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<![CDATA[ Minimally-invasive Non-surgical and Surgical Periodontitis Treatment ]]>
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
Email BHNT.Clinicaloralresearchcentre@nhs.net Email 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
Very good
Good
Fair
Poor
Very poor

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
Email 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
Diagnosis of 'Periodontitis' stage III or IV (grades A to C)
Presence of ≥1 'intrabony defect' (PPD, >5 mm with intrabony defect depth ≥3mm at screening radiograph),
Signed informed consent. –

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.

]]>

<![CDATA[ Influence of PESF on Oxygen Saturation, Quality of Life and Exercise Capacity in COPD ]]>
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
Email 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
Email j.westbroek@tjongerschans.nl Email 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
oxygen saturation without suppletion <=90% (home use of oxygen suppletion is allowed, but will be stopped during PESF-treatment)
Stable medication (no foreseeable need to change therapy)
Able to understand the purpose and method of research after adequate information and the ability to decide on participation
Signed informed consent

Exclusion Criteria:

Known malignant condition with limited life expectancy
Carrier of electrical equipment (pacemaker, ICD etc)
COPD exacerbation in the last 3 weeks
Woman who are pregnant or of childbearing age without effective contraception
Manifest acute infection
Patients with manifest decompensatio cordis
Rehabilitation/reactivation program within 2 months before or during the study

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

]]>

<![CDATA[ Protein Ingestion and Skeletal Muscle Atrophy ]]>
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.
Smoker
Medical conditions including (cardiovascular disease ((e.g. hypertension)), metabolic disease ((e.g. type 2 diabetes)), any personal or family history of deep vein thrombosis.

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.

]]>

<![CDATA[ Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal ]]>
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
Aged greater than and equal to 40 years
Full time residents in the study area and will be in the study area for at least one year

Exclusion Criteria:

Younger than 40 years of age
Self-reported pregnancy
having active pulmonary tuberculosis or being on medications for pulmonary tuberculosis
thoracic, abdominal or eye surgery in the last six months
History of Mental illness
MI in past 8 weeks prior to study
Hospital admission in the past six months for cardiac illness
Those who decline to provide consent to the study will be excluded.

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.

]]>

<![CDATA[ Prognosis of Patient Evaluated for Palliative Radiotherapy ]]>
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)
Email 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
Email 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

]]>

<![CDATA[ A Clinical Follow-up Study of Heart Failure Patients. ]]>
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
Email 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
Email 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%
enlarged left ventricular end-diastolic dimension
ICM group: with history of MI or revascularization; ≥ 75% stenosis of LM or proximal LAD; ≥ 75% stenosis of two or more epicardial vessels.
symptomatic heart failure

Exclusion Criteria:

Known malignant tumour diseases
Pregnancy or lactation period;
Investigators think not suitable to participate in this trial.

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

]]>

<![CDATA[ Early Initiation of Low Dose Tirofiban for PPCI in STEMI Patients. ]]>
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
Email chen.zhangwei@zs-hospital.sh.cn Email 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
Email chen.zhangwei@zs-hospital.sh.cn Email 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;
ST segment elevated ≥ 0.1mV in adjacent two or more leads;
Scheduled for primary percutaneous coronary intervention without contraindications;
Written informed consent is obtained.

Exclusion Criteria:

Life expectancy ≤ 1 year;
History of cerebral hemorrhage;
History of stroke in 6 months;
Active hemorrhage;
Severe hepatic and renal dysfunction(ALT > 3 folds of upper limit of normal, eGFR < 30ml/min/1.73mm^2 or Scr > 200 mmol/L);
Known hemorrhagic diseases;
Known malignant tumour diseases;
Active peptic ulcer disease;
Blood platelet counts < 100×10^9/L;
Blood hemoglobin < 90g/L;
Pregnancy or lactation period;
Take part in other intervention clinical trials;
Investigators think not suitable to participate in this trial.

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

]]>

<![CDATA[ Paediatric Peri-operative Anxiety: Does the Little Journey App Help? ]]>
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.
<![CDATA[

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
Email 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
Those undergoing surgery planned to be conducted as a day-case (surgery is defined as any therapeutic procedure taking place under the care of an anaesthetist and surgeon or dentist)
Requiring general anaesthetic (must be their first general anaesthetic)
American Society of Anesthetists physical status class I-III
Both child and parent able to speak / understand one of the languages available on the Little Journey app (to be confirmed)

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
Any child and/or parent that refuses to be part of the study
Patients and parents who do not speak one of the languages which are available on the app
American Society of Anesthetists physical status class IV-VI
Children undergoing diagnostic procedures (e.g. scans, cardiac catheterisation)
Any child with a visual or hearing impairments significant enough to prevent use of the intervention as decided on case-by-case basis.

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

]]>

<![CDATA[ Efficacy of Lidocaine Gel Enema After Endoscopic Hemorrhoid Band Ligation for Relief of Post Procedural Pain ]]>
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
Patients undergoing endoscopic hemorrhoid band ligation at Advocate Christ Medical Center

Exclusion Criteria:

Patients undergoing endoscopic hemorrhoids band ligation who are already on pain medications chronically due to other reasons
Patients with moderate to severe renal impairment, defined as creatinine greater than 2
Patients with hepatic dysfunction, defined as patients with signs or symptoms of liver dysfunction and/or patients with Childs Pugh Class C
Patients with any history of arrhythmias or are currently on anti-arrhythmic medications
Patients with any contraindications to lidocaine, including hypersensitivity to local anesthetics of the amide type or any other component within the lidocaine 2% jelly
Patients with traumatized rectal mucosa in the area of application at the time of the procedure
Patients who are currently pregnant

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

]]>

<![CDATA[ Effectiveness of Percutaneous Needle Aponeurotomy ]]>
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
Email johann.beaudreuil@aphp.fr Email 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
Email 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
Ascertained Dupuytren disease: palpable fibrotic nodule or cord developed from the palmar aponeurosis, flexion contracture of a metacarpophalangeal or proximal interphalangeal joint.
Presence of at least one flexion contracture of a metacarpophalangeal joint of the hand due to Dupuytren's disease and > or = 20°
Written informed consent signed by the patient
Patient affiliated to the social security

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.
Previous open surgery of the hand for any reason
Any other pathological condition or limited range of motion in the finger to be treated
Psychiatric status precluding patient evaluation; vulnerable persons; adults under legal protection order or incompetent, physically or mentally incapable of giving his consent.
Pregnant or beastfeeding women
Participation in another interventional trial

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

]]>

<![CDATA[ MN4000 for Treatment of CF and MND Patients in the Home Setting ]]>
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;
provide lung expansion therapy and;
enhance delivery of aerosol therapy.

