concentration during oral glucose tolerance test | Measure | GIP concentration during oral glucose tolerance test | Measure | Insulin sensitivity index (Matsuda) based on oral glucose tolerance test | Measure | Insulin secretion index based on oral glucose tolerance test | Measure | Concentration of galectin-3 (ng/ml), sST2 (ng/ml), and troponins (ng/ml) | Measure | Concentration of NT-proBNP (ng/l) | Measure | Z-value of left ventricle (LV) out of echocardiography | Measure | Z-value of right ventricle (RV) out of echocardiography | Measure | Z-value of left atrium (LA) out of echocardiography | Measure | Shortening fraction (SF) measured in echocardiography | Measure | Ejection fraction (EF) measured in echocardiography | Measure | Valvular insufficiency measured in echocardiography | Measure | Heart rate of 12-lead resting ECG | Measure | Rhythm during 12-lead resting ECG | Measure | Axis of the QRS complex out of the 12-lead resting ECG | Measure | Duration of PQ interval out of the 12-lead resting ECG | Measure | Duration of the QRS complex out of the 12-lead resting ECG | Measure | Number of cardiac events | Measure | Sputum samples to assess glucose and lactate concentration (measured by ABL) | Measure | Sputum samples to evaluate drug resistance and O2 content | Measure | Forced vital capacity (FVC) during spirometry | Measure | Forced expiratory volume in 1 second (FEV1) during spirometry | Measure | FEV1% predicted during spirometry | Measure | Chest x-ray to image inflammation of the lungs | Measure | Early Warning Score (EWS) to identify patients at risk of deterioration in hospital | Measure | HbA1c to assess the average blood glucose levels 3 months before admission |
Time Frame | From date of admission until the day of death from any causes, up to 24 months | Time Frame | Up to 24 months | Time Frame | Participants will be followed for the duration of hospital stay, an expected average of 5 days | Time Frame | Day 1, discharge (an average of 5 days), 1 month and 6-month | Time Frame | Up to 6 months | Time Frame | Day 1, 1 month and 6 months | Time Frame | Day 1, 1 month and 6 months | Time Frame | During admission (up to 7 days), 14 days from discharge (an average of 5 days) | Time Frame | Day 1 | Time Frame | Day 1, discharge (an average of 5 days), 1 months and 6 months | Time Frame | Day 1 and discharge (an average of 5 days) | Time Frame | Day 1 and discharge (an average of 5 days) | Time Frame | Discharge (an average of 5 days) | Time Frame | Day 1, discharge (an average of 5 days), 1 month and 6 months | Time Frame | Day 1, discharge (an average of 5 days), 1 month and 6 months | Time Frame | Day 1, discharge (an average of 5 days), 1 month and 6 months | Time Frame | Daily during admission, discharge (an average of 5 days), 1 month and 6 months | Time Frame | Day 1 | Time Frame | Daily during admission, 1 month and 6 months | Time Frame | Daily during admission, discharge (an average of 5 days), 1 month and 6 months | Time Frame | Day 1 and discharge (an average of 5 days) | Time Frame | Day 1, discharge (an average of 5 days), 1 month and 6 months | Time Frame | Day 1 | Time Frame | Day 1 | Time Frame | Day 1 | Time Frame | Day 1, discharge (an average of 5 days), 1 month and 6 months | Time Frame | Day 1, discharge (an average of 5 days), 1 month and 6 months | Time Frame | Day 1, discharge (an average of 5 days), 1 month and 6 months | Time Frame | Day 1, discharge (an average of 5 days), 1 month and 6 months | Time Frame | Day 1, discharge (an average of 5 days), 1 month and 6 months | Time Frame | Day 1, discharge (an average of 5 days), 1 month and 6 months | Time Frame | Day 1, discharge (an average of 5 days), 1 month and 6 months | Time Frame | Day 1, discharge (an average of 5 days), 1 month and 6 months | Time Frame | Day 1, discharge (an average of 5 days), 1 month and 6 months | Time Frame | Day 1, discharge (an average of 5 days), 1 month and 6 months | Time Frame | Daily during admission, 1 month and 6 months | Time Frame | Daily during admission, 1 month and 6 months | Time Frame | Discharge (an average of 5 days), 1 month and 6 months | Time Frame | Discharge (an average of 5 days), 1 month and 6 months | Time Frame | Discharge (an average of 5 days), 1 month and 6 months | Time Frame | Discharge (an average of 5 days), 1 month and 6 months | Time Frame | Discharge (an average of 5 days), 1 month and 6 months | Time Frame | Discharge (an average of 5 days), 1 month and 6 months | Time Frame | Daily during admission (up to 5 days) | Time Frame | Daily during admission (up to 5 days) | Time Frame | Daily during admission (up to 5 days) | Time Frame | Daily during admission (up to 5 days) | Time Frame | Daily during admission (up to 5 days) | Time Frame | From date of admission up to 24 months | Time Frame | On admission, 1 month and 6 months | Time Frame | On admission, 1 month and 6 months | Time Frame | Discharge (an average of 5 days) | Time Frame | Discharge (an average of 5 days) | Time Frame | Discharge (an average of 5 days) | Time Frame | On admission, 1 month and 6 months | Time Frame | Daily during admission (up to 5 days) | Time Frame | Day 1 |
Description | Assessed through patient files | Description | Assessed through patient files and the national registers | Description | Through patient files | Description | Through patient files | Description | Weight (kilograms) and height (cm) will be combined to report BMI in kg/m^2 | Description | Blood sampling | Description | Flow cytometry on whole blood | Description | Blood sampling | Description | Scale ranges from 0 to 33 points to predict survival (%) | Description | Blood sampling | Description | Blood sampling | Description | Blood sampling | Description | Blood sampling | Description | Blood sampling | Description | Blood sampling | Description | Blood sampling | Description | Blood sampling | Description | Z-value LV | Description | Z-value RV | Description | Z-value LA | Description | SF (%) | Description | EF (%) | Description | Aorta valve regurgitation, pulmonary valve regurgitation, tricuspid valve regurgitation and mitral valve regurgitation (no, minimal, moderate, severe) | Description | bpm | Description | Sinus rhythm yes/no | Description | Degree | Description | ms | Description | ms | Description | Assessed through patient files and the national registers | Description | Litre | Description | Litre |
Browse Conditions
Sequence: | 193432361 | Sequence: | 193432362 | Sequence: | 193432363 | Sequence: | 193432364 | Sequence: | 193432365 |
Mesh Term | Pneumonia | Mesh Term | Respiratory Tract Infections | Mesh Term | Infections | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases |
Downcase Mesh Term | pneumonia | Downcase Mesh Term | respiratory tract infections | Downcase Mesh Term | infections | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306173 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Nordsjaellands Hospital |
Overall Officials
Sequence: | 29277991 |
Role | Principal Investigator |
Name | Birgitte Lindegaard, Assoc. Prof |
Affiliation | Nordsjaellands Hospital |
Central Contacts
Sequence: | 12004764 | Sequence: | 12004765 |
Contact Type | primary | Contact Type | backup |
Name | Camilla Ryrsø, MSc | Name | Maria Hegelund, MSc |
Phone | +4548293250 | Phone | +4548293250 |
camilla.koch.ryrsoe.01@regionh.dk | maria.hein.hegelund.01@regionh.dk | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68130964 |
Design Group Id | 55577990 |
Intervention Id | 52472090 |
Eligibilities
Sequence: | 30757407 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Adults (≥18 years) admitted with community-acquired pneumonia |
Criteria | Inclusion Criteria:
Infiltrate on chest radiograph plus one or more of the following: Fever (temperature, ≥38.0°C) Exclusion Criteria: Patients unable to give informed consent |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254229052 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 3 |
Number Of Other Outcomes To Measure | 52 |
Designs
Sequence: | 30503632 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28869910 |
Responsible Party Type | Principal Investigator |
Name | Birgitte Lindegaard Madsen |
Title | Associated professor, MD, PhD |
Affiliation | Nordsjaellands Hospital |
Study References
Sequence: | 52049464 |
Pmid | 36362554 |
Reference Type | derived |
Citation | Ryrso CK, Hegelund MH, Dungu AM, Faurholt-Jepsen D, Pedersen BK, Ritz C, Krogh-Madsen R, Lindegaard B. Association between Barthel Index, Grip Strength, and Physical Activity Level at Admission and Prognosis in Community-Acquired Pneumonia: A Prospective Cohort Study. J Clin Med. 2022 Oct 27;11(21):6326. doi: 10.3390/jcm11216326. |
]]>
https://zephyrnet.com/NCT03795649
2018-12-18
https://zephyrnet.com/?p=NCT03795649
NCT03795649https://www.clinicaltrials.gov/study/NCT03795649?tab=tableRenata Letica-Brnadićrlbrnadic@gmail.com+38598340722The administration of the tranexamic acid (TRAXA), an antifibrinolytic, blocks primary fibrinolysis, and thus the haemorrhage, in the early postoperative period. Significant surgical operations, as well as trauma, initiate a similar dynamic homeostatic mechanism between the creation of a clot (primary and secondary haemostasis) and its dissolution (fibrinolysis). Antifibrinolytics have been proven effective in reducing haemorrhage in patients who have undergone significant surgical operations with normal fibrinolysis, with the use of an appropriate surgical technique.
A pharmacokinetic study has shown that peak fibrinolytic activity is present for 6 hours after the incision and it persists for 18 hours in total knee and hip arthroplasty. The administration of the tranexamic acid in optional orthopaedic surgery of total hip (THA) and knee (TKA) arthroplasty reduces the postoperative haemorrhage, as well as the number and volume of the postoperative autologous blood.
A trauma in the organism triggers the immunologic response. New term has been introduced – the post-traumatic immunosuppression (PTI), characterised by: a change on the immunologic cells (neutrophilia, monocytosis, increased number of mesenchymal stromal cells, reduced expression of HLA-DR on monocytes, reduced function of natural killer (NK) cells, increased lymphocyte apoptosis, a shift in homoeostasis towards the Th2 phenotype facilitated by Treg lymphocytes – CD4+CD25+CD127-); a change in production levels of various cytokines (anti-inflammatory cytokines): IL-10, IL-4; anti- and pro-inflammatory cytokine: IL-6; pro-inflammatory cytokines IL-2, TNF-α, IFN-γ); the activation of the complement system (C5a and C3a via factor VII – tissue factor system, activated by cell damage).
Post-traumatic immunosuppression can be made worse by transfusion, haemorrhage, stress, significant surgical operation and immunosuppressive drugs.
The research has shown that Treg lymphocytes CD4+CD25+CD127- have an important role in controlling the acquired and innate immunity (comprising 6-8% of all CD4+ lymphocytes).
Stopping haemorrhage prevents the occurrence of anaemia, as well as the need for transfusion of blood products, which lead to developing the post-traumatic immunosuppression (PTI).
<![CDATA[
Studies
Study First Submitted Date | 2018-12-30 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | December 18, 2018 |
Primary Completion Month Year | December 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-08 |
Detailed Descriptions
Sequence: | 20735748 |
Description | The administration of the tranexamic acid (TRAXA), an antifibrinolytic, blocks primary fibrinolysis, and thus the haemorrhage, in the early postoperative period. Significant surgical operations, as well as trauma, initiate a similar dynamic homeostatic mechanism between the creation of a clot (primary and secondary haemostasis) and its dissolution (fibrinolysis). Antifibrinolytics are initially used in patients with an accelerated fibrinolysis of different pathogeneses. However, they have been proven effective in reducing haemorrhage in patients who have undergone significant surgical operations with normal fibrinolysis, with the use of an appropriate surgical technique.
A pharmacokinetic study has shown that peak fibrinolytic activity is present for 6 hours after the incision and it persists for 18 hours in total knee and hip arthroplasty. The administration of the tranexamic acid in optional orthopaedic surgery of total hip (THA) and knee (TKA) arthroplasty reduces the postoperative haemorrhage, as well as the number and volume of the postoperative autologous blood. A randomized, placebo-controlled trial CRAS-2 has validated that the early post-traumatic administration of the tranexamic acid, within 8 hours after the injury, in adult patients with traumas or in patients with the risk of significant haemorrhage, reduces the fatality rate. The tranexamic acid is a synthetic derivative of lysine, an amino acid which blocks lysine binding sites of the plasminogen molecule which are essential for its biding to fibrin. This mechanism inhibits the plasminogen activation via a plasminogen activator which also binds to fibrin. Thus, it prevents the conversion of plasminogen into plasmin, which is essential for fibrin dissolution, the integral element of a stable clot. The second important antifibrinolytic effect is blocking the lysine binding sites on the free plasmin molecule which has already been formed through the conversion from the plasminogen. This inhibits its binding to fibrin, and the TRAXA-plasmin complex is rapidly inactivated with the α-2-antiplasmin and α-2-macroglobulin. Biological half-life is approximately 2-3 hours. A trauma in the organism triggers the immunologic response. The initial immunologic reaction occurs at the location of the injury, and it is called an inflammation. The inflammatory response is characterized by a complex interaction of macrophages (a type of leukocytes which develop from monocytes and are a part of the mononuclear phagocyte system, the main task of which are phagocytosis, i.e. the clearance of foreign materiel from the organism, performing the immunologic function – the defence against foreign materiel – antigens, and the regulation of the inflammation via interleukins which they secrete – IL1, IL-2,TNF) and dendritic cells (antigen-presenting cells), the consequence of which is the release of cytokines (interleukins – glycoproteins which regulate interactions among cells) and chemokine (small proteins from the cytokine group – able to induce chemotaxis, cell migration), and the activation of the neutrophils, monocytes and mesenchymal stem cells (cells not containing any information, located in the adipose tissue, cartilage and muscle tissue). If the initial inflammatory response at the location of the injury is strong enough, it will develop into a systemic inflammatory response, called systemic inflammatory response syndrome (SIRS), which implies an inflammatory response of the entire body without a proven source of infection. The criteria for the diagnosis of the SIRS are: heart rate higher than 90 bpm; body temperature lower than 36°C or higher than 38°C; tachypnoea, respiratory rate higher than 20 breaths per minute or the partial pressure of carbon dioxide in the blood lower than 4.3 kPa (32 mm Hg); the number of white blood cells, leukocytes, lower than 4.000 cells in 1 mm³ or higher than 12.000 cells in 1 mm³; or the presence of more than 10% of immature neutrophils. A destructive immunologic inflammatory cascade can prevent or delay healing. At the same time the compensatory anti-inflammatory response syndrome (CARS) is initiated, which includes the immunologic response with the aim of re-establishing the immunologic homeostasis. It is characterized by: a reduced cytokine response of monocytes to the stimulation; a reduced number of antigen-presenting receptors (human leukocyte antigens or HLA) on monocytes; an increased level of IL-10, an anti-inflammatory cytokine; lymphocyte apoptosis (T-cells); lymphocyte dysfunction, i.e. reduced proliferation; reduced Th1 proinflammatory cytokine production (a shift in homoeostasis towards the Th2 phenotype facilitated by the regulatory T lymphocytes). It clinically manifests as skin allergy, hypothermia and leukopenia. Additional criteria include elevated levels of C-reactive proteins, lactates and hyperglycaemia. If the immunosuppressive response persists, it may increase the possibility of an infection occurring, and the inability to defend against the infection, which may result in the development of sepsis, multiple organ failure and death. Due to the wide clinical and laboratory criteria which both the SIRS and CARS terms include, they are not the best terms for describing the immunologic response to a trauma, and a new term has been introduced – the post-traumatic immunosuppression (PTI), characterised by: a change on the immunologic cells (neutrophilia, monocytosis, increased number of mesenchymal stromal cells, reduced expression of HLA-DR on monocytes, reduced function of natural killer (NK) cells, increased lymphocyte apoptosis, a shift in homoeostasis towards the Th2 phenotype facilitated by Treg lymphocytes – CD4+CD25+CD127-); a change in production levels of various cytokines (anti-inflammatory cytokines): IL-10, IL-4; anti- and pro-inflammatory cytokine: IL-6; pro-inflammatory cytokines IL-2, TNF-α, IFN-γ); the activation of the complement system (C5a and C3a via factor VII – tissue factor system, activated by cell damage). Post-traumatic immunosuppression can be made worse by transfusion, haemorrhage, stress, significant surgical operation and immunosuppressive drugs. The research has shown that Treg lymphocytes CD4+CD25+CD127- have an important role in controlling the acquired and innate immunity (comprising 6-8% of all CD4+ lymphocytes). The normal function of Treg lymphocytes is the suppression of the T-cell response against its own antigens. Stopping haemorrhage prevents the occurrence of anaemia, as well as the need for transfusion of blood products, which lead to developing the post-traumatic immunosuppression (PTI). Monitoring the immunologic status of patients with the understanding of the PTI mechanism can enable timely and individual modulation of the immunologic status with pre-planned procedures (preventing haemorrhage, anaemia, avoiding transfusion) and/or immunotherapy (drugs and nutrients), and thereby prevent the occurrence of complications, such as infections. Infections may result in sepsis and multiple-organ failure, and eventually be lethal for the patient. The research has proved that Treg lymphocytes CD4+CD25+CD127- have an important role in controlling the acquired and innate immunity (comprising 6-8% of all CD4+ lymphocytes). The normal function of Treg lymphocytes is the suppression of the T-cell response against its own antigens. There are two main types of regulatory lymphocytes: natural Treg, which are mostly developed in the thymus, and inducible Treg, which arise in the periphery after being exposed to cytokines, antigen-presenting cells or immunosuppressive drugs. It may be difficult to differentiate these two lymphocyte Treg populations in vivo. Nevertheless, it is known that different stages of the infection require different regulations. Acute infection, tissue damage, inflammation caused by the innate immunologic response is limited, i.e. locally controlled via natural Treg lymphocytes. This mechanism triggers the activation of inducible Treg lymphocytes. For the first time, in 1995, it was described that the suppression of CD4+ T-lymphocytes is caused by a low T-cell population with the CD4+ CD25+ expression. Natural Treg lymphocytes, apart from belonging to CD4+ T-cell population, have a CD25+ receptor, an α-receptor chain for IL-2, and a receptor for the cytotoxic T-lymphocytic antigen 4 (CTLA 4), the tumour necrosis factor receptor (TNF), but it differs from the activated T-cells by the expression of the transcription factor FoxP3 (transcription factor encoded with the FoxP3 gene). The expression of CD 127lo, an α-chain receptor for the interleukin 7 enables us to differentiate Treg lymphocytes from the activated T-lymphocytes via flow cytometry. The number of CD25+CD127lo cells correlates to the number of CD25+FoxP3+ cells in the peripheral blood. Different studies show that the application of the 3-colour flow cytometry shows small variation in the percentage of Treg lymphocytes in the peripheral blood from 6.35% to 8.34%. There is a number of different mechanisms which achieve regulation by using the Treg lymphocytes: the long-term interaction with dendritic cells (DC), thereby modulating the function of antigen-presenting cells (APC), the production of the anti-inflammatory cytokine, IL-10 and the CTLA4 expression on Treg cells which induces the enzyme indoleamine 2,3-dioxygenase (IDO) in APC which degrade the amino acid tryptophan, the lack of which inhibits the activation of T-cells and induces T-cell apoptosis. Treg lymphocytes also induce the apoptosis of monocytes and affect the lower expression of HLA-DR on monocytes whereby they directly affect the innate immunological response. Elevated, suppressive activity of Treg cells in traumas prevents the protective Th1 response for up to 7 days in comparison with the healthy population. |
Facilities
Sequence: | 200244138 |
Status | Recruiting |
Name | Klinički Bolnički Centar Sestre Milosrdnice |
City | Zagreb |
Zip | 10000 |
Country | Croatia |
Facility Contacts
Sequence: | 28127956 |
Facility Id | 200244138 |
Contact Type | primary |
Name | Renata Letica-Brnadić |
rlbrnadic@gmail.com | |
Phone | +38598340722 |
Browse Interventions
Sequence: | 96112987 | Sequence: | 96112988 | Sequence: | 96112989 | Sequence: | 96112990 | Sequence: | 96112991 | Sequence: | 96112992 |
Mesh Term | Tranexamic Acid | Mesh Term | Antifibrinolytic Agents | Mesh Term | Fibrin Modulating Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Hemostatics | Mesh Term | Coagulants |
Downcase Mesh Term | tranexamic acid | Downcase Mesh Term | antifibrinolytic agents | Downcase Mesh Term | fibrin modulating agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | hemostatics | Downcase Mesh Term | coagulants |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52208043 |
Name | Hemorrhage |
Downcase Name | hemorrhage |
Id Information
Sequence: | 40186103 |
Id Source | org_study_id |
Id Value | EP-12939/18-1 |
Countries
Sequence: | 42599599 |
Name | Croatia |
Removed | False |
Design Groups
Sequence: | 55634590 | Sequence: | 55634591 | Sequence: | 55634592 | Sequence: | 55634593 |
Group Type | No Intervention | Group Type | Active Comparator | Group Type | Other | Group Type | Other |
Title | The control group (Group K) | Title | Group A, Tranexamic acid | Title | Group B, autologous transfusion | Title | Group C, alogenous transfusion |
Description | The control group (Group K) is comprised of surgical patients who will not receive blood transfusion, and who have contraindications for Tranexamic Acid. | Description | The treatment group (Group A) is comprised of the patients who will receive Tranexamic acid 1g intravenous 15 min. before releasing the pneumatic tourniquet and the repeating dose 3 hours later | Description | The treatment group (Group B) will be comprised of the patients who in the second selection have one or more contraindications for Tranexamic Acid administration and transfusion of autologous blood will be performed. | Description | The treatment group (Group C) contraindications for Tranexamic Acid administration and the transfusion of alogenous blood will be performed in the case of acute haemorrhage followed by patient's hemodynamic instability. |
Interventions
Sequence: | 52522015 |
Intervention Type | Drug |
Name | Tranexamic Acid |
Description | Imunomodulatory effect |
Design Outcomes
Sequence: | 177511000 | Sequence: | 177511001 |
Outcome Type | primary | Outcome Type | secondary |
Measure | The immunomodulation effect of Tranexamic Acid (IM) | Measure | The effect of the Tranexamic Acid on the primary fibrinolysis (F) |
Time Frame | two years | Time Frame | two years |
Description | Trial will include approximately 100 patients in total, which will be divided into four groups of 25 patients. The immunomodulation effect is monitored through the analysis of the lymphocyte subpopulation in the peripheral blood through flow cytometry.
The result of each lymphocyte subpopulation will be registered as a percentage of all helper cells (CD4+) and all lymphocytes, as well as their absolute number in the peripheral blood. These parameters will be monitored dynamically in the chronological order as shown below: Day 1 – Preoperatively; Day 1 – Postoperatively T1 (IM) K – 6 hrs postoperatively T1 (IM) A – 6 hrs after the first TRAXA dose, and two hours before LMWH T1 (IM) B – 6 hrs postoperatively (after the transfusion of the autologous blood by means of the autotransfusion system); Day 3 – Postoperatively; Day 5 – Postoperatively; Day 7 – Postoperatively; For immunologic testing of each patient's blood 25 ml (5 ml x 5) during 7 days will be sampled. |
Description | The fibrinolytic activity of plasma will be examined through euglobulin lysis time testing Blood sampling follows the same time intervals of blood sampling for determining Treg lymphocytes. Fibrinolysis is monitored until the third postoperative day.
In total per patient for analysis of the fibrinolytic activity 15 mL (5 mL x 3) of blood will be sampled during a 3-day period. Day 1 – Preoperatively; Day 3 – Postoperatively T1 (F) K – 6 hrs postoperatively T1 (F) A – 6 hrs after the first TRAXA dose, and two hours before LMWH T1 (F) B – 6 hrs postoperatively (after the transfusion of the autologous blood by means of the autotransfusion system); Day 3 – Postoperatively; |
Browse Conditions
Sequence: | 193626796 | Sequence: | 193626797 |
Mesh Term | Hemorrhage | Mesh Term | Pathologic Processes |
Downcase Mesh Term | hemorrhage | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48353632 | Sequence: | 48353633 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Sisters of Mercy University Hospital | Name | Clinical Hospital Centre Zagreb |
Overall Officials
Sequence: | 29305950 |
Role | Study Chair |
Name | Renata Letica-Brnadić |
Affiliation | Clinical Hospital Centre "Sisters of Mercy" |
Central Contacts
Sequence: | 12017196 |
Contact Type | primary |
Name | Renata Letica-Brnadić |
Phone | +38598340722 |
rlbrnadic@gmail.com | |
Role | Contact |
Design Group Interventions
Sequence: | 68199113 | Sequence: | 68199114 | Sequence: | 68199115 |
Design Group Id | 55634591 | Design Group Id | 55634592 | Design Group Id | 55634593 |
Intervention Id | 52522015 | Intervention Id | 52522015 | Intervention Id | 52522015 |
Eligibilities
Sequence: | 30786834 |
Gender | All |
Minimum Age | 30 Years |
Maximum Age | 80 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
ASA I/II status Exclusion criteria: general anaesthesia Exclusion Criteria refers to the patients for whom Tranexamic Acid was contraindicated: —-thromboembolic events (IM, CVI, DVT) known risk of thrombosis or thromboembolic events (thrombogenic valve disease, thrombogenic rhythm disorder, coagulation-hypercoagulation disorder) To patients who fulfil the participation criteria for the trial in the first selection, and for whom TRAXA is contraindicated in the second selection, blood transfusion will be administered in accordance with the indication. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989556 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 30 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30532904 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26692016 |
Intervention Id | 52522015 |
Name | Medsamic |
Responsible Parties
Sequence: | 28899198 |
Responsible Party Type | Principal Investigator |
Name | Renata Letica-Brnadić |
Title | Principal Investigator |
Affiliation | Sisters of Mercy University Hospital |
Study References
Sequence: | 52102984 | Sequence: | 52102985 | Sequence: | 52102986 | Sequence: | 52102987 | Sequence: | 52102988 | Sequence: | 52102989 | Sequence: | 52102990 | Sequence: | 52102991 | Sequence: | 52102992 | Sequence: | 52102993 | Sequence: | 52102994 | Sequence: | 52102995 | Sequence: | 52102996 | Sequence: | 52102997 | Sequence: | 52102998 | Sequence: | 52102999 | Sequence: | 52103000 | Sequence: | 52103001 | Sequence: | 52103002 |
Pmid | 17943760 | Pmid | 3321402 | Pmid | 23477634 | Pmid | 23614539 | Pmid | 24405302 | Pmid | 11403834 | Pmid | 27195120 | Pmid | 1303622 | Pmid | 8849154 | Pmid | 18954697 | Pmid | 29930824 | Pmid | 16818676 | Pmid | 18946659 | Pmid | 17913974 | Pmid | 17948021 | Pmid | 16903906 | Pmid | 17173927 | Pmid | 25270110 | Pmid | 23195143 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | result |
Citation | Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, McClelland B, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001886. doi: 10.1002/14651858.CD001886.pub2. | Citation | Astedt B. Clinical pharmacology of tranexamic acid. Scand J Gastroenterol Suppl. 1987;137:22-5. | Citation | Roberts I, Shakur H, Coats T, Hunt B, Balogun E, Barnetson L, Cook L, Kawahara T, Perel P, Prieto-Merino D, Ramos M, Cairns J, Guerriero C. The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients. Health Technol Assess. 2013 Mar;17(10):1-79. doi: 10.3310/hta17100. | Citation | Oremus K, Sostaric S, Trkulja V, Haspl M. Influence of tranexamic acid on postoperative autologous blood retransfusion in primary total hip and knee arthroplasty: a randomized controlled trial. Transfusion. 2014 Jan;54(1):31-41. doi: 10.1111/trf.12224. Epub 2013 Apr 25. | Citation | Raveendran R, Wong J. Tranexamic acid: more evidence for its use in joint replacement surgery. Transfusion. 2014 Jan;54(1):2-3. doi: 10.1111/trf.12494. No abstract available. | Citation | Parkin J, Cohen B. An overview of the immune system. Lancet. 2001 Jun 2;357(9270):1777-89. doi: 10.1016/S0140-6736(00)04904-7. | Citation | Islam MN, Bradley BA, Ceredig R. Sterile post-traumatic immunosuppression. Clin Transl Immunology. 2016 Apr 29;5(4):e77. doi: 10.1038/cti.2016.13. eCollection 2016 Apr. | Citation | Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest. 1992 Jun;101(6):1644-55. doi: 10.1378/chest.101.6.1644. | Citation | Bone RC. Immunologic dissonance: a continuing evolution in our understanding of the systemic inflammatory response syndrome (SIRS) and the multiple organ dysfunction syndrome (MODS). Ann Intern Med. 1996 Oct 15;125(8):680-7. doi: 10.7326/0003-4819-125-8-199610150-00009. | Citation | Ward NS, Casserly B, Ayala A. The compensatory anti-inflammatory response syndrome (CARS) in critically ill patients. Clin Chest Med. 2008 Dec;29(4):617-25, viii. doi: 10.1016/j.ccm.2008.06.010. | Citation | Osuka A, Ogura H, Ueyama M, Shimazu T, Lederer JA. Immune response to traumatic injury: harmony and discordance of immune system homeostasis. Acute Med Surg. 2014 Jan 28;1(2):63-69. doi: 10.1002/ams2.17. eCollection 2014 Apr. | Citation | Seddiki N, Santner-Nanan B, Martinson J, Zaunders J, Sasson S, Landay A, Solomon M, Selby W, Alexander SI, Nanan R, Kelleher A, Fazekas de St Groth B. Expression of interleukin (IL)-2 and IL-7 receptors discriminates between human regulatory and activated T cells. J Exp Med. 2006 Jul 10;203(7):1693-700. doi: 10.1084/jem.20060468. Epub 2006 Jul 3. | Citation | Venet F, Chung CS, Kherouf H, Geeraert A, Malcus C, Poitevin F, Bohe J, Lepape A, Ayala A, Monneret G. Increased circulating regulatory T cells (CD4(+)CD25 (+)CD127 (-)) contribute to lymphocyte anergy in septic shock patients. Intensive Care Med. 2009 Apr;35(4):678-86. doi: 10.1007/s00134-008-1337-8. Epub 2008 Oct 23. | Citation | Venet F, Chung CS, Monneret G, Huang X, Horner B, Garber M, Ayala A. Regulatory T cell populations in sepsis and trauma. J Leukoc Biol. 2008 Mar;83(3):523-35. doi: 10.1189/jlb.0607371. Epub 2007 Oct 3. | Citation | Belkaid Y. Regulatory T cells and infection: a dangerous necessity. Nat Rev Immunol. 2007 Nov;7(11):875-88. doi: 10.1038/nri2189. | Citation | Shevach EM, DiPaolo RA, Andersson J, Zhao DM, Stephens GL, Thornton AM. The lifestyle of naturally occurring CD4+ CD25+ Foxp3+ regulatory T cells. Immunol Rev. 2006 Aug;212:60-73. doi: 10.1111/j.0105-2896.2006.00415.x. | Citation | Hartigan-O'Connor DJ, Poon C, Sinclair E, McCune JM. Human CD4+ regulatory T cells express lower levels of the IL-7 receptor alpha chain (CD127), allowing consistent identification and sorting of live cells. J Immunol Methods. 2007 Jan 30;319(1-2):41-52. doi: 10.1016/j.jim.2006.10.008. Epub 2006 Nov 3. | Citation | Fragkou PC, Torrance HD, Pearse RM, Ackland GL, Prowle JR, Owen HC, Hinds CJ, O'Dwyer MJ. Perioperative blood transfusion is associated with a gene transcription profile characteristic of immunosuppression: a prospective cohort study. Crit Care. 2014 Oct 1;18(5):541. doi: 10.1186/s13054-014-0541-x. | Citation | Blanie A, Bellamy L, Rhayem Y, Flaujac C, Samama CM, Fontenay M, Rosencher N. Duration of postoperative fibrinolysis after total hip or knee replacement: a laboratory follow-up study. Thromb Res. 2013 Jan;131(1):e6-e11. doi: 10.1016/j.thromres.2012.11.006. Epub 2012 Nov 26. |
]]>
https://zephyrnet.com/NCT03795636
2016-10-30
https://zephyrnet.com/?p=NCT03795636
NCT03795636https://www.clinicaltrials.gov/study/NCT03795636?tab=tableNANANAGarlic extract as herbal compound has potent antibacterial properties and can be used safely as an irrigant for pulpectomy procedure of primary molars root canals with high clinical and radiographic outcomes
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2019-10-25 |
Start Month Year | October 30, 2016 |
Primary Completion Month Year | August 13, 2018 |
Verification Month Year | October 2019 |
Verification Date | 2019-10-31 |
Last Update Posted Date | 2019-10-25 |
Detailed Descriptions
Sequence: | 20721570 |
Description | Aim: This study indented to assess the clinical and radiographic assessment of garlic extract as an intracanal irrigant for pulpectomy of primary molars.
Methodology: 91 child with 100 teeth submitted into this study were equally categorized into the test group (group 1) which irrigated with garlic extract and control group (group 2) that received sodium hypochlorite (NaOCl). Then, each group has been subjected to further specification according to the tooth preoperative clinical and radiographic features into has been into 2 subgroups. Clinical and radiographic success rates were checked at 3, 6 and 12 months. Fisher's exact test for binary variable was used for data analysis with p-value ≤ 0.05. |
Conditions
Sequence: | 52171078 |
Name | Infected Root Canals of Primary Molars |
Downcase Name | infected root canals of primary molars |
Id Information
Sequence: | 40158522 |
Id Source | org_study_id |
Id Value | 307 |
Design Groups
Sequence: | 55593015 | Sequence: | 55593016 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Garlic extracts root canal irrigation group | Title | Sodium hypochlorite root canal irrigation group |
Description | Experimental group treated with garlic extract
A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water |
Description | Control group which treated conventionally using .5 ml of 5.25% NaOCl (COLTENE®ENDO, Switzerland) |
Interventions
Sequence: | 52485325 | Sequence: | 52485326 |
Intervention Type | Other | Intervention Type | Other |
Name | Garlic extract | Name | NaOCl (COLTENE®) |
Description | A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water | Description | Sodium hypochlorite |
Keywords
Sequence: | 79868265 | Sequence: | 79868266 | Sequence: | 79868267 | Sequence: | 79868268 |
Name | Primary molars | Name | Garlic extract | Name | Sodium hypochlorite | Name | Pulpectomy |
Downcase Name | primary molars | Downcase Name | garlic extract | Downcase Name | sodium hypochlorite | Downcase Name | pulpectomy |
Design Outcomes
Sequence: | 177378222 | Sequence: | 177378223 | Sequence: | 177378224 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary |
Measure | oral examination | Measure | radiographic success or failure | Measure | Types of failures |
Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months |
Description | Pain assessment using Visual Analog Score for pain | Description | Radiographic assessment using periapical radiograph and score (0) applied for absence of radiolucency and score (1) for presence of radiolucency | Description | detecting the percent of different failure types accompanied with pulpectomy procedures after using garlic as an irrigant solution. |
Sponsors
Sequence: | 48319138 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Minia University |
Design Group Interventions
Sequence: | 68148949 | Sequence: | 68148950 |
Design Group Id | 55593015 | Design Group Id | 55593016 |
Intervention Id | 52485325 | Intervention Id | 52485326 |
Eligibilities
Sequence: | 30765258 |
Gender | All |
Minimum Age | 4 Years |
Maximum Age | 6 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Class I or II according to American Society of Anesthesiologists (ASA) 1. Normal radiographic findings 2. Interruption of lamina dura 3. Furcation radiolucency Exclusion Criteria: Specifications of exclusion Uncooperativeness of child and/or parents or caregivers behavior |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253876643 |
Registered In Calendar Year | 2019 |
Actual Duration | 21 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 4 |
Maximum Age Num | 6 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30511425 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Outcomes Assessor Masked | True |
Pending Results
Sequence: | 1500674 | Sequence: | 1500675 |
Event | Release | Event | Reset |
Event Date Description | February 11, 2020 | Event Date Description | February 26, 2020 |
Event Date | 2020-02-11 | Event Date | 2020-02-26 |
Responsible Parties
Sequence: | 28877719 |
Responsible Party Type | Principal Investigator |
Name | Ahmad Elheeny |
Title | Lecturer of pediatric dentistry |
Affiliation | Minia University |
Study References
Sequence: | 52063126 |
Pmid | 31452953 |
Reference Type | derived |
Citation | Elheeny AAH. Allium sativum extract as an irrigant in pulpectomy of primary molars: A 12-month short-term evaluation. Clin Exp Dent Res. 2019 Jun 26;5(4):420-426. doi: 10.1002/cre2.197. eCollection 2019 Aug. |
]]>
https://zephyrnet.com/NCT03795623
2019-02-01
https://zephyrnet.com/?p=NCT03795623
NCT03795623https://www.clinicaltrials.gov/study/NCT03795623?tab=tableNANANAPatients with severe brain injuries, such as ischemic stroke and intracranial hemorrhage, frequently require mechanical ventilation. Weaning of stroke patients is complicated by impaired consciousness and respiratory drive. Higher rates of weaning failure and delayed extubation (≥ 48h) lead to ventilator associated pneumonia, higher mortality and necessity of tracheostomy.
Therefore, improving the weaning of stroke patients from mechanical ventilation is warranted to prevent ventilator-associated complications and eventually improve clinical outcomes.
This single-center, randomized, clinical trial aims at demonstrating that voices of patients’ relatives support weaning from mechanical ventilation and reduce weaning failure in brain-injured patients.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-31 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-02-02 |
Start Month Year | February 1, 2019 |
Primary Completion Month Year | January 31, 2021 |
Verification Month Year | January 2023 |
Verification Date | 2023-01-31 |
Last Update Posted Date | 2023-02-02 |
Detailed Descriptions
Sequence: | 20551406 |
Description | Methods: Adult ICU-patients with controlled mechanical ventilation ≥48h due to a neurological disease will be included in the intensive care unit. A predefined text – including information on the patient's condition and recurrent request to breath in and out – will be recorded as an audio file by one of the patient's relatives. Patients will be randomly assigned in a 1:1 ratio to the conventional treatment arm or the Voice-Weaning arm. In the conventional arm, audio recordings will be muted by an independent person resulting in a mute recording without audio signals.
When conversion from controlled to assisted mechanical ventilation is intended according to standard treatment, audio recordings will be administered in repeat mode for 10 minutes and performed three times per day. If spontaneous breathing trials (SBT) are intended according to standard treatment, the audio recordings will be played during the SBT three times per day. Criteria for weaning not to be intended – according to Boles et al. (Weaning from mechanical ventilation. Eur Respir J. 2007) and adapted to neurological patients: Objective measurements: Unstable clinical condition Cardiovascular status (fC≥140/min, systolic BP <90mmHg or >180mmHg, more than minimal vasopressors) Inadequate oxygenation SaO2 ≤90% on FiO2 >40% or pO2/FiO2 <150mmHg or pO2/FiO2 <120mmHg in case of chronic hypoxemia (Horowitz index) Inadequate pulmonary function fR ≥35/min Unstable neurological condition sedation or inadequate mentation on sedation Clinical assessment: Inadequate cough Ethics Approval: The Institutional Review Board of the Friedrich-Alexander-Universität Erlangen-Nürnberg approved of the study on 13 November 2018. Sample Size Calculation: The sample size is computed with 80% power and a 5% α-risk for the hypothesis of Voice Weaning achieving a 15% absolute weaning failure reduction. The sample size is increased by 10% to correct for dropouts and lost to follow up: a maximum of 354 patients will be included and an interim analysis be performed after inclusion of 50% of the calculated subjects. |
Facilities
Sequence: | 198429036 |
Name | University of Giessen |
City | Gießen |
Country | Germany |
Conditions
Sequence: | 51734127 | Sequence: | 51734128 | Sequence: | 51734129 |
Name | Ventilator Weaning | Name | Weaning Failure | Name | Brain Injuries |
Downcase Name | ventilator weaning | Downcase Name | weaning failure | Downcase Name | brain injuries |
Id Information
Sequence: | 39810772 |
Id Source | org_study_id |
Id Value | 417_18 B |
Countries
Sequence: | 42209988 |
Name | Germany |
Removed | False |
Design Groups
Sequence: | 55154575 | Sequence: | 55154576 |
Group Type | Sham Comparator | Group Type | Experimental |
Title | Conventional arm | Title | Voice-Weaning arm |
Description | Muted audio recordings of the patients relatives. | Description | Audio recordings of the patients relatives including information on the patient's condition and recurrent request to breath in and out. |
Interventions
Sequence: | 52055742 | Sequence: | 52055743 |
Intervention Type | Other | Intervention Type | Other |
Name | Voice-Weaning | Name | Sham control |
Description | Audio recordings of patients' relatives for 10 minutes x 3 daily from initiation of assisted mechanical ventilation to extubation or ICU discharge. | Description | Muted audio recordings of patients' relatives for 10 minutes x 3 daily from initiation of assisted mechanical ventilation to extubation or ICU discharge. |
Keywords
Sequence: | 79154846 | Sequence: | 79154847 | Sequence: | 79154848 |
Name | Critical Illness | Name | Respiration Disorder | Name | Neurology |
Downcase Name | critical illness | Downcase Name | respiration disorder | Downcase Name | neurology |
Design Outcomes
Sequence: | 175959860 | Sequence: | 175959861 | Sequence: | 175959862 | Sequence: | 175959863 | Sequence: | 175959864 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Rate of weaning failure | Measure | Time of controlled ventilation | Measure | Rate of tracheotomy | Measure | All cause mortality rate at 90 days | Measure | Rate of ICU delirium |
Time Frame | first 28 days after start of ventilation, or until 48 hours after extubation, or discharge from intensive care, whichever came first | Time Frame | first 28 days after start of ventilation or discharge from intensive care, whichever came first | Time Frame | first 28 days after start of ventilation or discharge from intensive care, whichever came first | Time Frame | first 90 days after start of ventilation | Time Frame | first 28 days after start of ventilation or discharge from intensive care, whichever came first |
Description | Reintubation and/or resumption of ventilatory support following extubation or death following extubation or failed spontaneous breathing trial | Description | Proportion of patients requiring tracheotomy performed as percutaneous dilatative tracheotomy or surgical tracheotomy | Description | Development of delirium according to the Confusion Assessment Method for intensive care unit (CAM-ICU) |
Browse Conditions
Sequence: | 191727693 | Sequence: | 191727694 | Sequence: | 191727695 | Sequence: | 191727696 | Sequence: | 191727697 | Sequence: | 191727698 | Sequence: | 191727699 |
Mesh Term | Brain Injuries | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Craniocerebral Trauma | Mesh Term | Trauma, Nervous System | Mesh Term | Wounds and Injuries |
Downcase Mesh Term | brain injuries | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | craniocerebral trauma | Downcase Mesh Term | trauma, nervous system | Downcase Mesh Term | wounds and injuries |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47913313 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Erlangen-Nürnberg Medical School |
Overall Officials
Sequence: | 29030699 | Sequence: | 29030700 | Sequence: | 29030701 |
Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator |
Name | Hagen B. Huttner, MD, PhD | Name | Joji B. Kuramatsu, MD | Name | Maximilian I. Sprügel, MD |
Affiliation | University of Erlangen-Nürnberg Medical School, Department of Neurology, Germany | Affiliation | University of Erlangen-Nürnberg Medical School, Department of Neurology, Germany | Affiliation | University of Erlangen-Nürnberg Medical School, Department of Neurology, Germany |
Design Group Interventions
Sequence: | 67617438 | Sequence: | 67617439 |
Design Group Id | 55154576 | Design Group Id | 55154575 |
Intervention Id | 52055742 | Intervention Id | 52055743 |
Eligibilities
Sequence: | 30510448 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Intubation and controlled mechanical ventilation ≥48h due to a neurological disease Exclusion Criteria: Age < 18 years |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254052421 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 24 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30259521 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28640017 |
Responsible Party Type | Principal Investigator |
Name | Hagen B. Huttner |
Title | Principal Investigator |
Affiliation | University of Erlangen-Nürnberg Medical School |
]]>
https://zephyrnet.com/NCT03795610
2020-03-06
https://zephyrnet.com/?p=NCT03795610
NCT03795610https://www.clinicaltrials.gov/study/NCT03795610?tab=tableElaine Enge1eng@ucsd.eduNAThe purpose of this study is to investigate how effective the study drug IPI-549 is against types of cancers. IPI-549 is considered experimental because it is not approved by the US Food and Drug Administration (FDA) for the treatment of cancer.
