Plato Data Intelligence

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 .

Excellent
Very good
Good
Fair
Poor
Very poor

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).

–

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

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.

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.

The indication will be as follow:

spinal cord compression brain metastases tumor bleeding tumoral mass Cancer pain Superior Vena Cava Syndrome/ Airway compression

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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

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.

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 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.

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

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

–

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

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