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
CPEP (Continuous Positive Expiratory Pressure) – delivers aerosol therapy while providing continuous positive pressure to help hold open and expand the airways
Aerosol – for delivery of aerosol only. In this mode, CHFO and CPEP are not available

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
Salivation
Swallowing
Handwriting
Cutting food and handling utensils (with or without gastrostomy)
Dressing and hygiene
turning in bed and adjusting bed clothes
Walking
Breathing
Climbing stairs

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
Age > 18 years
Signed informed consent

Exclusion Criteria:

Requirement for continuous mechanical ventilation
Anticipated requirement for hospitalization within the next three months
History of pneumothorax within past 6 months
History of hemoptysis requiring embolization within past 12 months
Inability to perform MN4000 therapy using a mouthpiece (e.g. inability to create adequate mouth seal)
Inability to perform MN4000 therapy as directed
Inability or unwillingness to complete study visits or provide follow-up data as required by the study protocol

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

]]>

<![CDATA[ A Study of the Safety and Tolerability of CDX-6114 in Healthy Volunteers ]]>
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.
Have a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Good general health, as determined by an experienced physician based on a medical evaluation including detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ECG) and clinical laboratory tests.

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.
These requirements do not apply to participants in a same sex relationship.
Male subjects must agree not to donate sperm 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.
Must have a negative serum pregnancy test at screening.

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.
These requirements do not apply to participants in a same sex relationship.

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.
Female subjects must agree not to breastfeed starting at screening and continuing throughout the clinical study period, and for 90 days after study drug administration.
Female subjects must agree not to donate ova starting at screening and continuing throughout the clinical study period, and for 90 days after study drug administration.
Subject must be competent to understand the nature of the study & capable of giving written informed consent. Be willing to report for the scheduled study visits and communicate to study personnel about adverse events and concomitant medication use.
Subject must abstain from the following foods from 1 week prior to study drug administration until the last PK sample has been obtained: grapefruit juice or products, pomegranate juice or products, foods containing poppy seeds, and/or drinks or foods containing quinine (e.g., tonic water) or Seville oranges (e.g., orange marmalade).

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.
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies and childhood asthma) at time of study drug administration.
Current or chronic history of gastrointestinal illness or conditions interfering with normal gastrointestinal anatomy or motility. Examples include gastrointestinal bypass surgery, cholecystectomy, partial or total gastrectomy, gastric band surgery, small bowel resection, vagotomy, malabsorption, Crohn's disease, ulcerative colitis, irritable bowel syndrome (IBS) or celiac sprue.
Treatment with any anti-platelet and/or anticoagulant medication.
Evidence or history of specific food intolerance. Examples include gluten intolerance, lactose intolerance, or dairy food intolerance or any food/ingredient included in the protein breakfast.
A positive result, on screening, for serum hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (HAV), hepatitis C virus antibodies (HCV) or antibodies to human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV-2).
A positive pre-study drug/alcohol screen. However, there is the option to re-screen during the screening period at the discretion of the PI or delegate in the case of a positive pre-study drug screen for a prescribed medication e.g. codeine.
Subject has a history of drinking > 21 units of alcohol/week for male subjects or > 14 units of alcohol/week for female subjects within the 3 months prior to screening.
Subject has a history of regular smoking (daily or most days in a week) or the use of nicotine products (3 or more nicotine-containing products) within the 6 months prior to screening.
Subjects who show evidence of use of any recreational drugs of abuse on testing or recent history (within the 3 months prior to screening).
Subject has a pulse rate <40 or > 100 bpm; mean systolic blood pressure (SBP) > 140 mmHg; mean diastolic blood pressure (DBP) > 90 mmHg at screening. Repeat measurements are allowed at the discretion of the PI or delegate.
Subject has any clinically significant abnormalities at screening in rhythm, conduction or morphology of the resting ECG and any clinically significant abnormalities in the 12-lead ECG, as considered by the Investigator, that may interfere with the interpretation of QTc interval changes including abnormal ST-T wave morphology.
Subject has prolonged QTcF (QT interval corrected for heart rate using Fridericia's formula) > 450 ms for male subjects or > 470 ms for female subjects, or shortened QTcF < 300 ms or a family history of prolonged QT syndrome, at screening.
Subject has any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis at screening as judged by the Investigator, including: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT) or Total bilirubin (TBL) more than 1.5 times the Upper Limit of Normal (ULN).
Plasma donation within the 14 days prior to screening or any whole blood donation/significant blood loss > 500 mL during the 3 months prior to screening.
Treatment with any Investigational Drug or Device/Treatment within the 30 days prior to the administration of study drug.
Use of any prescribed or non-prescribed medication including, herbal and dietary supplements, antacids, analgesics (other than oral contraceptives, paracetamol or multi-vitamins) during the two weeks prior to the administration of the study drug, or up to a minimum of 5 times the half-life of the medication if it has a long half-life.
Previous treatment with CDX-6114 active study drug (but not placebo) in study CDX6114-001.

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

]]>

<![CDATA[ Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial ]]>
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
Email 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
Email 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
Patients who received new generation sirolimus-eluting (Orsiro® series) stent implantation for treating ACS, including acute MI and unstable angina
Provision of informed consent

Exclusion Criteria:

Age> 80 years
Increased risk of bleeding, anemia, thrombocytopenia
A need for oral anticoagulation therapy
Pregnant women or women with potential childbearing
Life expectancy < 1 year

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

]]>

<![CDATA[ Characterization of Manual Dexterity by Finger Force Manipuladum (FFM) in Patients With Writer’s Cramp and in Control Subjects ]]>
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
Writer's cramp focal dystonia specific to the task of writing
Patient treated or not with botulinum toxin injection
Person having attended school in French

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.
Tremor of writing
Neurological condition other than writer's cramp (eg Parkinson's syndrome)
Pain, trauma or pathology of the upper limb of the writing member other than the writer's cramp who required medical or surgical treatment in the last 6 months preceding the initial check-up

Inclusion criteria for control subjects

•> 18 years old

Without writer's cramp
Person having attended school in French

Non inclusion criteria for control subjects

Tremor of writing
Neurological condition other than writer's cramp (eg Parkinson's syndrome)
Pain, trauma or pathology of the upper limb of the writing member other than the writer's cramp who required medical or surgical treatment in the last 6 months preceding the initial check-up

Matching criteria between cases and control patients

Age (± 5 years)
Gender
Hand writing

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

]]>

<![CDATA[ Endostar Combined With IP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas ]]>
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
Email 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.