Patients will be treated with 2 weeks of IPI-549, a specific PI3Kγ inhibitor. Tumor tissue for research purposes through core biopsies will be obtained prior to initiation of IPI-549 and at surgery.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-21 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2023-03-10 |
Start Month Year | March 6, 2020 |
Primary Completion Month Year | June 2023 |
Verification Month Year | March 2023 |
Verification Date | 2023-03-31 |
Last Update Posted Date | 2023-03-10 |
Detailed Descriptions
Sequence: | 20723420 |
Description | This is a phase 2 window of opportunity trial in patients with locally advanced head and neck cancer. A key objective is to provide the first proof that macrophage phenotype switching can be accomplished in humans and lay the groundwork for future trials of this novel approach to immune therapy. Patients who are candidates for surgical resection will be enrolled and treated with 2 weeks of IPI-549, a specific PI3Kγ inhibitor. Tumor tissue for research purposes through core biopsies will be obtained prior to initiation of IPI-549 and at surgery.
The study team hypothesizes that mRNA signatures of immune response will be increased in IPI-549-treated patients. For the efficacy endpoints, RECISTv1.1 will be used. |
Facilities
Sequence: | 200123964 |
Status | Recruiting |
Name | UC San Diego Moores Cancer Center |
City | La Jolla |
State | California |
Zip | 92093 |
Country | United States |
Conditions
Sequence: | 52175912 | Sequence: | 52175913 | Sequence: | 52175914 | Sequence: | 52175915 | Sequence: | 52175916 | Sequence: | 52175917 | Sequence: | 52175918 | Sequence: | 52175919 |
Name | Head and Neck Squamous Cell Carcinoma | Name | Head and Neck Cancer | Name | Head and Neck Carcinoma | Name | Head and Neck Cancer Stage IV | Name | Head and Neck Cancer Stage III | Name | HPV-Related Carcinoma | Name | HPV-Related Malignancy | Name | HPV-Related Squamous Cell Carcinoma |
Downcase Name | head and neck squamous cell carcinoma | Downcase Name | head and neck cancer | Downcase Name | head and neck carcinoma | Downcase Name | head and neck cancer stage iv | Downcase Name | head and neck cancer stage iii | Downcase Name | hpv-related carcinoma | Downcase Name | hpv-related malignancy | Downcase Name | hpv-related squamous cell carcinoma |
Id Information
Sequence: | 40161848 |
Id Source | org_study_id |
Id Value | 172058 |
Countries
Sequence: | 42572550 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55598338 |
Group Type | Experimental |
Title | Arm A: IPI-549 40 mg PO qdaily |
Description | Patients enrolled in Arm A will receive IPI-549 40 mg by mouth daily for at least 14 days |
Interventions
Sequence: | 52490003 |
Intervention Type | Drug |
Name | IPI-549 |
Description | 40mg by mouth (PO) every day (QD) for at least 14 days |
Keywords
Sequence: | 79874588 | Sequence: | 79874589 | Sequence: | 79874590 | Sequence: | 79874591 | Sequence: | 79874592 | Sequence: | 79874593 | Sequence: | 79874594 | Sequence: | 79874595 | Sequence: | 79874596 | Sequence: | 79874597 | Sequence: | 79874598 | Sequence: | 79874599 | Sequence: | 79874600 | Sequence: | 79874601 | Sequence: | 79874602 | Sequence: | 79874603 | Sequence: | 79874604 | Sequence: | 79874605 | Sequence: | 79874606 |
Name | HPV positive | Name | HPV negative | Name | HPV- | Name | HPV+ | Name | PI3K-γ | Name | microenvironment | Name | immunotherapy | Name | tumor | Name | resection | Name | PI3K | Name | cancer | Name | carcinoma | Name | malignancy | Name | head | Name | neck | Name | throat | Name | esophageal | Name | nasopharyngeal | Name | nasopharynx |
Downcase Name | hpv positive | Downcase Name | hpv negative | Downcase Name | hpv- | Downcase Name | hpv+ | Downcase Name | pi3k-γ | Downcase Name | microenvironment | Downcase Name | immunotherapy | Downcase Name | tumor | Downcase Name | resection | Downcase Name | pi3k | Downcase Name | cancer | Downcase Name | carcinoma | Downcase Name | malignancy | Downcase Name | head | Downcase Name | neck | Downcase Name | throat | Downcase Name | esophageal | Downcase Name | nasopharyngeal | Downcase Name | nasopharynx |
Design Outcomes
Sequence: | 177397508 | Sequence: | 177397509 | Sequence: | 177397510 | Sequence: | 177397511 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | PI3K-y changes | Measure | Changes of Myeloid composition | Measure | changes in T cell composition | Measure | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years |
Description | To detect IPI-549-induced changes in PI3Kγ-regulated signatures of immune suppression. | Description | Compare pre- vs. post-treatment tumor tissue | Description | T cell receptor (TCR) sequencing at baseline, surgery, end of treatment or at time of disease progression. | Description | To determine safety and tolerability of IPI-549 and change in tumor size in patients with locally advanced HNSCC |
Browse Conditions
Sequence: | 193504504 | Sequence: | 193504505 | Sequence: | 193504506 | Sequence: | 193504507 | Sequence: | 193504508 | Sequence: | 193504509 | Sequence: | 193504510 | Sequence: | 193504511 | Sequence: | 193504512 |
Mesh Term | Carcinoma | Mesh Term | Carcinoma, Squamous Cell | Mesh Term | Neoplasms | Mesh Term | Head and Neck Neoplasms | Mesh Term | Squamous Cell Carcinoma of Head and Neck | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms, Squamous Cell | Mesh Term | Neoplasms by Site |
Downcase Mesh Term | carcinoma | Downcase Mesh Term | carcinoma, squamous cell | Downcase Mesh Term | neoplasms | Downcase Mesh Term | head and neck neoplasms | Downcase Mesh Term | squamous cell carcinoma of head and neck | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms, squamous cell | Downcase Mesh Term | neoplasms by site |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48323436 | Sequence: | 48323437 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Ezra Cohen | Name | The V Foundation for Cancer Research |
Overall Officials
Sequence: | 29287671 |
Role | Principal Investigator |
Name | Ezra Cohen, MD |
Affiliation | University of California, San Diego |
Central Contacts
Sequence: | 12010070 | Sequence: | 12010071 |
Contact Type | primary | Contact Type | backup |
Name | Debanjali Ghosh, MA | Name | Elaine Eng |
Phone | 858-246-0357 | ||
d1ghosh@health.ucsd.edu | e1eng@ucsd.edu | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68155453 |
Design Group Id | 55598338 |
Intervention Id | 52490003 |
Eligibilities
Sequence: | 30767978 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Have locally advanced that is amenable to surgical resection Exclusion Criteria: Diagnosis of cutaneous squamous cell carcinoma (SCC) or Epstein-Barr virus (EBV) related nasopharynx cancer. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253927723 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30514138 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28880439 |
Responsible Party Type | Sponsor-Investigator |
Name | Ezra Cohen |
Title | Professor of Medicine |
Affiliation | University of California, San Diego |
Study References
Sequence: | 52068414 | Sequence: | 52068415 | Sequence: | 52068416 | Sequence: | 52068417 | Sequence: | 52068418 | Sequence: | 52068419 |
Pmid | 27179037 | Pmid | 27642729 | Pmid | 23518347 | Pmid | 22437938 | Pmid | 21665146 | Pmid | 19097774 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Kaneda MM, Cappello P, Nguyen AV, Ralainirina N, Hardamon CR, Foubert P, Schmid MC, Sun P, Mose E, Bouvet M, Lowy AM, Valasek MA, Sasik R, Novelli F, Hirsch E, Varner JA. Macrophage PI3Kgamma Drives Pancreatic Ductal Adenocarcinoma Progression. Cancer Discov. 2016 Aug;6(8):870-85. doi: 10.1158/2159-8290.CD-15-1346. Epub 2016 May 13. | Citation | Kaneda MM, Messer KS, Ralainirina N, Li H, Leem CJ, Gorjestani S, Woo G, Nguyen AV, Figueiredo CC, Foubert P, Schmid MC, Pink M, Winkler DG, Rausch M, Palombella VJ, Kutok J, McGovern K, Frazer KA, Wu X, Karin M, Sasik R, Cohen EE, Varner JA. PI3Kgamma is a molecular switch that controls immune suppression. Nature. 2016 Nov 17;539(7629):437-442. doi: 10.1038/nature19834. Epub 2016 Sep 19. Erratum In: Nature. 2017 Feb 2;542(7639):124. | Citation | De Palma M, Lewis CE. Macrophage regulation of tumor responses to anticancer therapies. Cancer Cell. 2013 Mar 18;23(3):277-86. doi: 10.1016/j.ccr.2013.02.013. | Citation | Gabrilovich DI, Ostrand-Rosenberg S, Bronte V. Coordinated regulation of myeloid cells by tumours. Nat Rev Immunol. 2012 Mar 22;12(4):253-68. doi: 10.1038/nri3175. | Citation | Schmid MC, Avraamides CJ, Dippold HC, Franco I, Foubert P, Ellies LG, Acevedo LM, Manglicmot JR, Song X, Wrasidlo W, Blair SL, Ginsberg MH, Cheresh DA, Hirsch E, Field SJ, Varner JA. Receptor tyrosine kinases and TLR/IL1Rs unexpectedly activate myeloid cell PI3kgamma, a single convergent point promoting tumor inflammation and progression. Cancer Cell. 2011 Jun 14;19(6):715-27. doi: 10.1016/j.ccr.2011.04.016. | Citation | Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026. |
]]>
https://zephyrnet.com/NCT03795597
2019-05-22
https://zephyrnet.com/?p=NCT03795597
NCT03795597https://www.clinicaltrials.gov/study/NCT03795597?tab=tableMary Lee, RNmailto:mlee@luc.edu708-327-2241In this protocol, the investigators hypothesize that the combination of intravenous busulfan and melphalan with carfilzomib will be an effective preparative regimen with acceptable toxicity for participants with multiple myeloma who are candidates for autologous stem cell transplantation. To test this hypothesis, the investigators designed a phase I/II trial combining IV busulfan 130 mg/m2 plus melphalan 140 mg combined with escalating doses of carfilzomib ranging from 20 mg/m2 to 45 mg/m2. These results will be compared with the center’s historical controls of participants treated with melphalan, busulfan and bortezomib.
<![CDATA[
Studies
Study First Submitted Date | 2018-10-17 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2021-04-26 |
Start Month Year | May 22, 2019 |
Primary Completion Month Year | November 1, 2022 |
Verification Month Year | April 2021 |
Verification Date | 2021-04-30 |
Last Update Posted Date | 2021-04-26 |
Detailed Descriptions
Sequence: | 20727227 |
Description | Participants enrolled in this study protocol will receive daily intravenous (IV) infusions of carfilzomib for a total of 4 days (Day-9, -8 and Days -2, -1). The first two daily infusions will be given at a fixed dose of 20 mg/m2 and the final two doses will be escalated from the standard dose of 27 mg/m2 to 56 mg/m2 in a Phase I design, based on toxicity. The busulfan will be administered for 2 days over 3 hours from D-7, -6, at 130 mg/m2 . This dose was found to be safe and equivalent to the standard daily dose of 3.2 mg/kg. The 3rd and 4th daily doses of IV Busulfan will be adjusted in order to yield a systemic plasma drug exposure represented by a daily area under the plasma concentration versus time curve (AUC) of approximately 5,000 millimoles-minute per dose (mM-min). These targeted plasma concentration of IV busulfan will be based on pharmacokinetics studies performed during the first day of IV busulfan. Melphalan will be given at a dose of 140 mg/m2 on Day -3. Each cohort will start with a goal of accruing three patients to determine the dose limiting toxicity. |
Facilities
Sequence: | 200159534 |
Status | Recruiting |
Name | Loyola University Medical Center |
City | Maywood |
State | Illinois |
Zip | 60153 |
Country | United States |
Facility Contacts
Sequence: | 28113759 | Sequence: | 28113760 |
Facility Id | 200159534 | Facility Id | 200159534 |
Contact Type | primary | Contact Type | backup |
Name | Patrick Stiff, MD | Name | Mary Lee, RN |
pstiff@lumc.edu | mlee@luc.edu | ||
Phone | 708-327-3148 | Phone | 708-327-2241 |
Browse Interventions
Sequence: | 96074372 | Sequence: | 96074373 | Sequence: | 96074374 | Sequence: | 96074375 | Sequence: | 96074376 | Sequence: | 96074377 | Sequence: | 96074378 | Sequence: | 96074379 | Sequence: | 96074380 | Sequence: | 96074381 |
Mesh Term | Melphalan | Mesh Term | Busulfan | Mesh Term | Antineoplastic Agents, Alkylating | Mesh Term | Alkylating Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antineoplastic Agents | Mesh Term | Myeloablative Agonists | Mesh Term | Immunosuppressive Agents | Mesh Term | Immunologic Factors | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | melphalan | Downcase Mesh Term | busulfan | Downcase Mesh Term | antineoplastic agents, alkylating | Downcase Mesh Term | alkylating agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | myeloablative agonists | Downcase Mesh Term | immunosuppressive agents | Downcase Mesh Term | immunologic factors | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52185613 |
Name | Multiple Myeloma |
Downcase Name | multiple myeloma |
Id Information
Sequence: | 40169154 |
Id Source | org_study_id |
Id Value | 209274 |
Countries
Sequence: | 42580737 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55609255 | Sequence: | 55609256 | Sequence: | 55609257 | Sequence: | 55609258 | Sequence: | 55609259 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | Carfilzomib IV at dose: 20 mg/m2 | Title | Carfilzomib IV at dose: 27 mg/m2 | Title | Carfilzomib IV at dose: 36 mg/m2 | Title | Carfilzomib IV at dose: 45 mg/m2 | Title | Carfilzomib IV at dose: 56 mg/m2 |
Description | The participants will receive Carfilzomib IV at dose: 20 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and Granulocyte-Colony stimulating factor (G-CSF) given daily until engraftment occurs. | Description | The participants will receive Carfilzomib IV at dose: 27 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs. | Description | The participants will receive Carfilzomib IV at dose: 36 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs. | Description | The participants will receive Carfilzomib IV at dose: 45 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs. | Description | The participants will receive Carfilzomib IV at dose: 56 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs. |
Interventions
Sequence: | 52499546 | Sequence: | 52499547 | Sequence: | 52499548 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Carfilzomib | Name | Busulfan IV | Name | Melphalan IV |
Description | Carfilzomib is an anti-cancer drug acting as a selective proteasome inhibitor that is used to treat Multiple Myeloma. | Description | Busulfan is an anti-cancer drug acting as a bifunctional alkylating agent that is used to treat Multiple Myeloma. | Description | Melphalan is an anti-cancer drug acting as alkylating agent that is used to treat Multiple Myeloma. |
Keywords
Sequence: | 79888957 | Sequence: | 79888958 | Sequence: | 79888959 | Sequence: | 79888960 | Sequence: | 79888961 |
Name | Multiple Myeloma | Name | Autologous | Name | Stem Cell Transplantation | Name | Bone Marrow Transplant | Name | Carfilzomib |
Downcase Name | multiple myeloma | Downcase Name | autologous | Downcase Name | stem cell transplantation | Downcase Name | bone marrow transplant | Downcase Name | carfilzomib |
Design Outcomes
Sequence: | 177432421 | Sequence: | 177432422 | Sequence: | 177432423 | Sequence: | 177432424 | Sequence: | 177432425 | Sequence: | 177432426 | Sequence: | 177432427 | Sequence: | 177432428 | Sequence: | 177432429 | Sequence: | 177432430 | Sequence: | 177432431 | Sequence: | 177432432 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | 36 participants evaluated for safety with treatment-related adverse events and grading by using CTCAE v4.0. | Measure | 36 participants evaluated for tolerability with treatment-related adverse events and grading by using CTCAE v4.0. | Measure | 36 participants evaluated for response to treatment by testing blood for multiple myeloma levels. | Measure | 36 participants evaluated for progression by testing blood for multiple myeloma levels. | Measure | 36 participants evaluated for overall survival by clinical visit or contact by phone. | Measure | 36 participants evaluated for absolute neutrophil count by testing white blood cells levels. | Measure | 36 participants evaluated for platelet engraftment by testing platelet count in blood cells. | Measure | 36 participants evaluated by oral exam to assess mucositis events and grading levels by using CTCAE v4.0. | Measure | 36 participants evaluated by the liver to assess Veno-occlusive disease and grading levels by using CTCAE v4.0. | Measure | 36 participants evaluated by a physical exam to assess peripheral neuropathy and grading by using CTCAE v4.0. | Measure | 36 participants evaluated for response to treatment by testing urine for multiple myeloma levels. | Measure | 36 participants evaluated for progression by testing urine for multiple myeloma levels. |
Time Frame | 3 years | Time Frame | 3 years | Time Frame | 100 days | Time Frame | 3 years | Time Frame | 3 years | Time Frame | 100 days | Time Frame | 100 days | Time Frame | 100 days | Time Frame | 100 days | Time Frame | 3 years | Time Frame | 100 days | Time Frame | 3 years |
Description | To determine the maximal tolerated dose of carfilzomib when added to busulfan and melphalan as a preparative regimen for high dose therapy with autologous hematopoietic transplantation for patients with multiply myeloma. | Description | To determine the maximal tolerated dose of carfilzomib when added to busulfan and melphalan as a preparative regimen for high dose therapy with autologous hematopoietic transplantation for patients with multiply myeloma. | Description | To evaluate complete, very good partial, partial and stable disease response rate for both clinical and biologic endpoints. | Description | Progression Free Survival | Description | Overall Survival | Description | Days to neutrophil engraftment: Absolute neutrophil count > 500/microliter | Description | Days to platelet engraftment: platelet count > 20,000/microliter untransfused | Description | Mucositis: CTCAE v 4.0 grade and severity | Description | Veno-occlusive disease | Description | Peripheral neuropathy greater than or equal to CTCAE V 4.0 Grade 3 | Description | To evaluate complete, very good partial, partial no stable disease response rate for both clinical and biologic endpoints | Description | Progression Free Survival |
Browse Conditions
Sequence: | 193540592 | Sequence: | 193540593 | Sequence: | 193540594 | Sequence: | 193540595 | Sequence: | 193540596 | Sequence: | 193540597 | Sequence: | 193540598 | Sequence: | 193540599 | Sequence: | 193540600 | Sequence: | 193540601 | Sequence: | 193540602 | Sequence: | 193540603 | Sequence: | 193540604 | Sequence: | 193540605 |
Mesh Term | Multiple Myeloma | Mesh Term | Neoplasms, Plasma Cell | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Hemostatic Disorders | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Paraproteinemias | Mesh Term | Blood Protein Disorders | Mesh Term | Hematologic Diseases | Mesh Term | Hemorrhagic Disorders | Mesh Term | Lymphoproliferative Disorders | Mesh Term | Immunoproliferative Disorders | Mesh Term | Immune System Diseases |
Downcase Mesh Term | multiple myeloma | Downcase Mesh Term | neoplasms, plasma cell | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | hemostatic disorders | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | paraproteinemias | Downcase Mesh Term | blood protein disorders | Downcase Mesh Term | hematologic diseases | Downcase Mesh Term | hemorrhagic disorders | Downcase Mesh Term | lymphoproliferative disorders | Downcase Mesh Term | immunoproliferative disorders | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332435 | Sequence: | 48332436 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Loyola University | Name | Amgen |
Overall Officials
Sequence: | 29293059 |
Role | Principal Investigator |
Name | Patrick Stiff, MD |
Affiliation | Loyola University |
Central Contacts
Sequence: | 12012332 | Sequence: | 12012333 |
Contact Type | primary | Contact Type | backup |
Name | Patrick Stiff, MD | Name | Mary Lee, RN |
Phone | 708-327-3148 | Phone | 708-327-2241 |
mailto:pstiff@lumc.edu | mailto:mlee@luc.edu | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68168331 | Sequence: | 68168332 | Sequence: | 68168333 | Sequence: | 68168334 | Sequence: | 68168335 | Sequence: | 68168336 | Sequence: | 68168337 | Sequence: | 68168338 | Sequence: | 68168339 | Sequence: | 68168340 | Sequence: | 68168341 | Sequence: | 68168342 | Sequence: | 68168343 | Sequence: | 68168344 | Sequence: | 68168345 |
Design Group Id | 55609255 | Design Group Id | 55609256 | Design Group Id | 55609257 | Design Group Id | 55609258 | Design Group Id | 55609259 | Design Group Id | 55609255 | Design Group Id | 55609256 | Design Group Id | 55609257 | Design Group Id | 55609258 | Design Group Id | 55609259 | Design Group Id | 55609255 | Design Group Id | 55609256 | Design Group Id | 55609257 | Design Group Id | 55609258 | Design Group Id | 55609259 |
Intervention Id | 52499546 | Intervention Id | 52499546 | Intervention Id | 52499546 | Intervention Id | 52499546 | Intervention Id | 52499546 | Intervention Id | 52499547 | Intervention Id | 52499547 | Intervention Id | 52499547 | Intervention Id | 52499547 | Intervention Id | 52499547 | Intervention Id | 52499548 | Intervention Id | 52499548 | Intervention Id | 52499548 | Intervention Id | 52499548 | Intervention Id | 52499548 |
Eligibilities
Sequence: | 30773647 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Participants must be greater than or equal to 18 years of age. Exclusion Criteria: Participants must not have below normal kidney function. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253953000 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 10 |
Designs
Sequence: | 30519778 |
Allocation | Non-Randomized |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Busulfan IV over 3 hours every 24 hours for a total of 4 doses from D-6 to D-3. First two daily infusions will be given at a fixed dose of 3.2 mg/kg over 3 hours from D-6 to D-5. The 3rd and 4th daily doses will be adjusted to an AUC of approximately 5,000 mMol-min per dose.
Melphalan 140 mg/ m2 IV over 15-30 minutes for one dose on day -3. Carfilzomib administration will follow a Phase I dose escalation design. Each cohort will start with a goal of accruing three patients to determine the dose limiting toxicities. Once the Maximum Tolerated Dose is established an expansion cohort will be treated to include a total of 10 additional patients. |
Intervention Other Names
Sequence: | 26680467 | Sequence: | 26680468 | Sequence: | 26680469 |
Intervention Id | 52499546 | Intervention Id | 52499547 | Intervention Id | 52499548 |
Name | Kyprolis | Name | Busulfex | Name | Alkeran |
Responsible Parties
Sequence: | 28886079 |
Responsible Party Type | Principal Investigator |
Name | Patrick Stiff |
Title | Principal Investigator |
Affiliation | Loyola University |
]]>
https://zephyrnet.com/NCT03795584
2018-05-01
https://zephyrnet.com/?p=NCT03795584
NCT03795584https://www.clinicaltrials.gov/study/NCT03795584?tab=tableYonghui Huang, MD13911765322@163.com86-10-13911765322Gallstones in the common bile duct (CBD) may be asymptomatic but may lead to complications such as acute cholangitis or acute pancreatitis. EST is widely used for the treatment of bile duct gallstones. Despite its efficacy and improvements over time, EST is still associated with complications such as hemorrhage, perforation, pancreatitis, and permanent loss of function of the sphincter of Oddi (SO). Permanent loss of SO function can cause duodenobiliary reflux, bacterial colonization of the biliary tract, gallstone recurrence, cholangitis, and liver abscess.
Endoscopic papillary balloon dilation (EPBD) was first proposed in 1983 and it is now recognized as an alternative technique for the removal of CBD gallstones. The small balloon (diameter <8 mm) is less invasive, reduces the occurrence of adverse effects, and preserves the SO function, but it has limitations in the presence of CBD gallstones ≥10 mm in diameter. EST combined with endoscopic papillary large-balloon dilation (EPLBD) has been introduced for patients with large gallstone, but EPLBD widens the distal common bile duct and still may cause SO function damage, partially or completely. Repairing the ampulla of Vater and SO may reduce the long-term complication rates, especially gallstone recurrence. Unfortunately, no efficient strategy has been proposed. The present pilot study aimed to examine the feasibility and efficiency of an innovative strategy named endoclip papilloplasty to repair the damaged ampulla and recover SO function. The advantage of this device is that it can be rotated clockwise or counterclockwise by turning the handle until the correct position is achieved. Another advantage is if the clip is not in desired position, it may be re-opened and repositioned. Once satisfying clip positioning is achieved, the clip can be firmly attached to the tissue by pulling the slider back until tactile resistance is felt in the handle.
<![CDATA[
Studies
Study First Submitted Date | 2018-06-12 |
Study First Posted Date | 2019-01-08 |
Last Update Posted Date | 2020-08-05 |
Start Month Year | May 1, 2018 |
Primary Completion Month Year | March 21, 2019 |
Verification Month Year | August 2020 |
Verification Date | 2020-08-31 |
Last Update Posted Date | 2020-08-05 |
Detailed Descriptions
Sequence: | 20716330 |
Description | Gallstones in the common bile duct (CBD) may be asymptomatic but may lead to complications such as acute cholangitis or acute pancreatitis. EST is widely used for the treatment of bile duct gallstones. Despite its efficacy and improvements over time, EST is still associated with complications such as hemorrhage, perforation, pancreatitis, and permanent loss of function of the sphincter of Oddi (SO). Permanent loss of SO function can cause duodenobiliary reflux, bacterial colonization of the biliary tract, gallstone recurrence, cholangitis, and liver abscess.
Endoscopic papillary balloon dilation (EPBD) was first proposed in 1983 and it is now recognized as an alternative technique for the removal of CBD gallstones. The small balloon (diameter <8 mm) is less invasive, reduces the occurrence of adverse effects, and preserves the SO function, but it has limitations in the presence of CBD gallstones ≥10 mm in diameter. EST combined with endoscopic papillary large-balloon dilation (EPLBD) has been introduced for patients with large gallstone, but EPLBD widens the distal common bile duct and still may cause SO function damage, partially or completely. Repairing the ampulla of Vater and SO may reduce the long-term complication rates, especially gallstone recurrence. Unfortunately, no efficient strategy has been proposed. The present pilot study aimed to examine the feasibility and efficiency of an innovative strategy named endoclip papilloplasty to repair the damaged ampulla and recover SO function. The advantage of this device is that it can be rotated clockwise or counterclockwise by turning the handle until the correct position is achieved. Another advantage is if the clip is not in desired position, it may be re-opened and repositioned. Once satisfying clip positioning is achieved, the clip can be firmly attached to the tissue by pulling the slider back until tactile resistance is felt in the handle. The investigators will recruit patients according to admission criteria and exclusion criteria. The participants underwent SOM before, immediately after EST, and 3 weeks after EST with endoclip papilloplasty. The participants were followed for 3 days during hospitalized. Complications including perforation, bleeding, and PEP were recorded. Blood routine, pancreatic enzymes (amylase and lipase), and liver function (serum alanine aminotransferase, aspartate aminotransferase, r-glutamyl transpeptidase, and alkaline phosphatase) were tested at 4 and 24 h after ERCP. All participants were followed at 3 weeks. Symptoms were examined and blood tests as above were repeated ahead of stents retrieval and sphincter of Oddi monitoring through duodenoscope. |
Facilities
Sequence: | 200053465 |
Status | Recruiting |
Name | Peking University Third Hosptial |
City | Beijing |
State | Beijing |
Zip | 100000 |
Country | China |
Facility Contacts
Sequence: | 28097581 |
Facility Id | 200053465 |
Contact Type | primary |
Name | Yonghui Huang, archiater |
pskyq@163.com | |
Phone | 13911765322 |
Browse Interventions
Sequence: | 96027937 | Sequence: | 96027938 |
Mesh Term | Hemostatics | Mesh Term | Coagulants |
Downcase Mesh Term | hemostatics | Downcase Mesh Term | coagulants |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52156581 |
Name | Sphincter of Oddi Function |
Downcase Name | sphincter of oddi function |
Id Information
Sequence: | 40148264 |
Id Source | org_study_id |
Id Value | HYH20180520 |
Countries
Sequence: | 42557800 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55577985 |
Title | Endoclip papillaplasty |
Description | Endoclip papilloplasty was performed to repair the Oddi sphincter using sterile repositionable hemostasis clipping device (Micro-tech (Nanjing), Co., Ltd.; stainless-steel). The participants underwent SOM before, immediately after EST, and 3 weeks after EST with endoclip papilloplasty. The participants were followed for 3 days during hospitalized. |
Interventions
Sequence: | 52472085 |
Intervention Type | Procedure |
Name | sterile repositionable hemostasis clipping device close the large duodenal papilla incision |
Description | After the bile duct stent was placed, the investigators can use sterile repositionable hemostasis clipping device to close large duodenal papilla incision at 11 o'clock on the duodenal papilla. |
Design Outcomes
Sequence: | 177328362 | Sequence: | 177328363 |
Outcome Type | primary | Outcome Type | secondary |
Measure | SO manometric data | Measure | Frequency of use of ML and the incidence of adverse events |
Time Frame | Before operation、During operation、Three weeks after operation | Time Frame | Three weeks after operation |
Description | The comparison of the SO manometric data before and after the procedure | Description | Measure the frequency of use of ML and the incidence of adverse events, and to evaluate the healing of the ampulla. |
Sponsors
Sequence: | 48306169 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Peking University Third Hospital |
Overall Officials
Sequence: | 29277988 |
Role | Study Director |
Name | Yonghui Huang, MD |
Affiliation | Peking University Third Hosptial |
Central Contacts
Sequence: | 12004761 |
Contact Type | primary |
Name | Yonghui Huang, MD |
Phone | 86-10-13911765322 |
13911765322@163.com | |
Role | Contact |
Design Group Interventions
Sequence: | 68130957 |
Design Group Id | 55577985 |
Intervention Id | 52472085 |
Eligibilities
Sequence: | 30757404 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 85 Years |
Healthy Volunteers | No |
Population | This was a prospective pilot study of consecutive patients with CBD gallstones (transverse diameter ≥10 mm) who were treated at the Gastroenterology Department of Peking University Third Hospital by large-EST combined with endoclip papilloplasty between May 2018 and March 2019. |
Criteria | Inclusion Criteria:
– 1)18-85 years of age; 2) informed consent obtained before ERCP; 3) CBD diameter ≥12 mm; 4) CBD gallstones visualized at magnetic resonance cholangiopancreatography (MRCP) with at least one gallstone ≥10 mm (transverse diameter) Exclusion Criteria: gallstone transverse diameter >35 mm, which is not appropriate to be extracted; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254228989 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 10 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 85 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30503629 |
Observational Model | Case-Only |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28869907 |
Responsible Party Type | Principal Investigator |
Name | Huang Yonghui |
Title | chief physician |
Affiliation | Peking University Third Hospital |
]]>
https://zephyrnet.com/NCT03795571
2019-01-01
https://zephyrnet.com/?p=NCT03795571
NCT03795571https://www.clinicaltrials.gov/study/NCT03795571?tab=tableHuayuan Zhu, PhD& MDhuayuan.zhu@hotmail.com86 25 68306034Previous study showed that Lenalidomide or R-GDP could achieve response in Relapse and Refractory DLBCL.The investigators therefore design this phase I study to investigate the safety and efficacy of R2-GOD in relapsed diffuse large-cell lymphoma.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-01 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2019-02-15 |
Start Month Year | January 1, 2019 |
Primary Completion Month Year | December 31, 2019 |
Verification Month Year | February 2019 |
Verification Date | 2019-02-28 |
Last Update Posted Date | 2019-02-15 |
Facilities
Sequence: | 200244112 |
Status | Recruiting |
Name | The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital |
City | Nanjing |
State | Jiangsu |
Zip | 210000 |
Country | China |
Facility Contacts
Sequence: | 28127955 |
Facility Id | 200244112 |
Contact Type | primary |
Name | Huayuan Zhu, PhD,MD |
huayuan.zhu@hotmail.com | |
Phone | +86 68136034 |
Browse Interventions
Sequence: | 96112984 | Sequence: | 96112961 | Sequence: | 96112962 | Sequence: | 96112963 | Sequence: | 96112964 | Sequence: | 96112965 | Sequence: | 96112966 | Sequence: | 96112967 | Sequence: | 96112968 | Sequence: | 96112969 | Sequence: | 96112970 | Sequence: | 96112971 | Sequence: | 96112972 | Sequence: | 96112973 | Sequence: | 96112974 | Sequence: | 96112975 | Sequence: | 96112976 | Sequence: | 96112977 | Sequence: | 96112978 | Sequence: | 96112979 | Sequence: | 96112980 | Sequence: | 96112981 | Sequence: | 96112982 | Sequence: | 96112983 | Sequence: | 96112985 | Sequence: | 96112986 |
Mesh Term | Angiogenesis Modulating Agents | Mesh Term | Dexamethasone | Mesh Term | Rituximab | Mesh Term | Gemcitabine | Mesh Term | Oxaliplatin | Mesh Term | Lenalidomide | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Antineoplastic Agents | Mesh Term | Immunologic Factors | Mesh Term | Physiological Effects of Drugs | Mesh Term | Antirheumatic Agents | Mesh Term | Anti-Inflammatory Agents | Mesh Term | Antiemetics | Mesh Term | Autonomic Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Gastrointestinal Agents | Mesh Term | Glucocorticoids | Mesh Term | Hormones | Mesh Term | Hormones, Hormone Substitutes, and Hormone Antagonists | Mesh Term | Antineoplastic Agents, Hormonal | Mesh Term | Antimetabolites, Antineoplastic | Mesh Term | Antimetabolites | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Angiogenesis Inhibitors | Mesh Term | Growth Substances | Mesh Term | Growth Inhibitors |
Downcase Mesh Term | angiogenesis modulating agents | Downcase Mesh Term | dexamethasone | Downcase Mesh Term | rituximab | Downcase Mesh Term | gemcitabine | Downcase Mesh Term | oxaliplatin | Downcase Mesh Term | lenalidomide | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | immunologic factors | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | antirheumatic agents | Downcase Mesh Term | anti-inflammatory agents | Downcase Mesh Term | antiemetics | Downcase Mesh Term | autonomic agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | gastrointestinal agents | Downcase Mesh Term | glucocorticoids | Downcase Mesh Term | hormones | Downcase Mesh Term | hormones, hormone substitutes, and hormone antagonists | Downcase Mesh Term | antineoplastic agents, hormonal | Downcase Mesh Term | antimetabolites, antineoplastic | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | angiogenesis inhibitors | Downcase Mesh Term | growth substances | Downcase Mesh Term | growth inhibitors |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52207990 | Sequence: | 52207991 |
Name | Diffuse Large B-cell Lymphoma Recurrent | Name | Diffuse Large B Cell Lymphoma Refractory |
Downcase Name | diffuse large b-cell lymphoma recurrent | Downcase Name | diffuse large b cell lymphoma refractory |
Id Information
Sequence: | 40186095 |
Id Source | org_study_id |
Id Value | R2-GOD regimen |
Countries
Sequence: | 42599596 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55634588 |
Group Type | Experimental |
Title | R2-GOD |
Interventions
Sequence: | 52522007 | Sequence: | 52522008 | Sequence: | 52522009 | Sequence: | 52522010 | Sequence: | 52522011 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Rituximab | Name | Gemcitabine | Name | Oxaliplatin | Name | Dexamethasone | Name | Lenalidomide Oral Capsule |
Description | Rituximab 375mg/m2,d0 | Description | Gemcitabine 1000mg/m2,d1,d5 | Description | Oxaliplatin 75mg/m2,d1 | Description | Dexamethasone 40mg/d,d1~d4 | Description | Lenalidomide 10mg/d、15mg/d、20mg/d、25mg/d d1~d10; 21days a cycle |
Keywords
Sequence: | 79922863 | Sequence: | 79922864 | Sequence: | 79922865 |
Name | lenalidomide | Name | R-GOD | Name | DLBCL |
Downcase Name | lenalidomide | Downcase Name | r-god | Downcase Name | dlbcl |
Design Outcomes
Sequence: | 177510991 | Sequence: | 177510992 | Sequence: | 177510993 | Sequence: | 177510994 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | maximum tolerated dose and dose limited toxicity | Measure | Overall response rate, | Measure | Progressive free survival | Measure | Overall survival |
Time Frame | 28 days after first cycle of R2-GOD regimen | Time Frame | 6 months | Time Frame | 2 years | Time Frame | 2 years |
Description | overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R2-GOD regimen regimen | Description | from date of inclusion to date of progression, relapse, or death from any causePFS:from date of inclusion to date of progression, relapse, or death from any cause | Description | from the date of inclusion to date of death, irrespective of cause |
Browse Conditions
Sequence: | 193626704 | Sequence: | 193626705 | Sequence: | 193626706 | Sequence: | 193626707 | Sequence: | 193626708 | Sequence: | 193626709 | Sequence: | 193626710 | Sequence: | 193626711 | Sequence: | 193626712 | Sequence: | 193626703 |
Mesh Term | Lymphoma, B-Cell | Mesh Term | Lymphoma, Large B-Cell, Diffuse | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Lymphoproliferative Disorders | Mesh Term | Lymphatic Diseases | Mesh Term | Immunoproliferative Disorders | Mesh Term | Immune System Diseases | Mesh Term | Lymphoma, Non-Hodgkin | Mesh Term | Lymphoma |
Downcase Mesh Term | lymphoma, b-cell | Downcase Mesh Term | lymphoma, large b-cell, diffuse | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lymphoproliferative disorders | Downcase Mesh Term | lymphatic diseases | Downcase Mesh Term | immunoproliferative disorders | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | lymphoma, non-hodgkin | Downcase Mesh Term | lymphoma |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list |
Sponsors
Sequence: | 48353630 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | The First Affiliated Hospital with Nanjing Medical University |
Overall Officials
Sequence: | 29305948 |
Role | Principal Investigator |
Name | Wei Xu, PhD& MD |
Affiliation | The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital) |
Central Contacts
Sequence: | 12017195 |
Contact Type | primary |
Name | Huayuan Zhu, PhD& MD |
Phone | 86 25 68306034 |
huayuan.zhu@hotmail.com | |
Role | Contact |
Design Group Interventions
Sequence: | 68199105 | Sequence: | 68199106 | Sequence: | 68199107 | Sequence: | 68199108 | Sequence: | 68199109 |
Design Group Id | 55634588 | Design Group Id | 55634588 | Design Group Id | 55634588 | Design Group Id | 55634588 | Design Group Id | 55634588 |
Intervention Id | 52522007 | Intervention Id | 52522008 | Intervention Id | 52522009 | Intervention Id | 52522010 | Intervention Id | 52522011 |
Eligibilities
Sequence: | 30786832 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age 18-65 years old; Histologically confirmed diffuse large B cell lymphoma(With exception of Primary mediastinal large B cell lymphoma、Primary central nervous system lymphoma、HIV-related lymphoma),relapse or refractory,defined as: relapse after standard first-line immunochemotherapy( R-CHOP or R-CHOP like) Exclusion Criteria: Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989549 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30532902 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28899196 |
Responsible Party Type | Principal Investigator |
Name | WEI XU |
Title | Professor |
Affiliation | The First Affiliated Hospital with Nanjing Medical University |
Study References
Sequence: | 52102980 | Sequence: | 52102981 | Sequence: | 52102982 | Sequence: | 52102983 |
Pmid | 24661044 | Pmid | 26847165 | Pmid | 25267740 | Pmid | 29752199 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Feldman T, Mato AR, Chow KF, Protomastro EA, Yannotti KM, Bhattacharyya P, Yang X, Donato ML, Rowley SD, Carini C, Valentinetti M, Smith J, Gadaleta G, Bejot C, Stives S, Timberg M, Kdiry S, Pecora AL, Beaven AW, Goy A. Addition of lenalidomide to rituximab, ifosfamide, carboplatin, etoposide (RICER) in first-relapse/primary refractory diffuse large B-cell lymphoma. Br J Haematol. 2014 Jul;166(1):77-83. doi: 10.1111/bjh.12846. Epub 2014 Mar 25. | Citation | Martin A, Redondo AM, Dlouhy I, Salar A, Gonzalez-Barca E, Canales M, Montes-Moreno S, Ocio EM, Lopez-Guillermo A, Caballero D; Spanish Group for Lymphomas and Autologous Bone Marrow (GELTAMO). Lenalidomide in combination with R-ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: a phase 1b study from GELTAMO group. Br J Haematol. 2016 Apr;173(2):245-52. doi: 10.1111/bjh.13945. Epub 2016 Feb 5. | Citation | Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. doi: 10.1200/JCO.2013.53.9593. Epub 2014 Sep 29. | Citation | Shen QD, Zhu HY, Wang L, Fan L, Liang JH, Cao L, Wu W, Xia Y, Li JY, Xu W. Gemcitabine-oxaliplatin plus rituximab (R-GemOx) as first-line treatment in elderly patients with diffuse large B-cell lymphoma: a single-arm, open-label, phase 2 trial. Lancet Haematol. 2018 Jun;5(6):e261-e269. doi: 10.1016/S2352-3026(18)30054-1. Epub 2018 May 8. |
]]>
https://zephyrnet.com/NCT03795558
2019-05-01
https://zephyrnet.com/?p=NCT03795558
NCT03795558https://www.clinicaltrials.gov/study/NCT03795558?tab=tableNANANAThis is a single-center, prospective, dose-escalation, pilot study in 15 end-stage renal disease patients on chronic hemodialysis with secondary hyperparathyroidism.