]]>

<![CDATA[ Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Knee Replacement in Patients With High PCS Scores ]]>
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
Scheduled for primary unilateral TKA with spinal anesthesia as the primary anesthetic for painful osteoarthritis without congenital knee pathology
American Society of Anesthesiologists Physical Status Classification System ≤ 3
Medically stable for elective surgery with spinal anesthetic as determined by the Investigator
Body mass index of 18-45 kg/m2
Stable medical regimen at least 1 week before randomization
Able to read and understand study instructions in English or Spanish, and willing to comply with all study procedures

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
Inflammatory arthridities (e.g., rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis), with the exception of clinically stable/non-active gout
Undergoing concomitant surgical procedures or non-elective TKA, or contralateral knee is likely to require TKA within 6 weeks (or would interfere with study assessments)
Use of cryoneurolysis (including Iovera) on the current operative knee region within 6 months prior to randomization and/or at any time through the duration of the study
Planned use of general anesthesia as the primary anesthetic; planned use of neuroaxial (intrathecal or epidural) opioids, or any use of extended release/long acting opioids or ketamine preoperatively and/or at any time through the duration of the study
Use of more than 40 mg per day (on average) of oral morphine or its equivalent within 1 month prior to randomization
Current neurologic disorder, which could confound the assessment of pain (e.g., Parkinson's, Multiple Sclerosis)
Unstable mental condition and/or evidence of an uncooperative attitude in the opinion of the Investigator; subjects diagnosed with schizophrenia, prescribed antipsychotic medications or MAOIs
Women who are pregnant or nursing
Subjects engaged in pending or active litigation, or seeking disability compensation; subjects whose cases have been settled or finally decided are not excluded
Participation in a clinical trial with the last dose or intervention within 1 month of randomization, or planned participation in a clinical trial during this study
Previous participation in any study involving brivoligide injection

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

]]>

<![CDATA[ Study Examining the Effects of Mindfulness and Similar Audio-guided Exercises. ]]>
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.
Adequate understanding of spoken and written English

Exclusion Criteria:

Currently experiencing significant difficulties with their mental wellbeing.
Currently have a personal mindfulness practice.
Currently participating in a mindfulness-based intervention.

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

]]>

<![CDATA[ Effect of Electroacupuncture on Opioid-induced Constipation in Patients With Cancer ]]>
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;
Patients recruited in this trial must have a history of OIC symptoms for at least 1 week;
Patients must be ≥18 years of age and ≤85 years of age;
Patient's cancer condition must be stable with a life expectancy that is more than six months;
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
Patients must have been receiving a relatively stable maintained opioid regimen, consisting of a total daily dose of 30 mg to 1000 mg oral morphine equivalents for at least 2 weeks prior to screening for cancer pain. Furthermore, it must be anticipated that the opioid will be maintained for at least 10 weeks;
The SBM frequency of the patients must be ≤ 2 times a week when laxatives are not being taken;
Patients must be capable of oral intake of drugs, food and beverages;
Provision of written informed consent before participation.

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;
Patients with a history of gastrointestinal tract operation, abdominal operation, or abdominal adhesion within one month prior to screening; history of intestinal obstruction within three months prior to screening;
Diagnosis of active diverticular disease; or severe hemorrhoid; or anal fissure; or artificial rectum or anus;
Patients with an intraperitoneal catheter or a feeding tube;
Diagnosis of pelvic disorder which are considered to have obvious effects on the intestinal transport of feces (such as uterine prolapse ≥degree 2, uterine fibroids [located in the posterior of the uterus with a diameter ≥ 5 cm] affecting bowel movement);
Patients that are being treated with a new cancer chemotherapy, which had never been administered in the past, within 14 days of the screening or are scheduled to receive such therapy during the study;
Patients that received radiotherapy within 28 days of the screening or are scheduled to receive such therapy during the study;
Patients that underwent a surgery or intervention that is considered to have an obvious effect on the gastrointestinal functions within 28 days of the screening or are scheduled to receive surgery or intervention which is considered to have obvious effects on the gastrointestinal functions during the study, or scheduled to receive surgery or intervention which will be anticipated to prevent the patients from completing the trial;
Patients with uncontrolled hyperthyroidism, severe hypertension, heart disease, systematic infection or blood coagulation disorders (hypercoagulation status or hemorrhagic tendency) at the time of study inclusion;
Patients that consumed >4 additional opioid doses per day, for breakthrough pain, for more than 3 days during the baseline period, or if their maintenance opioid dosing regimen was modified during this period;
Patients with severe cancerous pain (e.g., typical average daily pain intensity rating of 7 to 10 on a numerical rating scales (NRS; 0 [no pain] to 10 [the worst pain possible]) after the use of routine dose and frequency of opioids) refractory to opioid therapy;
Patients with a history of opioid discontinuation due to severe adverse events or patients that are expected to discontinue opioid use due to the potential risk of adverse events;
Patients that received an opioid receptor antagonist within one month of the screening, or those who are scheduled to receive such therapy during the study;
Patients with a history of nerve neurolysis;
Patients with severe cognitive impairment, aphasia, or psychiatric disorders; abdominal aortic aneurysm; hepatomegaly(liver span > 14cm at the mid-clavicular line by ultrasound examination); or splenomegaly (spleen length [cranial to caudal] > 13cm by ultrasound examination);
Patients that have received acupuncture within three months of the screening;
Other patients who are considered ineligible for the study by the investigator on the basis of concomitant therapy and medical findings.

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.

]]>

<![CDATA[ Multichannel tDCS to Reduce Hypertonia in Patients With Prolonged DOC ]]>
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
patients in minimally conscious state
patients with stable condition
patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)

Exclusion Criteria:

premorbid neurology antecedent
patients in coma
patients < 28 days after the acute brain injury
patients with a metallic cerebral implant
cranioplasty
shunt

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.

]]>

<![CDATA[ Comparison of Ba-Duan-Jin and Pregabalin in Patients With Fibromyalgia ]]>
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;
be between the ages of 18 to 70 years.

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;
be less than 40mm of pain VAS score;
had renal failure, and severe depression or anxiety;
had any poorly-controlled comorbid medical conditions, such as dementia, cancer, thyroid disease, inflammatory arthritis;
pregnancy or planned pregnancy within the study period;
patients residing more than 70 miles from the research site.

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.