<![CDATA[
Studies
Study First Submitted Date | 2018-09-18 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2022-03-23 |
Start Month Year | May 1, 2019 |
Primary Completion Month Year | December 21, 2021 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-03-23 |
Detailed Descriptions
Sequence: | 20588758 |
Description | Fifteen prevalent and stable hemodialysis patients with secondary hyperparathyroidism eligible for treatment with calcium receptor sensitizers according to current KDIGO will be included.
Study phases will begin and end on the day of the first hemodialysis session of the week. The run-in phase will last 4 weeks. No calcimimetics will be prescribed during the run-in phase. The treatment phase starts with a dose of etelcalcetide is 2.5mg thrice weekly. Etelcalcetide dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly. The wash-out Phase starts after completion of the 15mg thrice-weekly phase or in case a pre-specified safety endpoint is reached, etelcalcetide will be discontinued and patients will be followed for additional 8 weeks to study any potential reversibility of PTH lowering on T50 results. For the individual patient, the study duration will be 9 months |
Facilities
Sequence: | 198738355 |
Name | Ordensklinikum Linz GmbH Elisabethinen |
City | Linz |
State | Upper Austria |
Zip | 4020 |
Country | Austria |
Conditions
Sequence: | 51829160 |
Name | End Stage Renal Disease |
Downcase Name | end stage renal disease |
Id Information
Sequence: | 39885430 |
Id Source | org_study_id |
Id Value | Etelcalcetide-T50-CKD5D |
Countries
Sequence: | 42283957 |
Name | Austria |
Removed | False |
Design Groups
Sequence: | 55252117 | Sequence: | 55252112 | Sequence: | 55252113 | Sequence: | 55252114 | Sequence: | 55252115 | Sequence: | 55252116 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | Etelcalcetide 15 mg | Title | Etelcalcetide 2.5 mg | Title | Etelcalcetide 5 mg | Title | Etelcalcetide 7,5 mg | Title | Etelcalcetide 10 mg | Title | Etelcalcetide 12,5 mg |
Description | Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly | Description | Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly | Description | Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly | Description | Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly | Description | Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly | Description | Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly |
Interventions
Sequence: | 52150124 |
Intervention Type | Drug |
Name | Etelcalcetide |
Description | Up-Titration |
Design Outcomes
Sequence: | 176273042 |
Outcome Type | primary |
Measure | T50-Laboratory Test for measuring calcification |
Time Frame | 32 weeks |
Description | The changes in T50 values between the different study phases will be evaluated as the primary outcome. |
Browse Conditions
Sequence: | 192106952 | Sequence: | 192106948 | Sequence: | 192106949 | Sequence: | 192106950 | Sequence: | 192106951 | Sequence: | 192106953 | Sequence: | 192106954 | Sequence: | 192106955 | Sequence: | 192106956 | Sequence: | 192106957 | Sequence: | 192106958 | Sequence: | 192106959 |
Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Kidney Failure, Chronic | Mesh Term | Kidney Diseases | Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Urogenital Diseases | Mesh Term | Male Urogenital Diseases | Mesh Term | Renal Insufficiency, Chronic | Mesh Term | Renal Insufficiency | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | kidney failure, chronic | Downcase Mesh Term | kidney diseases | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | male urogenital diseases | Downcase Mesh Term | renal insufficiency, chronic | Downcase Mesh Term | renal insufficiency | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48001221 | Sequence: | 48001222 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Prim. Priv. Doz. Dr. Daniel Cejka | Name | Amgen |
Overall Officials
Sequence: | 29084329 |
Role | Principal Investigator |
Name | Daniel Cejka, Md |
Affiliation | Head of Nephrology |
Design Group Interventions
Sequence: | 67736273 | Sequence: | 67736274 | Sequence: | 67736275 | Sequence: | 67736276 | Sequence: | 67736277 | Sequence: | 67736278 |
Design Group Id | 55252115 | Design Group Id | 55252116 | Design Group Id | 55252117 | Design Group Id | 55252112 | Design Group Id | 55252113 | Design Group Id | 55252114 |
Intervention Id | 52150124 | Intervention Id | 52150124 | Intervention Id | 52150124 | Intervention Id | 52150124 | Intervention Id | 52150124 | Intervention Id | 52150124 |
Eligibilities
Sequence: | 30564637 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Prevalent patients (≥ 3 months on dialysis) treated with thrice weekly hemodialysis (HD) or hemodiafiltration (HDF) Exclusion Criteria: Currently receiving treatment in another investigational device or drug study or participation in non-interventional studies |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254259138 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 32 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30312915 |
Allocation | Non-Randomized |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Diagnostic |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | This is a single-center, prospective, dose-escalation, pilot study. Starting dose 2.5 mg thrice weekly dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly. |
Intervention Other Names
Sequence: | 26509167 |
Intervention Id | 52150124 |
Name | Parsabiv |
Responsible Parties
Sequence: | 28691556 |
Responsible Party Type | Sponsor-Investigator |
Name | Prim. Priv. Doz. Dr. Daniel Cejka |
Title | Head of Nephrology department |
Affiliation | Elisabethinen Hospital |
]]>
https://zephyrnet.com/NCT03795545
2019-01-11
https://zephyrnet.com/?p=NCT03795545
NCT03795545https://www.clinicaltrials.gov/study/NCT03795545?tab=tableNANANAUltraslow full-power SWL versus slow power-ramping SWL in ureteric stones with high attenuation value
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2019-12-10 |
Start Month Year | January 11, 2019 |
Primary Completion Month Year | July 16, 2019 |
Verification Month Year | December 2019 |
Verification Date | 2019-12-31 |
Last Update Posted Date | 2019-12-10 |
Detailed Descriptions
Sequence: | 20741102 |
Description | To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL |
Facilities
Sequence: | 200280141 |
Name | Beni-Suef Hospitals |
City | Banī Suwayf |
State | Outside U.S./Canada |
Country | Egypt |
Conditions
Sequence: | 52221355 |
Name | Ureteric Stone |
Downcase Name | ureteric stone |
Id Information
Sequence: | 40195507 |
Id Source | org_study_id |
Id Value | 16231 |
Countries
Sequence: | 42609498 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55649598 | Sequence: | 55649599 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | Ultraslow shock wave lithotripsy (SWL) | Title | Slow power-ramping SWL |
Description | SWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes.
The rest of the session at 22kv (full power). |
Description | SWL at a slow rate of 60 SW/min. Power ramping from 6 – 10 kv during the first 500 SW then from 11 – 14 kv during the second 500 SW then from 15 – 18 kv during the following 500 SW then from 19 – 22 kv during the remaining 1000 – 1500 SW. |
Interventions
Sequence: | 52535125 |
Intervention Type | Procedure |
Name | SWL |
Description | Shock wave lithotripsy |
Keywords
Sequence: | 79941537 | Sequence: | 79941538 | Sequence: | 79941539 | Sequence: | 79941540 | Sequence: | 79941541 | Sequence: | 79941542 | Sequence: | 79941543 |
Name | ureteric stone | Name | SWL | Name | High density stones | Name | Ultraslow SWL | Name | Slow SWL | Name | Ramping | Name | Pause |
Downcase Name | ureteric stone | Downcase Name | swl | Downcase Name | high density stones | Downcase Name | ultraslow swl | Downcase Name | slow swl | Downcase Name | ramping | Downcase Name | pause |
Design Outcomes
Sequence: | 177560766 | Sequence: | 177560767 |
Outcome Type | primary | Outcome Type | secondary |
Measure | stone free rate | Measure | Complications rate |
Time Frame | 3 months following last session of SWL | Time Frame | 3 months following last session of SWL |
Description | Complete clearance of stones in addition to clinically insignificant residual fragments | Description | Comparison of rate of complications in both groups |
Browse Conditions
Sequence: | 193677830 | Sequence: | 193677831 | Sequence: | 193677832 | Sequence: | 193677833 | Sequence: | 193677834 | Sequence: | 193677835 | Sequence: | 193677836 | Sequence: | 193677837 | Sequence: | 193677838 | Sequence: | 193677839 | Sequence: | 193677840 | Sequence: | 193677841 |
Mesh Term | Ureteral Calculi | Mesh Term | Ureterolithiasis | Mesh Term | Calculi | Mesh Term | Pathological Conditions, Anatomical | Mesh Term | Ureteral Diseases | Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Urolithiasis | Mesh Term | Urinary Calculi | Mesh Term | Male Urogenital Diseases |
Downcase Mesh Term | ureteral calculi | Downcase Mesh Term | ureterolithiasis | Downcase Mesh Term | calculi | Downcase Mesh Term | pathological conditions, anatomical | Downcase Mesh Term | ureteral diseases | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | urolithiasis | Downcase Mesh Term | urinary calculi | Downcase Mesh Term | male urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366261 | Sequence: | 48366262 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Cairo University | Name | Beni-Suef University |
Overall Officials
Sequence: | 29312829 |
Role | Study Director |
Name | Ahmad Aref Al-Dessoukey, Ass. Prof. |
Affiliation | Beni-Suef University |
Design Group Interventions
Sequence: | 68217118 | Sequence: | 68217119 |
Design Group Id | 55649599 | Design Group Id | 55649598 |
Intervention Id | 52535125 | Intervention Id | 52535125 |
Eligibilities
Sequence: | 30794604 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
single upper ureteric stone less than or equal to 2 cm Exclusion Criteria: Abnormal renal anatomy |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004123 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 6 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30540644 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Subject Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26696872 |
Intervention Id | 52535125 |
Name | ESWL |
Responsible Parties
Sequence: | 28906963 |
Responsible Party Type | Principal Investigator |
Name | Mohammed Said ElSheemy |
Title | Associate Professor of Urology |
Affiliation | Cairo University |
]]>
https://zephyrnet.com/NCT03795532
2019-01-11
https://zephyrnet.com/?p=NCT03795532
NCT03795532https://www.clinicaltrials.gov/study/NCT03795532?tab=tableAhmad Aref Al-Dessoukey, Ass. Prof.NANAUltraslow full-power SWL versus slow power-ramping SWL in Renal stones with high attenuation value
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2019-01-23 |
Start Month Year | January 11, 2019 |
Primary Completion Month Year | May 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-23 |
Detailed Descriptions
Sequence: | 20709990 |
Description | To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL for renal stones |
Facilities
Sequence: | 199965080 |
Status | Recruiting |
Name | Beni-Suef Hospitals |
City | Banī Suwayf |
State | Outside U.S./Canada |
Country | Egypt |
Facility Contacts
Sequence: | 28086651 |
Facility Id | 199965080 |
Contact Type | primary |
Name | A AlDessoukey, Ass. Prof. |
Facility Investigators
Sequence: | 18318892 |
Facility Id | 199965080 |
Role | Principal Investigator |
Name | Mohammed S ElSheemy, A Professor |
Conditions
Sequence: | 52139012 |
Name | Renal Stones |
Downcase Name | renal stones |
Id Information
Sequence: | 40135069 |
Id Source | org_study_id |
Id Value | 16224 |
Countries
Sequence: | 42542693 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55559362 | Sequence: | 55559363 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | Ultraslow shock wave lithotripsy (SWL) | Title | Slow power-ramping SWL |
Description | SWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes. The rest of the session at 22kv (full power). | Description | SWL at a slow rate of 60 SW/min. Power ramping from 6 – 10 kv during the first 500 SW then from 11 – 14 kv during the second 500 SW then from 15 – 18 kv during the following 500 SW then from 19 – 22 kv during the remaining 1000 – 1500 SW. |
Interventions
Sequence: | 52454916 |
Intervention Type | Procedure |
Name | SWL |
Description | Shock wave lithotripsy |
Keywords
Sequence: | 79822833 | Sequence: | 79822834 | Sequence: | 79822835 | Sequence: | 79822836 | Sequence: | 79822837 | Sequence: | 79822838 | Sequence: | 79822839 |
Name | renal stones | Name | SWL | Name | High density stones | Name | Ultraslow SWL | Name | Slow SWL | Name | Ramping | Name | Pause |
Downcase Name | renal stones | Downcase Name | swl | Downcase Name | high density stones | Downcase Name | ultraslow swl | Downcase Name | slow swl | Downcase Name | ramping | Downcase Name | pause |
Design Outcomes
Sequence: | 177263760 | Sequence: | 177263761 |
Outcome Type | primary | Outcome Type | secondary |
Measure | stone free rate | Measure | Complications rate |
Time Frame | 3 months following last session of SWL | Time Frame | 3 months following last session of SWL |
Description | Complete clearance of stones in addition to clinically insignificant residual fragments | Description | Comparison of rate of complications in both groups |
Browse Conditions
Sequence: | 193366556 | Sequence: | 193366557 | Sequence: | 193366558 | Sequence: | 193366559 | Sequence: | 193366560 | Sequence: | 193366561 | Sequence: | 193366562 | Sequence: | 193366563 | Sequence: | 193366564 | Sequence: | 193366565 | Sequence: | 193366566 | Sequence: | 193366567 |
Mesh Term | Kidney Calculi | Mesh Term | Nephrolithiasis | Mesh Term | Calculi | Mesh Term | Pathological Conditions, Anatomical | Mesh Term | Kidney Diseases | Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Urolithiasis | Mesh Term | Urinary Calculi | Mesh Term | Male Urogenital Diseases |
Downcase Mesh Term | kidney calculi | Downcase Mesh Term | nephrolithiasis | Downcase Mesh Term | calculi | Downcase Mesh Term | pathological conditions, anatomical | Downcase Mesh Term | kidney diseases | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | urolithiasis | Downcase Mesh Term | urinary calculi | Downcase Mesh Term | male urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290717 | Sequence: | 48290718 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Cairo University | Name | Beni-Suef University |
Overall Officials
Sequence: | 29268535 |
Role | Study Director |
Name | Ahmad Aref Al-Dessoukey |
Affiliation | Beni-Suef University |
Central Contacts
Sequence: | 12000490 | Sequence: | 12000491 |
Contact Type | primary | Contact Type | backup |
Name | Mohammed S ElSheemy, Ass. Prof. | Name | Ahmad Aref Al-Dessoukey, Ass. Prof. |
Phone | 01006117755 | ||
mohammedshemy@yahoo.com | |||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68107472 | Sequence: | 68107473 |
Design Group Id | 55559363 | Design Group Id | 55559362 |
Intervention Id | 52454916 | Intervention Id | 52454916 |
Eligibilities
Sequence: | 30747728 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
single Renal stone less than or equal to 3 cm (2 cm for lower calyceal stones) Exclusion Criteria: Abnormal renal anatomy |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121880 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30494011 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Subject Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26655415 |
Intervention Id | 52454916 |
Name | ESWL |
Responsible Parties
Sequence: | 28860291 |
Responsible Party Type | Principal Investigator |
Name | Mohammed Said ElSheemy |
Title | Associate Professor of Urology |
Affiliation | Cairo University |
]]>
https://zephyrnet.com/NCT03795519
2019-01-17
https://zephyrnet.com/?p=NCT03795519
NCT03795519https://www.clinicaltrials.gov/study/NCT03795519?tab=tableNANANAThe primary objective is to characterize the pharmacokinetics (PK) of olinciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of [14C]-olinciguat.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-14 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2019-04-03 |
Start Month Year | January 17, 2019 |
Primary Completion Month Year | February 27, 2019 |
Verification Month Year | April 2019 |
Verification Date | 2019-04-30 |
Last Update Posted Date | 2019-04-03 |
Detailed Descriptions
Sequence: | 20727233 |
Description | OLI-103 is a Phase 1 open-label, nonrandomized, single-dose study in up to 8 subjects that will be conducted at a single center in the US. Safety assessments will be performed throughout the clinic period and multiple PK samples will be collected. Subjects will be confined to the clinical research center for at least 8 days.
The purpose of the study is to determine the absorption, metabolism, and excretion of [14C]-olinciguat and to characterize and determine, where possible, the metabolites present in plasma, urine, and feces after a single oral dose. The study will help identify and characterize olinciguat metabolites, evaluate the likelihood of effects of liver or kidney impairment on the disposition of olinciguat, and assess the likelihood of drug-drug interactions with olinciguat. |
Facilities
Sequence: | 200159555 |
Name | Covance Clinical Research Unit Inc. |
City | Madison |
State | Wisconsin |
Zip | 53704 |
Country | United States |
Conditions
Sequence: | 52185629 |
Name | Healthy Volunteers |
Downcase Name | healthy volunteers |
Id Information
Sequence: | 40169167 |
Id Source | org_study_id |
Id Value | OLI-103 |
Countries
Sequence: | 42580749 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55609277 |
Group Type | Experimental |
Title | Healthy Male Volunteers |
Description | Single oral dose of [14C]-olinciguat |
Interventions
Sequence: | 52499567 |
Intervention Type | Drug |
Name | [14C]-olinciguat |
Description | oral capsule |
Design Outcomes
Sequence: | 177432495 | Sequence: | 177432496 | Sequence: | 177432497 | Sequence: | 177432498 | Sequence: | 177432499 | Sequence: | 177432500 | Sequence: | 177432501 | Sequence: | 177432523 | Sequence: | 177432524 | Sequence: | 177432502 | Sequence: | 177432503 | Sequence: | 177432504 | Sequence: | 177432505 | Sequence: | 177432506 | Sequence: | 177432507 | Sequence: | 177432508 | Sequence: | 177432509 | Sequence: | 177432510 | Sequence: | 177432511 | Sequence: | 177432512 | Sequence: | 177432513 | Sequence: | 177432514 | Sequence: | 177432515 | Sequence: | 177432516 | Sequence: | 177432517 | Sequence: | 177432518 | Sequence: | 177432519 | Sequence: | 177432520 | Sequence: | 177432521 | Sequence: | 177432522 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Amount of total radioactivity excreted in urine (Aeu) and feces (Aef) | Measure | Cumulative Aeu and cumulative Aef | Measure | Percentage of total radioactivity excreted in urine (feu) and feces (fef) | Measure | Cumulative feu and cumulative fef | Measure | Percentage of total radioactivity in total excreta (feces + urine) | Measure | Area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of olinciguat in plasma | Measure | AUC0-inf of total radioactivity in plasma and whole blood | Measure | Number(s) of participants with ≥1 Grade ≥3 AE (per CTCAE v. 5.0) | Measure | Number(s) of participants with ≥1 clinically significant abnormal physical examination finding | Measure | AUC from time zero to the last quantifiable concentration (AUC0-last) of olinciguat in plasma | Measure | AUC0-last of total radioactivity in plasma and whole blood | Measure | Maximum observed concentration (Cmax) of olinciguat in plasma | Measure | Cmax of total radioactivity in plasma and whole blood | Measure | Time of Cmax (Tmax) of olinciguat in plasma | Measure | Tmax of total radioactivity in plasma and whole blood | Measure | Apparent terminal elimination half-life (t1/2) of olinciguat in plasma | Measure | t1/2 total radioactivity in plasma and whole blood | Measure | Apparent total clearance of olinciguat (CL/F) | Measure | Apparent volume of distribution of olinciguat (Vz/F) | Measure | AUC0-inf of plasma olinciguat concentration relative to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Plasma Olinciguat/Plasma Total Radioactivity) | Measure | AUC0-inf of whole blood total radioactivity to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Blood Total Radioactivity/Plasma Total Radioactivity) | Measure | Levels of metabolite radioactivity excreted in urine and feces | Measure | AUC0-inf of metabolite radioactivity levels in plasma | Measure | AUC0-inf of plasma metabolite radioactivity levels relative to AUC0-inf of plasma total radioactivity (Plasma AUC0-inf Ratio of Metabolite Radioactivity/Total Radioactivity) | Measure | Chromatographic retention time of metabolites | Measure | Molecular ion mass of metabolites | Measure | Characteristic mass spectrometry fragmentation ions of metabolites | Measure | Chemical structures (graphical representations showing atom connectivity) proposed for plasma, urine, and feces metabolites | Measure | Number(s) of participants with ≥1 treatment-emergent serious adverse event (SAE) | Measure | Number(s) of participants with ≥1 adverse event (AE) leading to study drug discontinuation |
Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 | Time Frame | up to Day 15 |
Sponsors
Sequence: | 48332450 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Cyclerion Therapeutics |
Overall Officials
Sequence: | 29293071 |
Role | Study Director |
Name | Bina Tejura, MD |
Affiliation | Ironwood Pharmaceuticals, Inc. |
Design Group Interventions
Sequence: | 68168364 |
Design Group Id | 55609277 |
Intervention Id | 52499567 |
Eligibilities
Sequence: | 30773657 |
Gender | Male |
Minimum Age | 18 Years |
Maximum Age | 55 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Males of any race, between 18 and 55 years of age, inclusive Exclusion Criteria: Any active or unstable clinically significant medical condition Additional inclusion/exclusion criteria may apply per protocol |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253953024 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 1 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 55 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 19 |
Number Of Secondary Outcomes To Measure | 11 |
Designs
Sequence: | 30519788 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26680476 |
Intervention Id | 52499567 |
Name | 14C-IW-1701 |
Responsible Parties
Sequence: | 28886089 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03795506
2019-07-08
https://zephyrnet.com/?p=NCT03795506
NCT03795506https://www.clinicaltrials.gov/study/NCT03795506?tab=tableClaudia Gore, MD PhDcgore@nhs.net+44 203 312 6650This is a single centre randomised, placebo-controlled phase 2 study in which 96 children age 4 to 16 years with moderate to severe, longstanding allergic eczema will be enrolled.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-18 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2022-09-23 |
Start Month Year | July 8, 2019 |
Primary Completion Month Year | December 31, 2023 |
Verification Month Year | September 2022 |
Verification Date | 2022-09-30 |
Last Update Posted Date | 2022-09-23 |
Detailed Descriptions
Sequence: | 20850606 |
Description | Following a 4 to 6 week period on standardised treatment (run-in period, to ensure everyone starts with the same treatment approach), participants will be randomised to an active or dummy temperature-controlled laminar airflow (TLA) device, which has been shown to markedly reduce exposure to particles which can cause allergic reactions when being inhaled (inhaled allergens) and other particles which are in the air the investigators breathe in. This has been shown to be an effective treatment of atopic asthma.
The participants will undergo a 12-week treatment period. The device will then be removed and a final follow-up visit occurs at 16 weeks. The total study duration, including the run-in period is up to 22 weeks. |
Facilities
Sequence: | 201277256 |
Status | Recruiting |
Name | IMPERIAL COLLEGE HEALTHCARE NHS Trust |
City | London |
Zip | W2 1NY |
Country | United Kingdom |
Facility Contacts
Sequence: | 28280579 |
Facility Id | 201277256 |
Contact Type | primary |
Name | Claudia Gore, PhD |
cgore@nhs.net | |
Facility Investigators
Sequence: | 18437963 |
Facility Id | 201277256 |
Role | Principal Investigator |
Name | Claudia Gore, PhD |
Conditions
Sequence: | 52503087 |
Name | Atopic Dermatitis Eczema |
Downcase Name | atopic dermatitis eczema |
Id Information
Sequence: | 40395928 |
Id Source | org_study_id |
Id Value | 18SM4747 |
Countries
Sequence: | 42832466 |
Name | United Kingdom |
Removed | False |
Design Groups
Sequence: | 55959196 | Sequence: | 55959197 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Active TLA Device | Title | Placebo TLA Device |
Description | 12 week overnight treatment with the active Temperature Controlled Laminar Airflow device. | Description | 12 week overnight treatment with the placebo Temperature Controlled Laminar Airflow device. |
Interventions
Sequence: | 52811077 | Sequence: | 52811078 |
Intervention Type | Device | Intervention Type | Device |
Name | Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment | Name | Placebo TLA Device |
Description | 12 weeks of overnight treatment with active TLA device | Description | 12 weeks of overnight use of placebo TLA device |
Keywords
Sequence: | 80318916 |
Name | Atopic Dermatitis Eczema |
Downcase Name | atopic dermatitis eczema |
Design Outcomes
Sequence: | 178617001 | Sequence: | 178617002 | Sequence: | 178617003 | Sequence: | 178617004 | Sequence: | 178617005 | Sequence: | 178617006 | Sequence: | 178617007 | Sequence: | 178617008 | Sequence: | 178617009 | Sequence: | 178617010 | Sequence: | 178617011 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change of eczema severity (Eczema Area Severity Index = EASI Score, total) at week 12 compared to baseline | Measure | (Eczema Area Severity Index = EASI): EASI 50, EASI 75 | Measure | Change in SCORing Atopic Dermatitis = SCORAD Index | Measure | Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1 | Measure | Change in health related quality of life [QoL] from baseline for participants: CDQLI | Measure | Improvement of itch; Visual Analogue Score (VAS), from baseline | Measure | Improvement of sleep; Visual Analogue Score (VAS), from baseline | Measure | Change in adverse impact on participants' families from baseline | Measure | Change of patient reported eczema activity from baseline | Measure | Change in medication requirements (topical immunomodulators) from baseline | Measure | Change in sleep quality from baseline: actigraphy |
Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) | Time Frame | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) | Time Frame | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) | Time Frame | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) | Time Frame | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) | Time Frame | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) | Time Frame | 4-6 weeks |
Description | Change of eczema severity (EASI Score) at week 12 compared to baseline; higher score = higher severity. range 0-72 (0=no eczema, 72 highest severity) | Description | Proportion of participants achieving at least a 50% (EASI 50) or 75% (EASI 75) reduction of eczema severity. EASI range 0-72 (0=no eczema, 72 highest severity) | Description | Change in total SCORAD Index at week 12 compared to baseline; higher score = higher severity; range 0-103 (0=no eczema, 103 highest severity) | Description | Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1; maximum score is 5 = most severe | Description | Change in health related quality of life during run-in period, 12 week treatment period and 4 weeks after treatment end using Children's Dermatitis Quality of Life Index (CDQLI). Range 0-30 (0=no QoL impairment, 30 severe QoL impairment) | Description | Change of itch intensity during during run-in period, 12 week treatment period; and 4 weeks after treatment end; Visual Analogue Score (VAS) range 0-100; higher score = higher severity | Description | Change of sleep disturbance during run-in period, 12 week treatment period and 4 weeks after treatment end; Visual Analogue Score (VAS) range 0-100; higher score = higher severity | Description | Change in adverse impact of participants' eczema on families,during run-in period, 12 week treatment period and 4 weeks after treatment end using Dermatitis Family Impact Questionnaire (DFI); higher score = worse impact. Range 0-30 (0=no impact, 30 severe adverse impact) | Description | Change of patient reported eczema activity during run-in period, 12 week treatment period and 4 weeks after treatment end, using Patient Oriented Eczema Measure (POEM) tool; total score reported, higher score = higher severity; Range 0-28 (0=no impairment, 28 severe reported eczema symptoms) | Description | Change in medication requirements during run-in period, 12 week treatment period and 4 weeks after treatment end (topical immunomodulators, topical steroids, topical calcineurin inhibitors) from baseline | Description | Change in sleep quality, measured by actigraphy before and in first month after intervention start (total movement activity reported, higher scores = worse sleep disturbance); this is not a limited scale but simply counts the number of times an individual moves. |
Browse Conditions
Sequence: | 194752883 | Sequence: | 194752884 | Sequence: | 194752885 | Sequence: | 194752886 | Sequence: | 194752887 | Sequence: | 194752888 | Sequence: | 194752889 | Sequence: | 194752890 | Sequence: | 194752891 | Sequence: | 194752892 |
Mesh Term | Dermatitis, Atopic | Mesh Term | Dermatitis | Mesh Term | Eczema | Mesh Term | Skin Diseases | Mesh Term | Skin Diseases, Genetic | Mesh Term | Genetic Diseases, Inborn | Mesh Term | Skin Diseases, Eczematous | Mesh Term | Hypersensitivity, Immediate | Mesh Term | Hypersensitivity | Mesh Term | Immune System Diseases |
Downcase Mesh Term | dermatitis, atopic | Downcase Mesh Term | dermatitis | Downcase Mesh Term | eczema | Downcase Mesh Term | skin diseases | Downcase Mesh Term | skin diseases, genetic | Downcase Mesh Term | genetic diseases, inborn | Downcase Mesh Term | skin diseases, eczematous | Downcase Mesh Term | hypersensitivity, immediate | Downcase Mesh Term | hypersensitivity | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48626637 | Sequence: | 48626638 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Imperial College London | Name | JP Moulton Charitable Foundation |
Overall Officials
Sequence: | 29458472 |
Role | Principal Investigator |
Name | Claudia Gore, MD PhD |
Affiliation | Imperial College London |
Central Contacts
Sequence: | 12094392 |
Contact Type | primary |
Name | Claudia Gore, MD PhD |
Phone | +44 203 312 6650 |
cgore@nhs.net | |
Role | Contact |
Design Group Interventions
Sequence: | 68601131 | Sequence: | 68601132 |
Design Group Id | 55959196 | Design Group Id | 55959197 |
Intervention Id | 52811077 | Intervention Id | 52811078 |
Eligibilities
Sequence: | 30954618 |
Gender | All |
Minimum Age | 4 Years |
Maximum Age | 16 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age 4 to 16 years at time of consent Exclusion Criteria: very severe atopic dermatitis |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253909992 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 4 |
Maximum Age Num | 16 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 10 |
Designs
Sequence: | 30700198 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 29066964 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52410172 | Sequence: | 52410173 | Sequence: | 52410174 | Sequence: | 52410175 |
Pmid | 29383776 | Pmid | 24750266 | Pmid | 27898693 | Pmid | 22131290 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Gore C, Gore RB, Fontanella S, Haider S, Custovic A. Temperature-controlled laminar airflow (TLA) device in the treatment of children with severe atopic eczema: Open-label, proof-of-concept study. Clin Exp Allergy. 2018 May;48(5):594-603. doi: 10.1111/cea.13105. Epub 2018 Mar 13. | Citation | Gore RB, Boyle RJ, Gore C, Custovic A, Hanna H, Svensson P, Warner JO. Effect of a novel temperature-controlled laminar airflow device on personal breathing zone aeroallergen exposure. Indoor Air. 2015 Feb;25(1):36-44. doi: 10.1111/ina.12122. Epub 2014 Jun 10. | Citation | Spilak MP, Sigsgaard T, Takai H, Zhang G. A Comparison between Temperature-Controlled Laminar Airflow Device and a Room Air-Cleaner in Reducing Exposure to Particles While Asleep. PLoS One. 2016 Nov 29;11(11):e0166882. doi: 10.1371/journal.pone.0166882. eCollection 2016. | Citation | Boyle RJ, Pedroletti C, Wickman M, Bjermer L, Valovirta E, Dahl R, Von Berg A, Zetterstrom O, Warner JO; 4A Study Group. Nocturnal temperature controlled laminar airflow for treating atopic asthma: a randomised controlled trial. Thorax. 2012 Mar;67(3):215-21. doi: 10.1136/thoraxjnl-2011-200665. Epub 2011 Nov 30. |
]]>
https://zephyrnet.com/NCT03795493
2019-04-23
https://zephyrnet.com/?p=NCT03795493
NCT03795493https://www.clinicaltrials.gov/study/NCT03795493?tab=tableNANANAFifty patients with metastatic breast cancer will be randomly assigned to an acute intervention consisting of both aerobic exercise and caloric restriction administered acutely prior to each of six chemotherapy cycles, or to usual care. The aerobic exercise intervention will consist of a single supervised recumbent cycle ergometer session performed concurrent to each chemotherapy infusion. The diet intervention consists of provision of meals freshly prepared in a metabolic kitchen with caloric content equivalent to 50% of measured energy requirements and low carbohydrate content for 48-72 hours prior to each chemotherapy infusion. Tumor outcomes will be assessed via CT scan (tumor size) and MRI (novel marker of tumor regression), while treatment side effects will be assessed by MRI and treatment symptoms and quality of life will be assessed via questionnaire before, during and after up to six chemotherapy cycles of a consistent treatment protocol. Progression-free and overall survival will be tracked for two years after diagnosis.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-26 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2023-01-05 |
Start Month Year | April 23, 2019 |
Primary Completion Month Year | December 31, 2023 |
Verification Month Year | June 2022 |
Verification Date | 2022-06-30 |
Last Update Posted Date | 2023-01-05 |
Detailed Descriptions
Sequence: | 20548344 |
Description | Despite major advances in recent decades in treatment for early stage breast cancer leading to an 89% 5-year survival rate, metastatic breast cancer is still considered incurable due to resistance to most available treatments. As such, 5-year survival rate for metastatic breast cancer is only 22%. One mechanism for resistance to cancer therapies and promotion of metastasis in solid tumors is that their vascular system is impaired causing diminished delivery of systemic therapy and oxygen. Furthermore, toxicity can be quite high with metastatic regimens, which can limit the dose received. Both diet and exercise have been used to attenuate treatment toxicity, but the promising preclinical evidence showing their potential to enhance chemotherapy efficacy and survival has not been studied in humans. For example, a single bout of aerobic exercise substantially increased tumor blood flow and oxygen delivery, suggesting that chemotherapy delivery to the tumor would be enhanced. Short periods of fasting or caloric restriction also appear to be safe and effective strategies to inhibit tumor growth and enhance chemotherapy efficacy, while also promoting resistance to chemotherapy in healthy cells. Furthermore, combining aerobic exercise and caloric restriction can elicit synergistic effects on outcomes relevant to cancer, including body composition, aerobic fitness, fasting insulin and glucose, insulin-like growth factor, and tumor promoter pathways.
Study Design: With preclinical proof-of-principle and clinical safety and feasibility of each intervention independently established, this study will be a phase II, two-arm, single blind, randomized controlled trial. Fifty patients will be randomly assigned to an acute intervention consisting of both caloric restriction administered acutely prior to and aerobic exercise during each treatment of six chemotherapy cycles, or to usual care. Approach: Participants will include adults with metastatic breast cancer with measurable metastases that will receive intravenous chemotherapy. The aerobic exercise intervention will consist of a single supervised recumbent cycle ergometer session performed concurrent to each chemotherapy infusion. The diet intervention consists of provision of meals freshly prepared in a metabolic kitchen with caloric content equivalent to 50% of measured energy requirements and low carbohydrate content for 48-72 hours prior to each chemotherapy infusion. The diet period will be reduced from 72 to 48 hours when there are <7 days between infusions (ie weekly protocols) to avoid inducing a sustained caloric deficit leading to weight loss. This acute intervention does not lead to long-term nutritional imbalances. Exercise intensity and meals will be individualized to participant abilities and preferences. All participants, regardless of group assignment, will receive a one-time phone consultation with a registered dietitian and a certified exercise physiologist to enhance recruitment and retention. Tumor outcomes will be assessed via CT scan (tumor size) and MRI (novel marker of tumor regression), while treatment side effects will be assessed by MRI and treatment symptoms and quality of life will be assessed via questionnaire before, during and after up to six chemotherapy cycles of a consistent treatment protocol. Progression-free and overall survival will be tracked for two years after diagnosis. |
Facilities
Sequence: | 198399353 |
Name | University of Alberta |
City | Edmonton |
State | Alberta |
Zip | T6G 2E1 |
Country | Canada |
Conditions
Sequence: | 51726056 |
Name | Breast Cancer |
Downcase Name | breast cancer |
Id Information
Sequence: | 39804765 |
Id Source | org_study_id |
Id Value | HREBA.CC-18-0657 |
Countries
Sequence: | 42203624 |
Name | Canada |
Removed | False |
Design Groups
Sequence: | 55145824 | Sequence: | 55145825 |
Group Type | Experimental | Group Type | No Intervention |
Title | Intervention Group | Title | Control Group |
Description | Standard chemotherapy treatment and oncology care plus short-term diet and exercise intervention. | Description | Standard chemotherapy treatment and oncology care. |
Interventions
Sequence: | 52047612 |
Intervention Type | Behavioral |
Name | Short-term diet and exercise intervention |
Description | Participants assigned to the intervention group will perform both the diet and acute exercise interventions. The interventions will be applied prior to up to six chemotherapy cycles of a consistent protocol. The total number of treatments of a given protocol received prior to treatment conclusion is dependent on patient condition and oncologic care preferences. |
Keywords
Sequence: | 79143287 | Sequence: | 79143288 | Sequence: | 79143289 | Sequence: | 79143290 |
Name | Exercise | Name | Nutrition | Name | Caloric Restriction | Name | Chemotherapy |
Downcase Name | exercise | Downcase Name | nutrition | Downcase Name | caloric restriction | Downcase Name | chemotherapy |
Design Outcomes
Sequence: | 175929515 | Sequence: | 175929516 | Sequence: | 175929517 | Sequence: | 175929518 | Sequence: | 175929519 | Sequence: | 175929520 | Sequence: | 175929521 | Sequence: | 175929522 | Sequence: | 175929523 | Sequence: | 175929524 | Sequence: | 175929525 | Sequence: | 175929526 | Sequence: | 175929527 | Sequence: | 175929528 | Sequence: | 175929529 | Sequence: | 175929530 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Tumor size change after 6 cycles (mm) | Measure | Tumor response to therapy by magnetic resonance imaging (mm²/s) | Measure | Tumor size change after 3 cycles (mm) | Measure | Left ventricular ejection fraction (%) | Measure | Left ventricular global longitudinal strain (%) | Measure | Left ventricular mass (g/m²) | Measure | Liver fat fraction (%) | Measure | Liver T1 relaxation time (ms) | Measure | Thigh skeletal muscle T1 relaxation time (ms) | Measure | Thigh muscle volume (mL) | Measure | Thigh skeletal muscle fat fraction % | Measure | Patient-reported treatment symptoms | Measure | Self reported quality of life | Measure | Fatigue | Measure | Progression-free survival (months) | Measure | Overall survival (months) |
Time Frame | 0-6 weeks before the first chemotherapy treatment of the first cycle and 1-4 weeks after the last chemotherapy treatment of the last cycle | Time Frame | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | Time Frame | 0-6 weeks before the first chemotherapy treatment of the first cycle and 1-3 weeks after the last chemotherapy treatment of the third cycle | Time Frame | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | Time Frame | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | Time Frame | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | Time Frame | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | Time Frame | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | Time Frame | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | Time Frame | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | Time Frame | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | Time Frame | 0-2 weeks before the first chemotherapy treatment of the first cycle, at each chemotherapy treatment, and 2-3 weeks after the last chemotherapy treatment of the last cycle | Time Frame | 0-2 weeks before the first chemotherapy treatment of the first cycle, at the first chemotherapy treatment of 4th cycle, and 2-3 weeks after the last chemotherapy treatment of the last cycle | Time Frame | 0-2 weeks before the first chemotherapy treatment of the first cycle, at the first chemotherapy treatment of 4th cycle, and 2-3 weeks after the last chemotherapy treatment of the last cycle | Time Frame | Two years after study enrollment | Time Frame | Two years after study enrollment |
Description | Change in tumor size measured by computerized tomography after 6 cycles. | Description | Magnetic resonance imaging (MRI) derived water apparent diffusion coefficient within the tumor | Description | Change in tumor size measured by computerized tomography after 3 cycles. | Description | MRI-derived left ventricular ejection fraction | Description | MRI-derived left ventricular global longitudinal strain | Description | MRI-derived left ventricular mass | Description | Percent of fat in liver derived by PROFIT1 chemical-shift encoded MRI | Description | MRI-derived relaxation time from healthy liver | Description | MRI-derived skeletal muscle T1 relaxation time at mid-thigh | Description | PROFIT1 chemical-shift encoded MRI of the mid-thigh will be used to assess thigh muscle volume | Description | Percent of intermuscular fat in thigh muscle derived by PROFIT1 chemical-shift encoded MRI | Description | Patient-reported treatment symptoms assessed using the Rotterdam Symptom Checklist | Description | Quality of life assessed using the total score from the Functional Assessment of Cancer Therapy – Fatigue Questionnaire. Scores can range from 0 – 52 where a high score represents a better quality of life. | Description | Fatigue assessed using the total score from the Functional Assessment of Cancer Therapy – Fatigue Questionnaire. Scores can range from 0 – 52 where a high score represents a lower level of fatigue. | Description | Progression-free survival time extracted from Cancer Control Alberta's electronic database | Description | Overall survival time extracted from Cancer Control Alberta's electronic database |
Browse Conditions
Sequence: | 191696108 | Sequence: | 191696109 | Sequence: | 191696110 | Sequence: | 191696111 | Sequence: | 191696112 |
Mesh Term | Breast Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Breast Diseases | Mesh Term | Skin Diseases |
Downcase Mesh Term | breast neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | breast diseases | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47906138 | Sequence: | 47906139 | Sequence: | 47906140 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER_GOV |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | University of Alberta | Name | Canadian Cancer Society (CCS) | Name | Canadian Institutes of Health Research (CIHR) |
Overall Officials
Sequence: | 29026424 | Sequence: | 29026425 |
Role | Principal Investigator | Role | Principal Investigator |
Name | Carla Prado, PhD | Name | Richard Thompson, PhD |
Affiliation | University of Alberta | Affiliation | University of Alberta |
Design Group Interventions
Sequence: | 67606165 |
Design Group Id | 55145824 |
Intervention Id | 52047612 |
Eligibilities
Sequence: | 30505943 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Diagnosis of stage IV or metastatic breast cancer; Exclusion Criteria: Limitations to sustained exercise (including bone metastases in the femur neck); |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254051894 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Number Of Other Outcomes To Measure | 13 |
Designs
Sequence: | 30255025 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28635518 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 51617597 |
Pmid | 34629067 |
Reference Type | derived |
Citation | Kirkham AA, King K, Joy AA, Pelletier AB, Mackey JR, Young K, Zhu X, Meza-Junco J, Basi SK, Hiller JP, Brkin T, Michalowski B, Pituskin E, Paterson DI, Courneya KS, Thompson RB, Prado CM. Rationale and design of the Diet Restriction and Exercise-induced Adaptations in Metastatic breast cancer (DREAM) study: a 2-arm, parallel-group, phase II, randomized control trial of a short-term, calorie-restricted, and ketogenic diet plus exercise during intravenous chemotherapy versus usual care. BMC Cancer. 2021 Oct 10;21(1):1093. doi: 10.1186/s12885-021-08808-2. |
]]>
https://zephyrnet.com/NCT03795480
2018-05-07
https://zephyrnet.com/?p=NCT03795480
NCT03795480https://www.clinicaltrials.gov/study/NCT03795480?tab=tableNANANAThe study aims to examine the efficacy and acceptance of a self-help internet intervention “MOOD” in a sample of individuals with depressive symptoms. It is tested whether depressive symptomatology decreases in the intervention group compared to a wait-list control group. Further aims are to ascertain changes in self-worth and quality of life, to assess subjective evaluation of the program and to examine whether expectations of the program’s helpfulness would predict symptom reduction.