]]>

<![CDATA[ Real Life Study in Myopic Neovascularization ]]>
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).
High myopy defined by refractive error ≤ -6 D or History of high myopia among pseudophakic patient or patient treated with refractive surgery
Patient with active CNVm

• 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.
Treatment with PDT or laser administrated within 6 months prior to baseline in the study eye.
History of vitrectomy in the study eye
History of any other retinal disease
VA less than 20/250

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

]]>

<![CDATA[ Individualized Administration of Warfarin by Polymorphisms of VKORC1 and CYP2C9 Genes ]]>
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;
to obtain the consent of the patient and sign an informed consent certificate;
to collect 2ml anticoagulant blood before the drug, fill in the application form for individualized drug use in warfarin, and indicate the experimental group and control group;
the specimen assigned to the laboratory for Genotyping;
lab to calculate the predicted stable warfarin dose and the results fed back to the clinician within one working day after receiving the specimen;
in the control group, the drug retained at the regular dose, and the first 3 days of the experimental group administered at the predicted dose;
the dosage of warfarin in the two groups of cases adjusted to the stable dose according to the value, and the adjustment amplitude of the experimental group also referred to the predicted stable dose.
to monitor INR once a day during hospitalization, and to those who do not receive a stable dose of discharge, follow up and monitor INR once a week until a stable dose or medication is obtained for 90 days;
to document clinical trial records, including the daily use of warfarin, each detection of the appearance of the situation like INR value, bleeding, venous embolism and other side effects.

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
Email 343983217@qq.com Email 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;
Warfarin anticoagulant therapy is required for at least 3 months;
The genotype of patient VKORC1 is non-AA, CYP2C9 genotype is non*1/*1; the patients who are followed up, regularly monitored for INR and willing to provide peripheral blood for DNA extraction and genetic testing;
The patient or family members can understand the research plan and will participate in this study and provide a written informed consent;

Exclusion Criteria:

Severe liver dysfunction (ChildPugh ≥ 10);
Severe infection, respiratory failure;
Severe heart failure ( NYHA ≥ IV);
Severe renal insufficiency (Ccr ≤ 20ml / min);
Cancer;
Diseases of the blood system;
Severe pulmonary hypertension (PAPm ≥ 45mmHg);
Abnormal thyroid function;
Patients with a history of venous thromboembolism, or serious events such as severe bleeding or embolism;
Women who are pregnant or breastfeeding;
Taking or planning to take other oral anticoagulants;
The base INR value is >1.4;
VKORC1, CYP2C9 genotypes are AA, *1/*1;
Secondary valve replacement surgery;
Emergency hospital admission for valve surgery;
Diagnosis of coronary atherosclerotic heart disease;
Severe mental illness, mental disorder ; –

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.

]]>

<![CDATA[ A Study in Patients With Trichotillomania ]]>
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.
Provided signed written informed consent with willingness and ability to comply with all aspects of the protocol.

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
Have a history of daily hair pulling for at least 6 months prior to the first dose
Except for SSRIs or SNRIs, has not used any psychoactive medications including, but not limited to, other antidepressants, anxiolytics, mood stabilizers, anti-psychotics, benzodiazepines, stimulants, sulfasalazine, and St. John's Wort 30 days prior to first dose. Subjects will be allowed to maintain background therapy with SSRIs or SNRIs if on stable regimen for a minimum of 90 days prior to first dose and there are no anticipated changes to the SSRI/SNRI during course of trial.
Has not used N-acetylcysteine for at least 90 days prior to the first dose.
Has not used gemfibrozil or repaglinide for 1 week prior to the first screening visit.
Medically healthy with no clinically significant findings in medical history, physical examination, laboratory profiles, vital signs, or ECGs, as deemed by the Principal Investigator (PI) or designee.

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
IUD (either hormone-releasing or non-hormone releasing) for at least minimum duration per current labeling 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
Depo contraception for at least minimum duration per current labeling 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
Double physical barrier method (e.g., condom and diaphragm) from 14 days prior to the first dose and throughout the study
Physical plus chemical barrier method (e.g., condom with spermicide) from 14 days prior to the first dose 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;
bilateral tubal ligation or bilateral salpingectomy;
hysterectomy;
bilateral oophorectomy; Or be postmenopausal with amenorrhea for at least 1 year prior to the first dose with serum follicle stimulating hormone levels consistent with postmenopausal status or have medically documented history of biological or congenital sterility.
A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 30 days beyond the last dose of study drug/placebo.
If male, must agree not to donate sperm from the first dose until 30 days after the last dose administration.
Must be able to fluently read and write in English.
Understands the study procedures in the informed consent form (ICF) and is willing and able to comply with the protocol.

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 engaged in cognitive behavioral therapy (CBT) for TTM or other body-focused repetitive behavior or any obsessive-compulsive related or impulse control disorder any time within 60 days prior to first dose. For other psychotherapies, subject must have been engaged in that psychotherapy for a minimum of 60 days at the time of first dose and must be willing to maintain the same frequency and type of therapy for the duration of the study period.
Subjects engaged in any other behavioral interventions (e.g., wearable devices, behavioral self-help strategies) within 60 days prior to first dose.
Mentally or legally incompetent.
Suffered a concussion in the past 6 months prior to screening. Any history of traumatic brain injury with loss of consciousness in the year prior to first screening visit.
Any lifetime history of any psychotic disorder, including schizophrenia or any bipolar or bipolar-related disorder as determined by clinical history or confirmed at screening with the MINI, version 7.0.2.
Current major depressive episode confirmed at screening with the MINI, version 7.0.2.
Per PI judgment, the presence of any emotional problems or psychiatric disorders that may obscure evaluation of primary TTM or pose a risk to subject safety or stability during the study period. Other emotional problems or diagnoses may include, but are not limited to, other body-focused repetitive behaviors, post-traumatic stress disorder, obsessive-compulsive disorder, panic disorder, compulsive gambling, borderline personality disorder, or antisocial personality disorder.
History of any injury, illness, or condition that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
Laboratory evidence of renal impairment (e.g. a creatine clearance of < 80)
Presence of any substance use disorder or, in the opinion of the PI or designee, problematic substance use (excluding nicotine or caffeine) within the 2 years prior to screening.
History of seizure disorder with the exception of subjects who have been off anti-seizure medication and have not had a seizure in the past 5 years.

Subjects with any of the following:

Any psychiatric hospitalizations in the past year,
Imminent risk of suicide based on PI's or designee's clinical judgment or psychiatric examination,
Active suicidal ideation in the past 6 months as evidenced by positive endorsement to Item 4 or 5 on the C-SSRS, OR
Any history of suicidal behavior in the past year as evidenced by positive endorsement to any of the suicidal behavior items on the C-SSRS.
Has previously participated in any Promentis Phase 1 study.
Participation in another interventional clinical study (including CBT or other behavioral intervention) within 30 days prior to the first screening visit. The 30 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to the date of initiation of screening in the current study.

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.

]]>

<![CDATA[ Biochemical Versus Ultrasound Findings as Predictors of Fetal Loss in Cases of First Trimester Threatened Miscarriage ]]>
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,
the crown rump length
gestational sac diameter
yolk sac diameter. b) The second ultra sound will be after two weeks from the first one to follow up the patient for pregnancy survival, take the same measures again and correlate them with the results of laboratory investigations to select the investigation which is most accurate in anticipating outcome in cases of threatened abortion.

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
Email 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.
Age20-35years.
Gestational age between6 to 8weeks.
Threatened miscarriage is diagnosed by vaginal bleeding, closed cervix and positive fetal life.
Patients who are sure of their dates (three regular menstrual cycles before conception without the use of hormonal contraception.

Exclusion Criteria:

Patients with recurrent miscarriage or pregnancy of unknown location (PUL).

Patients had ovulation induction medications or on progesterone treatment.
Patients with past medical history of diabetes mellitus or chronic hypertension.
Patients who are unsure of the last menstrual period date or with irregular menstrual cycle.
Pregnancy associated with presence of ovarian cyst.
Molar pregnancy.
Those who had a history of maternal disease which would cause an increase in CA-125level. These diseases include chronic pelvic infection, endometriosis, myoma uteri, endometrioma and lung, kidney and hepatic diseases.

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

]]>

<![CDATA[ Study of Individuals Affected With Hypoplasminogenemia ]]>
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.
Identify factors that correlate with disease expression and severity.
Create a specimen biobank for further studies, available to other researchers.

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
Email nthukral@ihtc.org Email cnakar@ihtc.org Email fxavier@hmc.psu.edu Email dvehec@vitalant.org Email delia.h.darst@vumc.org Email heather.mcdaniel@vumc.org Email Heather.Urbanek@cookchildrens.org Email marcela.torres@cookchildrens.org Email Katherine.E.Addy@uth.tmc.edu Email Nidra.I.Rodriguez@uth.tmc.edu Email jaavilar@gmail.com Email jceresetto@intramed.net Email paul.monagle@rch.org.au Email jodi.hislop@rch.org.au Email Sarah.Tehseen@saskhealthauthority.ca Email rashmi.nagaraj@usask.ca Email marzia.menegatti@guest.unimi.it Email mtsart@unipd.it Email cesare.dallaporta@gmail.com Email rungrote.n@cmu.ac.th Email drserdaral@gmail.com Email s_basakkoc@hotmail.com Email goncakacar@gmail.com Email tirajecelkan@yahoo.com Email 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
Email ashapiro@ihtc.org Email 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)
A. Males or females with type 1 PD diagnosed locally with plasminogen activity levels <50% OR B. First degree family members of a person diagnosed with type 1 PD (includes parents, siblings, half-siblings)
All ages included
Available clinical history and treatment for at least 1 year prior to entry except for infants < 1 year of age
Willingness to provide samples for analysis including DNA, plasma etc.
Willingness to participate in prospective follow-up for up to 3 years

Exclusion Criteria:

Previous organ transplant recipient
Any psychiatric disorder, other mental disorder, or any other medical disorder that impairs the subject's ability to give informed consent or to comply with the requirements of the study protocol
Refuses to provide informed consent
Special patient populations, including prisoners or, are deemed medically or cognitively unsuitable for research by their treating physician
Inability to obtain a blood sample due to poor or limited venous access

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.

]]>

<![CDATA[ A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer ]]>
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)
The middle intra-operative sample, which will be collected when half the tumour has been devascularized (i.e., somewhere midway during the surgery). (Sample B)
A third post excision (anoxic sample C). These tumour tissue samples will be stored as snap frozen, in RNA later and as paraffin sections.

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
Email drjoshishalaka@gmail.com Email 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
Email drjoshishalaka@gmail.com Email 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)
Not received any chemotherapy or surgical intervention except core biopsy.
Planed for Breast cancer surgery
Willing to give consent for the study

Exclusion Criteria:

Clinically diagnosis of Metastatic breast cancer
Received any anticancer therapy

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.

]]>

<![CDATA[ Nutritional Supplements and Performance During Visual Field Testing (B3 Vitamin) ]]>
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;
Visual field loss on 24-2 standard automated perimetry (SAP) worse than -3 decibels (dB) and better than -12 dB in both eyes;
Best corrected visual acuity better than 20/40 in both eyes;
Prior experience with 24-2 visual fields (at least 3 tests done in the past 3 years).

Exclusion Criteria:

Significant cataract or media opacity;
Diagnosis of dementia, Alzheimer's, and other neurological diseases;
Current use or use in the past 1 month of nutritional supplements;
Inability to take or intolerance to nicotinamide and/or pyruvate.

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.

]]>

<![CDATA[ A Study to Evaluate ICP-022 in Patients With R/R Marginal Zone Lymphoma (MZL) ]]>
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
Histologically confirmed marginal zone lymphoma (MZL), and at least one measurable tumor of greater than 1.5 centimeter outside of the spleen
Subjects with refractory or relapsed MZL who has received at least 1 but no more than 4 prior therapies for MZL
ECOG performance status of 0-2
Documented failure to achieve at least partial response (PR) or documented disease progression after response to the most recent treatment regimen
Subjects who have indications for treatment (threatened end-organ function, bulky disease >5cm, symptoms, steady progression, wish to treat)

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
Total bilirubin ≤ 1.5× ULN; AST or ALT ≤ 2× ULN; Creatinine ≤ 1.5× ULN; Amylase ≤ ULN and Lipase ≤ ULN
International normalized ratio (INR) ≤ 1.5 ULN
Life expectancy ≥ 3 months
Able to provide signed written informed consent

Exclusion Criteria:

History of other active malignancies within 5 years of study entry, unless cured without evidence of relapse or metastasis
Current or history of lymphoma involved central nervous system
Prior corticosteroids (at dosages equivalent to prednisone > 20 mg/day) given with anti-neoplastic intent within 7 days, prior chemotherapy, targeted therapy, radiation therapy, or antibody-based therapies or anti-cancer TCM within 4 weeks of the start of study drug
Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy (except for alopecia)

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%
Primary cardiomyopathy
Clinical significant QTc prolong history or QTc>470ms (female) QTc>450ms (male)
Uncontrolled hypertension
Known active bleeding within 2 months of screening or currently taking anticoagulant/antiplatelet drugs
Urine protein ≥ 2+ and quantitation ≥ 2g/24hours
History of deep vein thrombosis or pulmonary embolism
Toxicity must be recovered to ≤ Grade 1 from prior anti-cancer therapy
Disease significantly affecting gastrointestinal function such as dysphagia, chronic diarrhea, intestinal obstruction, or resection of the stomach
Prior organ or hematopoietic stem cell transplant
Major surgery within 6 weeks of screening, except for diagnostic test or vascular access setup
Known active infection with HBV, HCV or HIV or any uncontrolled active systemic infection
Any history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe lung function impairment
Prior exposure to a BTK or BCR pathway inhibitor (PI3K or Syk) and BCL-2 inhibitor
Suitable and ready for allogeneic stem cell transplant
Inability to comply with study procedures
Drug abuser or alcoholics
Lactating or pregnant women, or women who will not use contraception during the study and for 180 days after the last dose of study drug if sexually active and able to bear children
Requires treatment with moderate or strong cytochrome P450 family 3, subfamily A (CYP3A) inhibitors or strong CYP3A inducers.