<![CDATA[
Studies
Study First Submitted Date | 2018-08-16 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2019-01-07 |
Start Month Year | May 7, 2018 |
Primary Completion Month Year | July 22, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-07 |
Detailed Descriptions
Sequence: | 20721576 |
Description | The study aims to examine the efficacy and acceptance of a self-help internet intervention "MOOD" in a sample of individuals with depressive symptoms. It is tested whether depressive symptomatology decreases in the intervention group compared to a wait-list control group. Secondary aims are to ascertain changes in self-worth and quality of life, to assess subjective evaluation of the program and to examine whether expectations of the program's helpfulness would predict symptom reduction. During the intervention period of six weeks, participants of the intervention group have access to the online program MOOD. Prior and following this period both groups complete a pre- and post-assessment. Participants of the wait-list control group receive access to MOOD following the post-assessment. |
Facilities
Sequence: | 200107801 |
Name | Department for Psychiatry and Psychotherapy of University Medical Center Hamburg-Eppendorf |
City | Hamburg |
Zip | 20246 |
Country | Germany |
Conditions
Sequence: | 52171091 |
Name | Depressive Symptoms |
Downcase Name | depressive symptoms |
Id Information
Sequence: | 40158535 |
Id Source | org_study_id |
Id Value | MOOD |
Countries
Sequence: | 42568837 |
Name | Germany |
Removed | False |
Design Groups
Sequence: | 55593027 | Sequence: | 55593028 |
Group Type | Experimental | Group Type | No Intervention |
Title | MOOD | Title | Control |
Description | The online program "MOOD" is based on methods of cognitive behavior therapy (KVT) and contains elements of mindfulness and metacognition. Participants can contact a moderator (trained psychologists) if they have any questions. However, this function is optional. The program consists of nine interactive modules, one of which is an introductory module. The other modules are called: ABC-Scheme, Positive Activities, Self-Worth, Social Competence, Mindfulness, Modifying Thoughts, Sleep, and Relapse Prevention. | Description | The wait-list control group does not receive additional treatment. However, previously started therapies (psychotherapy/ psychopharmacotherapy) may be continued during the study. Individuals of the wait-list control group receive access to MOOD after completion of the post-assessment. |
Interventions
Sequence: | 52485337 |
Intervention Type | Behavioral |
Name | MOOD |
Description | MOOD is an online self-help program targeted on depressive symptoms. The program consists of nine modules, one of which is an introductory module. The other modules are called: ABC-Scheme, Positive Activities, Self-Worth, Social Competence, Mindfulness, Modifying Thoughts, Sleep, and Relapse Prevention. All modules are based on principles of cognitive behavioral therapy (CBT) and include elements of mindfulness-based and metacognitive techniques. The modules contain interactive exercises which are aimed at incorporating the participant's experiences into the program and increasing identification of the participant with the presented material. Participants are free to work through the different modules in their own speed and way, however, it is recommended to work on one to two modules per week. |
Design Outcomes
Sequence: | 177378357 | Sequence: | 177378358 | Sequence: | 177378359 | Sequence: | 177378360 | Sequence: | 177378361 | Sequence: | 177378362 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Beck Depression Inventory (BDI) | Measure | Rosenberg self-esteem scale (RSE) | Measure | WHOQOL-Bref | Measure | University of Rhode Island Change Assessment (URICA) | Measure | Subjective appraisal | Measure | Patient Health Questionnaire-9 Depression Module (PHQ-9) |
Time Frame | Change in BDI from baseline to post (intervention period is 6 weeks) | Time Frame | Change in RSE from baseline to post (intervention period is 6 weeks) | Time Frame | Change in WHOQOL-Bref from baseline to post (intervention period is 6 weeks) | Time Frame | Only at Baseline (pre intervention) | Time Frame | Only at post-assessment (6 weeks) | Time Frame | Change in PHQ-9 from baseline to post (intervention period is 6 weeks) |
Description | This questionnaire assesses symptoms of depression and their severity (Beck, Steer, & Brown, 1996). It contains 21 items and the participant is asked to rate how severe he or she experiences each symptom on a 4-point Likert scale ranging from 0 (not at all severe) to 3 (extreme form of each symptom). | Description | The RSE is a self-report questionnaire assessing an individual's self-esteem (Rosenberg, 1965) The scale consists of 10 items and the participants are asked to rate in how far they agree with each item on a 4-point Likert scale ranging from "strongly disagree" to "strongly agree". | Description | The WHOQOL-Bref is a questionnaire assessing Quality of Life (QOL) (Whoqol Group, 1998). It is an abbreviated version of the WHOQOL-100 and contains 26 items. The questionnaire has four types of 5-point Likert scales asking the participant "how much", "how completely", "how often", "how good" or "how satisfied" he felt in the last two weeks. The four different scales are distributed across the four domains sampled in this questionnaire: Physical health, Psychological, Social relations, Environment. | Description | The URICA is a measure of willingness to change (Dozois, Westra, Collins, Fung & Garry, 2004) and was assessed at baseline. It consists of 32 items that depict four stages of change: pre-contemplation, contemplation, action and maintenance. In the present study, in total 9 items are used which were chosen from the subscales of pre-contemplation, contemplation and action. Internal consistency is .83 and test-retest reliability lies between .63-.75. | Description | In the post-assessment, individuals of the intervention group also answered questions on subjective evaluation and appraisal of the program. Items were for example "I think this program is useful as a self-help tool" or "I had to bring myself to make use of the program". The items could be answered on a 4-point Likert scale ranging from "Totally disagree" to "Totally agree". Participants also had the possibility to provide feedback on the program. | Description | The PHQ-9 is used to measure depression and its severity (Kroenke, Spitzer, & Williams, 2001). It consists of 9 items which can be rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day), depending on the severity and frequency of the symptoms. |
Browse Conditions
Sequence: | 193486117 | Sequence: | 193486118 |
Mesh Term | Depression | Mesh Term | Behavioral Symptoms |
Downcase Mesh Term | depression | Downcase Mesh Term | behavioral symptoms |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319153 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Universitätsklinikum Hamburg-Eppendorf |
Overall Officials
Sequence: | 29285274 |
Role | Principal Investigator |
Name | Steffen Moritz, Prof. |
Affiliation | Universitätsklinikum Hamburg-Eppendorf |
Design Group Interventions
Sequence: | 68148962 |
Design Group Id | 55593027 |
Intervention Id | 52485337 |
Eligibilities
Sequence: | 30765267 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
presence of psychological strain and desire for treatment for depressive symptoms Exclusion Criteria: acute suicidality (as assessed with one item of the BDI) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253877212 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 2 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30511434 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28877728 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52063131 |
Pmid | 31579014 |
Reference Type | derived |
Citation | Bucker L, Schnakenberg P, Karyotaki E, Moritz S, Westermann S. Diminishing Effects After Recurrent Use of Self-Guided Internet-Based Interventions in Depression: Randomized Controlled Trial. J Med Internet Res. 2019 Oct 2;21(10):e14240. doi: 10.2196/14240. |
]]>
https://zephyrnet.com/NCT03795467
2017-11-01
https://zephyrnet.com/?p=NCT03795467
NCT03795467https://www.clinicaltrials.gov/study/NCT03795467?tab=tableNANANAThe peripheral perfusion index (PPI) is a non-invasive, feasible measure of peripheral perfusion and, assumed, the overall circulation, which all patients are monitored by.
This study is carried out to assess the association between values of PPI, haemoglobin and blood transfusion.
Hypothetically, patients with low values of hb are more susceptible to a deteriorating circulation reflected in poorer PPI regardless of blood pressure and that resuscitation with blood products improves PPI measurements. Moreover, that patients with low values of PPI have more surgical complications and higher mortality.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2019-01-07 |
Start Month Year | November 1, 2017 |
Primary Completion Month Year | October 31, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-07 |
Detailed Descriptions
Sequence: | 20783049 |
Description | Background: Acute surgical patients with e.g. hip fracture (HF) or acute abdominal surgical conditions often have comorbidities and a fragile circulation. Haemodynamic challenges make these patients vulnerable during anaesthesia, and perioperative complications are frequent.
Anaemia is associated with increased mortality and adverse outcomes in patients undergoing surgery. One of the consequences of acute anaemia is reduced blood oxygen content, leading to reduced tissue oxygen delivery and development of tissue hypoxia. Patients with e.g. HF have a large drop in haemoglobin (hb) level that occurs after the injury, yet prior to the surgery. It is therefore important to be aware of the risk of preoperative anaemia even when the initial hb levels appear to be normal. Perioperative hb are associated with shorter lengths of hospital stay, reduced mortality and lower readmission rates, and patients with postoperative anaemia have increased mortality and length of hospital stay. Haemodynamic monitoring is traditionally based on measurement of blood pressure (BP) and heart rate (HR) but these measurements may be insufficient in evaluating overall oxygen delivery and perfusion of vital organs. An apparently sufficient BP and, for patients with more specialised monitoring, cardiac output (CO), does not necessarily mean a sufficient peripheral microcirculatory flow due to compensatory mechanisms, but on the other hand a low CO may be sufficient in context of low metabolic demand. The non-invasive peripheral perfusion index (PPI) is a numerical value of peripheral perfusion measured by the pulse oximeter derived from the photoelectric plethysmographic signal. PPI is represents the ratio between the pulsatile component (arterial) and the non-pulsatile component (venous blood, capillary blood and other tissues) of the light reaching the detector of the pulse oximeter, and reflects changes in peripheral blood flow as the pulsatile component increases with vasodilatation and decreases with vasoconstriction. It is an accessible way to obtain a measure for peripheral perfusion as pulse oximeters are universally available in all operating rooms and intensive care units. Previous studies have shown that PPI is a useful indicator of reduced peripheral blood flow both in clinical and experimental settings. Correlation between clinical symptoms of reduced peripheral perfusion such as low temperature, increased capillary response and reduced PPI in critically ill patients has been demonstrated, and a reduced peripheral perfusion may be a predictor of mortality and complications in patients undergoing major surgical procedures and in septic shock patients. Hypothetically, patients with low values of hb are more susceptible to a deteriorating circulation reflected in poorer PPI regardless of blood pressure and that resuscitation with blood products improves PPI measurements. Moreover, that patients with low values of PPI have more surgical complications and higher mortality. Method: The main objective of this study is to estimate the association between perioperative values of PPI and haemoglobin levels. The secondary objectives are to evaluate PPI in patients with low hb in relation to mean arterial blood pressure (MAP), and evaluate changes in PPI with patients with low and normal hb in relation to transfusion with blood products. |
Facilities
Sequence: | 200618374 |
Name | Department of Anesthesia, Hvidovre Hospital |
City | Hvidovre |
State | Copenhagen |
Zip | 2650 |
Country | Denmark |
Conditions
Sequence: | 52328331 | Sequence: | 52328332 | Sequence: | 52328333 | Sequence: | 52328334 |
Name | Fracture of Hip | Name | Ileus | Name | Perforated Viscus | Name | Anastomotic Leak |
Downcase Name | fracture of hip | Downcase Name | ileus | Downcase Name | perforated viscus | Downcase Name | anastomotic leak |
Countries
Sequence: | 42691179 |
Name | Denmark |
Removed | False |
Design Outcomes
Sequence: | 177960026 | Sequence: | 177960027 | Sequence: | 177960028 | Sequence: | 177960029 | Sequence: | 177960030 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Peripheral perfusion index | Measure | Haemoglobin level | Measure | Evaluation of Peripheral perfusion index in patients with high vs. low haemoglobin levels in relation to mean arterial blood pressure (MAP). | Measure | Proportion of transfusion with blood products in patients with perioperative high vs. low haemoglobin levels. | Measure | Evaluation of peripheral perfusion index changes in patients with perioperative high vs. low haemoglobin levels in relation to transfusion with blood products . |
Time Frame | Perioperative with 5 minute interval | Time Frame | Time interval: From 3 hours preoperative to 10 hours postoperative | Time Frame | Perioperative | Time Frame | Perioperative | Time Frame | Perioperative |
Description | Absolute PPI levels | Description | Measurement of haemoglobin by blood sample or artery gas. | Description | High vs. low hb defined as 6,0 < hb > 6,0. Absolute PPI levels perioperative with a 5 minute interval. Absolute values of MAP measured perioperative with a 5 minute interval. | Description | High vs. low hb defined as 6,0 < hb > 6,0. Blood transfusion measured as total amount used perioperatively. | Description | High vs. low hb defined as 6,0 < hb > 6,0. Absolute PPI levels perioperative measured with a 5 minute interval. Blood transfusion measured as total amount used perioperatively. |
Browse Conditions
Sequence: | 194085256 | Sequence: | 194085257 | Sequence: | 194085258 | Sequence: | 194085259 | Sequence: | 194085260 | Sequence: | 194085261 | Sequence: | 194085262 | Sequence: | 194085263 | Sequence: | 194085264 |
Mesh Term | Anastomotic Leak | Mesh Term | Hip Fractures | Mesh Term | Postoperative Complications | Mesh Term | Pathologic Processes | Mesh Term | Femoral Fractures | Mesh Term | Fractures, Bone | Mesh Term | Wounds and Injuries | Mesh Term | Hip Injuries | Mesh Term | Leg Injuries |
Downcase Mesh Term | anastomotic leak | Downcase Mesh Term | hip fractures | Downcase Mesh Term | postoperative complications | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | femoral fractures | Downcase Mesh Term | fractures, bone | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | hip injuries | Downcase Mesh Term | leg injuries |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48466456 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Hvidovre University Hospital |
Eligibilities
Sequence: | 30856350 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Patients > 18 years of age having performed acute abdominal or orthopedic surgery from 1th November 2017 through 31th October 2018 at Hvidovre and Bispebjerg University Hospitals. Study subjects will be obtained from the hospitals electronic medical records via specific procedural- or diagnostic codes representing the acute orthopedic or abdominal surgery in the specified one-year period. |
Criteria | Inclusion Criteria:
Orthopedic surgery patients with fracture of the hip, booked in the electronic patient record for operation with procedural codes:KNFB02 HNFJ81 KNFJ51 KNFJ52 KNFJ70 Exclusion Criteria: No sampling of PPI registered |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254313070 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 12 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30602188 |
Observational Model | Cohort |
Time Perspective | Retrospective |
Responsible Parties
Sequence: | 28968704 |
Responsible Party Type | Principal Investigator |
Name | Marianne Agerskov |
Title | MD, Research Fellow |
Affiliation | Hvidovre University Hospital |
]]>
https://zephyrnet.com/NCT03795454
2013-05-03
https://zephyrnet.com/?p=NCT03795454
NCT03795454https://www.clinicaltrials.gov/study/NCT03795454?tab=tableNANANATo assess whether a musical intervention (maternal/paternal singing) during the skin-to-skin sessions (Kangaroo care) would improve the language development of the preterm infant. Infants will be randomized to singing or silence during the Kangaroo care from the age corresponding to 30th gestational week until term age (40 gestational weeks).
<![CDATA[
Studies
Study First Submitted Date | 2018-11-30 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2023-06-02 |
Start Month Year | May 3, 2013 |
Primary Completion Month Year | May 31, 2018 |
Verification Month Year | June 2023 |
Verification Date | 2023-06-30 |
Last Update Posted Date | 2023-06-02 |
Detailed Descriptions
Sequence: | 20820184 |
Description | The outcomes are:
a 2- (3-)year neurodevelopmental follow up – Bayley Scales of Infant and Toddler Development, Third Edition (in Finnish in Finland and in Swedish in Sweden) At the age corresponding to term (40 gestational weeks) Auditory event related potentials (AERPs) in electroencephalography (EEG), in Helsinki cohort |
Conditions
Sequence: | 52423699 | Sequence: | 52423700 |
Name | Neurocognitive Dysfunction | Name | Language Development |
Downcase Name | neurocognitive dysfunction | Downcase Name | language development |
Id Information
Sequence: | 40337873 |
Id Source | org_study_id |
Id Value | IRB00003181SK |
Design Groups
Sequence: | 55873513 | Sequence: | 55873514 |
Group Type | Experimental | Group Type | No Intervention |
Title | Singing Kangaroo | Title | Silent Kangaroo |
Description | The parent is singing during the skin-to -skin sessions Musical therapeutist gives the instructions | Description | The parent is silent during the skin-to -skin sessions Musical therapeutist gives the instructions |
Interventions
Sequence: | 52732914 |
Intervention Type | Behavioral |
Name | Singing |
Description | Infant-directed singing and singing of self-invented songs, especially songs emerging from the interaction with the infant, are especially encouraged. The families will receive audio material of children's songs, lullabies, and lyrics of the lullabies to support them if they feel unable to accomplish the task otherwise. |
Keywords
Sequence: | 80210000 | Sequence: | 80210001 | Sequence: | 80210002 | Sequence: | 80210003 |
Name | Kangaroo care | Name | MEG | Name | AERP | Name | preterm infant |
Downcase Name | kangaroo care | Downcase Name | meg | Downcase Name | aerp | Downcase Name | preterm infant |
Design Outcomes
Sequence: | 178325870 | Sequence: | 178325871 | Sequence: | 178325872 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary |
Measure | Auditory cortical responses | Measure | Parental anxiety | Measure | Neurocognitive development, language development |
Time Frame | Age corresponding to term, ie 40 gestational weeks | Time Frame | 3 months age | Time Frame | 2 year of age |
Description | Auditory Event-Related Potentials (AERPs) at full-term age will be recorded with multi-feature paradigm (MFP), in which the mismatch negativity (MMN) to 5 speech-related auditory features can be recorded in a short time period. | Description | Parents' state anxiety is measured using the STAI (State-Trait Anxiety Inventory, Spielberger, 1983) with 20 self-descriptive statements once per week until the infant leaves the hospital and once in two weeks until the infant reaches the corrected age of 3 months, | Description | "Bayley III" :- Bayley Scales of Infant and Toddler Develoment, Third Edition (in Finnish in Finland and in Swedish in Sweden)
– The following scales will be used: Cognitive, Language, Motor, Language scale includes Expressive Language and Receptive Language Motor scale includes Fine Motorics and Gross Motorics All scale ranges will be included (i.e., minimum and maximum scores) required to interpret any values. For example, if the *total* score is reported, the *total* range should be provided. If *subscale* scores are reported, the range for each *subscale* should be provided. |
Browse Conditions
Sequence: | 194446880 | Sequence: | 194446881 | Sequence: | 194446882 | Sequence: | 194446883 |
Mesh Term | Cognitive Dysfunction | Mesh Term | Cognition Disorders | Mesh Term | Neurocognitive Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | cognitive dysfunction | Downcase Mesh Term | cognition disorders | Downcase Mesh Term | neurocognitive disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48553415 | Sequence: | 48553416 | Sequence: | 48553417 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | University of Helsinki | Name | Helsinki University Central Hospital | Name | Karolinska University Hospital |
Overall Officials
Sequence: | 29416620 |
Role | Principal Investigator |
Name | Kaija Mikkola, M.D. PhD |
Affiliation | Helsinki University Central Hospital |
Design Group Interventions
Sequence: | 68493628 |
Design Group Id | 55873513 |
Intervention Id | 52732914 |
Eligibilities
Sequence: | 30910372 |
Gender | All |
Minimum Age | 7 Days |
Maximum Age | 6 Weeks |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
preterm infants at 30th gestational week capable of being in Kangaroo care Exclusion Criteria: intensive care preventing Kangaroo care |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254171452 |
Registered In Calendar Year | 2018 |
Actual Duration | 61 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 7 |
Maximum Age Num | 6 |
Minimum Age Unit | Days |
Maximum Age Unit | Weeks |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30656076 |
Allocation | Randomized |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | Single |
Masking Description | Assessors do not know the intervention that took place before outcome assessed |
Intervention Model Description | In Helsinki, block randomization, one intervention at the time in the hospital. In Stockholm, both groups simultaneously cared in the hospital |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 29022740 |
Responsible Party Type | Principal Investigator |
Name | Vineta Fellman |
Title | professor |
Affiliation | University of Helsinki |
Study References
Sequence: | 52334440 | Sequence: | 52334441 | Sequence: | 52334442 |
Pmid | 35444514 | Pmid | 34539329 | Pmid | 37026177 |
Reference Type | result | Reference Type | result | Reference Type | result |
Citation | Partanen E, Martensson G, Hugoson P, Huotilainen M, Fellman V, Aden U. Auditory Processing of the Brain Is Enhanced by Parental Singing for Preterm Infants. Front Neurosci. 2022 Apr 4;16:772008. doi: 10.3389/fnins.2022.772008. eCollection 2022. | Citation | Kostilainen K, Partanen E, Mikkola K, Wikstrom V, Pakarinen S, Fellman V, Huotilainen M. Repeated Parental Singing During Kangaroo Care Improved Neural Processing of Speech Sound Changes in Preterm Infants at Term Age. Front Neurosci. 2021 Sep 3;15:686027. doi: 10.3389/fnins.2021.686027. eCollection 2021. | Citation | Kostilainen K, Hugoson P, Haavisto A, Partanen E, Mikkola K, Huotilainen M, Pakarinen S, Furmark C, Aden U, Fellman V. No impact of parental singing during the neonatal period on cognition in preterm-born children at 2-3 years. Acta Paediatr. 2023 Jul;112(7):1471-1477. doi: 10.1111/apa.16788. Epub 2023 Apr 25. |
]]>
https://zephyrnet.com/NCT03795441
2019-01-07
https://zephyrnet.com/?p=NCT03795441
NCT03795441https://www.clinicaltrials.gov/study/NCT03795441?tab=tableNANANAThe purpose of this study is to assess the shedding and kinetics of the Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF) vaccine after one intramuscular injection of Ad26.RSV.preF in adults.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2019-08-30 |
Start Month Year | January 7, 2019 |
Primary Completion Month Year | July 28, 2019 |
Verification Month Year | August 2019 |
Verification Date | 2019-08-31 |
Last Update Posted Date | 2019-08-30 |
Facilities
Sequence: | 200159641 |
Name | Clinical Pharmacology Unit |
City | Merksem |
Zip | 2170 |
Country | Belgium |
Conditions
Sequence: | 52185669 |
Name | Healthy |
Downcase Name | healthy |
Id Information
Sequence: | 40169197 | Sequence: | 40169198 | Sequence: | 40169199 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | CR108554 | Id Value | 2018-003261-34 | Id Value | VAC18193RSV1005 |
Id Type | EudraCT Number | Id Type | Other Identifier | ||
Id Type Description | Janssen Vaccines & Prevention B.V. | ||||
Countries
Sequence: | 42580785 |
Name | Belgium |
Removed | False |
Design Groups
Sequence: | 55609326 |
Group Type | Experimental |
Title | Ad26.RSV.preF |
Description | Participants will receive one intramuscular injection of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) on Day 1. |
Interventions
Sequence: | 52499605 |
Intervention Type | Biological |
Name | Ad26.RSV.preF |
Description | Ad26.RSV.preF will be administered as intramuscular injection on Day 1. |
Design Outcomes
Sequence: | 177432645 | Sequence: | 177432646 | Sequence: | 177432647 | Sequence: | 177432648 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Percentage of Participants with Presence of Ad26.RSV.preF (shedding) as Assessed by qPCR | Measure | Number of Participants with Serious Adverse Events (SAEs) | Measure | Number of Participants with Solicited Local and Systemic Adverse Events (AEs) After Vaccination | Measure | Number of Participants with Unsolicited AEs as a Measure of Safety |
Time Frame | Up to Day 183 | Time Frame | First vaccination (Day 1) to the end of the study (Day 183) | Time Frame | 7 days after vaccination (Day 1 up to Day 7) | Time Frame | Day 1 Up to Day 28 |
Description | Percentage of Participants with presence of Ad26.RSV.preF in the adhesive bandage covering the injection site, the injection site area, nares (mid-turbinate), throat, rectum, urine, semen and blood, will be assessed by Quantitative Polymerase Chain Reaction (qPCR). Percentage of participants with presence of Ad26.RSV.preF (shedding) will be assessed. | Description | Number of participants with SAEs will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above. | Description | Number of participants with solicited local and systemic AEs will be evaluated. Solicited local AEs (erythema, swelling/induration, and pain/tenderness at the injection site) and solicited systemic AEs (fatigue, headache, myalgia, arthralgia, chills, nausea, and fever) will be noted in the participant diary through the 7 days post-vaccination. Local and systemic AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). | Description | Number of participants with unsolicited AEs will be evaluated. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product, and it does not necessarily have a causal relationship with the intervention, therefore an AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. Unsolicited AEs will include all AEs for which the participant is specifically not questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). |
Sponsors
Sequence: | 48332487 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Janssen Vaccines & Prevention B.V. |
Overall Officials
Sequence: | 29293094 |
Role | Study Director |
Name | Janssen Vaccines & Prevention B.V. Clinical Trial |
Affiliation | Janssen Vaccines & Prevention B.V. |
Design Group Interventions
Sequence: | 68168415 |
Design Group Id | 55609326 |
Intervention Id | 52499605 |
Eligibilities
Sequence: | 30773683 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
In the investigator's clinical judgment, participant must be in good or stable health. Participants may have underlying illnesses such as hypertension, Type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs measurement and 12-lead electrocardiogram (ECG; for participants greater than [>] 65 years of age only) performed at screening Exclusion Criteria: Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253953140 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 6 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30519814 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26680487 |
Intervention Id | 52499605 |
Name | JNJ-64400141 |
Responsible Parties
Sequence: | 28886115 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03795428
2019-04-10
https://zephyrnet.com/?p=NCT03795428
NCT03795428https://www.clinicaltrials.gov/study/NCT03795428?tab=tableNANANAThis is a multi-center, Phase 2 Long-Term, Open Label Extension (OLE) Study to assess the safety and tolerability of pemziviptadil (PB1046) at an optimally titrated dose. This is a Long-Term, Open label Extension (OLE) Study for subjects with (PAH), having participated in double-blind Study PB1046-PT-CL-0004. The study will include adult subjects previously diagnosed with symptomatic PAH, who are receiving background clinician-directed therapy for PAH.
During this period, subjects will continue to be followed for safety and tolerability, as well as for periodic efficacy, quality of life data and immunogenicity. The study will continue per the schedule of events until such time when pemziviptadil (PB1046) is able to be self-administered, becomes commercially available to the subjects in a particular country or region, or the sponsor terminates the study due to lack of efficacy, safety or other reasons.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-18 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2022-02-22 |
Start Month Year | April 10, 2019 |
Primary Completion Month Year | January 11, 2022 |
Verification Month Year | February 2022 |
Verification Date | 2022-02-28 |
Last Update Posted Date | 2022-02-22 |
Detailed Descriptions
Sequence: | 20731479 |
Description | Subjects entering this study will enter from the double-blind Study PB1046-PT-CL-0004. The starting dose level of pemziviptadil (PB1046) for all subjects in this parent study was a sub-therapeutic or minimally effective dose (MED) of 0.2 mg/kg, administered by SC injection.
Subjects were randomized into the MED) Group or a dose-titration group. In the dose-titration group, individual subjects were titrated up to their maximum tolerated dose (MTD) in a blinded fashion, with the objective of titrating subjects up to a dose of at least 1.2 mg/kg or higher in the MTD Group, while subjects in the MED Group remained at the MED level of 0.2 mg/kg, and underwent "sham dose-titration" to maintain the blind. Subjects entering the 0006 trial prior to implementation of this protocol amendment will remain blinded until such time that open label dosing will not unblind the 0004 study. |
Facilities
Sequence: | 200216877 | Sequence: | 200216878 | Sequence: | 200216879 | Sequence: | 200216880 | Sequence: | 200216881 | Sequence: | 200216882 | Sequence: | 200216883 | Sequence: | 200216884 | Sequence: | 200216885 | Sequence: | 200216886 | Sequence: | 200216887 | Sequence: | 200216888 | Sequence: | 200216889 | Sequence: | 200216890 | Sequence: | 200216891 | Sequence: | 200216892 |
Name | University of California San Diego | Name | University of California – Davis | Name | University of Miami – Pulmonary Research Center | Name | Emory University, The Emory Clinic | Name | University of Iowa Hospitals and Clinics | Name | University of Kansas Medical Center | Name | Tufts Medical Center | Name | Brigham and Women's Hospital | Name | NYU Langone Health | Name | University of Rochester Medical Center | Name | The Lindner Center for Research and Education at The Christ Hospital | Name | University of Cincinnati | Name | INTEGRIS Baptist Medical Center | Name | Allegheny General Hospital | Name | UPMC Presbyterian | Name | University of Texas Southwestern Medical Center |
City | La Jolla | City | Sacramento | City | Miami | City | Atlanta | City | Iowa City | City | Kansas City | City | Boston | City | Boston | City | New York | City | Rochester | City | Cincinnati | City | Cincinnati | City | Oklahoma City | City | Pittsburgh | City | Pittsburgh | City | Dallas |
State | California | State | California | State | Florida | State | Georgia | State | Iowa | State | Kansas | State | Massachusetts | State | Massachusetts | State | New York | State | New York | State | Ohio | State | Ohio | State | Oklahoma | State | Pennsylvania | State | Pennsylvania | State | Texas |
Zip | 92037 | Zip | 95817 | Zip | 33125 | Zip | 30322 | Zip | 52242 | Zip | 66160 | Zip | 02111 | Zip | 02115 | Zip | 10016 | Zip | 14642 | Zip | 45219 | Zip | 45267 | Zip | 73112 | Zip | 15212 | Zip | 15213 | Zip | 75390 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States |
Browse Interventions
Sequence: | 96095642 | Sequence: | 96095643 |
Mesh Term | VIP-ELP fusion molecule PB1046 | Mesh Term | Vasodilator Agents |
Downcase Mesh Term | vip-elp fusion molecule pb1046 | Downcase Mesh Term | vasodilator agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52196928 |
Name | Pulmonary Arterial Hypertension |
Downcase Name | pulmonary arterial hypertension |
Id Information
Sequence: | 40178041 |
Id Source | org_study_id |
Id Value | PB1046-PT-CL-0006 |
Countries
Sequence: | 42591830 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55622640 |
Group Type | Experimental |
Title | Pemziviptadil (PB1046) Injection-OL Active Drug-Up-Titration to Stable Dose |
Description | Pemziviptadil (PB1046) Injection: Regardless of dose assignment, all subjects will be up-titrated in 0.2 mg/kg weekly increments, beginning with 0.4 mg/kg at Week 1, to the target dose of 1.2 mg/kg or higher depending on safety and tolerability. |
Interventions
Sequence: | 52511740 |
Intervention Type | Drug |
Name | Pemziviptadil (PB1046) Injection |
Description | Once-weekly subcutaneous injection |
Design Outcomes
Sequence: | 177474658 | Sequence: | 177474642 | Sequence: | 177474643 | Sequence: | 177474644 | Sequence: | 177474645 | Sequence: | 177474646 | Sequence: | 177474647 | Sequence: | 177474648 | Sequence: | 177474649 | Sequence: | 177474650 | Sequence: | 177474651 | Sequence: | 177474652 | Sequence: | 177474653 | Sequence: | 177474654 | Sequence: | 177474655 | Sequence: | 177474656 | Sequence: | 177474657 | Sequence: | 177474659 | Sequence: | 177474660 | Sequence: | 177474661 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Change in REVEAL Registry Risk Calculator Score | Measure | Incidence and Severity of Adverse Events | Measure | Incidence of Clinical Laboratory Abnormalities | Measure | Change in Diastolic Blood Pressure from baseline | Measure | Change in Systolic Blood Pressure from baseline | Measure | Change in Oral Body Temperature from baseline | Measure | Change in Respiratory Rate from baseline | Measure | Change in Heart Rate from baseline | Measure | 12-Lead ECG – Incidence of clinically significant abnormal ECG findings as measured by 12 Lead ECG | Measure | Incidence of Immunogenicity | Measure | Survival | Measure | Change from baseline in 6MWD (6 minute walk distance test) | Measure | Change from baseline in NT-proBNP | Measure | Change from baseline in NYHA/WHO Functional Class (FC) | Measure | Change from baseline in emPHasis-10 (Health Related Quality of Life) score | Measure | Change from baseline in Borg Dyspnea Index (BDI) | Measure | Incidence of Clinical Worsening | Measure | Change in pulmonary artery pressure from baseline | Measure | Change in cardiac index from baseline | Measure | Change in total pulmonary resistance from baseline |
Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting up to 30 days prior to first dose of study drug in original study (PB1046-PT-CL-0004/0005) and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. | Time Frame | Duration of extension study – Starting the day of first dose and completing 28 days after last dose. |
Description | Risk scores range from 0 (Lowest risk) to 22 (Highest risk) in PAH subjects | Description | Incidence of positive immunogenicity results after receipt of study drug | Description | Measured in meters walked in 6 minutes. | Description | Scores, which assess breathlessness, fatigue, control and confidence, range from 0 to 50, higher scores indicate worse quality of life. | Description | BDI scale as measured from 0 to 10 (0 being no breathlessness and 10 being maximal breathlessness) | Description | As defined by any one of the following: 1. All cause mortality; 2. Hospitalization due to worsening PAH; 3. Initiation of parenteral prostacyclin; 4. Any three of the following: 15% decrease in 6MWD, Functional class III or IV symptoms, Addition of PAH therapy, Worsening right heart failure | Description | PB1046-PT-CL-0005 subjects only as measured by CardioMEMS device | Description | PB1046-PT-CL-0005 subjects only as measured by CardioMEMS device | Description | PB1046-PT-CL-0005 subjects only as measured by CardioMEMS device |
Browse Conditions
Sequence: | 193584728 | Sequence: | 193584729 | Sequence: | 193584730 | Sequence: | 193584731 | Sequence: | 193584732 | Sequence: | 193584733 | Sequence: | 193584734 | Sequence: | 193584735 |
Mesh Term | Pulmonary Arterial Hypertension | Mesh Term | Familial Primary Pulmonary Hypertension | Mesh Term | Hypertension | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Hypertension, Pulmonary | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases |
Downcase Mesh Term | pulmonary arterial hypertension | Downcase Mesh Term | familial primary pulmonary hypertension | Downcase Mesh Term | hypertension | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | hypertension, pulmonary | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48343021 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | PhaseBio Pharmaceuticals Inc. |
Design Group Interventions
Sequence: | 68185308 |
Design Group Id | 55622640 |
Intervention Id | 52511740 |
Eligibilities
Sequence: | 30780377 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 79 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Subjects must have completed Week 17 / End of Study of PB1046-PT-CL-0004; Exclusion Criteria: Concomitant medical disorder, condition, or history, that in the opinion of the Investigator, would impair the subject's ability to participate in or complete the requirements of the study; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253975613 |
Number Of Facilities | 16 |
Registered In Calendar Year | 2018 |
Actual Duration | 33 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 79 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 9 |
Number Of Secondary Outcomes To Measure | 8 |
Number Of Other Outcomes To Measure | 3 |
Designs
Sequence: | 30526476 |
Allocation | N/A |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Masking Description | Subjects entering the 0006 trial prior to the implementation of this protocol amendment will remain blinded until such time that open label dosing will not unblind the 0004 study. |
Intervention Model Description | To protect the blind of the parent study (PB1046-PT-CL-0004), all subjects entering PB1046-PT-CL-0006 will commence dosing at Week 1 on 0.4 mg/kg and will be up-titrated in 0.2 mg/kg increments in an open label fashion for 9 weeks. |
Responsible Parties
Sequence: | 28892779 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03795415
2019-05-27
https://zephyrnet.com/?p=NCT03795415
NCT03795415https://www.clinicaltrials.gov/study/NCT03795415?tab=tableMarie Préau, Prmarie.preau@univ-lyon2.fr+33 4 78 77 31 63The objective of this research is to measure the short- and mid-term effects of an empowerment program focused on serostatus disclosure management for women living with HIV (WLHIV) in Mali on the “burden of secrecy”.
<![CDATA[
Studies
Study First Submitted Date | 2018-06-15 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2019-07-05 |
Start Month Year | May 27, 2019 |
Primary Completion Month Year | February 2020 |
Verification Month Year | July 2019 |
Verification Date | 2019-07-31 |
Last Update Posted Date | 2019-07-05 |
Detailed Descriptions
Sequence: | 20735785 |
Description | Serostatus disclosure is a critical issue for persons living with HIV (PLHIV). Studies identified numerous benefits associated with disclosure, but various negative consequences have also been documented. Gender inequality must be taken into account regarding the disclosure issue, in particular in Mali, where women are economically dependent and have a low decision-making power. Moreover, in Mali, since 2006, PLHIV have a legal obligation to disclose their serostatus to their spouse and sexual partner(s) " as soon as possible, or within 6 weeks " after the diagnosis. Although this law is not enforced, it highlights the sensitive nature of the serostatus disclosure issue and raise concerns among PLHIV and other stakeholders.
To support women living with HIV (WLHIV), an empowerment program (Gundo-So) was implemented by ARCAD-SIDA in Mali, in collaboration with several partners. This program aims to empower WLHIV, so that they can make informed decision about disclosing or keeping their serostatus secret in their various life contexts, and that they can identify strategies to disclose or to keep the secret, as well as to manage potential negative reactions. Gundo-So ("The room of confidences") was adapted from a program established in quebec and has been implemented in Mali. The objective of this research is to measure the short- and mid-term effects of an empowerment program focused on serostatus disclosure management for women living with HIV (WLHIV) in Mali on the "burden of secrecy". The evaluation of the effects of the Gundo-So program will be helpful to assess the relevance of a national or subregional extension of the program, or even an adaptation to other target populations (e.g. heterosexual men and men who have sex with men living with HIV). |
Facilities
Sequence: | 200244319 | Sequence: | 200244320 | Sequence: | 200244321 | Sequence: | 200244322 | Sequence: | 200244323 | Sequence: | 200244324 |
Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting |
Name | CESAC de BAMAKO | Name | Usac Cnam | Name | USAC commune IV | Name | USAC commune I | Name | USAC commune VI | Name | USAC commune V |
City | Bamako | City | Bamako | City | Bamako | City | Bamako | City | Bamako | City | Bamako |
Country | Mali | Country | Mali | Country | Mali | Country | Mali | Country | Mali | Country | Mali |
Facility Contacts
Sequence: | 28128019 | Sequence: | 28128020 | Sequence: | 28128021 | Sequence: | 28128022 | Sequence: | 28128023 | Sequence: | 28128024 |
Facility Id | 200244319 | Facility Id | 200244320 | Facility Id | 200244321 | Facility Id | 200244322 | Facility Id | 200244323 | Facility Id | 200244324 |
Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary |
Name | Djénébou Traoré, Dr | Name | Djénébou Traore, Dr | Name | Djénébou Traoré, Dr | Name | Djénébou Traore, Dr | Name | Djénébou Traore, Dr | Name | Djénébou Traore, Dr |
Conditions
Sequence: | 52208134 | Sequence: | 52208135 | Sequence: | 52208136 | Sequence: | 52208137 |
Name | HIV Seropositivity | Name | Disclosure | Name | Empowerment | Name | HIV/AIDS |
Downcase Name | hiv seropositivity | Downcase Name | disclosure | Downcase Name | empowerment | Downcase Name | hiv/aids |
Id Information
Sequence: | 40186167 |
Id Source | org_study_id |
Id Value | ANRS12373 |
Countries
Sequence: | 42599663 |
Name | Mali |
Removed | False |
Design Groups
Sequence: | 55634691 | Sequence: | 55634692 |
Title | Immediate Arm (G1) | Title | Delayed Arm (G2) |
Description | 3 months after enrollment, each big groups of 16 will be split in two groups. Women in G1 will receive the intervention Gundo-So immediately. (From month 3 to month 6).
112 women will be in immediate arm in 14 groups of 8 women. |
Description | 3 months after enrollment, each big groups of 16 will be split in two groups. Women in G2 will receive the intervention Gundo-So 3 months after. (From month 6 to month 9).
112 women will be in delayed arm in 14 groups of 8 women. |
Interventions
Sequence: | 52522097 |
Intervention Type | Behavioral |
Name | Gundo So |
Description | Gundo-So was adapted from a program established in quebec. It has been implemented in Mali following 3 phases: 1) cultural adaptation; 2) validation using a pre-post intervention evaluation; 3) scale-up
The programm consists on 9 group meetings group spread over 9 weeks (for 8 WLHIV + 2 trained community-based leaders). Each meeting has some particular thematics with adapted tools. |
Keywords
Sequence: | 79922980 | Sequence: | 79922981 | Sequence: | 79922982 | Sequence: | 79922983 |
Name | WLHIV | Name | empowerment | Name | disclosure | Name | Mali |
Downcase Name | wlhiv | Downcase Name | empowerment | Downcase Name | disclosure | Downcase Name | mali |
Design Outcomes
Sequence: | 177511416 | Sequence: | 177511417 | Sequence: | 177511418 | Sequence: | 177511419 | Sequence: | 177511420 | Sequence: | 177511421 | Sequence: | 177511422 | Sequence: | 177511423 | Sequence: | 177511424 | Sequence: | 177511425 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Short term evaluation of the burden associated with the disclosure issue using questionnaires | Measure | Short term evaluation of the burden associated with the secrecy issue using questionnaires | Measure | Mid term evaluation of the burden associated with the disclosure issue using questionnaires | Measure | Mid term evaluation of the burden associated with the secrecy issue using questionnaires | Measure | Changes in quality of life of WLHIV: questionnaire | Measure | Evolution of sexual practices and use of risk reduction strategies | Measure | Reported compliance (questionnaire) | Measure | Biological data : HIV viral load | Measure | Biological data : cluster of differentiation 4 levels | Measure | Satisfaction of the intervention: questionnaire |
Time Frame | The short term effect will be measured at the end of the intervention and compared between Group 1 and 2. Up to 6 months from the beginning of the randomization to the end of the intervention | Time Frame | The short term effect will be measured at the end of the intervention and compared between Group 1 and 2. Up to 6 months from the beginning of the randomization to the end of the intervention | Time Frame | The mid term effect will be measured 9 months after the intervention : up to 9 months after the intervention | Time Frame | The mid term effect will be measured 9 months after the intervention : up to 9 months after the intervention | Time Frame | Measured at the randomization and then immediately after the intervention | Time Frame | Measured at the randomization and then immediately after the intervention | Time Frame | Measured at the randomization and then immediately after the intervention | Time Frame | From 6 months before the intervention until the last follow up (total 2 years) | Time Frame | From 6 months before the intervention until the last follow up (total 2 years) | Time Frame | Measured immediately after the intervention |
Description | Improvement of the management of the sharing of the serological status. Empowerment in sharing the HIV status (questionnaire) | Description | Improvement of the management of the secret of the serological status. Empowerment in keeping secret the HIV status (questionnaire) | Description | Improvement of the management of the sharing of the serological status. Empowerment in sharing the HIV status (questionnaire) | Description | Improvement of the management of the secret of the serological status. Empowerment in keeping secret the HIV status (questionnaire) | Description | Assess the changes in quality of life (questionnaire) | Description | Assess changes of sexual practices and risk reductions strategies (questionnaire) | Description | Assess changes of reported compliance throught HIV antiretroviral treatments (questionnaire) | Description | Access changes in HIV viral load due to the intervention (via the medical file) | Description | Access changes in cluster of differentiation 4 levels due to the intervention (via the medical file) | Description | Assess the satisfaction of the intervention using questionnaire |
Browse Conditions
Sequence: | 193627114 | Sequence: | 193627115 | Sequence: | 193627116 | Sequence: | 193627117 | Sequence: | 193627118 | Sequence: | 193627119 | Sequence: | 193627120 | Sequence: | 193627121 | Sequence: | 193627122 | Sequence: | 193627123 | Sequence: | 193627124 | Sequence: | 193627125 | Sequence: | 193627126 | Sequence: | 193627127 | Sequence: | 193627128 |
Mesh Term | HIV Seropositivity | Mesh Term | HIV Infections | Mesh Term | Blood-Borne Infections | Mesh Term | Communicable Diseases | Mesh Term | Infections | Mesh Term | Sexually Transmitted Diseases, Viral | Mesh Term | Sexually Transmitted Diseases | Mesh Term | Lentivirus Infections | Mesh Term | Retroviridae Infections | Mesh Term | RNA Virus Infections | Mesh Term | Virus Diseases | Mesh Term | Genital Diseases | Mesh Term | Urogenital Diseases | Mesh Term | Immunologic Deficiency Syndromes | Mesh Term | Immune System Diseases |
Downcase Mesh Term | hiv seropositivity | Downcase Mesh Term | hiv infections | Downcase Mesh Term | blood-borne infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | infections | Downcase Mesh Term | sexually transmitted diseases, viral | Downcase Mesh Term | sexually transmitted diseases | Downcase Mesh Term | lentivirus infections | Downcase Mesh Term | retroviridae infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | genital diseases | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | immunologic deficiency syndromes | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48353714 | Sequence: | 48353715 | Sequence: | 48353716 | Sequence: | 48353717 | Sequence: | 48353718 | Sequence: | 48353719 | Sequence: | 48353720 | Sequence: | 48353721 |
Agency Class | OTHER_GOV | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | ANRS, Emerging Infectious Diseases | Name | Fondation de France | Name | Aix Marseille Université | Name | Université du Québec a Montréal | Name | Centre Population et Développement (CEPED), Paris, France | Name | ARCAD-SIDA MALI | Name | Groupe de Recherche en Psychologie Sociale (GRePS), Bron, France | Name | Coalition Plus, France |
Overall Officials
Sequence: | 29305993 |
Role | Principal Investigator |
Name | Marie Préau, Pr |
Affiliation | GRePS |
Central Contacts
Sequence: | 12017224 | Sequence: | 12017225 |
Contact Type | primary | Contact Type | backup |
Name | Lucas Riegel | Name | Marie Préau, Pr |
Phone | +33 1 77 93 97 63 | Phone | +33 4 78 77 31 63 |
lriegel@coalitionplus.org | marie.preau@univ-lyon2.fr | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68199216 | Sequence: | 68199217 |
Design Group Id | 55634692 | Design Group Id | 55634691 |
Intervention Id | 52522097 | Intervention Id | 52522097 |
Eligibilities
Sequence: | 30786885 |
Sampling Method | Probability Sample |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | The programm Gundo So has been adapted for groups of malian women living with HIV (WLHIV). The study population is described with the inclusion criteria. Moreover, in order to participate at this research, women have to answer "Yes" at at least one of those 2 questions :
(1) is it difficult for you to share your HIV serostatus ; and (1.1) is it inconvenient for you? |
Criteria | Inclusion Criteria:
women living with HIV Exclusion Criteria: having already participated in Gundo-So |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989644 |
Number Of Facilities | 6 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30532955 |
Observational Model | Case-Control |
Time Perspective | Prospective |
Intervention Other Names
Sequence: | 26692039 |
Intervention Id | 52522097 |
Name | Gundo So – The room of confidences |
Responsible Parties
Sequence: | 28899249 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52103098 |
Pmid | 28789863 |
Reference Type | background |
Citation | Bernier A, Yattassaye A, Beaulieu-Prevost D, Otis J, Henry E, Flores-Aranda J, Massie L, Preau M, Keita BD. Empowering Malian women living with HIV regarding serostatus disclosure management: Short-term effects of a community-based intervention. Patient Educ Couns. 2018 Feb;101(2):248-255. doi: 10.1016/j.pec.2017.07.030. Epub 2017 Jul 26. |
]]>
https://zephyrnet.com/NCT03795402
2019-03-15
https://zephyrnet.com/?p=NCT03795402
NCT03795402https://www.clinicaltrials.gov/study/NCT03795402?tab=tableNANANAThe purpose of this study is to collect skin biopsies and non-invasive microneedle device samples from participants with mild chronic plaque psoriasis vulgaris to use for transcriptomics profiling for further investigation.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2019-12-13 |
Start Month Year | March 15, 2019 |
Primary Completion Month Year | November 25, 2019 |
Verification Month Year | December 2019 |
Verification Date | 2019-12-31 |
Last Update Posted Date | 2019-12-13 |
Facilities
Sequence: | 200107811 |
Name | Innovaderm Research Inc. |
City | Montreal |
State | Quebec |
Zip | H2K 4L5 |
Country | Canada |
Conditions
Sequence: | 52171106 |
Name | Psoriasis Vulgaris |
Downcase Name | psoriasis vulgaris |
Id Information
Sequence: | 40158545 | Sequence: | 40158546 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 8004053 | Id Value | 8004053 |
Id Type | Other Identifier | ||
Id Type Description | Janssen Research & Development, LLC | ||
Countries
Sequence: | 42568845 |
Name | Canada |
Removed | False |
Design Groups
Sequence: | 55593046 | Sequence: | 55593047 |
Title | Group A | Title | Group B |
Description | Three microneedle device samples will be collected from a psoriasis lesion and from nonlesional (healthy) skin on Day 1. Two skin biopsies of 4 millimeter (mm) will be performed on Day 1. No investigational drug product will be administered during this study. | Description | One microneedle device sample will be collected from a psoriasis lesion and from nonlesional (healthy) skin on Day 1 and at Weeks 2 and 4. Two skin biopsies of 4 mm will be performed on Day 1. No investigational drug product will be administered during this study. |
Interventions
Sequence: | 52485352 |
Intervention Type | Device |
Name | Microneedle Device |
Description | Microneedle device will be used for collecting skin samples as a non-invasive method. |
Design Outcomes
Sequence: | 177378421 |
Outcome Type | primary |
Measure | Measurement of Expression by RNA-sequencing (RNAseq) of Extracted RNA Using Punch Biopsy Method Versus Microneedle Device Sampling Method |
Time Frame | Up to 28 days |
Description | Measurement of expression by ribonucleic acid (RNA)-sequencing of extracted RNA by the frequently used punch biopsy method and the microneedle device will be performed to have a comparison between both the methods. |
Browse Conditions
Sequence: | 193486196 | Sequence: | 193486197 | Sequence: | 193486198 |
Mesh Term | Psoriasis | Mesh Term | Skin Diseases, Papulosquamous | Mesh Term | Skin Diseases |
Downcase Mesh Term | psoriasis | Downcase Mesh Term | skin diseases, papulosquamous | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319170 | Sequence: | 48319171 |
Agency Class | INDUSTRY | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Janssen Research & Development, LLC | Name | Innovaderm Research Inc. |
Overall Officials
Sequence: | 29285291 |
Role | Study Director |
Name | Janssen Research & Development, LLC Clinical Trial |
Affiliation | Janssen Research & Development, LLC |
Design Group Interventions
Sequence: | 68148978 | Sequence: | 68148979 |
Design Group Id | 55593046 | Design Group Id | 55593047 |
Intervention Id | 52485352 | Intervention Id | 52485352 |
Eligibilities
Sequence: | 30765277 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Participants with mild chronic plaque psoriasis vulgaris, defined as having a body surface area (BSA) greater than or equal to (>=) 1 percent (%) and less than (<) 10% (excluding palms, soles, face, scalp, and genitals), will be included in this study. |
Criteria | Inclusion Criteria:
Participant has a history of chronic plaque psoriasis vulgaris for at least 6 months prior to the screening visit Exclusion Criteria: Participant is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253877529 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 8 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30511444 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28877738 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03795389
2019-02-12
https://zephyrnet.com/?p=NCT03795389
NCT03795389https://www.clinicaltrials.gov/study/NCT03795389?tab=tableNANANAAn open-label, phase IB, multi-center study evaluating DM199 in subjects with Type 1 Diabetes or Type 2 Diabetes and Stage 3 or 4 Chronic Kidney Disease. The primary objectives of this study are to evaluate safety, tolerability, and PK profile of DM199 in these subjects.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2021-09-13 |
Start Month Year | February 12, 2019 |
Primary Completion Month Year | July 21, 2019 |
Verification Month Year | July 2019 |
Verification Date | 2019-07-31 |
Last Update Posted Date | 2021-09-13 |
Detailed Descriptions
Sequence: | 20741142 |
Description | The study evaluates the safety, tolerability, and PK profile of DM199 in subjects with T1D or T2D and with Stage 3 or Stage 4 CKD. Additionally, this study evaluates urine concentrations of KLK1 pre and post dose.
Cohort 1: Subjects with T1D or T2D and Stage 3 CKD will be administered one of three DM199 doses: 3.0 ug/kg or 5.0 ug/kg or 8.0 ug/kg single SC dose. Cohort 2: Subjects with T1D or T2D and Stage 4 CKD will be administered a single 3.0 µg/kg single SC dose. Secondary and exploratory study objectives include collection and analysis of vital signs, biomarkers, eGFR, blood glucose, and ECG's. |
Facilities
Sequence: | 200280512 | Sequence: | 200280513 | Sequence: | 200280514 |
Name | Clinical Pharmacology of Miami | Name | Orlando Clinical Research Center Inc | Name | Prism Research |
City | Hialeah | City | Orlando | City | Saint Paul |
State | Florida | State | Florida | State | Minnesota |
Zip | 33014 | Zip | 32803 | Zip | 55114 |
Country | United States | Country | United States | Country | United States |
Conditions
Sequence: | 52221455 | Sequence: | 52221456 | Sequence: | 52221457 | Sequence: | 52221458 |
Name | Chronic Kidney Disease | Name | Chronic Kidney Disease, Stage 3 (Moderate) | Name | Chronic Kidney Disease, Stage 4 (Severe) | Name | Diabetes |
Downcase Name | chronic kidney disease | Downcase Name | chronic kidney disease, stage 3 (moderate) | Downcase Name | chronic kidney disease, stage 4 (severe) | Downcase Name | diabetes |
Id Information
Sequence: | 40195583 |
Id Source | org_study_id |
Id Value | DM199-2018-001 |
Countries
Sequence: | 42609615 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55649736 | Sequence: | 55649737 | Sequence: | 55649738 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | 3.0 µg/kg SC, single dose | Title | 5.0 µg/kg SC, single dose | Title | 8.0 µg/kg SC, single dose |
Description | n=8, study group of T1D or T2D with stage 3 CKD. separate n=8 of study group with T1D or T2D with CKD stage 4). | Description | n=8, study group of T1D or T2D with stage 3 CKD. | Description | n=8, study group of T1D or T2D with stage 3 CKD. |
Interventions
Sequence: | 52535271 |
Intervention Type | Drug |
Name | DM199 |
Description | Single SC dose |
Keywords
Sequence: | 79941658 | Sequence: | 79941659 |
Name | Diabetes | Name | Chronic Kidney Disease |
Downcase Name | diabetes | Downcase Name | chronic kidney disease |
Design Outcomes
Sequence: | 177561241 | Sequence: | 177561242 | Sequence: | 177561243 | Sequence: | 177561244 | Sequence: | 177561245 | Sequence: | 177561246 | Sequence: | 177561247 | Sequence: | 177561248 | Sequence: | 177561249 | Sequence: | 177561250 | Sequence: | 177561251 | Sequence: | 177561252 | Sequence: | 177561253 | Sequence: | 177561254 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other |
Measure | Safety as assessed by incidence, severity, and causality of adverse events | Measure | Tolerability as assessed by incidence and severity of AEs | Measure | plasma measurements of DM199 | Measure | DM199 urine concentrations of KLK1 | Measure | C Reactive protein (CRP) | Measure | Matrix Metalloproteinase-9 (MMP-9) | Measure | Vascular Endothelial Growth Factor (VEGF) | Measure | Nitric Oxide (NO) | Measure | Serum creatinine | Measure | Cystatin C | Measure | neutrophil gelatinase-associated prostaglandin E2 | Measure | Urine Kidney Injury Molecule-1 (Kim1) | Measure | serum creatinine | Measure | Blood glucose |
Time Frame | 11 days | Time Frame | 11 days | Time Frame | 11 days | Time Frame | 11 days | Time Frame | 11 days | Time Frame | 11 days | Time Frame | 11 days | Time Frame | 11 days | Time Frame | 11 days | Time Frame | 11 days | Time Frame | 11 days | Time Frame | 11 days | Time Frame | 11 days | Time Frame | 11 days |
Description | as measured in the three different dosing groups; 3.0 ug/kg, 5.0 ug/kg, and 8.0 ug/kg. | Description | urine KLK1 will be measured pre and post study drug administration. |
Browse Conditions
Sequence: | 193678175 | Sequence: | 193678176 | Sequence: | 193678177 | Sequence: | 193678178 | Sequence: | 193678183 | Sequence: | 193678184 | Sequence: | 193678185 | Sequence: | 193678179 | Sequence: | 193678180 | Sequence: | 193678181 | Sequence: | 193678182 |
Mesh Term | Kidney Diseases | Mesh Term | Renal Insufficiency, Chronic | Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Male Urogenital Diseases | Mesh Term | Renal Insufficiency |
Downcase Mesh Term | kidney diseases | Downcase Mesh Term | renal insufficiency, chronic | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | male urogenital diseases | Downcase Mesh Term | renal insufficiency |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366364 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | DiaMedica Therapeutics Inc |
Overall Officials
Sequence: | 29312883 |
Role | Study Director |
Name | Harry Alcorn, Pharm.D. |
Affiliation | DiaMedica Inc. |
Design Group Interventions
Sequence: | 68217310 | Sequence: | 68217311 | Sequence: | 68217312 |
Design Group Id | 55649736 | Design Group Id | 55649737 | Design Group Id | 55649738 |
Intervention Id | 52535271 | Intervention Id | 52535271 | Intervention Id | 52535271 |
Eligibilities
Sequence: | 30794669 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Subject is willing and able to provide informed consent for study participation. Exclusion Criteria: Subject has positive drug test for drugs of abuse and/or positive alcohol breath test at screening and Day 0. Subject has any of the following conditions as determined by ECG or medical record: Any significant arrhythmia or conduction abnormality, which, in the opinion of the Investigators and Medical Monitor, may interfere with the safety of the subject. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004254 |
Number Of Facilities | 3 |
Registered In Calendar Year | 2019 |
Actual Duration | 5 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 8 |
Number Of Other Outcomes To Measure | 2 |
Designs
Sequence: | 30540709 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28907029 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03795376
2019-01-01
https://zephyrnet.com/?p=NCT03795376
NCT03795376https://www.clinicaltrials.gov/study/NCT03795376?tab=tableSolène Secherdpo@dataids.orgNADatAIDS prevention is a cohort study of HIV prevention in over 23 HIV sites in France including overseas, aiming to describe HIV prevention in every aspect including HIV screening, STI and hepatitis screening, post-exposure prophylaxis and pre-exposure prophylaxis
<![CDATA[
Studies
Study First Submitted Date | 2018-12-21 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2023-02-16 |
Start Month Year | January 1, 2019 |
Primary Completion Month Year | January 1, 2024 |
Verification Month Year | February 2023 |
Verification Date | 2023-02-28 |
Last Update Posted Date | 2023-02-16 |
Facilities
Sequence: | 201134191 | Sequence: | 201134192 | Sequence: | 201134193 | Sequence: | 201134194 | Sequence: | 201134195 | Sequence: | 201134196 | Sequence: | 201134197 | Sequence: | 201134198 | Sequence: | 201134199 | Sequence: | 201134200 | Sequence: | 201134201 | Sequence: | 201134202 | Sequence: | 201134203 | Sequence: | 201134204 | Sequence: | 201134205 | Sequence: | 201134206 | Sequence: | 201134207 | Sequence: | 201134208 | Sequence: | 201134209 | Sequence: | 201134210 | Sequence: | 201134211 | Sequence: | 201134212 | Sequence: | 201134213 | Sequence: | 201134214 | Sequence: | 201134215 | Sequence: | 201134216 | Sequence: | 201134217 |
Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting |
Name | CHU Besançon – Hôpital Jean Minjoz | Name | CHRU Brest | Name | CHU Clermont-Ferrand – Hôpital Gabriel-Montpied | Name | CHD Vendée | Name | Hôpital Bicêtre – Assistance Publique des Hôpitaux de Paris | Name | Hôpital de la Croix-Rousse – Hospices Civils de Lyon | Name | Hôpital de la Conception – Assistance Publique des Hôpitaux de Marseille | Name | Hôpital Sainte Marguerite – Assistance Publique des Hôpitaux de Marseille | Name | CHR Metz-Thionville | Name | Hôpital Gui de Chauliac | Name | CHU Nancy – Hôpital Brabois | Name | CHU Nantes – Hôtel-Dieu | Name | CHU Nice – Hôpital l'Archet | Name | CH Niort | Name | Groupe Hospitalier Pitié Salpêtrière – Assistance Publique des Hôpitaux de Paris | Name | Hôpital Bichat – Assistance Publique des Hôpitaux de Paris | Name | Hôpital Necker-Pasteur – Assistance Publique des Hôpitaux de Paris | Name | Centre Hospitalier de Cornouaille | Name | CHU Reims – Hôpital Robert Debré | Name | CHU Rennes – Hôpital Pontchaillou | Name | CHU St Etienne – Hôpital Nord | Name | CHU Strasbourg – Hôpital Civil | Name | CHU Toulouse – Hôpital Purpan | Name | CHU Tourcoing – Hôpital Guy Chatiliez | Name | CH Bretagne-Atlantique | Name | CHU de Guadeloupe | Name | CHU de Martinique |
City | Besançon | City | Brest | City | Clermont-Ferrand | City | La Roche-sur-Yon | City | Le Kremlin-Bicêtre | City | Lyon | City | Marseille | City | Marseille | City | Metz | City | Montpellier | City | Nancy | City | Nantes | City | Nice | City | Niort | City | Paris | City | Paris | City | Paris | City | Quimper | City | Reims | City | Rennes | City | Saint-Étienne | City | Strasbourg | City | Toulouse | City | Tourcoing | City | Vannes | City | Pointe-à-Pitre | City | Fort-de-France |
Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | Guadeloupe | Country | Martinique |
Facility Contacts
Sequence: | 28261127 | Sequence: | 28261128 | Sequence: | 28261129 | Sequence: | 28261130 | Sequence: | 28261131 | Sequence: | 28261132 | Sequence: | 28261133 | Sequence: | 28261134 | Sequence: | 28261135 | Sequence: | 28261136 | Sequence: | 28261137 | Sequence: | 28261138 | Sequence: | 28261139 | Sequence: | 28261140 | Sequence: | 28261141 | Sequence: | 28261142 | Sequence: | 28261143 | Sequence: | 28261144 | Sequence: | 28261145 | Sequence: | 28261146 | Sequence: | 28261147 | Sequence: | 28261148 | Sequence: | 28261149 | Sequence: | 28261150 | Sequence: | 28261151 | Sequence: | 28261152 | Sequence: | 28261153 |
Facility Id | 201134191 | Facility Id | 201134192 | Facility Id | 201134193 | Facility Id | 201134194 | Facility Id | 201134195 | Facility Id | 201134196 | Facility Id | 201134197 | Facility Id | 201134198 | Facility Id | 201134199 | Facility Id | 201134200 | Facility Id | 201134201 | Facility Id | 201134202 | Facility Id | 201134203 | Facility Id | 201134204 | Facility Id | 201134205 | Facility Id | 201134206 | Facility Id | 201134207 | Facility Id | 201134208 | Facility Id | 201134209 | Facility Id | 201134210 | Facility Id | 201134211 | Facility Id | 201134212 | Facility Id | 201134213 | Facility Id | 201134214 | Facility Id | 201134215 | Facility Id | 201134216 | Facility Id | 201134217 |
Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary |
Name | Catherine CHIROUZE | Name | Sylvain JAFFUEL | Name | Christine JACOMET | Name | Dominique MERRIEN | Name | Antoine CHERET | Name | Laurent COTTE | Name | Isabelle RAVAUX | Name | Sylvie BREGIGEON-RONOT | Name | Céline ROBERT | Name | Alain MAKINSON | Name | Benjamin LEFEVRE | Name | François RAFFI | Name | Pascal PUGLIESE | Name | Simon SUNDER | Name | Christine KATLAMA | Name | Yazdan YAZDANPANAH | Name | Claudine DUVIVIER | Name | Nolwenn HALL | Name | Firouze BANISADR | Name | Pierre TATTEVIN | Name | Amandine GAGNEUX-BRUNON | Name | David REY | Name | Pierre DELOBEL | Name | Olivier ROBINEAU | Name | Grégory CORVAISIER | Name | Isabelle LAMAURY | Name | André CABIE |
Facility Investigators
Sequence: | 18427536 | Sequence: | 18427537 | Sequence: | 18427538 | Sequence: | 18427539 | Sequence: | 18427540 | Sequence: | 18427541 | Sequence: | 18427542 | Sequence: | 18427543 | Sequence: | 18427544 | Sequence: | 18427545 | Sequence: | 18427546 | Sequence: | 18427547 | Sequence: | 18427548 | Sequence: | 18427549 | Sequence: | 18427550 | Sequence: | 18427551 | Sequence: | 18427552 | Sequence: | 18427553 | Sequence: | 18427554 | Sequence: | 18427555 | Sequence: | 18427556 | Sequence: | 18427557 | Sequence: | 18427558 | Sequence: | 18427559 | Sequence: | 18427560 | Sequence: | 18427561 | Sequence: | 18427562 |
Facility Id | 201134191 | Facility Id | 201134192 | Facility Id | 201134193 | Facility Id | 201134194 | Facility Id | 201134195 | Facility Id | 201134196 | Facility Id | 201134197 | Facility Id | 201134198 | Facility Id | 201134199 | Facility Id | 201134200 | Facility Id | 201134201 | Facility Id | 201134202 | Facility Id | 201134203 | Facility Id | 201134204 | Facility Id | 201134205 | Facility Id | 201134206 | Facility Id | 201134207 | Facility Id | 201134208 | Facility Id | 201134209 | Facility Id | 201134210 | Facility Id | 201134211 | Facility Id | 201134212 | Facility Id | 201134213 | Facility Id | 201134214 | Facility Id | 201134215 | Facility Id | 201134216 | Facility Id | 201134217 |
Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator |
Name | Catherine CHIROUZE | Name | Sylvain JAFFUEL | Name | Christine JACOMET | Name | Dominique MERRIEN | Name | Antoine CHERET | Name | Laurent COTTE | Name | Isabelle RAVAUX | Name | Sylvie BREGIGEON-RONOT | Name | Céline ROBERT | Name | Alain MAKINSON | Name | Benjamin LEFEVRE | Name | François RAFFI | Name | Pascal PUGLIESE | Name | Simon SUNDER | Name | Christine KATLAMA | Name | Yazdan YAZDANPANAH | Name | Claudine DUVIVIER | Name | Nolwenn HALL | Name | Firouze BANISADR | Name | Pierre TATTEVIN | Name | Amandine GAGNEUX-BRUNON | Name | David REY | Name | Pierre DELOBEL | Name | Olivier ROBINEAU | Name | Grégory CORVAISIER | Name | Isabelle LAMAURY | Name | André CABIE |
Conditions
Sequence: | 52460702 |
Name | HIV Prevention |
Downcase Name | hiv prevention |
Id Information
Sequence: | 40365787 |
Id Source | org_study_id |
Id Value | DAT_002 |
Countries
Sequence: | 42799728 | Sequence: | 42799729 | Sequence: | 42799730 |
Name | France | Name | Guadeloupe | Name | Martinique |
Removed | False | Removed | False | Removed | False |
Design Outcomes
Sequence: | 178465106 | Sequence: | 178465107 | Sequence: | 178465108 | Sequence: | 178465109 | Sequence: | 178465110 | Sequence: | 178465111 | Sequence: | 178465112 | Sequence: | 178465113 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Number of patients enrolled for HIV prevention in the cohort | Measure | Proportion of persons enrolled for pre-exposure prophylaxis in the cohort | Measure | Proportion of persons enrolled for post-exposure prophylaxis in the cohort | Measure | Proportion of persons enrolled for hepatitis screening in the cohort | Measure | Proportion of persons enrolled for pre-exposure prophylaxis in the cohort according to national French guidelines | Measure | Proportion of persons enrolled for post-exposure prophylaxis in the cohort according to national French guidelines | Measure | Incidence of STIs | Measure | Incidence of hepatitis |
Time Frame | From date of enrollment, through study completion, an average of 1 year | Time Frame | From date of enrollment, through study completion, an average of 1 year | Time Frame | From date of enrollment, through study completion, an average of 1 year | Time Frame | From date of enrollment, through study completion, an average of 1 year | Time Frame | From date of enrollment, through study completion, an average of 1 year | Time Frame | From date of enrollment, through study completion, an average of 1 year | Time Frame | From date of enrollment, through study completion, an average of 1 year | Time Frame | From date of enrollment, through study completion, an average of 1 year |
Description | Demographics, risk factors clinical and biological characteristics, treatment of patients enrolled for HIV prevention in the cohort | Description | Demographics, risk factors clinical and biological characteristics, treatment of patients attending for pre-exposure prophylaxis in the cohort | Description | Demographics, risk factors clinical and biological characteristics, treatment of patients attending for post-exposure prophylaxis in the cohort | Description | Demographics, risk factors clinical and biological characteristics, treatment of patients attending for hepatitis screening in the cohort | Description | Adequation between prevention practices and guidelines | Description | Adequation between prevention practices and guidelines |
Sponsors
Sequence: | 48588516 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | DatAids |
Overall Officials
Sequence: | 29436901 | Sequence: | 29436902 |
Role | Principal Investigator | Role | Principal Investigator |
Name | Pascal PUGLIESE, MD | Name | André CABIE, MD-PhD |
Affiliation | Centre Hospitalier Universitaire de Nice | Affiliation | Centre Hospitalier Universitaire de Martinique |
Central Contacts
Sequence: | 12083325 | Sequence: | 12083326 |
Contact Type | primary | Contact Type | backup |
Name | Pascal Pugliese, MD | Name | Solène Secher |
Phone | 0033492035802 | ||
pugliese.p@chu-nice.fr | dpo@dataids.org | ||
Role | Contact | Role | Contact |
Eligibilities
Sequence: | 30931494 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | All persons attending for HIV prevention and seeking care at 23 centers using NADIS are included in the Dataids Prevention cohort after receiving oral information and giving written consent. NADIS is an electronic medical record (EMR) for HIV infection (and Hepatitis B virus (HBV), Hepatitis C virus (HCV), STI) and HIV prevention in French public hospitals.