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

]]>

<![CDATA[ High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer ]]>
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.
Be ≥ 18 years of age on day of signing informed consent.
Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (with measurable disease according to RECIST 1.1)
Have a performance status of 0 or 1 on the ECOG performance scale.
Demonstrate adequate organ function as defined below in Table 4, all screening labs should be performed within 21 days of treatment initiation.
Female participants of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving first dose of study medication.
Female participants of childbearing potential must be willing to use adequate method of contraception (as outlined in section 4.4.2) for the duration of the trial through one month after the last dose of trial treatment.
Male participants must agree to use adequate contraception (as outlined in section 4.4.2) for the duration of the trial through one month after the last dose of trial treatment. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.

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.
Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
Patients who need constant use of finger stick blood glucose monitoring for tight control of their diabetes being that the ascorbic acid causes false low readings of glucose via that technology (Vasudevan and Hirsch 2014) 39
Any person with a G6PD deficiency
History of renal oxalate stones (if type of stone is unknown, need to assess urine oxalates level if >60mg/dL, then patient is not eligible for the study)
Patient is taking acetaminophen at any dose or any medication that contains acetaminophen within 72 hours of first dose of ascorbic acid
Hypersensitivity to any of the agents proposed for treatment.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.
Has an active infection requiring systemic therapy.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
For female participants: Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the pre-screening or screening visit through one month after the last dose of trial treatment.
For male participants: Is expecting to impregnate a sexual partner within the projected duration of the trial, starting with the pre-screening or screening visit through one month after the last dose of trial treatment.
Patients with evidence of iron overload, defined as a transferrin saturation > 45 percent AND serum ferritin > 200 ng/mL (males) or >150 ng/mL (females).
Current, serious, clinically significant cardiac arrhythmias as determined by the investigator, or patient receiving a digitalis derivative.

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

]]>

<![CDATA[ Determination of Normal Values for the Star Excursion Balance Test (SEBT) in Handball Players ]]>
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
age from 14 to 18 years old
national or international level for handball

Exclusion Criteria:

no french language
players who don't understand the instructions to perform the test
Refusal to perform the test

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

]]>

<![CDATA[ Gut Microbiome and Metabolic Pathways Changes in Vitiligo ]]>
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
Email 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
Email 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;
Male or female subjects 3-65 years of age;
Clinically confirmed the diagnosis of advanced vitiligo as per the diagnostic criteria for vitiligo specified in Clinical Dermatology;
Stable vital signs.

Exclusion Criteria:

Patients who had taken systemic or local treatment with vitiligo in the last month;
Patients who had taken systemic antibiotics,systemic hormones,cytokines, immunosuppressors in the previous three months;
The combination of other autoimmune diseases,gastrointestinal diseases, hepatic diseases, psychiatric and psycho-related diseases, or other skin diseases;
The combination of Serious, life-threatening condition such as cardiac diseases, renal diseases, endocrine system disease, cancer, or immunodeficiency diseases;
Women of child-bearing potential who are pregnant, plan to become pregnant during the study or are lactating;
Any other condition that the investigator deems unsuitable for entering the study.

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

]]>

<![CDATA[ Airway Remodeling During Mepolizumab Treatment ]]>
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
Changes in BAL levels of inflammatory and remodeling mediators and of ECM components after 6 months and 12 months of mepolizumab treatment
Changes in the number of PGP9 sections in the bronchial wall after 6 months and 12 months of mepolizumab treatment
Relationship between clinical response to mepolizumab and remodeling changes after 6 months and 12 months of mepolizumab treatment
Demographic and clinical characteristics of asthma (atopy, level of asthma control, FEV1…) will be available at inclusion and follow up, to assess clinical effect 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…)
benefit of mepolizumab will be evaluated according to the physician's Global Evaluation of Treatment Effectiveness (GETE)
asthma control test
lung function test (FEV1, FEV1/VC, TLC, RV, pre/post salbutamol)
FOB with BAL and 6 biopsies at inclusion, 6 months and 12 months

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.
Main tests or procedures All biopsies, BAL and serum analysis will be performed in the UMR1152 lab unit (Head: Dr Marina Pretolani).

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
Asthma control test
Lung function test
Fiber optic fibroscopy with BAL and bronchial biopsies (note that if a fiber optic fibroscopy with BAL and bronchial biopsies has already been performed in the month prior to inclusion, it will not be repeated at inclusion and the tissue and BAL samples will be retrieved for analysis)
Blood sampling
first treatment by Mepolizumab is administrated in the hospital.
Patient injection training if this prescription is chosen
Prescription for Mepolizumab, given at home for the next 6 months

V2: 6-month visit

Clinical response assessment by GETE and ACT, clinical evaluation
Lung function test
Fiber optic fibroscopy with BAL and bronchial biopsies
Blood sampling
If responders, continuation of Mepolizumab treatment
Compliance evaluation (file signed by the nurse or patient after each injection)

V3: 12-month visit

clinical response assessment by GETE and ACT, clinical evaluation
Lung function test
Fiber optic fibroscopy with BAL and bronchial biopsies
Blood sampling
Compliance evaluation (file signed by the nurse or patient after each injection)

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)
each item is evaluated by a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled).

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,
severe uncontrolled asthma, defined as eosinophil blood count >300/mm3 in the previous 12 months and at least 2 exacerbations in the previous 12 months or requiring oral steroids for more than half of the previous year,
indication for mepolizumab decided by an asthma specialist,
efficient contraception, for women of reproductive age

Exclusion criteria :

pregnancy,
smokers or ex smokers >10 pack/yr,
contra indication for fiberoptic bronchoscopy (allergy to xylocain, antiaggregant or anticoagulant treatment…),
contra indication for mepolizumab,
patient who previously received mepolizumab or already received mepolizumab at inclusion,
participation in another interventional trial

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

]]>

<![CDATA[ A Dose Escalation With Expansion Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors ]]>
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
Email xdsun@epimab.com Email 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.
Generalized radiation therapy must have stopped 3 weeks before first dose of EMB 01, or local radiotherapy or radiation therapy for bone metastases must have stopped 2 weeks before first dose of EMB-01. No therapeutic radiopharmaceuticals are taken within 8 weeks before first dose of EMB-01.
Patients must have recovered to ≤Grade 1 from the adverse effects of such above treatment before beginning study treatment.
Female patient with fertility or male patient whose partner has fertility should use one or more contraceptive methods for contraception starting from screening period and continue throughout the study treatment and for 3 months.
ECOG score 0 or 1 for phase I, and ≤2 for phase II.