The Dataids Prevention study recruits persons HIV- and above the age of 18 years. |
Criteria | Inclusion Criteria:
Male and female over 18 years old, Exclusion Criteria: HIV-infection |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254214857 |
Number Of Facilities | 27 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 7 |
Designs
Sequence: | 30677136 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 29043846 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03795363
2019-04-10
https://zephyrnet.com/?p=NCT03795363
NCT03795363https://www.clinicaltrials.gov/study/NCT03795363?tab=tableNANANAThe purpose of this observational research study is to determine the effects of clinically prescribed Orkambi treatment on 2 to 5 year old children homozygous for the F508del Mutations in the Cystic fibrosis transmembrane conductance regulator (CFTR) gene on sleeping energy expenditure, growth status and gut health and function.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-28 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2021-12-02 |
Start Month Year | April 10, 2019 |
Primary Completion Month Year | June 16, 2021 |
Verification Month Year | December 2021 |
Verification Date | 2021-12-31 |
Last Update Posted Date | 2021-12-02 |
Detailed Descriptions
Sequence: | 20762942 |
Description | Orkambi is a novel FDA approved (August, 2018) therapy for use in patients with cystic fibrosis (CF) who are 2 to 5 years of age and homozygous for F508del mutations in the CFTR gene. It is a combination of lumacaftor and ivacaftor that addresses both the processing and gating defects of the F508del mutation. This investigator-initiated study is designed to evaluate the nutritional, growth and GI impact of Orkambi treatment for this unique younger (2 to 5 years) patient cohort. This proposal extends previous highly informative nutrition and weight gain investigation of ivacaftor treatment in people with CF gating mutations to another CFTR modulator treatment (Orkambi) in people homozygous for F508del mutations. The primary aims of the study are to evaluate the impact of 24 weeks of Orkambi treatment in 2 to 5 year old subjects with CF homozygous for F508del mutations on sleeping or resting energy expenditure, growth status and gut health and function in n=32 children ages 2.0 to 5.9 years of age. Protocol evaluations will occur at baseline (pre-treatment) and 12 and 24 weeks after clinically prescribed Orkambi treatment has begun. Other outcomes of significant clinical interest in young subjects with CF will be explored. All subjects will be evaluated as outpatient at The Children's Hospital of Philadelphia, and will be recruited both regionally and nationally to ensure timely enrollment. |
Facilities
Sequence: | 200458228 |
Name | Children's Hospital of Philadelphia |
City | Philadelphia |
State | Pennsylvania |
Zip | 19146 |
Country | United States |
Conditions
Sequence: | 52277487 |
Name | Cystic Fibrosis |
Downcase Name | cystic fibrosis |
Id Information
Sequence: | 40235487 |
Id Source | org_study_id |
Id Value | 18-015669 |
Countries
Sequence: | 42653081 |
Name | United States |
Removed | False |
Interventions
Sequence: | 52589550 |
Intervention Type | Drug |
Name | Orkambi |
Description | Orkambi is a novel approved therapy for use in people homozygous for the F508del mutation in the CFTR gene. It is a combination of lumacaftor (VX-809) and ivacaftor( VX-770) that addresses both the processing and gating defects of the F508del mutation. The small-molecule corrector lumacaftor corrects the F508del processing defect and increases epithelial delivery of CFTR protein1. Ivacaftor is a CFTR potentiator that increases the channel open probability in F508del-mutant CFTRs that undergo epithelial delivery in vitro and has an additive effect with lumacaftor on chloride transport (2,3,4,5). |
Keywords
Sequence: | 80019010 | Sequence: | 80019011 | Sequence: | 80019012 |
Name | CF | Name | CFTR | Name | Cystic Fibrosis |
Downcase Name | cf | Downcase Name | cftr | Downcase Name | cystic fibrosis |
Design Outcomes
Sequence: | 177770768 | Sequence: | 177770769 | Sequence: | 177770770 | Sequence: | 177770771 | Sequence: | 177770772 | Sequence: | 177770773 | Sequence: | 177770774 | Sequence: | 177770775 | Sequence: | 177770776 | Sequence: | 177770777 | Sequence: | 177770778 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Sleeping or Resting Energy Expenditure | Measure | Anthropometric Assessment | Measure | Fecal Elastase I/Pancreatic Function | Measure | Fecal Calprotectin/Gut Inflammation | Measure | Plasma Total Fatty Acids | Measure | Dietary Intake | Measure | Serum fat soluble vitamin levels | Measure | Changes in bile acid concentration levels | Measure | Changes in concentration levels of serum calprotectin | Measure | Muscle-Fat Stores | Measure | Growth status changes |
Time Frame | 24 Weeks | Time Frame | 24 Weeks | Time Frame | 24 Weeks | Time Frame | 24 Weeks | Time Frame | 24 Weeks | Time Frame | 24 Weeks | Time Frame | 24 Weeks | Time Frame | 24 Weeks | Time Frame | 24 Weeks | Time Frame | 24 Weeks | Time Frame | 24 Weeks |
Description | Investigators will examine the effects of 24 weeks of orkambi treatment on subject's SEE (sleeping energy expenditure) or REE (resting energy expenditure). Using indirect calorimetry, SEE/REE will be assessed using a computerized metabolic cart Vmax ENCORE at each protocol visit while the child is asleep or resting quietly. SEE/REE will be assessed in the morning if possible and careful note of previous feeding of the child, including the time of day, amount of food, and feeding interval prior to test. It will depend on the age of the subject, and if the subject still takes daily naps and is able to rest quietly without moving, if they will perform sleeping energy expenditure or resting energy expenditure. This will be one outcome measure for each subject, and it will depend on if the subject can nap (SEE) or rest quietly without moving (REE). | Description | Investigators will examine the effects of 24 weeks of orkambi treatment on subject's body mass index (BMI). Investigators will compare the results to BMI Z scores over 24 weeks compared to baseline. | Description | Investigators will examine the effects of 24 weeks of orkambi treatment on subject's pancreatic function. Pancreatic function will be assessed at two visits by obtaining spot stool samples with fecal elastase 1. The concentration of fecal elastase I is indicative of pancreatic function. | Description | Investigators will examine the effects of 24 weeks of orkambi treatment on subject's fecal calprotectin concentration. Spot stool samples will be obtained to determine fecal calprotectin concentration, which is a marker for gut inflammation. | Description | Investigators will examine the effects of 24 weeks of orkambi treatment on subject's dietary fat absorption. A total plasma fatty acid panel will be assessed to measure the change in status of 22 fatty acids. | Description | Three day weighed food record will be obtained and to determine changes in dietary caloric intake and micro and macronutrient intake over the course of 24 weeks on orkambi treatment. | Description | Investigators will examine the changes in serum fat soluble vitamin A, E, D and K concentration levels after 24 weeks of orkambi treatment. | Description | Investigators will examine changes in the concentration levels of 14 bile acid species in subjects over the course of 24 weeks on orkambi treatment. | Description | Investigators will examine changes in the concentration levels of serum calprotectin in subjects over the course of 24 weeks on orkambi treatment. | Description | Investigators will measure body composition to determine muscle and fat store changes over the course of 24 weeks on orkambi treatment compared to baseline. | Description | Investigators will observe the changes in growth status over time. Growth status will be measured by determining the changes in three different measurements- length (cm), weight (kg) and head circumference (cm). Each value will be used to calculate BMI (kg/cm^2), which will be used in accordance with age to determine the growth velocity percentile of the subjects over the course of 24 weeks on orkambi treatment. The growth velocity percentile will be indicative of changes in growth status over time. |
Browse Conditions
Sequence: | 193892896 | Sequence: | 193892897 | Sequence: | 193892898 | Sequence: | 193892899 | Sequence: | 193892900 | Sequence: | 193892901 | Sequence: | 193892902 | Sequence: | 193892903 | Sequence: | 193892904 |
Mesh Term | Cystic Fibrosis | Mesh Term | Fibrosis | Mesh Term | Pathologic Processes | Mesh Term | Pancreatic Diseases | Mesh Term | Digestive System Diseases | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Genetic Diseases, Inborn | Mesh Term | Infant, Newborn, Diseases |
Downcase Mesh Term | cystic fibrosis | Downcase Mesh Term | fibrosis | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | pancreatic diseases | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | genetic diseases, inborn | Downcase Mesh Term | infant, newborn, diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48418669 | Sequence: | 48418670 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Children's Hospital of Philadelphia | Name | Vertex Pharmaceuticals Incorporated |
Overall Officials
Sequence: | 29342635 |
Role | Principal Investigator |
Name | Virginia Stallings, MD |
Affiliation | Children's Hospital of Philadelphia |
Eligibilities
Sequence: | 30827051 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 2 Years |
Maximum Age | 5 Years |
Healthy Volunteers | No |
Population | 2 to 5 year old subjects with a diagnosis of cystic fibrosis and homozygous for F508del mutations and who are in a usual state of good health with a clinical decision to start orkambi treatment. |
Criteria | Inclusion Criteria:
Cystic fibrosis and homozygous for F508del mutations, approved for treatment Exclusion Criteria: On parenteral nutrition |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254123752 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 26 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 2 |
Maximum Age Num | 5 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 3 |
Number Of Other Outcomes To Measure | 6 |
Designs
Sequence: | 30572981 |
Observational Model | Cohort |
Time Perspective | Prospective |
Provided Documents
Sequence: | 2589081 | Sequence: | 2589082 |
Document Type | Study Protocol | Document Type | Informed Consent Form |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | True |
Has Sap | False | Has Sap | False |
Document Date | 2019-10-28 | Document Date | 2019-12-04 |
Url | https://ClinicalTrials.gov/ProvidedDocs/63/NCT03795363/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/63/NCT03795363/ICF_001.pdf |
Responsible Parties
Sequence: | 28939403 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52177395 | Sequence: | 52177396 | Sequence: | 52177397 | Sequence: | 52177398 | Sequence: | 52177399 | Sequence: | 52177400 | Sequence: | 52177401 | Sequence: | 52177402 | Sequence: | 52177403 | Sequence: | 52177404 | Sequence: | 52177405 | Sequence: | 52177406 | Sequence: | 52177407 |
Pmid | 30029855 | Pmid | 22383668 | Pmid | 19846789 | Pmid | 27805836 | Pmid | 26510034 | Pmid | 3937340 | Pmid | 4044297 | Pmid | 15343184 | Pmid | 17255835 | Pmid | 27473897 | ||||||
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Stallings VA, Sainath N, Oberle M, Bertolaso C, Schall JI. Energy Balance and Mechanisms of Weight Gain with Ivacaftor Treatment of Cystic Fibrosis Gating Mutations. J Pediatr. 2018 Oct;201:229-237.e4. doi: 10.1016/j.jpeds.2018.05.018. Epub 2018 Jul 18. | Citation | Flume PA, Liou TG, Borowitz DS, Li H, Yen K, Ordonez CL, Geller DE; VX 08-770-104 Study Group. Ivacaftor in subjects with cystic fibrosis who are homozygous for the F508del-CFTR mutation. Chest. 2012 Sep;142(3):718-724. doi: 10.1378/chest.11-2672. | Citation | Van Goor F, Hadida S, Grootenhuis PD, Burton B, Cao D, Neuberger T, Turnbull A, Singh A, Joubran J, Hazlewood A, Zhou J, McCartney J, Arumugam V, Decker C, Yang J, Young C, Olson ER, Wine JJ, Frizzell RA, Ashlock M, Negulescu P. Rescue of CF airway epithelial cell function in vitro by a CFTR potentiator, VX-770. Proc Natl Acad Sci U S A. 2009 Nov 3;106(44):18825-30. doi: 10.1073/pnas.0904709106. Epub 2009 Oct 21. | Citation | Milla CE, Ratjen F, Marigowda G, Liu F, Waltz D, Rosenfeld M; VX13-809-011 Part B Investigator Group *. Lumacaftor/Ivacaftor in Patients Aged 6-11 Years with Cystic Fibrosis and Homozygous for F508del-CFTR. Am J Respir Crit Care Med. 2017 Apr 1;195(7):912-920. doi: 10.1164/rccm.201608-1754OC. | Citation | Wainwright CE, Elborn JS, Ramsey BW. Lumacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del CFTR. N Engl J Med. 2015 Oct 29;373(18):1783-4. doi: 10.1056/NEJMc1510466. No abstract available. | Citation | Energy and protein requirements. Report of a joint FAO/WHO/UNU Expert Consultation. World Health Organ Tech Rep Ser. 1985;724:1-206. No abstract available. | Citation | Schofield WN. Predicting basal metabolic rate, new standards and review of previous work. Hum Nutr Clin Nutr. 1985;39 Suppl 1:5-41. | Citation | World Health Organization. WHO Child Growth Standards: Length/height-for-age, weight-for-age, weight-for-length, weight-for-height, and body mass index-for-age. Geneva, Switzerland: WHO Press, World Health Organization; 2006. | Citation | Borowitz D, Baker SS, Duffy L, Baker RD, Fitzpatrick L, Gyamfi J, Jarembek K. Use of fecal elastase-1 to classify pancreatic status in patients with cystic fibrosis. J Pediatr. 2004 Sep;145(3):322-6. doi: 10.1016/j.jpeds.2004.04.049. | Citation | Borowitz D, Lin R, Baker SS. Comparison of monoclonal and polyclonal ELISAs for fecal elastase in patients with cystic fibrosis and pancreatic insufficiency. J Pediatr Gastroenterol Nutr. 2007 Feb;44(2):219-23. doi: 10.1097/MPG.0b013e31802c41de. | Citation | O'Connor MG, Seegmiller A. The effects of ivacaftor on CF fatty acid metabolism: An analysis from the GOAL study. J Cyst Fibros. 2017 Jan;16(1):132-138. doi: 10.1016/j.jcf.2016.07.006. Epub 2016 Jul 26. | Citation | World Health Organization. WHO Child Growth Standards: Head circumference-for-age, arm circumference-for-age, triceps skinfold-for-age, and subscapular skinfold-for-age. Geneva, Switzerland: WHO Press, World Health Organization; 2007. | Citation | WHO Multicenter Growth Reference Study Group. WHO Child Growth Standards: Growth Velocity Based on Weight, Length and Head Circumference: Methods and Development. Geneva, Switzerland: WHO Press: World Health Organization; 2009. |
]]>
https://zephyrnet.com/NCT03795350
2019-01-14
https://zephyrnet.com/?p=NCT03795350
NCT03795350https://www.clinicaltrials.gov/study/NCT03795350?tab=tableNANANAThe purpose of this study is to investigate the lung deposition and distribution pattern of TRIMBOW using a Gamma-scintigraphic technique after inhalation of a single dose of 99mTc radiolabelled TRIMBOW administered via pMDI in healthy volunteers, asthmatic and COPD patients
<![CDATA[
Studies
Study First Submitted Date | 2018-12-18 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2022-05-06 |
Start Month Year | January 14, 2019 |
Primary Completion Month Year | April 3, 2020 |
Verification Month Year | May 2022 |
Verification Date | 2022-05-31 |
Last Update Posted Date | 2022-05-06 |
Facilities
Sequence: | 198524740 |
Name | Simbec Research Ltd |
City | Merthyr Tydfil |
Country | United Kingdom |
Browse Interventions
Sequence: | 95242344 | Sequence: | 95242348 | Sequence: | 95242343 | Sequence: | 95242345 | Sequence: | 95242346 | Sequence: | 95242347 | Sequence: | 95242349 | Sequence: | 95242350 | Sequence: | 95242351 | Sequence: | 95242352 | Sequence: | 95242353 | Sequence: | 95242354 | Sequence: | 95242355 | Sequence: | 95242356 | Sequence: | 95242357 | Sequence: | 95242358 | Sequence: | 95242359 | Sequence: | 95242360 | Sequence: | 95242361 | Sequence: | 95242362 | Sequence: | 95242363 | Sequence: | 95242364 | Sequence: | 95242365 | Sequence: | 95242366 | Sequence: | 95242367 |
Mesh Term | Glycopyrrolate | Mesh Term | Autonomic Agents | Mesh Term | Beclomethasone | Mesh Term | Bromides | Mesh Term | Formoterol Fumarate | Mesh Term | Bronchodilator Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Anti-Asthmatic Agents | Mesh Term | Respiratory System Agents | Mesh Term | Adrenergic beta-2 Receptor Agonists | Mesh Term | Adrenergic beta-Agonists | Mesh Term | Adrenergic Agonists | Mesh Term | Adrenergic Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Anticonvulsants | Mesh Term | Adjuvants, Anesthesia | Mesh Term | Muscarinic Antagonists | Mesh Term | Cholinergic Antagonists | Mesh Term | Cholinergic Agents | Mesh Term | Anti-Inflammatory Agents | Mesh Term | Glucocorticoids | Mesh Term | Hormones | Mesh Term | Hormones, Hormone Substitutes, and Hormone Antagonists |
Downcase Mesh Term | glycopyrrolate | Downcase Mesh Term | autonomic agents | Downcase Mesh Term | beclomethasone | Downcase Mesh Term | bromides | Downcase Mesh Term | formoterol fumarate | Downcase Mesh Term | bronchodilator agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | anti-asthmatic agents | Downcase Mesh Term | respiratory system agents | Downcase Mesh Term | adrenergic beta-2 receptor agonists | Downcase Mesh Term | adrenergic beta-agonists | Downcase Mesh Term | adrenergic agonists | Downcase Mesh Term | adrenergic agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | anticonvulsants | Downcase Mesh Term | adjuvants, anesthesia | Downcase Mesh Term | muscarinic antagonists | Downcase Mesh Term | cholinergic antagonists | Downcase Mesh Term | cholinergic agents | Downcase Mesh Term | anti-inflammatory agents | Downcase Mesh Term | glucocorticoids | Downcase Mesh Term | hormones | Downcase Mesh Term | hormones, hormone substitutes, and hormone antagonists |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51761838 | Sequence: | 51761839 |
Name | Chronic Obstructive Pulmonary Disease | Name | Asthma |
Downcase Name | chronic obstructive pulmonary disease | Downcase Name | asthma |
Id Information
Sequence: | 39831237 | Sequence: | 39831238 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | CLI-05993AA1-20 | Id Value | 2017-005030-29 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42231003 |
Name | United Kingdom |
Removed | False |
Design Groups
Sequence: | 55182582 |
Group Type | Experimental |
Title | TRIMBOW |
Description | Experimental: BDP/FF/GB
4 puffs of 99mTc Radiolabelled Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide administered via pMDI |
Interventions
Sequence: | 52082952 |
Intervention Type | Drug |
Name | Beclometasone dipropionate Formoterol Fumarate Glycopyrronium Bromide |
Description | single inhalation of 99mTc radiolabelled TRIMBOW pMDI (4 puffs for a total dose of 400mcg BDP, 24mcg FF, 50 mcg GB) |
Keywords
Sequence: | 79193847 | Sequence: | 79193848 |
Name | Lung deposition | Name | Gamma scintigraphy |
Downcase Name | lung deposition | Downcase Name | gamma scintigraphy |
Design Outcomes
Sequence: | 176060042 | Sequence: | 176060043 | Sequence: | 176060044 | Sequence: | 176060045 | Sequence: | 176060046 | Sequence: | 176060047 | Sequence: | 176060048 | Sequence: | 176060049 | Sequence: | 176060050 | Sequence: | 176060051 | Sequence: | 176060052 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | intrapulmonary lung deposition | Measure | Intrapulmonary lung distribution of deposition: C/P ratio | Measure | extrathoracic deposition | Measure | amount of exhaled drug | Measure | TRIMBOW pharmacokinetics – (AUC0-t) | Measure | lung function assessment – FEV1, FVC, FEV1/FVC, FEF25%, FEF50%, FEF75% | Measure | TRIMBOW pharmacokinetics – (AUC0-30) | Measure | TRIMBOW pharmacokinetics – (Cmax) | Measure | TRIMBOW – (tmax) | Measure | TRIMBOW pharmacokinetics – (AUC0-∞) | Measure | TRIMBOW pharmacokinetics – (t1/2) |
Time Frame | immediately after dosing | Time Frame | immediately after dosing | Time Frame | immediately after dosing | Time Frame | immediately after dosing | Time Frame | up to 24 hours post dose | Time Frame | up to 24 hours post dose | Time Frame | up to 24 hours post dose | Time Frame | up to 24 hours post dose | Time Frame | up to 24 hours post dose | Time Frame | up to 24 hours post dose | Time Frame | up to 24 hours post dose |
Description | calculated using individual Gamma camera images | Description | Area Under plasma Concentration from 0 to last quantifiable concentration (AUC0-t) for BDP, B17MP, FF and GB | Description | FEV1, FVC, FEV1/FVC, FEF25%, FEF50%, FEF75% | Description | area under plasma concentration from 0 to 30 min (AUC0-30) for B17MP, FF and GB | Description | Maximum plasma concentration (Cmax) for BDP, B17MP, FF and GB | Description | time of the maximum plasma concentration (tmax) for BDP, B17MP, FF and GB | Description | area under curve extrapolated to infinity (AUC0-∞) for B17MP, FF and GB | Description | terminal half-life (t1/2) for B17MP, FF and GB |
Browse Conditions
Sequence: | 191834733 | Sequence: | 191834734 | Sequence: | 191834735 | Sequence: | 191834736 | Sequence: | 191834737 | Sequence: | 191834738 | Sequence: | 191834739 |
Mesh Term | Lung Diseases, Obstructive | Mesh Term | Pulmonary Disease, Chronic Obstructive | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | lung diseases, obstructive | Downcase Mesh Term | pulmonary disease, chronic obstructive | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47938464 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Chiesi Farmaceutici S.p.A. |
Design Group Interventions
Sequence: | 67652701 |
Design Group Id | 55182582 |
Intervention Id | 52082952 |
Eligibilities
Sequence: | 30525771 |
Gender | All |
Minimum Age | 28 Years |
Maximum Age | 80 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Inclusion criteria for all subjects: Subject's written informed consent obtained prior to any study-related procedure; Males fulfilling one of the following criteria: Males with non-pregnant Women of childbearing potential (WOCBP) partners: they and/or their partner of childbearing potential must be willing to use a highly effective birth control method in addition to the male condom from the signature of the informed consent and until 90 days after the follow-up visit. Subjects must not donate sperm during the study and for 90 days after the follow-up visit or WOCBP fulfilling one of the following criteria: WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method with low user dependency from the signature of the informed consent and until 30 days after the follow-up visit or Additional Criteria only for Healthy Volunteers and Asthmatic patients: Male and female subjects aged 28-55 years inclusive; Additional Inclusion Criteria only for Healthy Volunteers: 1. Lung function measurements within normal limits at screening: FEV1 equal to or more than 80% of predicted Additional Inclusion Criteria only for Asthmatic patients: Diagnosis of asthma: Established diagnosis of permanent asthma for at least 12 months according to GINA guidelines Additional Inclusion Criteria only for COPD patients: Male and female patients aged 40-80 years inclusive Exclusion Criteria: Inclusion criteria for all subjects: Pregnant or lactating women; Additional exclusion Criteria only for Healthy volunteers and Asthmatic patients: Positive urine test for cotinine at screening or prior Day 1 Additional exclusion criteria only for Asthmatic and COPD patients: Use of systemic corticosteroids medication within 4 weeks prior to the screening or slow release corticosteroids within 12 weeks before the screening or prior Day 1 Additional exclusion Criteria only for Healthy volunteers: 1. Subjects with history of breathing problems Additional exclusion Criteria only for Asthmatic patients: History of near fatal asthma, hospitalization for asthma in intensive care unit Additional exclusion Criteria only for COPD patients: Any change in dose, schedule or formulation in the treatment for COPD in the 4 weeks prior to the screening |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254091713 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 14 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 28 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 10 |
Designs
Sequence: | 30274680 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28654602 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 51654575 |
Pmid | 35128939 |
Reference Type | result |
Citation | Usmani OS, Baldi S, Warren S, Panni I, Girardello L, Rony F, Taylor G, DeBacker W, Georges G. Lung Deposition of Inhaled Extrafine Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrronium Bromide in Healthy Volunteers and Asthma: The STORM Study. J Aerosol Med Pulm Drug Deliv. 2022 Aug;35(4):179-185. doi: 10.1089/jamp.2021.0046. Epub 2022 Feb 4. |
]]>
https://zephyrnet.com/NCT03795337
2019-03-05
https://zephyrnet.com/?p=NCT03795337
NCT03795337https://www.clinicaltrials.gov/study/NCT03795337?tab=tableOliver Blanck, Dr.blanck@saphir-rc.com+4943123989970Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe and feasible.
Investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 3 years amounts 4.1% and is significant lower than 12.3% and 8.7% currently.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-19 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2022-04-04 |
Start Month Year | March 5, 2019 |
Primary Completion Month Year | June 2024 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-04-04 |
Detailed Descriptions
Sequence: | 20735798 |
Description | Experimental radiosurgery of prostate with 5 fractions each with 7,00 Gy (total application rate of 35,00 Gy).
Planned visits are: Baseline, visits at every radiation day and eight follow ups (4-6 weeks, 3 months, 6 months, 1 year and every year thereafter after last day of radiation). |
Facilities
Sequence: | 200244447 | Sequence: | 200244448 | Sequence: | 200244449 | Sequence: | 200244450 | Sequence: | 200244451 | Sequence: | 200244452 | Sequence: | 200244453 |
Status | Recruiting | Status | Recruiting | Status | Active, not recruiting | Status | Recruiting | Status | Active, not recruiting | Status | Recruiting | Status | Recruiting |
Name | Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK) | Name | University Medical Center Cologne, Department of Radiation Oncology, Cyberknife- and Radiotherapy | Name | Saphir Radiosurgery Center Frankfurt am Main | Name | University Hospital Frankfurt, Department of Radiation Therapy and Oncology | Name | Saphir Radiosurgery Center Northern Germany | Name | University Medical Center Schleswig-Holstein | Name | European Cyberknife Center Munich |
City | Berlin | City | Cologne | City | Frankfurt am Main | City | Frankfurt am Main | City | Kiel | City | Kiel | City | Munich |
Zip | 13353 | Zip | 50937 | Zip | 60528 | Zip | 60590 | Zip | 24105 | Zip | 24105 | Zip | 81377 |
Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany |
Facility Investigators
Sequence: | 18343628 | Sequence: | 18343629 | Sequence: | 18343630 | Sequence: | 18343631 | Sequence: | 18343632 | Sequence: | 18343633 | Sequence: | 18343634 | Sequence: | 18343635 | Sequence: | 18343636 | Sequence: | 18343637 | Sequence: | 18343638 | Sequence: | 18343639 |
Facility Id | 200244447 | Facility Id | 200244447 | Facility Id | 200244448 | Facility Id | 200244448 | Facility Id | 200244450 | Facility Id | 200244450 | Facility Id | 200244452 | Facility Id | 200244452 | Facility Id | 200244452 | Facility Id | 200244453 | Facility Id | 200244453 | Facility Id | 200244453 |
Role | Principal Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Sub-Investigator | Role | Sub-Investigator |
Name | Arne Grün, Dr. | Name | David Kaul, Dr. | Name | Christian Baues, Dr. | Name | Karolina Jablonska, Dr. | Name | Georgios Chatzikonstantinou, Dr. | Name | Detlef Imhoff, Dr. | Name | Juergen Dunst, Prof. | Name | Krug David, Dr. | Name | Schulz Christian, Dr. | Name | Alexander Muacevic, Prof. | Name | Alfred Haidenberger, Dr. | Name | Markus Kufeld, Dr. |
Conditions
Sequence: | 52208169 |
Name | Prostate Cancer |
Downcase Name | prostate cancer |
Id Information
Sequence: | 40186192 | Sequence: | 40186193 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | ZKS-121-08 | Id Value | ARO-2018-4 |
Id Type | Other Identifier | ||
Id Type Description | German Cancer Society | ||
Countries
Sequence: | 42599693 |
Name | Germany |
Removed | False |
Design Groups
Sequence: | 55634728 |
Group Type | Experimental |
Title | Hypofractionated Radiosurgery |
Description | 5 fractions with 7 Gy, total dose 35 Gy |
Interventions
Sequence: | 52522128 |
Intervention Type | Radiation |
Name | Hypofractionated Radiosurgery |
Description | Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife |
Keywords
Sequence: | 79923026 | Sequence: | 79923027 | Sequence: | 79923028 | Sequence: | 79923029 |
Name | Hypofractionation | Name | Prostate Cancer | Name | Radiotherapy | Name | long-term toxicity |
Downcase Name | hypofractionation | Downcase Name | prostate cancer | Downcase Name | radiotherapy | Downcase Name | long-term toxicity |
Design Outcomes
Sequence: | 177511532 | Sequence: | 177511533 | Sequence: | 177511534 | Sequence: | 177511535 | Sequence: | 177511536 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score | Measure | Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports. | Measure | Prostate Specific Antigen (PSA) | Measure | International Prostate Symptom Score (IPSS) | Measure | EORTC Quality of Life Questionnaire (QLQ) C30 |
Time Frame | 3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy | Time Frame | 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy | Time Frame | At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy | Time Frame | At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy | Time Frame | At the time of inclusion; 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy |
Browse Conditions
Sequence: | 193627225 | Sequence: | 193627226 | Sequence: | 193627227 | Sequence: | 193627228 | Sequence: | 193627229 | Sequence: | 193627230 | Sequence: | 193627231 | Sequence: | 193627232 | Sequence: | 193627233 | Sequence: | 193627234 |
Mesh Term | Prostatic Neoplasms | Mesh Term | Genital Neoplasms, Male | Mesh Term | Urogenital Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Genital Diseases, Male | Mesh Term | Genital Diseases | Mesh Term | Urogenital Diseases | Mesh Term | Prostatic Diseases | Mesh Term | Male Urogenital Diseases |
Downcase Mesh Term | prostatic neoplasms | Downcase Mesh Term | genital neoplasms, male | Downcase Mesh Term | urogenital neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | genital diseases, male | Downcase Mesh Term | genital diseases | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | prostatic diseases | Downcase Mesh Term | male urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48353749 | Sequence: | 48353750 | Sequence: | 48353751 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | University Hospital Schleswig-Holstein | Name | University of Luebeck | Name | Saphir Radiosurgery Center Northern Germany |
Overall Officials
Sequence: | 29306010 | Sequence: | 29306011 |
Role | Principal Investigator | Role | Principal Investigator |
Name | Juergen Dunst, Prof. | Name | Alexander Muacevic, Prof. |
Affiliation | University Hospital Schleswig-Holstein | Affiliation | European CyberKnife Center Munich |
Central Contacts
Sequence: | 12017229 | Sequence: | 12017230 |
Contact Type | primary | Contact Type | backup |
Name | Juergen Dunst, Prof. | Name | Oliver Blanck, Dr. |
Phone | +494315973011 | Phone | +4943123989970 |
Juergen.Dunst@uksh.de | blanck@saphir-rc.com | ||
Phone Extension | 3011 | Phone Extension | 0 |
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68199254 |
Design Group Id | 55634728 |
Intervention Id | 52522128 |
Eligibilities
Sequence: | 30786904 |
Gender | Male |
Minimum Age | 60 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
non-metastatic, histopathologically confirmed prostate carcinoma cT 1-3 N0 M0 Exclusion Criteria: Age ≤ 60 years |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989665 |
Number Of Facilities | 7 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 60 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30532974 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28899268 |
Responsible Party Type | Principal Investigator |
Name | Juergen Dunst, Prof. |
Title | Clinical Professor, Director, Head of Department |
Affiliation | University Hospital Schleswig-Holstein |
]]>
https://zephyrnet.com/NCT03795324
2019-01-31
https://zephyrnet.com/?p=NCT03795324
NCT03795324https://www.clinicaltrials.gov/study/NCT03795324?tab=tableRosa Solà, Drrosa.sola@urv.cat636 944 723The primary aim is to evaluate the added health value of the presence of anthocyanins in the redlove apple, versus a green apple with a similar matrix, on cardiometabolic risk, and compare the matrix effect on the bioavailability of anthocyanins, and its effect on cardiometabolic risk factors, in two different products with a similar phenolic and anthocyanin content: the redlove apple and an aronia drink.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-21 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2019-01-07 |
Start Month Year | January 2019 |
Primary Completion Month Year | December 2019 |
Verification Month Year | December 2018 |
Verification Date | 2018-12-31 |
Last Update Posted Date | 2019-01-07 |
Detailed Descriptions
Sequence: | 20721584 |
Description | The worldwide high prevalence of cardiovascular disease (CVD) requires lifestyle changes and new dietary prevention strategies based on the increased intake of foods rich in bioactive compounds, as they are considered as key mediators in the improvement of CVD risk factors.
Regarding the health impact on anthocyanins in cardiometalic risk factors and CVD, it has been reported that the dietary intake of anthocyanidins, among other classes of flavonoids, is inversely associated with the risk of CVD in both European and US population. A recent systematic review of human randomized controlled trials assessing the impact of anthocyanins on CVD markers concluded that one of the main modulated outcomes is the decrease of serum LDLc. However, diet does not appear to be sufficient to guarantee the necessary intake to obtain the health benefits specified. Due to previous positive results, a new dietetic strategy based on biofortification to enhance the levels of phenolic compounds is proposed in the present project. The primary aim is to evaluate the added health value of the presence of anthocyanins in the redlove apple, versus a green apple with a similar matrix, on cardiometabolic risk, and compare the matrix effect on the bioavailability of anthocyanins and its effect on cardiometabolic risk factors, in two different products with a similar phenolic and anthocyanin content: the redlove apple and an aronia drink. Participants will be 120 free-living volunteers (men and women) with high LDL-cholesterol levels (LDL-cholesterol levels ≥115 mg/dl and ≥190 mg/dl) who will be assigned to one of the three arms for 6-week period of dietary treatment. The design of the intervention study is controlled, parallel and randomized. The intervention will combine acute (post-prandial) and chronic effects. The sample size was computed to be sufficient to detect differences between treatment groups regarding the evolution in time of LDL-cholesterol levels. Justification of chosen sample size is based on assuming a 0.50mmol/l (approximately 15%) post-intervention difference of LDL-cholesterol and a 0.72mmol/l Standard deviation (SD), with α=0.05 and 1-β=0.08 a minimum of 22 participants were required. However the sample size will be 40 participants for arm, in total 120 subjects. For the acute study, the investigators have chosen n=10 subjects per arm according to the most studies that have addressed the metabolic effects of a postprandial intervention have been performed using a very similar number of subjects with statistically good quality results. |
Facilities
Sequence: | 200107810 |
Name | University Rovira i Virgili |
City | Reus |
State | Tarragona |
Country | Spain |
Conditions
Sequence: | 52171105 |
Name | High LDL-cholesterol Levels |
Downcase Name | high ldl-cholesterol levels |
Id Information
Sequence: | 40158544 |
Id Source | org_study_id |
Id Value | AppleCor |
Countries
Sequence: | 42568844 |
Name | Spain |
Removed | False |
Design Groups
Sequence: | 55593043 | Sequence: | 55593044 | Sequence: | 55593045 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | Redlove Apple | Title | Green Apple | Title | Aronia Drink |
Description | Redlove Apple intervention
This product is a biofortified cultivar apple with anthocyanins. |
Description | Green Apple intervention
This product is a common cultivar apple without anthocyanins. |
Description | Aronia drink intervention
This product is an infusion of aronia fruit extract rich in anthocyanin. |
Interventions
Sequence: | 52485349 | Sequence: | 52485350 | Sequence: | 52485351 |
Intervention Type | Other | Intervention Type | Other | Intervention Type | Other |
Name | Redlove Apple intervention | Name | Green Apple intervention | Name | Aronia drink intervention |
Description | The bioactive compounds present in this product are anthocyanins (50mg per 80g of product).It was a 6 weeks nutritional intervention. Volunteers will eat 80g per day of lyophilized redlove apple. | Description | It was a 6 weeks nutritional intervention. Volunteers will eat 80g per day of lyophilized green apple. | Description | The bioactive compounds present in this extract are anthocyanins (50mg per 1L of water).It was a 6 weeks nutritional intervention. Volunteers will drink 1L per day of an aronia drink |
Keywords
Sequence: | 79868318 | Sequence: | 79868319 | Sequence: | 79868320 | Sequence: | 79868321 | Sequence: | 79868322 | Sequence: | 79868323 |
Name | Anthocyanins | Name | apple | Name | biofortification | Name | cardiometabolic | Name | LDL cholesterol | Name | polyphenols |
Downcase Name | anthocyanins | Downcase Name | apple | Downcase Name | biofortification | Downcase Name | cardiometabolic | Downcase Name | ldl cholesterol | Downcase Name | polyphenols |
Design Outcomes
Sequence: | 177378405 | Sequence: | 177378406 | Sequence: | 177378407 | Sequence: | 177378408 | Sequence: | 177378409 | Sequence: | 177378410 | Sequence: | 177378411 | Sequence: | 177378412 | Sequence: | 177378413 | Sequence: | 177378414 | Sequence: | 177378415 | Sequence: | 177378416 | Sequence: | 177378417 | Sequence: | 177378418 | Sequence: | 177378419 | Sequence: | 177378420 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Changes in serum LDL-cholesterol (measured in mg/dL) | Measure | Changes in parameters of body composition (weight measured in kg) | Measure | Parameters of body composition (height measured in meters) | Measure | Changes in parameters of body composition (BMI measured in kg/m2) | Measure | Changes in parameters of body composition (waist circumference measured in cm) | Measure | Changes in blood pressure (systolic blood pressure and diastolic blood pressure measured in mmHg) | Measure | Changes in ischemic reactive hyperemia (IRH measured in perfusion units) | Measure | Changes in lipid plasmatic markers (total cholesterol, HDL cholesterol, triglycerides, non-esterified fatty acids, Apo B100 and Apo A. All these lipid plasmatic markers will be measured in mg/dL) | Measure | Changes in glucose markers (glucose and insulin measured in mg/dL) | Measure | Changes in oxidative markers (LDLox and Endogenous fat soluble antioxidants measured in mg/dL) | Measure | Changes in inflammation markers (c-reactive protein and serum endothelin-1 measured in mg/dL) | Measure | Changes in dietary compliance markers (Phenolic compounds and metabolites measured in mg/L in 24h urine samples) | Measure | Changes in faeces metabolites (Short Chain Fatty Acids, bile acids and sterols measured in mg/L in faeces samples) | Measure | Changes in fecal microbiota composition (relative abundance of the identified operational taxonomic units (OTUs) measured as % change from baseline) | Measure | Changes in lipoprotein profile (number of LDL and HDL particles measured as % change from baseline) | Measure | Changes in cholesterol efflux (measured as % change from baseline) |
Time Frame | 6 weeks, week 1 and week 6 | Time Frame | 6 weeks, week 1, week 2, week 4 and week 6 | Time Frame | 6 weeks, week 1 | Time Frame | 6 weeks, week 1, week 2, week 4 and week 6 | Time Frame | 6 weeks, week 1, week 2, week 4 and week 6 | Time Frame | 6 weeks, week 1, week 2, week 4 and week 6 | Time Frame | 6 weeks, week 1 and week 6 | Time Frame | 6 weeks, week 1 and week 6 | Time Frame | 6 weeks, week 1 and week 6 | Time Frame | 6 weeks, week 1 and week 6 | Time Frame | 6 weeks, week 1 and week 6 | Time Frame | 6 weeks, week 1 and week 6 | Time Frame | 6 weeks, week 1 and week 6 | Time Frame | 6 weeks, week 1 and week 6 | Time Frame | 6 weeks, week 1 and week 6 | Time Frame | 6 weeks, week 1 and week 6 |
Description | Serum lipids will be measured by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland). Then, LDL-cholesterol will be alculated by the Friedewald formula. | Description | Trained dieticians measure weight using a body composition analyzer (Tanita SC 330-S; Tanita Corp., Barcelona, Sapin) | Description | Trained dieticians measure height using a well mounted stadiometer (Tanita Leicester Portable; Tanita Corp., Barcelona, Spain). | Description | Body mass index (BMI) is calculated as the ratio between measured weight (kg)/and the square of height (m). | Description | Waist circumference (WC) is measured at the umbilicus using a 150 cm anthropometric steel measuring tape. | Description | Systolic and diastolic blood pressure (SBP and DBP) are measured twice after 2-5 minutes of patient seated, with one-minute interval in between, using an automatic sphygmomanometer (OMRON HEM-907; Peroxfarma, Barcelona, Spain). | Description | The endothelial-dependent vasomotor functions will be measured as IRH by a Laser-Doppler linear Periflux 5000 flowmeter (Perimed AB, Järfälla, Stockholm, Sweden) | Description | Total cholesterol, HDL cholesterol, triglycerides, non-esterified fatty acids, Apo B100 and Apo A will be measured by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland). | Description | measured by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland). | Description | Plasma oxidized LDL measured by ELISA kit (Mercodia AB, Uppsala, Sweden). The analysis of fat-soluble vitamins (vitamin D, alpha-tocopherol, and carotenoids) will be carried out in whole blood with DBS cards. The determinations will be performed by ultra-performance liquid chromatography (UPLC) coupled to photodiode array (PDA) and tandem mass spectrometry (MS/MS) detectors. | Description | Serum high sensitive C reactive measured by standardized methods in a Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain). Serum endothelin type 1 measured by ELISA kits (R&D Systems, Minneapolis, USA). | Description | will be analysed by UPLC-MS/MS as previously described. | Description | will be performed by gas chromatography (GC). | Description | will be studied by sequencing its whole genomic content. Illumina platform will be used to obtain the metagenomics and metatranscriptomics of each sample following previous protocols developed. | Description | Number of particles and size LDL and HDL measured by NMR technology, in a Vantera Clinical Analyzer (LipoScience Inc., Raleigh, NC, USA). | Description | Cholesterol efflux measured by in vitro assays in Murine J-774A.1 macrophages labeled with TopFluor-Cholesterol, a fluorescent cholesterol probe in which the cholesterol molecule is linked to boron dipyrromethene difluoride (BODIPY) moiety (Avanti Polar Lipids, USA). |
Sponsors
Sequence: | 48319167 | Sequence: | 48319168 | Sequence: | 48319169 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER_GOV |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | University Rovira i Virgili | Name | Universitat de Lleida | Name | Ministerio de Ciencia e Innovación, Spain |
Overall Officials
Sequence: | 29285290 |
Role | Principal Investigator |
Name | Rosa Sola, MD, PhD |
Affiliation | University Rovira i Virgili |
Central Contacts
Sequence: | 12008848 |
Contact Type | primary |
Name | Rosa Solà, Dr |
Phone | 636 944 723 |
rosa.sola@urv.cat | |
Phone Extension | 0034 |
Role | Contact |
Design Group Interventions
Sequence: | 68148975 | Sequence: | 68148976 | Sequence: | 68148977 |
Design Group Id | 55593043 | Design Group Id | 55593044 | Design Group Id | 55593045 |
Intervention Id | 52485349 | Intervention Id | 52485350 | Intervention Id | 52485351 |
Eligibilities
Sequence: | 30765276 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Men and women over 18 years old. Exclusion Criteria: LDL-cholesterol levels ≤115 mg/dl and <190 mg/dl. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253877527 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 15 |
Designs
Sequence: | 30511443 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28877737 |
Responsible Party Type | Principal Investigator |
Name | Rosa Sola |
Title | MD, PhD |
Affiliation | University Rovira i Virgili |
]]>
https://zephyrnet.com/NCT03795311
2018-11-07
https://zephyrnet.com/?p=NCT03795311
NCT03795311https://www.clinicaltrials.gov/study/NCT03795311?tab=tableEmilie REDERSTORFFerederstorff@cgfl.fr03 45 34 81 16In patients in progression after oxaliplatin and irinotecan, the study FOLFIRINOX 3 proposes to evaluate the interest of modifying the standard pattern of administration of the molecule of irinotecan in order to make it more efficient. In combination with other chemotherapy drugs (5-fluorouracil, oxaliplatin, folinic acid and bevacizumab), irinotecan will be administered at the beginning and end of each cycle of chemotherapy, whereas it is normally administered at one time in the regimen. standard of treatment.
The hypothesis of this study is an increase in the objective response rate at 2 months of 10 to 30% with a scheme by FOLFIRINOX3 – bevacizumab compared to an optimal treatment to date by FOLFIRINOX-bevacizumab.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2019-03-15 |
Start Month Year | November 7, 2018 |
Primary Completion Month Year | January 7, 2023 |
Verification Month Year | March 2019 |
Verification Date | 2019-03-31 |
Last Update Posted Date | 2019-03-15 |
Detailed Descriptions
Sequence: | 20741130 |
Description | Primary objective
Main objective of phase I: To evaluate the acute toxicity of treatment with FOLFIRINOX 3 – bevacizumab Secondary objectives To evaluate the efficacy of treatment with FOLFIRINOX 3 – bevacizumab in terms of objective response according to the criteria of CHOI, progression-free survival (PFS) and overall survival (OS) |
Facilities
Sequence: | 200280341 |
Status | Recruiting |
Name | Centre Georges François Leclerc |
City | Dijon |
Zip | 21000 |
Country | France |
Facility Contacts
Sequence: | 28132843 | Sequence: | 28132844 |
Facility Id | 200280341 | Facility Id | 200280341 |
Contact Type | primary | Contact Type | backup |
Name | François Ghiringhelli, PU PH | Name | Emilie Rederstorff |
FGhiringhelli@cgfl.fr | erederstorgg@cgfl.fr | ||
Phone | 03 80 73 77 53 | Phone | 03 45 34 81 16 |
Browse Interventions
Sequence: | 96132802 | Sequence: | 96132803 | Sequence: | 96132804 | Sequence: | 96132805 | Sequence: | 96132806 | Sequence: | 96132807 | Sequence: | 96132808 | Sequence: | 96132809 | Sequence: | 96132810 |
Mesh Term | Bevacizumab | Mesh Term | Folfirinox | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Antineoplastic Agents | Mesh Term | Angiogenesis Inhibitors | Mesh Term | Angiogenesis Modulating Agents | Mesh Term | Growth Substances | Mesh Term | Physiological Effects of Drugs | Mesh Term | Growth Inhibitors |
Downcase Mesh Term | bevacizumab | Downcase Mesh Term | folfirinox | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | angiogenesis inhibitors | Downcase Mesh Term | angiogenesis modulating agents | Downcase Mesh Term | growth substances | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | growth inhibitors |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52221424 |
Name | Colorectal Cancer |
Downcase Name | colorectal cancer |
Id Information
Sequence: | 40195559 |
Id Source | org_study_id |
Id Value | FOLFIRINOX3 |
Countries
Sequence: | 42609570 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55649689 |
Group Type | Experimental |
Title | Administration of chemotherapy molecules |
Description | The treatment period is divided into 15-day periods.
Schema of the administration to the treatments which will proceed in the same way with each cycle: Bevacizumab (5 mg/kg; during 30 min) + Oxaliplatine (85 mg/m2, during 2 hours) + Acide folinique (400 mg/m2) or Levofolinate de calcium (200 mg/m2) AND Irinotecan (during 2 hours) + 5-fluorouracile (2400 mg/m2 ; 46 hours) + Irinotecan (1 hour) |
Interventions
Sequence: | 52535226 |
Intervention Type | Drug |
Name | FOLFIRINOX Bevacizumab |
Description | In phase 1, the goal is to define the DLT (maximum tolerated dose). 3 levels of doses will be evaluated with a different dose of irinotecan in each level.
Level -1: Bevacizumab + Oxaliplatine + Acide folinique + Irinotecan: 60mg / m2 The inclusion of patients will start at level 0. Dose-limiting toxicities will be identified during the first 2 cycles. |
Keywords
Sequence: | 79941620 |
Name | FOLFIRINOX3 Bevacizumab |
Downcase Name | folfirinox3 bevacizumab |
Design Outcomes
Sequence: | 177561118 |
Outcome Type | primary |
Measure | Number of Participants with Acute toxicities as a Measure of treatment specific Safety and Tolerability |
Time Frame | each chemotherapy cycle (15 days) up to progression (6 months on average) |
Description | Acute toxicities will be assessed according to the NCI CTCAE v4.03 |
Browse Conditions
Sequence: | 193678078 | Sequence: | 193678079 | Sequence: | 193678080 | Sequence: | 193678081 | Sequence: | 193678082 | Sequence: | 193678083 | Sequence: | 193678084 | Sequence: | 193678085 | Sequence: | 193678086 | Sequence: | 193678087 | Sequence: | 193678088 |
Mesh Term | Colorectal Neoplasms | Mesh Term | Intestinal Neoplasms | Mesh Term | Gastrointestinal Neoplasms | Mesh Term | Digestive System Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Digestive System Diseases | Mesh Term | Gastrointestinal Diseases | Mesh Term | Colonic Diseases | Mesh Term | Intestinal Diseases | Mesh Term | Rectal Diseases |
Downcase Mesh Term | colorectal neoplasms | Downcase Mesh Term | intestinal neoplasms | Downcase Mesh Term | gastrointestinal neoplasms | Downcase Mesh Term | digestive system neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | colonic diseases | Downcase Mesh Term | intestinal diseases | Downcase Mesh Term | rectal diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366327 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Centre Georges Francois Leclerc |
Central Contacts
Sequence: | 12020567 | Sequence: | 12020568 |
Contact Type | primary | Contact Type | backup |
Name | François Ghiringhelli, PU PH | Name | Emilie REDERSTORFF |
Phone | 03 80 73 77 53 | Phone | 03 45 34 81 16 |
FGhiringhelli@cgfl.fr | erederstorff@cgfl.fr | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68217238 |
Design Group Id | 55649689 |
Intervention Id | 52535226 |
Eligibilities
Sequence: | 30794649 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Men or women Biological values within the following limits: Bilirubinemia ≤ 1.5 times the upper limit of normal (N) Exclusion Criteria: Other cancer in the 5 years prior to entry into the trial or concomitant (except in situ cancer of the cervix or basal cell carcinoma of the skin). |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004196 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30540689 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28907009 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03795298
2019-05-20
https://zephyrnet.com/?p=NCT03795298
NCT03795298https://www.clinicaltrials.gov/study/NCT03795298?tab=tableNANANAThe primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2023-07-24 |
Start Month Year | May 20, 2019 |
Primary Completion Month Year | November 2024 |
Verification Month Year | July 2023 |
Verification Date | 2023-07-31 |
Last Update Posted Date | 2023-07-24 |
Detailed Descriptions
Sequence: | 20682790 |
Description | This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation.
A subject who signs informed consent is considered enrolled in the study. Subjects will be randomized to OAC or WATCHMAN FLX in equal fashion. Randomization will be stratified by sequential vs. concomitant planned ablation +/- WATCHMAN implantation, to help ensure balance of treatment assignments within the sequential and concomitant groups. |
Facilities
Sequence: | 199631683 | Sequence: | 199631684 | Sequence: | 199631685 | Sequence: | 199631686 | Sequence: | 199631687 | Sequence: | 199631688 | Sequence: | 199631689 | Sequence: | 199631690 | Sequence: | 199631691 | Sequence: | 199631692 | Sequence: | 199631693 | Sequence: | 199631694 | Sequence: | 199631695 | Sequence: | 199631696 | Sequence: | 199631697 | Sequence: | 199631698 | Sequence: | 199631699 | Sequence: | 199631700 | Sequence: | 199631701 | Sequence: | 199631702 | Sequence: | 199631703 | Sequence: | 199631704 | Sequence: | 199631705 | Sequence: | 199631706 | Sequence: | 199631707 | Sequence: | 199631708 | Sequence: | 199631709 | Sequence: | 199631710 | Sequence: | 199631711 | Sequence: | 199631712 | Sequence: | 199631713 | Sequence: | 199631714 | Sequence: | 199631715 | Sequence: | 199631716 | Sequence: | 199631717 | Sequence: | 199631718 | Sequence: | 199631719 | Sequence: | 199631720 | Sequence: | 199631721 | Sequence: | 199631722 | Sequence: | 199631723 | Sequence: | 199631724 | Sequence: | 199631725 | Sequence: | 199631726 | Sequence: | 199631727 | Sequence: | 199631728 | Sequence: | 199631729 | Sequence: | 199631730 | Sequence: | 199631731 | Sequence: | 199631732 | Sequence: | 199631733 | Sequence: | 199631734 | Sequence: | 199631735 | Sequence: | 199631736 | Sequence: | 199631737 | Sequence: | 199631738 | Sequence: | 199631739 | Sequence: | 199631740 | Sequence: | 199631741 | Sequence: | 199631742 | Sequence: | 199631743 | Sequence: | 199631744 | Sequence: | 199631745 | Sequence: | 199631746 | Sequence: | 199631747 | Sequence: | 199631748 | Sequence: | 199631749 | Sequence: | 199631750 | Sequence: | 199631751 | Sequence: | 199631752 | Sequence: | 199631753 | Sequence: | 199631754 | Sequence: | 199631755 | Sequence: | 199631756 | Sequence: | 199631757 | Sequence: | 199631758 | Sequence: | 199631759 | Sequence: | 199631760 | Sequence: | 199631761 | Sequence: | 199631762 | Sequence: | 199631763 | Sequence: | 199631764 | Sequence: | 199631765 | Sequence: | 199631766 | Sequence: | 199631767 | Sequence: | 199631768 | Sequence: | 199631769 | Sequence: | 199631770 | Sequence: | 199631771 | Sequence: | 199631772 | Sequence: | 199631773 | Sequence: | 199631774 | Sequence: | 199631775 | Sequence: | 199631776 | Sequence: | 199631777 | Sequence: | 199631778 | Sequence: | 199631779 | Sequence: | 199631780 | Sequence: | 199631781 | Sequence: | 199631782 | Sequence: | 199631783 | Sequence: | 199631784 | Sequence: | 199631785 | Sequence: | 199631786 | Sequence: | 199631787 | Sequence: | 199631788 | Sequence: | 199631789 | Sequence: | 199631790 | Sequence: | 199631791 | Sequence: | 199631792 | Sequence: | 199631793 | Sequence: | 199631794 | Sequence: | 199631795 | Sequence: | 199631796 | Sequence: | 199631797 | Sequence: | 199631798 |
Name | Grandview Medical Center | Name | Heart Center Research | Name | Alaska Regional Hospital | Name | Arizona Arrhythmia Research Center | Name | Phoenix Cardiovascular Research Group | Name | St. Bernard's Medical Center | Name | Heart Clinic Arkansas | Name | Mills Peninsula Health Services | Name | Scripps Memorial Hospital | Name | Marin General Hospital | Name | University of Southern California Hospital | Name | Sharp Memorial Hospital | Name | Kaiser Permanente Santa Clara Medical Center | Name | Marian Regional Medical Center | Name | Los Robles Hospital & Medical Center | Name | Memorial Hospital | Name | Centura Health | Name | Medical Center of the Rockies (Loveland) | Name | Yale University School of Medicine | Name | Washington Hospital Center | Name | Manatee Memorial Hospital | Name | Broward General Medical Center | Name | St. Vincent's Medical Center | Name | AdventHealth Ocala | Name | Tallahassee Memorial Hospital | Name | Emory University Hospital | Name | Wellstar Kennestone Hospital | Name | St. Alphonsus Regional Medical Center | Name | St. Lukes Idaho Cardiology Associates | Name | Edward Hospital | Name | St. John's Hospital | Name | Methodist Hospital of Indianapolis | Name | St. Vincent Heart Center of Indiana | Name | Iowa Heart Center | Name | Overland Park Regional Medical Center | Name | University of Kansas Hospital | Name | Kansas City Cardiac Arrhythmia Research | Name | Baptist Health Lexington | Name | Massachusetts General Hospital | Name | Lahey Clinic Hospital | Name | Henry Ford Hospital | Name | MyMichigan Medical Center Midland | Name | Abbott Northwestern Hospital | Name | Mayo Clinic | Name | HealthEast St. Joseph's Hospital | Name | St. Luke's Hospital of Kansas City | Name | Mercy Research | Name | Nebraska Heart Institute | Name | Catholic Medical Center | Name | Cardiovascular Associates of the Delaware Valley | Name | Valley Hospital | Name | Northwell Health | Name | Montefiore Medical Center | Name | New York University Medical Center | Name | Mount Sinai Medical Center | Name | Carolinas Medical Center | Name | Duke University Medical Center | Name | Rex Hospital | Name | Lindner Center for Research and Education at Christ Hospital | Name | Cleveland Clinic Foundation | Name | OhioHealth Research and Innovation Institute – Riverside Methodist Hospital | Name | Pinnacle Health at Harrisburg Hospital | Name | Presbyterian University of Pennsylvania Medical Center | Name | University of Pittsburgh Medical Center | Name | Lankenau Institute for Medical Research | Name | York Hospital | Name | Centennial Medical Center | Name | Saint Thomas Health | Name | Vanderbilt University Medical Center | Name | Texas Cardiac Arrhythmia Research | Name | HeartPlace Mid-Cities EP | Name | The Heart Hospital Baylor Plano | Name | Cardiology Clinic of San Antonio | Name | Christus Trinity Mother Frances Health System | Name | St. Mark's Hospital | Name | Chippenham Medical Center | Name | CHI Franciscan Health System | Name | PeaceHealth Southwest Medical | Name | Monongalia General Hospital | Name | West Virginia University Hospitals | Name | Advara HeartCare | Name | Monash Health | Name | Onze Lieve Vrouw Ziekenhuis | Name | Aarhus University Hospital | Name | CHRU de Lille | Name | Hospital de la Pitie-Salpetriere | Name | CHRU de Clermont-Ferrand | Name | CHU Grenoble – Hopital Michallon | Name | Hospital Europeen Georges-Pompidou | Name | Clinique Pasteur | Name | Centre Hôpital Universitaire Rangueil | Name | CHU Henri Mondor | Name | DHZC – Deutsches Herzzentrum der Charité | Name | Klinik für Kardiologie, Angiologie und Intensivmedizin Mittelallee | Name | Klinikum Coburg GmbH | Name | St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH | Name | Cardioangiologisches Centrum Bethanien | Name | Universitatsklinik Greifswald | Name | Asklepios Klinik Saint Georg | Name | Allgemeines Krankenhaus Altona | Name | Klinikum St. Georg | Name | Universitaetsklinikum Schleswig-Holstein | Name | St. Josefs-Hospital GmbH | Name | Centro Cardiologico Monzino | Name | Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino | Name | St. Antonius Ziekenhuis | Name | Gornoslaskie Centrum Medyczne im. Prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach Ziolow | Name | University Clinical Hospital in Poznań/ UNIWERSYTECKI SZPITAL KLINICZNY W POZNANIU | Name | Slaskie Centrum Chorob Serca | Name | Hospital General Universitario | Name | Hospital Puerta Del Mar | Name | Hospital Clinico San Carlos | Name | Clinica Universidad de Navarra | Name | Hospital Clinico Salamanca | Name | Clinico de Valladolid | Name | Hospital Alvaro Cunqueiro |
City | Birmingham | City | Huntsville | City | Anchorage | City | Phoenix | City | Phoenix | City | Jonesboro | City | Little Rock | City | Burlingame | City | La Jolla | City | Larkspur | City | Los Angeles | City | San Diego | City | Santa Clara | City | Santa Maria | City | Thousand Oaks | City | Colorado Springs | City | Littleton | City | Loveland | City | New Haven | City | Washington | City | Bradenton | City | Fort Lauderdale | City | Jacksonville | City | Ocala | City | Tallahassee | City | Atlanta | City | Marietta | City | Boise | City | Boise | City | Naperville | City | Springfield | City | Indianapolis | City | Indianapolis | City | Des Moines | City | Kansas City | City | Kansas City | City | Overland Park | City | Lexington | City | Boston | City | Burlington | City | Detroit | City | Midland | City | Minneapolis | City | Rochester | City | Saint Paul | City | Kansas City | City | Saint Louis | City | Lincoln | City | Manchester | City | Haddon Heights | City | Ridgewood | City | Bay Shore | City | Bronx | City | New York | City | New York | City | Charlotte | City | Durham | City | Raleigh | City | Cincinnati | City | Cleveland | City | Columbus | City | Harrisburg | City | Philadelphia | City | Pittsburgh | City | Wynnewood | City | York | City | Nashville | City | Nashville | City | Nashville | City | Austin | City | Bedford | City | Plano | City | San Antonio | City | Tyler | City | Salt Lake City | City | Richmond | City | Tacoma | City | Vancouver | City | Morgantown | City | Morgantown | City | Brisbane | City | Clayton | City | Aalst | City | Aarhus | City | Lille | City | Paris | City | Clermont-Ferrand | City | Grenoble | City | Paris | City | Toulouse | City | Toulouse | City | Créteil | City | Berlin | City | Berlin | City | Coburg | City | Erfurt | City | Frankfurt | City | Greifswald | City | Hamburg | City | Hamburg | City | Leipzig | City | Lübeck | City | Wiesbaden | City | Milano | City | Torino | City | Nieuwegein | City | Katowice | City | Poznan | City | Zabrze | City | Alicante | City | Cadiz | City | Madrid | City | Pamplona | City | Salamanca | City | Valladolid | City | Vigo |
State | Alabama | State | Alabama | State | Alaska | State | Arizona | State | Arizona | State | Arkansas | State | Arkansas | State | California | State | California | State | California | State | California | State | California | State | California | State | California | State | California | State | Colorado | State | Colorado | State | Colorado | State | Connecticut | State | District of Columbia | State | Florida | State | Florida | State | Florida | State | Florida | State | Florida | State | Georgia | State | Georgia | State | Idaho | State | Idaho | State | Illinois | State | Illinois | State | Indiana | State | Indiana | State | Iowa | State | Kansas | State | Kansas | State | Kansas | State | Kentucky | State | Massachusetts | State | Massachusetts | State | Michigan | State | Michigan | State | Minnesota | State | Minnesota | State | Minnesota | State | Missouri | State | Missouri | State | Nebraska | State | New Hampshire | State | New Jersey | State | New Jersey | State | New York | State | New York | State | New York | State | New York | State | North Carolina | State | North Carolina | State | North Carolina | State | Ohio | State | Ohio | State | Ohio | State | Pennsylvania | State | Pennsylvania | State | Pennsylvania | State | Pennsylvania | State | Pennsylvania | State | Tennessee | State | Tennessee | State | Tennessee | State | Texas | State | Texas | State | Texas | State | Texas | State | Texas | State | Utah | State | Virginia | State | Washington | State | Washington | State | West Virginia | State | West Virginia | State | Queensland | State | Victoria | State | East Flanders | State | Hauts-de-France | State | Ile-de-France | State | Île-de-France | State | Utrecht | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Zip | 35243 | Zip | 35801 | Zip | 99508 | Zip | 85016 | Zip | 85016 | Zip | 72401 | Zip | 72205 | Zip | 94010 | Zip | 92037 | Zip | 94939 | Zip | 90017 | Zip | 92123 | Zip | 95051 | Zip | 93454 | Zip | 91360 | Zip | 80909 | Zip | 80120 | Zip | 80538 | Zip | 06510 | Zip | 20010 | Zip | 34205 | Zip | 33316 | Zip | 32204 | Zip | 34471 | Zip | 32308 | Zip | 30322 | Zip | 30060 | Zip | 83704 | Zip | 83712 | Zip | 60540 | Zip | 62701 | Zip | 46202 | Zip | 46290 | Zip | 50266 | Zip | 66160 | Zip | 66160 | Zip | 66215 | Zip | 40503 | Zip | 02114 | Zip | 01805 | Zip | 48202 | Zip | 48670 | Zip | 55407 | Zip | 55905 | Zip | 55102 | Zip | 64111 | Zip | 63141 | Zip | 68526 | Zip | 03102 | Zip | 08035 | Zip | 07450 | Zip | 11706 | Zip | 10467 | Zip | 10016 | Zip | 10029 | Zip | 28203 | Zip | 27705 | Zip | 27607 | Zip | 45219 | Zip | 44195 | Zip | 43214 | Zip | 17101 | Zip | 19104 | Zip | 15237 | Zip | 19096 | Zip | 17403 | Zip | 37203 | Zip | 37205 | Zip | 37232 | Zip | 78705 | Zip | 76021 | Zip | 75093 | Zip | 78229 | Zip | 75702 | Zip | 84124 | Zip | 23225 | Zip | 98405 | Zip | 98664 | Zip | 26506 | Zip | 26506 | Zip | 4120 QLD | Zip | 3168 | Zip | 9300 | Zip | 8200 | Zip | 59037 | Zip | 75013 | Zip | 63000 | Zip | 38043 | Zip | 75015 | Zip | 31076 | Zip | 31400 | Zip | 94010 | Zip | 12203 | Zip | 13353 | Zip | 96450 | Zip | 99097 | Zip | 60431 | Zip | 17475 | Zip | 20099 | Zip | 22763 | Zip | 4129 | Zip | D-23538 | Zip | 65189 | Zip | 20138 | Zip | 10123 | Zip | 3430 EM | Zip | 40635 | Zip | 61-848 | Zip | 41800 | Zip | 3010 | Zip | 11009 | Zip | 28040 | Zip | 31008 | Zip | 37007 | Zip | 47005 | Zip | 36312 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | Australia | Country | Australia | Country | Belgium | Country | Denmark | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Italy | Country | Italy | Country | Netherlands | Country | Poland | Country | Poland | Country | Poland | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain |
Conditions
Sequence: | 52068454 |
Name | Atrial Fibrillation |
Downcase Name | atrial fibrillation |
Id Information
Sequence: | 40076840 |
Id Source | org_study_id |
Id Value | S2239 |
Countries
Sequence: | 42474945 | Sequence: | 42474946 | Sequence: | 42474947 | Sequence: | 42474948 | Sequence: | 42474949 | Sequence: | 42474950 | Sequence: | 42474951 | Sequence: | 42474952 | Sequence: | 42474953 | Sequence: | 42474954 |
Name | United States | Name | Australia | Name | Belgium | Name | Denmark | Name | France | Name | Germany | Name | Italy | Name | Netherlands | Name | Poland | Name | Spain |
Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False |
Design Groups
Sequence: | 55480370 | Sequence: | 55480371 |
Group Type | Experimental | Group Type | Active Comparator |
Title | WATCHMAN FLX | Title | Market-approved OAC |
Description | WATCHMAN FLX implant including modified post-implant drug regimen. | Description | Used per IFU for atrial fibrillation stroke prevention for the duration of the trial. |
Interventions
Sequence: | 52380861 | Sequence: | 52380862 |
Intervention Type | Device | Intervention Type | Drug |
Name | WATCHMAN FLX Implant | Name | Market-approved OAC |
Description | Left atrial appendage closure with the WATCHMAN FLX device | Description | Used per IFU for atrial fibrillation stroke prevention for the duration of the trial. |
Keywords
Sequence: | 79698919 | Sequence: | 79698920 | Sequence: | 79698921 |
Name | Non-valvular atrial fibrillation | Name | Left atrial appendage | Name | Ablation |
Downcase Name | non-valvular atrial fibrillation | Downcase Name | left atrial appendage | Downcase Name | ablation |
Design Outcomes
Sequence: | 177025793 | Sequence: | 177025794 | Sequence: | 177025795 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary |
Measure | Stroke, all cause death, and systemic embolism | Measure | Non-procedural bleeding | Measure | Major bleeding |
Time Frame | 36 months | Time Frame | 36 months | Time Frame | 36 months |
Description | WATCHMAN therapy is non-inferior for the occurrence of stroke (including ischemic and/or hemorrhagic), all cause death, and systemic embolism. | Description | WATCHMAN therapy is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding). | Description | WATCHMAN therapy is non-inferior for ISTH major bleeding (including procedural bleeding). |
Browse Conditions
Sequence: | 193076454 | Sequence: | 193076455 | Sequence: | 193076456 | Sequence: | 193076457 | Sequence: | 193076458 |
Mesh Term | Atrial Fibrillation | Mesh Term | Arrhythmias, Cardiac | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Pathologic Processes |
Downcase Mesh Term | atrial fibrillation | Downcase Mesh Term | arrhythmias, cardiac | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48223673 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Boston Scientific Corporation |
Overall Officials
Sequence: | 29225043 |
Role | Principal Investigator |
Name | Oussama Wazni, MD |
Affiliation | The Cleveland Clinic |
Design Group Interventions
Sequence: | 68011976 | Sequence: | 68011977 |
Design Group Id | 55480370 | Design Group Id | 55480371 |
Intervention Id | 52380861 | Intervention Id | 52380862 |
Eligibilities
Sequence: | 30705274 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
The subject is of legal age to participate in the study per the laws of their respective geography. Exclusion Criteria: The subject is currently enrolled in another investigational study that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility, regardless of type of co-enrollment being proposed. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253924550 |
Number Of Facilities | 116 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30451892 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28818366 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03795285
2019-02-20
https://zephyrnet.com/?p=NCT03795285
NCT03795285https://www.clinicaltrials.gov/study/NCT03795285?tab=tablereham elmahdyreham.elmahdy@aun.edu.eg+201002714637Neonatal sepsis (NS) is a rather serious but relatively common health problem. Despite recent advances in the treatment of neonatal infection, mortality and comorbidities remain high.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2019-01-08 |
Start Month Year | February 20, 2019 |
Primary Completion Month Year | September 20, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-08 |
Detailed Descriptions
Sequence: | 20727252 |
Description | Neonatal sepsis is a major contributor to an estimated 2.6 million annual deaths and accounts for approximately 3 % of all disability-adjusted life years. The consequences of NS can be minimized by early initiation of antibiotic therapy. Due to high NS rates, the vulnerability of the organism in the neonatal period and concerns about consequences (considerable mortality, association with other acute or chronic complications), antibiotic therapy is com¬monly started in clinical practice even though non-spe¬cific clinical signs develop. This is in spite of the fact that antibiotic overuse is linked to major negative outcomes. The reliable and early diagnosis of NS is therefore essential but, unfortunately, rather difficult.
Probably the most widely used "biochemical" marker of NS, C-reactive protein (CRP), is one of the so-called late markers. Its sensitivity is mainly low in the early stages of infection; its reliability increases, particularly with serial measurements. In that case, its negativity practically rules out the presence of NS. It is not completely specific for NS. Procalcitonin (PCT), an intermediate marker, is relatively specific, providing prognostic information as well; it decreases rapidly in response to effective therapy. However, its complex postnatal "physiological" dynamics makes its measurements difficult, particularly in early-onset sepsis. CD64 is normally expressed in very low concentrations by unstimulated neutrophils. It is considerably upregulated on the trigger of bacterial invasion and has been shown to be involved in the process of phagocytosis and intracellular killing of pathogens. More importantly, neutrophils from preterm infants express CD64 during bacterial infections to the same degree as those from term infants, children, and adults. So in newborns, neutrophil CD64 have been found to be promising markers for diagnosis of early and late infections. Among several candidate receptors, triggering Receptor Expressed on Myeloid cells 1 (TREM-1) appears to play a relevant role in the modulation of innate immunity, amplifying or attenuating Toll-Like Receptor (TLR)-induced signals. TREM-1 is a receptor of the immunoglobulin superfamily, expressed on human neutrophils and monocytes. In the early phase of infection, the engagements of Pattern Recognition Receptors (PRRs) by microbial components induce up-regulation of TREM-1. After recognition of a still unknown ligand, TREM-1 associates with a signal transduction molecule called DAP12, triggering the sustained release of pro-inflammatory cytokines (TNF-alpha and IL-1b) and chemokines (IL-8 and monocyte chemotactic protein), which may result in prolonged survival of neutrophils and monocytes at the inflammatory site. |
Conditions
Sequence: | 52185677 |
Name | Neonatal SEPSIS |
Downcase Name | neonatal sepsis |
Id Information
Sequence: | 40169205 |
Id Source | org_study_id |
Id Value | Neonatal sepsis |
Design Groups
Sequence: | 55609337 | Sequence: | 55609338 |
Title | Septic neonates: | Title | Controls: |
Description | fifty neonates with sepsis. | Description | twenty healthy neonates. |
Interventions
Sequence: | 52499615 |
Intervention Type | Diagnostic Test |
Name | Expression of neutrophil CD64 |
Description | Expression of neutrophil CD64 will be measured by Flow cytometry. In addition, sTREM-1 will be measured in the serum by ELISA |
Keywords
Sequence: | 79889043 | Sequence: | 79889044 | Sequence: | 79889045 |
Name | Early onset sepsis | Name | sTREM-1 | Name | Neutrophil CD64 |
Downcase Name | early onset sepsis | Downcase Name | strem-1 | Downcase Name | neutrophil cd64 |
Design Outcomes
Sequence: | 177432677 |
Outcome Type | primary |
Measure | The mean difference of neutrophil CD64 expression and sTREM-1 before and after treatment |
Time Frame | 72 hours |
Description | better understanding of neutrophil CD64 role as an essential player in pathogenesis of neonatal sepsis and the role of and sTREM-1 in pathogenesis of neonatal sepsis |
Browse Conditions
Sequence: | 193540830 | Sequence: | 193540831 | Sequence: | 193540836 | Sequence: | 193540837 | Sequence: | 193540832 | Sequence: | 193540833 | Sequence: | 193540834 | Sequence: | 193540835 |
Mesh Term | Sepsis | Mesh Term | Toxemia | Mesh Term | Pathologic Processes | Mesh Term | Infant, Newborn, Diseases | Mesh Term | Neonatal Sepsis | Mesh Term | Infections | Mesh Term | Systemic Inflammatory Response Syndrome | Mesh Term | Inflammation |
Downcase Mesh Term | sepsis | Downcase Mesh Term | toxemia | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | infant, newborn, diseases | Downcase Mesh Term | neonatal sepsis | Downcase Mesh Term | infections | Downcase Mesh Term | systemic inflammatory response syndrome | Downcase Mesh Term | inflammation |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332503 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Assiut University |
Central Contacts
Sequence: | 12012343 |
Contact Type | primary |
Name | reham elmahdy |
Phone | +201002714637 |
reham.elmahdy@aun.edu.eg | |
Role | Contact |
Design Group Interventions
Sequence: | 68168425 | Sequence: | 68168426 |
Design Group Id | 55609338 | Design Group Id | 55609337 |
Intervention Id | 52499615 | Intervention Id | 52499615 |
Eligibilities
Sequence: | 30773689 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 1 Day |
Maximum Age | 50 Days |
Population | Neonatal sepsis |
Criteria | Inclusion Criteria:
Sepsis was defined as a positive blood culture in infants with clinical and laboratory findings of infection. Manifestations of sepsis include poor suckling, sleepiness, respiratory distress, apnea, poor perfusion, cyanosis, bradycardia, fever or hypothermia, feeding intolerance, and neurological signs (as seizures). Routine sepsis evaluations included complete blood count, C-reactive protein, and blood culture. Exclusion Criteria: malformations |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253953148 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 1 |
Maximum Age Num | 50 |
Minimum Age Unit | Day |
Maximum Age Unit | Days |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30519820 |
Observational Model | Case-Control |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28886121 |
Responsible Party Type | Principal Investigator |
Name | Reham I El-mahdy |
Title | Principal Investigator |
Affiliation | Assiut University |
Study References
Sequence: | 52079194 | Sequence: | 52079195 | Sequence: | 52079196 | Sequence: | 52079197 |
Pmid | 29955185 | Pmid | 29571293 | Pmid | 19230638 | Pmid | 18604302 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Halek J, Novak M, Medkova A, Furst T, Juranova J. The role of nCD64 in the diagnosis of neonatal sepsis in preterm newborns. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2018 Jun 21. doi: 10.5507/bp.2018.033. Online ahead of print. | Citation | Wright JK, Hayford K, Tran V, Al Kibria GM, Baqui A, Manajjir A, Mahmud A, Begum N, Siddiquee M, Kain KC, Farzin A. Biomarkers of endothelial dysfunction predict sepsis mortality in young infants: a matched case-control study. BMC Pediatr. 2018 Mar 23;18(1):118. doi: 10.1186/s12887-018-1087-x. | Citation | Ford JW, McVicar DW. TREM and TREM-like receptors in inflammation and disease. Curr Opin Immunol. 2009 Feb;21(1):38-46. doi: 10.1016/j.coi.2009.01.009. Epub 2009 Feb 21. | Citation | Groselj-Grenc M, Ihan A, Derganc M. Neutrophil and monocyte CD64 and CD163 expression in critically ill neonates and children with sepsis: comparison of fluorescence intensities and calculated indexes. Mediators Inflamm. 2008;2008:202646. doi: 10.1155/2008/202646. |
]]>
https://zephyrnet.com/NCT03795272
2019-10-01
https://zephyrnet.com/?p=NCT03795272
NCT03795272https://www.clinicaltrials.gov/study/NCT03795272?tab=tableNANANATo evaluate the efficacy of PARP inhibitor, rucaparib as maintenance therapy for locally advanced cervical cancer
<![CDATA[
Studies
Study First Submitted Date | 2018-11-03 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2019-11-01 |
Start Month Year | October 1, 2019 |
Primary Completion Month Year | October 10, 2019 |
Verification Month Year | October 2019 |
Verification Date | 2019-10-31 |
Last Update Posted Date | 2019-11-01 |
Detailed Descriptions
Sequence: | 20716336 |
Description | The use of concomitant cisplatin-based chemo-radiation for cervical cancer has improved survival of locally advanced cervical cancer patients and has become the standard of care. A meta-analysis revealed that the addition of concurrent chemotherapy to radiation increased the 5-year overall survival rate by 6% (HR 0.81: 60 vs 66%), and 5-year disease-free survival rate by 8%, though there is still considerable need for improvement as most patients who relapse are incurable. The unmet need is particularly higher in patients that are at high risk of recurrence. The main negative prognostic factors are higher FIGO stage as well as the presence of positive lymph nodes. Current studies are evaluating role of adjuvant chemotherapy following chemo-radiation in locally advanced disease and will possibly improve survival by reducing risk of distant metastases, however at the cost of excessive toxicity.
PARP inhibitors have shown considerable clinical benefit especially in platinum-sensitive relapsed ovarian cancer. Several PARP inhibitors have been evaluated in other gynaecological malignancies and three PARP inhibitors (olaparib, rucaparib & niraparib) are approved by European Medicines Agency and Food & Drug Administration for treatment or as maintenance therapy in ovarian cancer. Human papillomavirus causes oxidative stress that may result in DNA single-strand breaks. In cervical cancer PARP-1 expression/activity may be up-regulated in response to the ongoing oxidative stress (HPV and inflammation), and this may promote progression. This may create a vicious circle of inflammation, PARP activation, NAD+ consumption, adenosine triphosphate consumption, necrosis, and inflammation. PARPi may limit the role of PARP-1 in promoting inflammation and oxidative stress. There is theoretical plausibility that PARPi may have a role in the treatment of cervical carcinoma. This phase II randomized placebo-controlled double-blind study will evaluate the efficacy and safety of rucaparib as adjuvant treatment for patients with locally advanced cervical cancer who are responding to chemo-radiation. This investigator-initiated study will be performed within the GCIG/ENGOT collaboration |
Facilities
Sequence: | 200053474 | Sequence: | 200053475 |
Name | Rigshospitalet | Name | Rigshospitalet |
City | Copenhagen | City | København Ø |
State | Sjaelland | State | Sjaelland |
Zip | 2100 | Zip | 2100 |
Country | Denmark | Country | Denmark |
Browse Interventions
Sequence: | 96027951 | Sequence: | 96027952 | Sequence: | 96027953 | Sequence: | 96027954 | Sequence: | 96027955 |
Mesh Term | Rucaparib | Mesh Term | Poly(ADP-ribose) Polymerase Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antineoplastic Agents |
Downcase Mesh Term | rucaparib | Downcase Mesh Term | poly(adp-ribose) polymerase inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antineoplastic agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52156593 |
Name | Cervical Cancer |
Downcase Name | cervical cancer |
Id Information
Sequence: | 40148275 |
Id Source | org_study_id |
Id Value | ENGOT-Cx7-NSGO/MaRuC |
Countries
Sequence: | 42557809 |
Name | Denmark |
Removed | False |
Design Groups
Sequence: | 55578004 | Sequence: | 55578005 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Rucaparib | Title | Placebo |
Description | Patients will be treated with active oral drug, Rucaparib twice daily for 24 months | Description | Patients will be treated with oral placebo twice daily for 24 months |
Interventions
Sequence: | 52472101 | Sequence: | 52472102 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Rucaparib | Name | Placebo |
Description | 2:1 randomization to receive rucaparib/placebo twice daily for 24 month | Description | placebo |
Keywords
Sequence: | 79848239 | Sequence: | 79848238 | Sequence: | 79848240 | Sequence: | 79848241 |
Name | rucaparib | Name | Cervical cancer | Name | maintenance therapy | Name | placebo-controlled |
Downcase Name | rucaparib | Downcase Name | cervical cancer | Downcase Name | maintenance therapy | Downcase Name | placebo-controlled |
Design Outcomes
Sequence: | 177328461 | Sequence: | 177328462 | Sequence: | 177328463 | Sequence: | 177328464 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Progression-Free Survival in months | Measure | Progression Free Survival in Sub-Population in months | Measure | Patient Reported Outcomes | Measure | Overall Survival in months |
Time Frame | 42 months | Time Frame | 42 months | Time Frame | 42 months | Time Frame | 60 months |
Description | the time from randomization until the date of the first objective radiological disease progression according to investigator assessment of RECIST v1.1 or death by any cause, whichever occurs first. | Description | the time from randomization until the date of the first objective radiological disease progression according to investigator assessment of RECIST v1.1 or death by any cause, whichever occurs first for the predefined study subgroups. | Description | Quality of Life Questionnaire | Description | the time from randomization until the date of death by any cause |
Browse Conditions
Sequence: | 193432394 | Sequence: | 193432395 | Sequence: | 193432396 | Sequence: | 193432397 | Sequence: | 193432398 | Sequence: | 193432399 | Sequence: | 193432400 | Sequence: | 193432401 | Sequence: | 193432402 | Sequence: | 193432403 | Sequence: | 193432404 | Sequence: | 193432405 | Sequence: | 193432406 |
Mesh Term | Uterine Cervical Neoplasms | Mesh Term | Uterine Neoplasms | Mesh Term | Genital Neoplasms, Female | Mesh Term | Urogenital Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Uterine Cervical Diseases | Mesh Term | Uterine Diseases | Mesh Term | Genital Diseases, Female | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Genital Diseases |
Downcase Mesh Term | uterine cervical neoplasms | Downcase Mesh Term | uterine neoplasms | Downcase Mesh Term | genital neoplasms, female | Downcase Mesh Term | urogenital neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | uterine cervical diseases | Downcase Mesh Term | uterine diseases | Downcase Mesh Term | genital diseases, female | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | genital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306182 | Sequence: | 48306183 | Sequence: | 48306184 | Sequence: | 48306185 | Sequence: | 48306186 | Sequence: | 48306187 | Sequence: | 48306188 | Sequence: | 48306189 | Sequence: | 48306190 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Nordic Society of Gynaecological Oncology – Clinical Trials Unit | Name | Institute of Cancer Research, United Kingdom | Name | Central and Eastern European Oncology Group | Name | North Eastern German Society of Gynaecological Oncology | Name | Belgian Gynaecological Oncology Group | Name | Princess Margaret Hospital, Canada | Name | PGOG (Polish Gynaecologic Oncology Group) | Name | GSO Global Clinical Research BV | Name | GCP-enhederne |
Design Group Interventions
Sequence: | 68130984 | Sequence: | 68130985 |
Design Group Id | 55578004 | Design Group Id | 55578005 |
Intervention Id | 52472101 | Intervention Id | 52472102 |
Eligibilities
Sequence: | 30757412 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 100 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Histologically confirmed squamous cell, adenocarcinoma or adenosquamous carcinoma of the cervix. Adequate organ function Absolute neutrophil count (ANC) ≥1,500/mcL Exclusion Criteria: Histological types other than in inclusion criteria, like sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial cancers. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254229126 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2018 |
Actual Duration | 0 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 100 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30503637 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Masking Description | double-blinded placebo-controlled |
Intervention Model Description | This is a multicentre, phase 2, double-blind, placebo-controlled trial of maintenance rucaparib to obtain evidence of clinical benefit of rucaparib in locally advanced cervical cancer. |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Intervention Other Names
Sequence: | 26665951 | Sequence: | 26665952 |
Intervention Id | 52472101 | Intervention Id | 52472102 |
Name | active maintenance | Name | matched placebo maintenance |
Responsible Parties
Sequence: | 28869915 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03795259
2018-12-28
https://zephyrnet.com/?p=NCT03795259
NCT03795259https://www.clinicaltrials.gov/study/NCT03795259?tab=tableNANANASugammadex is the first selective relaxant binding agent approved to reverse certain non-depolarizing neuromuscular drugs in patients 2 years old and above. Although it has been in use over the last 10 years, more pharmacological studies are needed to understand its overall effects on participants.
As investigators’ primary outcome, the investigators aimed to investigate how differently sugammadex reverses neumuscular blockade caused by rocuronium under general anesthesia maintenance with sevoflurane compared with desflurane. Also, to compare the changes in peak airway pressure. As investigators’ secondary outcome, the investigators aimed to compare the changes in heart rate and blood pressures after sugammadex injection under sevoflurane and desflurane general anesthesia.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-27 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2021-05-04 |
Start Month Year | December 28, 2018 |
Primary Completion Month Year | May 19, 2019 |
Verification Month Year | April 2021 |
Verification Date | 2021-04-30 |
Last Update Posted Date | 2021-05-04 |
Detailed Descriptions
Sequence: | 20735782 |
Description | 160 participants aged between 2-10 years old and scheduled for lower urinary tract or minor abdominal surgery will be enrolled in the study. Each participant will be assigned sevoflurane (Group S) or desflurane (Group D) anesthesia at enrollment by drawing lots. Parental consent after written and verbal information will be asked on the morning of the surgery.
Participants will be premedicated with midazolam (0.05 mg/kg, Zolamid, Defarma-Turkey) and ketamine (0.1 mg/kg, Ketalar, Pfizer-USA) and brought into operating theater. Routine monitoring will be done with non-invasive blood pressure (every 5 minutes), continuous peripheral oxygen saturation, continuous 3-lead ECG, body temperature and continuous end-tidal carbon dioxide measurements. Participants will be actively warmed to ensure normo-thermia. Train-of-four (TOF) measurements will be performed on the arm without the vascular access. Anesthesia will be induced with thiopenthal (5-6 mg/kg, Pental, Ulagay-Turkey) and fentanyl (2 mcg/kg, Talinat, VEM-Turkey). After the participant loses consciousness, TOF calibration will be performed and baseline value will be recorded. Then 0.6 mg/kg rocuronium (Myocron, VEM-Turkey) will be given intravenously and serial TOF measurements at 15 seconds intervals will be taken. The time from TOF of 100% to 0% will be recorded as T1. Participant will be orotracheal intubated when the TOF value is 0%. All the patients will be ventilated with Datex Ohmeda S/5 Avance in a volume controlled ventilation mode (air-oxygen mixture, FiO2: 40%, I/E: 1/1.5, PEEP: 5 cmH2O, tidal volume: 8ml/kg). Participant will receive 2% sevoflurane (Sevoran, Abbvie-Italy) or 6% desflurane (Suprane, Baxter-Belgium) according to their groups. Non-invasive blood pressure, heart rate and peak airway pressure will be recorded at 5 minute intervals after orotracheal intubation. Continuous TOF measurements will be taken until TOF value reaches 25%. Time from TOF of 0% to 25% will be recorded as T2. When the TOF value is 25%, 2 mg/kg sugammadex (Bridion, MSD-Greece) will be given intravenously and TOF measurements will continue every 15 seconds. The time from sugammadex injection (TOF of 25%) to TOF of 90% will be recorded as T3. Non-invasive blood pressure, heart rate and peak airway pressure will be recorded at the time of sugammadex injection and at 1st, 2nd, 3rd and 10th minutes. Any reactions to sugammadex will be recorded (anaphylaxis, bronchospasm, etc.). T1, T2 and T3 of Group S and D will be compared. Non-invasive blood pressure, heart rate and peak airway pressure after sugammadex injection at time 0min, 1min, 2min, 3min and 10min will be compared. |
Facilities
Sequence: | 200244316 |
Name | Istanbul University Cerrahpasa Medical Faculty |
City | Istanbul |
State | Please Select |
Zip | 34098 |
Country | Turkey |
Browse Interventions
Sequence: | 96113114 | Sequence: | 96113115 | Sequence: | 96113116 | Sequence: | 96113117 | Sequence: | 96113118 | Sequence: | 96113119 |
Mesh Term | Rocuronium | Mesh Term | Neuromuscular Nondepolarizing Agents | Mesh Term | Neuromuscular Blocking Agents | Mesh Term | Neuromuscular Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | rocuronium | Downcase Mesh Term | neuromuscular nondepolarizing agents | Downcase Mesh Term | neuromuscular blocking agents | Downcase Mesh Term | neuromuscular agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52208124 | Sequence: | 52208125 | Sequence: | 52208126 |
Name | Anesthetics, Inhalation | Name | Neuromuscular Blockade | Name | Anesthesia, General |
Downcase Name | anesthetics, inhalation | Downcase Name | neuromuscular blockade | Downcase Name | anesthesia, general |
Id Information
Sequence: | 40186163 |
Id Source | org_study_id |
Id Value | 83045809-604.01 |
Countries
Sequence: | 42599660 |
Name | Turkey |
Removed | False |
Design Groups
Sequence: | 55634684 | Sequence: | 55634685 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | Sevoflurane | Title | Desflurane |
Description | Anesthesia will be induced with thiopenthal 5-6 mg/kg and fentanyl 2 mcg/kg. Then rocuronium 0.6 mg/kg will be given by intravenously and patients will be orotracheal intubated when TOF value reaches 0%. Anesthesia will continue with 2% sevoflurane while the patient is ventilated in volume controlled mode (FiO2: 40%, I/E: 1/1.5, PEEP: 5 cmH2O, tidal volume: 8ml/kg). Continuous TOF measurement will continue until the value reaches %25. At this time, sugammadex 2 mg/kg will be given to measure the time for TOF to reach 90%. | Description | Anesthesia will be induced with thiopenthal 5-6 mg/kg and fentanyl 2 mcg/kg. Then rocuronium 0.6 mg/kg will be given by intravenously and patients will be orotracheal intubated when TOF value reaches 0%. Anesthesia will continue with 6% desflurane while the patient is ventilated in volume controlled mode (FiO2: 40%, I/E: 1/1.5, PEEP: 5 cmH2O, tidal volume: 8ml/kg). Continuous TOF measurement will continue until the value reaches %25. At this time, sugammadex 2 mg/kg will be given to measure the time for TOF to reach 90%. |
Interventions
Sequence: | 52522090 | Sequence: | 52522091 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Rocuronium | Name | Sugammadex |
Description | After induction, rocuronium 0.6 mg/kg will be given by intravenously and patients will be orotracheal intubated when TOF value reaches 0%. | Description | Continuous TOF measurement will continue until the value reaches %25. At this time, sugammadex 2 mg/kg will be given intravenously. |
Keywords
Sequence: | 79922967 | Sequence: | 79922968 | Sequence: | 79922969 | Sequence: | 79922970 | Sequence: | 79922971 | Sequence: | 79922972 | Sequence: | 79922973 |
Name | Sugammadex | Name | Sevoflurane | Name | Desflurane | Name | Rocuronium | Name | TOF | Name | Child | Name | Train-of-four |
Downcase Name | sugammadex | Downcase Name | sevoflurane | Downcase Name | desflurane | Downcase Name | rocuronium | Downcase Name | tof | Downcase Name | child | Downcase Name | train-of-four |
Design Outcomes
Sequence: | 177511392 | Sequence: | 177511386 | Sequence: | 177511387 | Sequence: | 177511388 | Sequence: | 177511389 | Sequence: | 177511390 | Sequence: | 177511391 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Percentage of Participants Experiencing an Adverse Event (AE) after Administration of Study Intervention | Measure | Time from TOF of 25% to 90% after 2 mg/kg sugammadex injection | Measure | Time from TOF of 100% to 0% after 0.6 mg/kg rocuronium injection | Measure | Time from TOF of 0% to 25% after orotracheal intubation | Measure | Sugammadex effects on respiratory parameters | Measure | Sugammadex effects on heart rate | Measure | Sugammadex effects on systolic and diastolic blood pressures |
Time Frame | Intraoperative and postoperative first 24 hour. | Time Frame | Up to end of surgery | Time Frame | Up to end of surgery | Time Frame | Up to end of surgery | Time Frame | Up to 10 minutes post-administration of study intervention | Time Frame | Up to 10 minutes post-administration of study intervention | Time Frame | Up to 10 minutes post-administration of study intervention |
Description | Observation bronchospasm and anaphylaxis after sugammadex injection | Description | When the TOF value reaches 25% from 0% after the anesthesia induction, 2 mg/kg sugammadex will be given to reverse neuromuscular blockade. Continuous TOF monitoring will continue every 15 seconds. The time it takes for TOF to reach 90% is the primary outcome. | Description | After induction of anesthesia a baseline TOF will be recorded (anticipated 100%). 0.6 mg/kg rocuronium will be injected and TOF will be measured every 15 seconds. The time it takes for TOF to reach 0% is the second primary outcome. | Description | After TOF reaches 0%, orotracheal intubation will be performed. Continuous TOF monitoring will be done every 5 minutes in first 15 minutes and every 15 seconds afterwards. No additional neuromuscular blocking drugs will be given. The time it takes for TOF to reach 25% is the third primary outcome. | Description | Peak airway pressure observed at and after sugammadex injection at 1st, 2nd, 3rd and 10th minutes. | Description | Heart rate observed at and after sugammadex injection at 1st, 2nd, 3rd and 10th minutes. | Description | blood pressures observed at and after sugammadex injection at 1st, 2nd, 3rd and 10th minutes. |
Browse Conditions
Sequence: | 193627083 | Sequence: | 193627084 | Sequence: | 193627085 | Sequence: | 193627086 |
Mesh Term | Respiratory Aspiration | Mesh Term | Respiration Disorders | Mesh Term | Respiratory Tract Diseases | Mesh Term | Pathologic Processes |
Downcase Mesh Term | respiratory aspiration | Downcase Mesh Term | respiration disorders | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48353706 | Sequence: | 48353707 | Sequence: | 48353708 | Sequence: | 48353709 |
Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | UNKNOWN | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Istanbul University | Name | GAMZE PİRİNÇ ŞAŞIOĞLU | Name | GÜNER KAYA | Name | Ayse Cigdem Tutuncu |
Overall Officials
Sequence: | 29305990 |
Role | Study Director |
Name | Guner Kaya, Prof. |
Affiliation | Istanbul University Cerrahpasa Medical Faculty |
Design Group Interventions
Sequence: | 68199207 | Sequence: | 68199208 | Sequence: | 68199209 | Sequence: | 68199210 |
Design Group Id | 55634685 | Design Group Id | 55634684 | Design Group Id | 55634685 | Design Group Id | 55634684 |
Intervention Id | 52522090 | Intervention Id | 52522090 | Intervention Id | 52522091 | Intervention Id | 52522091 |
Eligibilities
Sequence: | 30786881 |
Gender | All |
Minimum Age | 2 Years |
Maximum Age | 10 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Lower urinary tract surgery (cystoscopy, examination under general anaesthesia, circumcision etc.) and inguinal hernia surgery expected no to last more than 2 hours Exclusion Criteria: Liver and failure |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253989640 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 4 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 2 |
Maximum Age Num | 10 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30532951 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Screening |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26692037 | Sequence: | 26692038 |
Intervention Id | 52522090 | Intervention Id | 52522091 |
Name | Esmeron, MSD | Name | Bridion, MSD |
Responsible Parties
Sequence: | 28899245 |
Responsible Party Type | Principal Investigator |
Name | pinar kendigelen |
Title | MD, Principal investigator |
Affiliation | Istanbul University |
]]>
https://zephyrnet.com/NCT03795246
2018-03-23
https://zephyrnet.com/?p=NCT03795246
NCT03795246https://www.clinicaltrials.gov/study/NCT03795246?tab=tableNANANAInterventional research with low risks and constraints, prospective and monocentric on the assessment of long-term fertility in patients who underwent an adjuvant sequential chemotherapy with or without a controled ovarian hyperstimulation. This study follows a previous one called NCT 01614704.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-31 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2022-02-03 |
Start Month Year | March 23, 2018 |
Primary Completion Month Year | January 2028 |
Verification Month Year | February 2022 |
Verification Date | 2022-02-28 |
Last Update Posted Date | 2022-02-03 |
Detailed Descriptions
Sequence: | 20747690 |
Description | The patients will have a follow-up once a year during ten years beginning at the end of their chemotherapy.