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.
Patients for whom local EGFR and/or cMET data or the results of central laboratory testing do not meet the molecular pre-screening inclusion criteria.

Screening Exclusion Criteria

Life expectancy < 3 months.
Subject with primacy central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases.
Pregnant or nursing females.
Subjects who have had major surgery within 28 days prior to screening.
Serious underlying medical conditions, including but not limited to un-controlled hypertension, other cardiovascular disease or diabetes, ongoing or active infection, psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere the compliance with study treatment.

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

]]>

<![CDATA[ Movement-2-Music: Lakeshore Examination of Activity, Disability, and Exercise Response Study ]]>
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
Able to use upper limbs and/or lower limbs to exercise and follow instructions
Physician clearance to participate
Willing to participate in an exercise program three times per week
Conversant in and reads English

Exclusion Criteria:

Participate in an exercise intervention or a similar intervention in the last 6 months
Current smoker or recently quit less than 6 months prior
Cognitive impairment (Folstein's Mini-Mental State Exam score <24)
Presence of active pressure ulcer
Any contraindications to exercise based on the American College of Sports Medicine (ACSM) guidelines
Visual acuity that prevents following a group exercise class
Significant hearing impairment impeding ability to hear music to engage in exercise

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)

]]>

<![CDATA[ French Study to Evaluate the Impact of a Cognitive Therapy on Urinary Incontinent Women of All Age’s Perineal Settings. ]]>
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
Email Thibault.thubert@chu-nantes.fr Email 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
Women able to read, understand, accept and sign the consent.

Exclusion Criteria:

Pregnant women,
Refusal to participate
Dementia and cognitive troubles (MMS<30).

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.

]]>

<![CDATA[ HOPE (Healthy Older People Everyday) To Age in Place ]]>
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
Email 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)
Able to walk 400m aided or unaided (at least one bus stop away)
Has no significant heart or lung problems
Grip strength not more than 25kg for males and 18kg for females

Exclusion Criteria:

Unable to give consent personally
Wheelchair bound or at a very high falls risk
Unable to participate due to underlying health problems including severe weakness due to stroke
Undergoing active cancer treatment

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

]]>

<![CDATA[ Multi-omics Study of Clinical Endpoints in CHD ]]>
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
Email zhongsl@hotmail.com Email chenliu81@hotmail.com Email mqilin2004@163.com Email drshenlinghong@126.com Email 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
Email zhongsl@hotmail.com Email 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
Chinese Han patients with coronary artery disease
inpatients undergoing coronary angiography or percutaneous coronary intervention

Exclusion Criteria:

renal insufficiency (defined as serum creatinine concentration > 2 times the upper limit of normal [230 μmol/L], renal transplantation or dialysis)
hepatic insufficiency (defined as serum transaminase concentration > 2 times the upper limit of normal [80 U/L], or a diagnosis of cirrhosis)
pre-existing bleeding disorders
being pregnant or lactating
advanced cancer or haemodialysis
history of thyroid problems, and use of antithyroid drugs or thyroid hormone medication
incomplete information about cardiovascular events during follow-up

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

]]>

<![CDATA[ Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) ]]>
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
Must have progressed on or since the last treatment
Has measurable disease per RECIST 1.1 (RANO for the GBM cohort) as assessed by the local site investigator/radiology and confirmed by BICR
Has provided a PD-L1 evaluable archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib, or refrain from heterosexual intercourse during this period
Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib, whichever occurs last
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of study treatment initiation
Has adequate organ function

For Triple Negative Breast Cancer Participants:

Has received one or 2 prior lines of therapy
Has Lactate Dehydrogenase (LDH) <2.0 x Upper Limit of Normal (ULN)
Has locally determined results for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 tumor analyses

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
Have the following time periods elapsed before the projected start of scheduled study treatment: 1) at least 3 weeks from prior surgical resection, 2) at least 1 week from stereotactic biopsy, 3) at least 6 months from completion of prior radiotherapy, 4) at least 4 weeks (or 5 half-lives, whichever is shorter) from any investigational agent, 5) at least 4 weeks from cytotoxic therapy, 6) at least 6 weeks from antibodies, 7) at least 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies and 1 week for cancer vaccines
Be neurologically stable (e.g. without a progression of neurologic symptoms or requiring escalating doses of systemic steroid therapy within last 2 weeks) and clinically stable
Has histologically confirmed World Health Organization (WHO) Grade IV GBM
Has locally determined result for O^6-methylguanine-DNA methyltransferase (MGMT) analysis

For Biliary Tract Cancer Participants:

Has received 1 prior line of therapy
Child-Pugh Score, Class A: well-compensated disease. Child-Pugh Score of 5-6

For Pancreatic Cancer Participants:

Has pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma that is metastatic at enrollment
Has received one or 2 prior lines of therapy
Has received prior therapy with at least 1 (platinum-containing regimen or gemcitabine-containing regimen) but no more than 2 prior systemic therapies for unresectable or metastatic pancreatic cancer

Exclusion Criteria:

Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment (applies to all cohorts except the ovarian cancer cohort)
Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation. Participants with portal vein invasion (Vp4), inferior vena cava, or cardiac involvement based on imaging in the BTC cohort are not eligible for enrollment
Has clinical significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment
Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA), or cardiac arrhythmia associated with hemodynamic instability
Has a history of arterial thromboembolism within 12 months of start of study treatment
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has a serious nonhealing wound, ulcer or bone fracture
Has had major surgery within 3 weeks prior to first dose of study interventions
Has biologic response modifiers therapy (e.g. granulocyte colony-stimulating factor) within 4 weeks before study entry
Has preexisting ≥Grade 3 gastrointestinal (GI) or non-gastrointestinal fistula
Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137])
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment start
If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
Has received a live vaccine within 30 days prior to the first dose of study treatment
Has known intolerance to lenvatinib (and/or any of the excipients)
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
Has known active CNS metastases and/or carcinomatous meningitis
Has tumors involving the brain stem
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of hepatitis B or known active hepatitis C virus infection
Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
Has had an allogenic tissue/solid organ transplant (large organ transplants, stem-cell transplant requiring chronic immunosuppressant therapy necessary to prevent graft rejection)

For GBM Participants:

Has carcinomatous meningitis
Has recurrent tumor greater than 6 cm in maximum diameter
Has tumor primarily localized to the brainstem or spinal cord
Has presence of multifocal tumor, diffuse leptomeningeal or extracranial disease
Has evidence of intratumoral or peritumoral hemorrhage on baseline magnetic resonance imaging (MRI) scan other than those that are grade ≤ 1 and either post-operative or stable on at least 2 consecutive MRI scans
Has received Optune® TTFields within 2 weeks of study intervention

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

]]>

<![CDATA[ Observational Study of Expected ARF Recovery ]]>
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
Respiratory failure managed in the ICU, where respiratory failure is defined as ≥1 of the following:
Mechanical ventilation via an endotracheal tube ≥ 24 hours OR
Non-invasive ventilation (CPAP, BiPAP) ≥ 24 consecutive hours* provided for acute respiratory failure (not for Obstructive Sleep Apnea or other stable use) OR

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
Mechanical ventilation at baseline or mechanical ventilation solely for airway protection or obstruction
Residing in a medical institution at the time of hospital admission
Homeless / Prisoner / Primary residence not in the USA / Unable to communicate by telephone in English
More than mild dementia (either known diagnosis of moderate or worse dementia or IQ-CODE > 3.6; screening performed on patients > 50 years old or with family reports of possible memory decline)
Patient on hospice at or before time of enrollment
Patients who, based solely on pre-existing medical problems (such as poorly controlled neoplasm or other end stage disease, including Stage IV heart failure or severe burns), would not be expected to survive 6 months in the absence of the acute respiratory failure.
Patients with neurological injury either receiving treatment for intracranial hypertension or who are not expected to return to consciousness.
Pregnancy

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.

]]>

<![CDATA[ Pulse Oximeter and Respiratory Rate Test ]]>
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
Low perfusion
Smoking

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

]]>

<![CDATA[ Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair ]]>
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
Full thickness rotator cuff tears of any size (documented by MRI or ultrasound)
Patients planning surgical repair with Dr. Uma Srikumaran (PI of this study) at Johns Hopkins Shoulder Service (Columbia, Odenton Clinic sites; Howard County General Hospital/Bayview/Johns Hopkins Hospital operative sites)

Exclusion Criteria:

Patients with partial tears, massive rotator cuff tears that are irreparable, isolated subscapularis tears, and associated pathology (advanced degenerative changes)
Patients undergoing revision rotator cuff tears will be excluded.

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

]]>

<![CDATA[ Quantitative EEG During Anesthesia Emergence in Children ]]>
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
crying, but can be consoled
Crying, cannot be consoled
Agitated and thrashing around

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
with developmental delay, neurological disorders or psychiatric diseases associated with symptoms of agitation, anxiety, attention deficit, sleep disturbances, etc
refusal of consent
Recent history (within a month) of received general anesthesia or surgery
presence of congenital or other genetic conditions thought to influence brain development

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.

]]>

<![CDATA[ A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies ]]>
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.
Diagnosis of relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R Non-Hodgkin's lymphoma (NHL)/diffuse large B-cell lymphoma (DLBCL) confirmed by the World Health Organization (WHO) criteria, as appropriate.
Meets the following disease activity criteria:
AML: must have received at least 1 prior therapy for AML and be ineligible for cytotoxic therapy and allogeneic stem cell transplant.
NHL/DLBCL: measurable disease with a bidimensional lesion measuring at least 1.5 cm; received at least 1 prior therapy for NHL with no curative treatment option as determined by the investigator and be ineligible for a stem cell transplant.

Exclusion Criteria:

History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.
History of of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment such as non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostate cancer in situ.
Prior allogeneic stem cell transplant or autologous stem cell transplant within 100 days of study drug administration and no signs or symptoms of acute or chronic graft-versus-host disease.
Previous enrollment in a randomized trial including either venetoclax or AMG 176.
Known active or chronic pancreatitis; severe chronic obstructive pulmonary disease with hypoxemia; central nervous system manifestations of malignancy.
Active, uncontrolled infection.

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

]]>

<![CDATA[ Prospective Cohort Study of Traditional Chinese Medicine for Survival of Patients With Early Breast Cancer ]]>
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
Email 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
Email 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;
Patients with histologically proven stage 1-3 breast cancer after surgery;
The duration from the end of radical surgery to the beginning of the trail is less than 1 month;
ECOG score is 0-2 points;
Agreed to participate in this study and signed informed consent.

Exclusion Criteria:

Combined with inadequate heart, liver, kidney and hematopoietic function and other serious diseases;
Pregnant and lactating women;
Patients with a history of mental illness;
Patients with distant metastasis and/or expected lifetime less than 3 months;
Patients undergoing other medicinal herbs outside our hospital.

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.

]]>

<![CDATA[ The Impact of Nerve Cross Section Area on Sensory Block Onset ]]>
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
≥ 18 years old
< 65 years old
Written informed consent as documented by signature

Exclusion Criteria:

Known allergy or hypersensitivity to a study drug or class of drug.
Severe coagulopathy.
History of alcohol abuse or the intake of psychotropic drugs.
Pregnancy.
Infection at the injection site or a systemic infection.
Fever of unknown origin.
Motor or sensory abnormalities in the arm.
Previous enrollment into the current study

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.

]]>

<![CDATA[ Vitamin E Supplementation in Hyperinsulinism/Hyperammonemia Syndrome ]]>
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
Diagnosis of HI/HA syndrome
On diazoxide therapy for treatment of hypoglycemia
Females ≥11 years of age or menstruating must have a negative urine/serum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
Informed consent for participants ≥18 years. Parental/guardian permission (informed consent) and, if appropriate, child assent for participants <18 years.

Exclusion Criteria:

Individuals age <12 months or >40 years
Individuals who have experienced an allergic reaction to Vitamin E
Individuals with a known allergy to dairy, whey, or soy
On concurrent therapy with a medication known to be metabolized by the CYP3A pathway
Individuals with a known increased risk of bleeding (bleeding disorder or on antiplatelet or anticoagulation therapy)
Vitamin E supplementation within 30 days prior to enrollment, including multivitamins containing Vitamin E
Severe hypoglycemia (plasma glucose <50 mg/dL on repeat checks using home glucose meter) more than once weekly within 30 days prior to enrollment.
Evidence of a medical condition that might alter results or compromise the interpretation of results, including active infection, kidney failure, severe liver dysfunction, severe respiratory or cardiac failure.
Evidence of severe hematologic abnormality including severe anemia and/or thrombocytopenia.
Any investigational drug use within 30 days prior to enrollment.
Pregnant or lactating females.
Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Unable to provide informed consent (e.g. impaired cognition or judgment).
Parents/guardians or subjects with limited English proficiency.

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 Te