They will have a consultation in oncology consisting of: a clinical exam, and a consultation in gynecology consisting of: a pelvic ultrasound scan (for AFC: Antral Follicle Count) |
Facilities
Sequence: | 200326984 |
Name | Centre Oscar Lambret |
City | Lille |
Country | France |
Conditions
Sequence: | 52237537 |
Name | Breast Cancer |
Downcase Name | breast cancer |
Id Information
Sequence: | 40207057 |
Id Source | org_study_id |
Id Value | KSF2-1707 |
Countries
Sequence: | 42621450 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55667921 |
Group Type | Experimental |
Title | Study Process |
Description | Consultation, Biological Test, Pelvic Ultrasound |
Interventions
Sequence: | 52551164 | Sequence: | 52551165 | Sequence: | 52551166 |
Intervention Type | Procedure | Intervention Type | Biological | Intervention Type | Procedure |
Name | Consultation | Name | Biological Test | Name | Pelvic Ultrasound |
Description | Consultation in oncology: collection of oncological data and ongoing cancer treatments, clinical exam Consultation in gynecology: collection of gynecological data, contraception and reproductive medicine | Description | Blood test:
FSH, LH, E2 and AMH |
Description | Antral Follicles Count |
Design Outcomes
Sequence: | 177621208 | Sequence: | 177621209 | Sequence: | 177621210 | Sequence: | 177621211 | Sequence: | 177621212 | Sequence: | 177621213 | Sequence: | 177621214 | Sequence: | 177621215 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Assessment of fertility in terms of cumulative incidence of long-term pregnancy | Measure | Assessment of fertility in terms of cumulative incidence of births | Measure | Assessment of fertility – number of pegnancies spontaneous versus assisted | Measure | Assessment of fertility – pregnancy outcome : miscarriage or single or multiple birth separately | Measure | Assessment of the number of patient willing to re-exploit their frozen gametes | Measure | Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes – AMH rate | Measure | Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes – Antral Follicle Count | Measure | Study the long-term carcinologic safety of Controlled Ovarian Hyperstimulation without Letrozole or Tamoxifen co-treatment in terms of survival without relapse |
Time Frame | 10 years after chemotherapy | Time Frame | 10 years after chemotherapy | Time Frame | 10 years after chemotherapy | Time Frame | 10 years after chemotherapy | Time Frame | 10 years after chemotherapy | Time Frame | 10 years after chemotherapy | Time Frame | 10 years after chemotherapy | Time Frame | After chemotherapy ad until disease progression or death regardless of the cause, up to 10 years after chemotherapy |
Description | for patients who underwent adjuvant sequential chemotherapy of anthracycline and taxane separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation | Description | separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation | Description | describing the pregnancy type – number of pegnancies spontaneous versus assisted, with ot without the use of frozen gametes) | Description | describing the pregnancy outcome : miscarriage or single or multiple birth separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation | Description | for patients who have had Controlled Ovarian Hyperstimulation | Description | in terms of AMH rate depending on whether or not they have had Controlled Ovarian Hyperstimulation | Description | in terms of Antral Follicle Count depending on whether or not they have had Controlled Ovarian Hyperstimulation | Description | Survival without relapse defined by the time frame between the date of surgery and the date of the first recurrence |
Browse Conditions
Sequence: | 193739150 | Sequence: | 193739151 | Sequence: | 193739152 | Sequence: | 193739153 | Sequence: | 193739154 |
Mesh Term | Breast Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Breast Diseases | Mesh Term | Skin Diseases |
Downcase Mesh Term | breast neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | breast diseases | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48381601 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Centre Oscar Lambret |
Overall Officials
Sequence: | 29321570 | Sequence: | 29321571 |
Role | Study Director | Role | Study Director |
Name | Audrey MAILLIEZ, MD | Name | Christine DECANTER, MD |
Affiliation | Centre Oscar Lambret | Affiliation | Centre Hopsitalier Regional Universitaire de Lille – Hôpital Jeanne de Flandre |
Design Group Interventions
Sequence: | 68239185 | Sequence: | 68239186 | Sequence: | 68239187 |
Design Group Id | 55667921 | Design Group Id | 55667921 | Design Group Id | 55667921 |
Intervention Id | 52551164 | Intervention Id | 52551165 | Intervention Id | 52551166 |
Eligibilities
Sequence: | 30804156 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients included in the study CT 01614704 Exclusion Criteria: Impossibility to submit at the study procedures due to geographic, social or mental reasons |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254022143 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 7 |
Designs
Sequence: | 30550166 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28916516 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03795233
2019-08-23
https://zephyrnet.com/?p=NCT03795233
NCT03795233https://www.clinicaltrials.gov/study/NCT03795233?tab=tableNANANAClostridium difficile infection (CDI) is one of the most urgent health threats in the U.S. associated with antibiotic use. After an initial episode, disease recurrence is high and relapses can occur in 20-30% of people treated with oral vancomycin. An antibiotic course can affect the gut microbiome for years, and patients with CDI have additional dysbiosis of their gut flora. Oral vancomycin perturbs the gut microbiome further. Restoration of the microbiome with Fecal Microbiota Transplant (FMT) has been proven a highly efficacious and cost-effective treatment for recurrent CDI. FMT has had very limited study for a primary episode of CDI to date because an endoscopic procedure was the recommended route of delivery. However, FMT is now available via frozen oral capsules and has been shown to be non-inferior to FMT via colonoscopy in randomized controlled trials.
The investigators hypothesize that outcomes after a first episode of CDI can be improved if the microbiome is restored with oral FMT. It is further hypothesized that this will compensate for any additional microbiome perturbation caused by administration of oral vancomycin and decrease the likelihood of recurrence. Because the hypothesis is based on restoration of the microbiome, the investigators propose this proof-of-concept pilot study to examine whether FMT administered after oral vancomycin therapy for primary CDI restores microbiome diversity compared to patients who do not receive FMT. Because of the potential health benefits, this approach deserves further study. The results from this pilot study on the microbiome diversity as well as the surveys to be conducted about GI symptomatology (e.g., diarrhea, abdominal pain, bloating), CDI recurrence and healthcare utilization, would provide preliminary data to support a randomized controlled, multicenter clinical trial.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-21 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2021-12-15 |
Start Month Year | August 23, 2019 |
Primary Completion Month Year | January 15, 2021 |
Verification Month Year | November 2021 |
Verification Date | 2021-11-30 |
Last Update Posted Date | 2021-12-15 |
Results First Posted Date | 2021-12-15 |
Detailed Descriptions
Sequence: | 20794793 |
Description | Population: Patients >= 18 years hospitalized at Boston Medical Center (BMC) with a first documented episode of CDI.
Intervention: 30 FMT capsules administered orally under direct observation within 7 days of completion of 10-14 day treatment of oral vancomycin for CDI. Objectives: To characterize the microbial diversity in stool samples from subjects with a primary episode of CDI before and after oral vancomycin and determine the impact of FMT after completion of oral vancomycin course. Design/Methodology: 15 subjects will be enrolled who are hospitalized at BMC for a primary episode of CDI. A discard aliquot from baseline stool samples obtained clinically for diagnosis will be frozen. Subjects will receive the standard of care treatment (oral vancomycin for 10-14 days) and within 7 days following completion will receive oral FMT during a 2 hour visit in the Infectious Disease (ID) Clinical Trials Unit. An additional 5 subjects will be enrolled as controls. Stool samples will be collected at time of CDI diagnosis and again 3 weeks after FMT for intervention group and 4 weeks after completion of oral vancomycin treatment for control subjects. The post-treatment samples will be obtained by the patient using special stool sample collection kits known as RNAlater kits (ribonucleic acid stabilization). These contain a liquid nontoxic tissue storage reagent known as RNAlater and helps preserve the stool sample. The subjects will mail this stool sample to the BMC Clinical Trials Unit (CTU) where it will aliquoted, centrifuged and frozen. Samples will be processed at a collaborating lab at Tufts to characterize the fecal microbiome pre- and post oral FMT. Study personnel will contact participants via telephone 60 days after FMT dosing to administer a follow-up survey (including questions on residual symptoms. CDI recurrence, re-hospitalization, adverse events and FMT acceptability). Total Study Duration: Anticipated time: 12 months Subject Participation Duration: The researchers anticipate a period of 1-2 hours while an inpatient for the screening and consent process, 2 hours for the CTU visit for FMT and 20-30 minutes responding to a follow up telephone survey. Total time in the study from enrollment to completion of follow-up will be approximately 3 months and will include 10-14 days of CDI treatment with oral vancomycin (per standard of care treatment), the FMT administration and a 60 day follow up. |
Facilities
Sequence: | 200756068 |
Name | Boston Medical Center |
City | Boston |
State | Massachusetts |
Zip | 02118 |
Country | United States |
Browse Interventions
Sequence: | 96347443 | Sequence: | 96347444 | Sequence: | 96347445 |
Mesh Term | Vancomycin | Mesh Term | Anti-Bacterial Agents | Mesh Term | Anti-Infective Agents |
Downcase Mesh Term | vancomycin | Downcase Mesh Term | anti-bacterial agents | Downcase Mesh Term | anti-infective agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52359128 |
Name | Clostridium Difficile Infection |
Downcase Name | clostridium difficile infection |
Id Information
Sequence: | 40293197 |
Id Source | org_study_id |
Id Value | H-37574 |
Countries
Sequence: | 42716303 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55802142 | Sequence: | 55802143 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Fecal microbiota transplantation | Title | Oral vancomycin alone (Control) |
Description | Fecal microbiota transplant G3 capsules will be administered after standard of care with oral vancomycin therapy in participants with primary Clostridium difficile infection. | Description | Oral vancomycin therapy will be administered as per standard of care in participants with primary clostridium difficile infection. |
Interventions
Sequence: | 52670006 | Sequence: | 52670005 |
Intervention Type | Other | Intervention Type | Biological |
Name | Oral Vancomycin alone | Name | Fecal microbiota transplant G3 capsules |
Description | Standard of care will be provided with oral vancomycin therapy. | Description | After standard of care therapy with oral vancomycin, frozen oral FMT capsules will be provided in a formulation designed to deliver the product to the large intestine. 30 FMT capsules will be administered over a 2 hour period under direct observation |
Keywords
Sequence: | 80126968 | Sequence: | 80126969 | Sequence: | 80126970 | Sequence: | 80126971 | Sequence: | 80126972 |
Name | Fecal Microbiota Transplant (FMT) | Name | Vancomycin | Name | Dysbiosis | Name | fecal microbiome | Name | C difficile infection |
Downcase Name | fecal microbiota transplant (fmt) | Downcase Name | vancomycin | Downcase Name | dysbiosis | Downcase Name | fecal microbiome | Downcase Name | c difficile infection |
Design Outcomes
Sequence: | 178073071 | Sequence: | 178073072 | Sequence: | 178073073 | Sequence: | 178073074 | Sequence: | 178073075 | Sequence: | 178073076 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Stool Microbiome With and Without FMT Administration | Measure | Feasibility of Administering FMT After Completion of a Course of Oral Vancomycin Therapy | Measure | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of FMT After a Course of Oral Vancomycin Therapy | Measure | Incidence of Gastrointestinal Symptomatology Based on a Survey After CDI | Measure | CDI Recurrence | Measure | Number of Hospital Readmissions After Treatment |
Time Frame | 11 months | Time Frame | 12 months | Time Frame | During test dose, during 90 minutes of FMT administration, 30 minutes after FMT administration, 48-72 hours after FMT administration | Time Frame | 60 days | Time Frame | 60 days | Time Frame | 30 days |
Description | The stool microbiome in participants who receive additional FMT at end of Clostridium difficile infection (CDI) treatment with oral vancomycin will be compared to the stool microbiome in participants with standard treatment or oral vancomycin alone | Description | The number and proportion of FMT pills participants ingest after completion of a course of oral vancomycin therapy will be documented. | Description | Study participants will be monitored for any adverse events to FMT such as nausea or vomiting, abdominal pain or diarrhea. | Description | A detailed survey with 15 questions will be administered on GI symptoms Physicians will go over any significant adverse events to determine if they are related, possibly related or unrelated to oral FMT administration | Description | Patients will be monitored for recurrent C difficile infection defined as non-resolution or recurrence of GI symptoms (abdominal pain, diarrhea etc) and/or a positive stool C difficile test The proportion of participants with CDI recurrence will be documented. | Description | The number of hospital readmissions within 30 days after CDI treatment per patient history and chart review will be obtained |
Browse Conditions
Sequence: | 194201955 | Sequence: | 194201956 | Sequence: | 194201957 | Sequence: | 194201958 | Sequence: | 194201959 |
Mesh Term | Infections | Mesh Term | Clostridium Infections | Mesh Term | Gram-Positive Bacterial Infections | Mesh Term | Bacterial Infections | Mesh Term | Bacterial Infections and Mycoses |
Downcase Mesh Term | infections | Downcase Mesh Term | clostridium infections | Downcase Mesh Term | gram-positive bacterial infections | Downcase Mesh Term | bacterial infections | Downcase Mesh Term | bacterial infections and mycoses |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48494171 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Boston Medical Center |
Overall Officials
Sequence: | 29384700 |
Role | Principal Investigator |
Name | Tamar Barlam, MD MSC |
Affiliation | Boston Medical Center |
Design Group Interventions
Sequence: | 68405513 | Sequence: | 68405514 |
Design Group Id | 55802142 | Design Group Id | 55802143 |
Intervention Id | 52670005 | Intervention Id | 52670006 |
Eligibilities
Sequence: | 30873712 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Diagnosis of primary clostridium difficile infection (CDI) defined by the presence of diarrhea and a positive C. difficile Polymerase chain reaction (PCR) test Exclusion Criteria: Primary CDI treatment failure |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254049153 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 17 |
Were Results Reported | True |
Months To Report Results | 10 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30619505 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Drop Withdrawals
Sequence: | 29076734 | Sequence: | 29076735 | Sequence: | 29076736 | Sequence: | 29076737 | Sequence: | 29076738 | Sequence: | 29076739 |
Result Group Id | 56202117 | Result Group Id | 56202118 | Result Group Id | 56202117 | Result Group Id | 56202118 | Result Group Id | 56202117 | Result Group Id | 56202118 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Death | Reason | Death |
Count | 2 | Count | 1 | Count | 1 | Count | 0 | Count | 1 | Count | 0 |
Intervention Other Names
Sequence: | 26768686 | Sequence: | 26768687 |
Intervention Id | 52670005 | Intervention Id | 52670006 |
Name | FMT | Name | Oral Vancocin alone |
Milestones
Sequence: | 41123172 | Sequence: | 41123173 | Sequence: | 41123174 | Sequence: | 41123175 | Sequence: | 41123176 | Sequence: | 41123177 |
Result Group Id | 56202117 | Result Group Id | 56202118 | Result Group Id | 56202117 | Result Group Id | 56202118 | Result Group Id | 56202117 | Result Group Id | 56202118 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 4 | Count | 1 | Count | 0 | Count | 0 | Count | 4 | Count | 1 |
Participant Flows
Sequence: | 3930289 |
Outcome Counts
Sequence: | 74215440 | Sequence: | 74215441 | Sequence: | 74215442 | Sequence: | 74215443 | Sequence: | 74215444 | Sequence: | 74215445 | Sequence: | 74215446 | Sequence: | 74215447 | Sequence: | 74215448 | Sequence: | 74215449 | Sequence: | 74215450 | Sequence: | 74215451 |
Outcome Id | 30891810 | Outcome Id | 30891810 | Outcome Id | 30891811 | Outcome Id | 30891811 | Outcome Id | 30891812 | Outcome Id | 30891812 | Outcome Id | 30891813 | Outcome Id | 30891813 | Outcome Id | 30891814 | Outcome Id | 30891814 | Outcome Id | 30891815 | Outcome Id | 30891815 |
Result Group Id | 56202119 | Result Group Id | 56202120 | Result Group Id | 56202119 | Result Group Id | 56202120 | Result Group Id | 56202119 | Result Group Id | 56202120 | Result Group Id | 56202119 | Result Group Id | 56202120 | Result Group Id | 56202119 | Result Group Id | 56202120 | Result Group Id | 56202119 | Result Group Id | 56202120 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 |
Provided Documents
Sequence: | 2593322 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2020-02-18 |
Url | https://ClinicalTrials.gov/ProvidedDocs/33/NCT03795233/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 28013689 | Sequence: | 28013690 | Sequence: | 28013691 | Sequence: | 28013692 | Sequence: | 28013693 | Sequence: | 28013694 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 4 | Subjects At Risk | 4 | Subjects At Risk | 4 | Subjects At Risk | 1 | Subjects At Risk | 1 | Subjects At Risk | 1 |
Created At | 2023-08-10 06:29:42.775791 | Created At | 2023-08-10 06:29:42.775791 | Created At | 2023-08-10 06:29:42.775791 | Created At | 2023-08-10 06:29:42.775791 | Created At | 2023-08-10 06:29:42.775791 | Created At | 2023-08-10 06:29:42.775791 |
Updated At | 2023-08-10 06:29:42.775791 | Updated At | 2023-08-10 06:29:42.775791 | Updated At | 2023-08-10 06:29:42.775791 | Updated At | 2023-08-10 06:29:42.775791 | Updated At | 2023-08-10 06:29:42.775791 | Updated At | 2023-08-10 06:29:42.775791 |
Responsible Parties
Sequence: | 28986033 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3861033 |
Pi Employee | Yes |
Result Contacts
Sequence: | 3860998 |
Organization | Boston Medical Center |
Name | Tamar Barlam, MD MSC |
Phone | 617 414 5190 |
tamar.barlam@bmc.org | |
Outcomes
Sequence: | 30891810 | Sequence: | 30891811 | Sequence: | 30891812 | Sequence: | 30891813 | Sequence: | 30891814 | Sequence: | 30891815 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Stool Microbiome With and Without FMT Administration | Title | Feasibility of Administering FMT After Completion of a Course of Oral Vancomycin Therapy | Title | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of FMT After a Course of Oral Vancomycin Therapy | Title | Incidence of Gastrointestinal Symptomatology Based on a Survey After CDI | Title | CDI Recurrence | Title | Number of Hospital Readmissions After Treatment |
Description | The stool microbiome in participants who receive additional FMT at end of Clostridium difficile infection (CDI) treatment with oral vancomycin will be compared to the stool microbiome in participants with standard treatment or oral vancomycin alone | Description | The number and proportion of FMT pills participants ingest after completion of a course of oral vancomycin therapy will be documented. | Description | Study participants will be monitored for any adverse events to FMT such as nausea or vomiting, abdominal pain or diarrhea. | Description | A detailed survey with 15 questions will be administered on GI symptoms Physicians will go over any significant adverse events to determine if they are related, possibly related or unrelated to oral FMT administration | Description | Patients will be monitored for recurrent C difficile infection defined as non-resolution or recurrence of GI symptoms (abdominal pain, diarrhea etc) and/or a positive stool C difficile test The proportion of participants with CDI recurrence will be documented. | Description | The number of hospital readmissions within 30 days after CDI treatment per patient history and chart review will be obtained |
Time Frame | 11 months | Time Frame | 12 months | Time Frame | During test dose, during 90 minutes of FMT administration, 30 minutes after FMT administration, 48-72 hours after FMT administration | Time Frame | 60 days | Time Frame | 60 days | Time Frame | 30 days |
Population | This outcome measure was not obtained on any of the participants as no participant was in the study at 11 months. | Population | This outcome measure was not obtained on any of the participants as no participant was in the study at 12 months. | Population | Only one participant in the FMT arm ingested the intervention. | Population | This outcome measure was not obtained on any of the participants. | Population | This outcome measure was not obtained on any of the participants. | Population | This outcome measure was not obtained on any of the participants. |
Units | Participants | ||||||||||
Param Type | Count of Participants |
Outcome Measurements
Sequence: | 236371372 |
Outcome Id | 30891812 |
Result Group Id | 56202119 |
Ctgov Group Code | OG000 |
Title | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of FMT After a Course of Oral Vancomycin Therapy |
Description | Study participants will be monitored for any adverse events to FMT such as nausea or vomiting, abdominal pain or diarrhea. |
Units | Participants |
Param Type | Count of Participants |
Param Value | 0 |
Param Value Num | 0.0 |
Baseline Counts
Sequence: | 11411301 | Sequence: | 11411302 | Sequence: | 11411303 |
Result Group Id | 56202114 | Result Group Id | 56202115 | Result Group Id | 56202116 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 4 | Count | 1 | Count | 5 |
Result Groups
Sequence: | 56202114 | Sequence: | 56202115 | Sequence: | 56202116 | Sequence: | 56202117 | Sequence: | 56202118 | Sequence: | 56202119 | Sequence: | 56202120 | Sequence: | 56202121 | Sequence: | 56202122 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Fecal Microbiota Transplantation | Title | Oral Vancomycin Alone (Control) | Title | Total | Title | Fecal Microbiota Transplantation | Title | Oral Vancomycin Alone (Control) | Title | Fecal Microbiota Transplantation | Title | Oral Vancomycin Alone (Control) | Title | Fecal Microbiota Transplantation | Title | Oral Vancomycin Alone (Control) |
Description | Fecal microbiota transplant G3 capsules will be administered after standard of care with oral vancomycin therapy in participants with primary Clostridium difficile infection.
Fecal microbiota transplant G3 capsules: After standard of care therapy with oral vancomycin, frozen oral FMT capsules will be provided in a formulation designed to deliver the product to the large intestine. 30 FMT capsules will be administered over a 2 hour period under direct observation |
Description | Oral vancomycin therapy will be administered as per standard of care in participants with primary clostridium difficile infection.
Oral Vancomycin alone: Standard of care will be provided with oral vancomycin therapy. |
Description | Total of all reporting groups | Description | Fecal microbiota transplant (FMT) G3 capsules will be administered after standard of care with oral vancomycin therapy in participants with primary Clostridium difficile infection.
Fecal microbiota transplant G3 capsules: After standard of care therapy with oral vancomycin, frozen oral FMT capsules will be provided in a formulation designed to deliver the product to the large intestine. 30 FMT capsules will be administered over a 2 hour period under direct observation |
Description | Oral vancomycin therapy will be administered as per standard of care in participants with primary clostridium difficile infection.
Oral Vancomycin alone: Standard of care will be provided with oral vancomycin therapy. |
Description | Fecal microbiota transplant G3 capsules will be administered after standard of care with oral vancomycin therapy in participants with primary Clostridium difficile infection.
Fecal microbiota transplant G3 capsules: After standard of care therapy with oral vancomycin, frozen oral FMT capsules will be provided in a formulation designed to deliver the product to the large intestine. 30 FMT capsules will be administered over a 2 hour period under direct observation |
Description | Oral vancomycin therapy will be administered as per standard of care in participants with primary clostridium difficile infection.
Oral Vancomycin alone: Standard of care will be provided with oral vancomycin therapy. |
Description | Fecal microbiota transplant G3 capsules will be administered after standard of care with oral vancomycin therapy in participants with primary Clostridium difficile infection.
Fecal microbiota transplant G3 capsules: After standard of care therapy with oral vancomycin, frozen oral FMT capsules will be provided in a formulation designed to deliver the product to the large intestine. 30 FMT capsules will be administered over a 2 hour period under direct observation |
Description | Oral vancomycin therapy will be administered as per standard of care in participants with primary clostridium difficile infection.
Oral Vancomycin alone: Standard of care will be provided with oral vancomycin therapy. |
Baseline Measurements
Sequence: | 125972760 | Sequence: | 125972761 | Sequence: | 125972762 | Sequence: | 125972763 | Sequence: | 125972764 | Sequence: | 125972765 | Sequence: | 125972766 | Sequence: | 125972767 | Sequence: | 125972768 | Sequence: | 125972769 | Sequence: | 125972770 | Sequence: | 125972771 | Sequence: | 125972772 | Sequence: | 125972773 | Sequence: | 125972774 | Sequence: | 125972775 | Sequence: | 125972776 | Sequence: | 125972777 | Sequence: | 125972778 | Sequence: | 125972779 | Sequence: | 125972780 | Sequence: | 125972781 | Sequence: | 125972782 | Sequence: | 125972783 | Sequence: | 125972784 | Sequence: | 125972785 | Sequence: | 125972786 |
Result Group Id | 56202114 | Result Group Id | 56202115 | Result Group Id | 56202116 | Result Group Id | 56202114 | Result Group Id | 56202115 | Result Group Id | 56202116 | Result Group Id | 56202114 | Result Group Id | 56202115 | Result Group Id | 56202116 | Result Group Id | 56202114 | Result Group Id | 56202115 | Result Group Id | 56202116 | Result Group Id | 56202114 | Result Group Id | 56202115 | Result Group Id | 56202116 | Result Group Id | 56202114 | Result Group Id | 56202115 | Result Group Id | 56202116 | Result Group Id | 56202114 | Result Group Id | 56202115 | Result Group Id | 56202116 | Result Group Id | 56202114 | Result Group Id | 56202115 | Result Group Id | 56202116 | Result Group Id | 56202114 | Result Group Id | 56202115 | Result Group Id | 56202116 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Classification | Black or African Am | Classification | Black or African Am | Classification | Black or African Am | Classification | White | Classification | White | Classification | White | Classification | United States | Classification | United States | Classification | United States | ||||||||||||||||||||||||||||||||||||
Category | <=18 years | Category | <=18 years | Category | <=18 years | Category | Between 18 and 65 years | Category | Between 18 and 65 years | Category | Between 18 and 65 years | Category | >=65 years | Category | >=65 years | Category | >=65 years | Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | ||||||||||||||||||||||||
Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Region of Enrollment | Title | Region of Enrollment | Title | Region of Enrollment |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | participants | Units | participants |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number |
Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 4 | Param Value | 1 | Param Value | 5 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 49.8 | Param Value | 58 | Param Value | 51.4 | Param Value | 2 | Param Value | 0 | Param Value | 2 | Param Value | 2 | Param Value | 1 | Param Value | 3 | Param Value | 2 | Param Value | 0 | Param Value | 2 | Param Value | 2 | Param Value | 1 | Param Value | 3 | Param Value | 4 | Param Value | 1 | Param Value | 5 |
Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 4.0 | Param Value Num | 1.0 | Param Value Num | 5.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 49.8 | Param Value Num | 58.0 | Param Value Num | 51.4 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 4.0 | Param Value Num | 1.0 | Param Value Num | 5.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 11.9 | Dispersion Value | 10.9 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 11.9 | Dispersion Value Num | 10.9 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 4 | Number Analyzed | 1 | Number Analyzed | 5 | Number Analyzed | 4 | Number Analyzed | 1 | Number Analyzed | 5 | Number Analyzed | 4 | Number Analyzed | 1 | Number Analyzed | 5 | Number Analyzed | 4 | Number Analyzed | 1 | Number Analyzed | 5 | Number Analyzed | 4 | Number Analyzed | 1 | Number Analyzed | 5 | Number Analyzed | 4 | Number Analyzed | 1 | Number Analyzed | 5 | Number Analyzed | 4 | Number Analyzed | 1 | Number Analyzed | 5 | Number Analyzed | 4 | Number Analyzed | 1 | Number Analyzed | 5 | Number Analyzed | 4 | Number Analyzed | 1 | Number Analyzed | 5 |
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https://zephyrnet.com/NCT03795220
2019-01-06
https://zephyrnet.com/?p=NCT03795220
NCT03795220https://www.clinicaltrials.gov/study/NCT03795220?tab=tableMarte Saupstad, MDmarte.saupstad@regionh.dkNAThe increasing use of FET emphasizes the importance of preparing and timing the endometrium in FET cycles, however there is no consensus on luteal phase progesterone supplementation in mNC-FET and the optimal day of blastocyst warming and transfer. The aim of this multicenter RCT is to assess the effect of progesterone supplementation in hCG-triggered mNC-FET and the effect of embryo thawing and transfer at hCG+6 or hCG+7 days, respectively. In total 604 patients will be included with n=151 in each of the four study arms. The primary outcome is live birth rate per transfer (LBR) and the goal is to show a 10% increase in LBR after progesterone supplementation and to assess whether blastocyst warming+transfer 6 days after hCG trigger is superior to 7 days after hCG trigger in mNC-FET.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-04 |
Study First Posted Date | 2019-01-07 |
Last Update Posted Date | 2023-04-05 |
Start Month Year | January 6, 2019 |
Primary Completion Month Year | January 1, 2024 |
Verification Month Year | April 2023 |
Verification Date | 2023-04-30 |
Last Update Posted Date | 2023-04-05 |
Detailed Descriptions
Sequence: | 20835576 |
Description | Single embryo transfer and freezing of surplus embryos has lowered twin birth rates after in vitro fertilization (IVF) to a level of less than 5% in Denmark. However, several treatments with repeated frozen embryo transfers (FET) before a viable pregnancy is confirmed are burdensome to the patients. New freezing techniques has optimized the quality of the embryo transferred in FET cycles, but optimization of the endometrium in the luteal phase is still lacking behind. In a mNC-FET, which is the routine in many clinics, ovulation is induced with an hCG injection when the leading follicle is ≥17 mm. The hCG trigger is important for controlling the time of ovulation, but triggering an unhealthy follicle at an inappropriate time may cause luteal phase insufficiency and thus suboptimal function of the endometrium. Danish public fertility clinics are not routinely using progesterone supplementation in mNC-FET, but there may be a rationale to do so, and some implantations may be rescued. In this study we will compare live birth rates in mNC-FET with and without progesterone supplementation in the luteal phase, and further we will explore the optimal timing of blastocyst warming and transfer by comparing embryo transfer at hCG trigger +6 days versus +7 days. This is a superiority study with the aim to detect an increase in live birth rates of 10%. Hence, this adequately powered RCT may make a major contribution to knowledge on mNC-FET to the benefits of patients. We will include 604 patients divided 1:1 (302:302) in each arm +/- progesterone and these will further be divided 1:1 in blastocyst warming and transfer +6 and +7 days after hCG injection. The primary endpoint is live birth rate per transfer. |
Facilities
Sequence: | 201146938 |
Status | Recruiting |
Name | Fertility Clinic, Rigshospitalet, Copenhagen University Hospital |
City | Copenhagen |
Zip | 2100 |
Country | Denmark |
Facility Contacts
Sequence: | 28262590 | Sequence: | 28262591 |
Facility Id | 201146938 | Facility Id | 201146938 |
Contact Type | primary | Contact Type | backup |
Name | Anja B. Pinborg, Prof., DMSc | Name | Marte Saupstad, MD |
anja.bisgaard.pinborg@regionh.dk | marte.saupstad@regionh.dk | ||
Phone | 004535456430 | Phone | 004535455289 |
Conditions
Sequence: | 52463356 |
Name | Infertility |
Downcase Name | infertility |
Id Information
Sequence: | 40367774 | Sequence: | 40367775 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 63569 | Id Value | 2018-002207-34 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42802234 |
Name | Denmark |
Removed | False |
Design Groups
Sequence: | 55917557 | Sequence: | 55917558 | Sequence: | 55917559 | Sequence: | 55917560 |
Group Type | Active Comparator | Group Type | Active Comparator | Group Type | Active Comparator | Group Type | Active Comparator |
Title | Vaginal progesterone + transfer 6. day | Title | Vaginal progesterone + transfer 7. day | Title | No progesterone + transfer 6. day | Title | No progesterone + transfer 7. day |
Description | Lutinus + blastocyst warming and transfer 6 days after hCG trigger | Description | Lutinus + blastocyst warming and transfer 7 days after hCG trigger | Description | No Lutinus + blastocyst warming and transfer 6 days after hCG trigger | Description | No Lutinus + blastocyst warming and transfer 7 days after hCG trigger |
Interventions
Sequence: | 52773294 | Sequence: | 52773295 | Sequence: | 52773296 | Sequence: | 52773297 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Lutinus + transfer day 6 | Name | Lutinus + transfer day 7 | Name | No Lutinus + transfer day 6 | Name | No Lutinus + transfer day 7 |
Description | Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger. | Description | Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger. | Description | Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger. | Description | Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger. |
Design Outcomes
Sequence: | 178475421 | Sequence: | 178475422 | Sequence: | 178475423 | Sequence: | 178475424 | Sequence: | 178475425 | Sequence: | 178475426 | Sequence: | 178475427 | Sequence: | 178475428 | Sequence: | 178475429 | Sequence: | 178475430 | Sequence: | 178475431 | Sequence: | 178475432 | Sequence: | 178475433 | Sequence: | 178475434 | Sequence: | 178475435 | Sequence: | 178475436 | Sequence: | 178475437 | Sequence: | 178475438 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Live birth rates per transfer | Measure | Chemical pregnancy rates per transfer | Measure | Clinical pregnancy rates per transfer | Measure | Abortion rates per transfer | Measure | ASAT (U/L) | Measure | ALAT (U/L) | Measure | AMH (pol/L) | Measure | Estradiole (mmol/L) | Measure | FSH (IU/L) | Measure | LH (IU/L) | Measure | Progesterone (nmol/L) | Measure | OH-progesterone (nmol/L) | Measure | beta-hCG | Measure | TSH (*10^3 IU/L) | Measure | Thyroglobulin antibodies (arb.units/L) | Measure | Thyroid peroxidase anitbodies (arb.units/L) | Measure | Obstetric complication rates | Measure | Neonatal complication rates |
Time Frame | Registered at the one-year follow-up after a positive pregnancy test. | Time Frame | Measured 16 days after ovulation trigger (hCG+16). | Time Frame | Ultrasound performed at 7-8 weeks of gestation. | Time Frame | Registered at the one-year follow-up after a positive pregnancy test. | Time Frame | Measured at baseline. | Time Frame | Measured at baseline. | Time Frame | Measured at baseline. | Time Frame | Measured at baseline, at ovulation trigger day (hCG+0), at transfer day (hCG+6/7) and at hCG+11. | Time Frame | Measured at baseline, at ovulation trigger day (hCG+0), at transfer day (hCG+6/7) and at hCG+11. | Time Frame | Measured at baseline, at ovulation trigger day (hCG+0), at transfer day (hCG+6/7) and at hCG+11. | Time Frame | Measured at baseline, at ovulation trigger day (hCG+0), at transfer day (hCG+6/7) and at hCG+11. | Time Frame | Measured at ovulation trigger day (hCG+0), at transfer day (hCG+6/7) and at hCG+11. | Time Frame | Measured at transfer day (hCG+6/7), hCG+11 and hCG+16. | Time Frame | Measured at baseline, at ovulation trigger day (hCG+0), at transfer day (hCG+6/7), at hCG+11, at hCG+14 and at hCG+19. | Time Frame | Measured at baseline. | Time Frame | Measured at baseline. | Time Frame | Registered at the one-year follow-up after a positive pregnancy test. | Time Frame | Registered at the one-year follow-up after a positive pregnancy test. |
Description | Comparison of live birth rates between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger. | Description | Comparison of chemical pregnancy rates between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger. | Description | Comparison of clinical pregnancy rates (ultrasound) between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or seven after hCG trigger. | Description | Comparison of abortion rates between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger. | Description | ALAT measured by blood sample to ensure normal liver parameters before administration of progesterone. | Description | ALAT measured by blood sample to ensure normal liver parameters before administration of progesterone. | Description | Comparison of AMH measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger. | Description | Comparison of estradiole measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger. | Description | Comparison of FSH measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger. | Description | Comparison of LH measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger. | Description | Comparison of progesterone measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger. | Description | Comparison OH-progesterone measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger. | Description | Comparison of beta-hCG measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger. | Description | Comparison of TSH measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger. | Description | Comparison of thyroglobulin antibodies measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger. | Description | Comparison of thyroid peroxidase antibodies measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger. | Description | Comparison of obstetric complication rates between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger. | Description | Comparison of neonatal complication rates for children of patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger. |
Browse Conditions
Sequence: | 194602077 | Sequence: | 194602078 | Sequence: | 194602079 |
Mesh Term | Infertility | Mesh Term | Genital Diseases | Mesh Term | Urogenital Diseases |
Downcase Mesh Term | infertility | Downcase Mesh Term | genital diseases | Downcase Mesh Term | urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48590793 | Sequence: | 48590794 | Sequence: | 48590795 | Sequence: | 48590796 | Sequence: | 48590797 | Sequence: | 48590798 | Sequence: | 48590799 | Sequence: | 48590800 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Anja Bisgaard Pinborg | Name | Copenhagen University Hospital, Hvidovre | Name | Regionshospitalet Horsens | Name | Copenhagen University Hospital at Herlev | Name | Aalborg University Hospital | Name | Hillerod Hospital, Denmark | Name | Zealand University Hospital | Name | Regionshospitalet Viborg, Skive |
Overall Officials
Sequence: | 29438259 |
Role | Principal Investigator |
Name | Anja B. Pinborg, Prof., DMSC |
Affiliation | Fertility Clinic Rigshospitalet |
Central Contacts
Sequence: | 12083938 | Sequence: | 12083939 |
Contact Type | primary | Contact Type | backup |
Name | Anja B. Pinborg, Prof., DMSC | Name | Marte Saupstad, MD |
Phone | 0045 35 45 64 30 | ||
anja.bisgaard.pinborg@regionh.dk | marte.saupstad@regionh.dk | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68549347 | Sequence: | 68549348 | Sequence: | 68549349 | Sequence: | 68549350 |
Design Group Id | 55917557 | Design Group Id | 55917558 | Design Group Id | 55917559 | Design Group Id | 55917560 |
Intervention Id | 52773294 | Intervention Id | 52773295 | Intervention Id | 52773296 | Intervention Id | 52773297 |
Eligibilities
Sequence: | 30932952 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 41 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Female age 18-41 years, regular menstrual cycle (23-35 days), vitrified blastocysts derived from 1.-3. IVF/ICSI cycle in a public hospital and undergoing single blastocyst transfer. Exclusion Criteria: – Previous participation in the study, uterine malformations, intrauterine polyps or submucosal myomas, breast feeding, oocyte donation, preimplantation genetic testing, blastocyst conceived with sperm from testicular sperm aspiration, HIV (woman), hepatitis B and C (woman), known luteal phase insufficiency or if patients are not fulfilling the inclusion criteria. Further exclusion criteria are the following contraindications to progesterone; allergy to the study medication, undiagnosed vaginal bleeding, current missed abortion or ectopic pregnancy, hepatic insufficiency or severe hepatic disease, genital or breast cancer, arterial or venous thromboembolism, thrombophlebitis or porphyria. For patients participating in the sub-study, thyroid disease is an exclusion criterion. |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254218164 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 41 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 17 |
Designs
Sequence: | 30678590 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Masking Description | The study is a single blinded study; therefore, the study medication will be blinded for the treating doctors, but not for the patients, the non-treating doctors or the study nurses. Patients will only be seen by a treating doctor at the day of blastocyst transfer and at the day of the pregnancy scan. The participants will not take progesterone the morning of the blastocyst transfer, but immediately after to keep the treating doctors blinded. Patients will be instructed in not disclosing their study group to the treating doctor. |
Intervention Model Description | Randomized, controlled multicenter trial with inclusion of 604 mNC-FET cycles. We will include 604 patients divided 1:1 (302:302) in each arm +/- progesterone supplementation and these will further be divided 1:1 in blastocyst warming and transfer +6 and +7 days after hCG injection. Patients randomised to progesterone supplementation will start administering medicine four days after the ovulation trigger up til the day of the pregnancy test. If the pregnancy test is positive, medication will continue for 30 days more. |
Investigator Masked | True |
Intervention Other Names
Sequence: | 26818956 | Sequence: | 26818957 |
Intervention Id | 52773294 | Intervention Id | 52773295 |
Name | Lutinus | Name | Lutinus |
Responsible Parties
Sequence: | 29045300 |
Responsible Party Type | Sponsor-Investigator |
Name | Anja Bisgaard Pinborg |
Title | Professor, chief consultant, DMSC |
Affiliation | Rigshospitalet, Denmark |
Study References
Sequence: | 52373884 |
Pmid | 31843833 |
Reference Type | derived |
Citation | Saupstad M, Freiesleben NC, Skouby SO, Andersen LF, Knudsen UB, Petersen KB, Husth M, Egeberg A, Petersen MR, Ziebe S, Andersen AN, Lossl K, Pinborg A. Preparation of the endometrium and timing of blastocyst transfer in modified natural cycle frozen-thawed embryo transfers (mNC-FET): a study protocol for a randomised controlled multicentre trial. BMJ Open. 2019 Dec 15;9(12):e031811. doi: 10.1136/bmjopen-2019-031811. |
Ipd Information Types
Sequence: | 3358203 |
Name | Study Protocol |
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