linjc16/ctgov huggingface dataset:
Retrospective Study on the Outcome of Cleft Palate Repair: Comparing US Surgical and Ethicon Suture Materials

Study Overview
=================
Brief Summary
-----------------
Investigator initiated retrospective chart review to study the effects of changing suture material on the healing and outcome of cleft palate surgery were.

Detailed Description
-----------------
This study aims to show what the effects of changing suture material were on the healing and outcome of cleft palate surgery. The study will be considered successful if we find that either there is an effect on the healing after surgery, one of the suture materials seems to promote better healing and final outcome, or that there is no difference between the suture materials.

Official Title
-----------------
Retrospective Study on the Outcome of Cleft Palate Repair: Comparing US Surgical and Ethicon Suture Materials

Conditions
-----------------
Cleft Palate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cleft palate repair performed at UCDMC between 1/1996 and 6/2006 Exclusion Criteria: Those who do not meet the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cleft palate, suture materials
The Chloroquine for Influenza Prevention Trial

Study Overview
=================
Brief Summary
-----------------
A randomised controlled trial to determine the efficacy of chloroquine for the prevention of influenza

Official Title
-----------------
A Randomised, Double-blind, Placebo Controlled Trial of Chloroquine for the Prevention of Influenza

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Drug: Chloroquine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 -65 Have the ability to provide informed consent If a woman of child-bearing potential, willing to use contraception for the period of the trial Exclusion Criteria: Acute influenza-like illness at screening History of psoriasis, porphyria cutanea tarda, epilepsy, myasthenia gravis, myopathy of any cause, cardiac arrhythmias, or serious hepatic or renal disease Pregnancy or breast feeding Current use of medication with known serious hepatotoxic effects Current use of medication with known serious interaction with CQ: amiodarone, anticonvulsants, ciclosporin, digoxin, mefloquine, moxifloxacin Current severe depression (as indicated by current use of antidepressant medication) Known serious retinal disease Current or recent (within the past 30 days) participation in any other clinical intervention trial. Known G6PD deficiency Vaccination for influenza (seasonal or H1N1 strain) within the 3 months prior to screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chloroquine<br> | Drug: Chloroquine<br>* Chloroquine phosphate 250mg capsule, two capsules daily for 7 days then 2 capsules once a week for a total treatment duration of 12 weeks<br>* Other names: Plaquenil;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo capsules, 2 capsules daily for 7 days then 2 capsules weekly for a total treatment duration of 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory-confirmed influenza-like illness |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serologically-confirmed influenza infection (symptomatic or asymptomatic) | Four-fold rise in influenza antibody titre at week 12 compared to the baseline sample | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza, Prevention, Chloroquine, Randomised controlled trial, Respiratory virus infection
Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of SMP-114 (120 and 240 mg/d) versus placebo in terms of the percentage of patients meeting the American College of Rheumatology criteria for 20% improvement in RA (ACR20) at week 24. The study hypothesis would be to demonstrate that the use of methotrexate and SMP-114 is more efficacious than Methotrexate alone.

Official Title
-----------------
A Phase 2, Multi-Centre, Randomised, Double Blind, Placebo Controlled Study Evaluating the Efficacy, Safety and Pharmacokinetics of Two Doses of a Candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg Once Daily), Administered in Combination With Ongoing Methotrexate Treatment in Patients With Active Rheumatoid Arthritis.

Conditions
-----------------
Rheumatoid Arthritis (RA)

Intervention / Treatment
-----------------
* Drug: SMP-114


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients aged at least 18 years, with RA for a minimum of 6 months Has been receiving methotrexate treatment (stable for 8 weeks) Has active disease classified as ACR functional class of I, II or III Exclusion Criteria: Has previously discontinued DMARD therapy due to hepatic intolerance Has received any DMARD in addition to methotrexate during the 4 weeks prior to randomisation Is receiving more than 2 DMARDs in addition to methotrexate at the time of screening Is receiving or has received Gold, leflunomide or biological agents including TNF/IL-1 inhibitors within the 8 weeks prior to randomisation Has previously failed 2 or more DMARDS

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SMP-114|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of SMP-114 versus placebo in terms of the percentage of patients meeting the ACR criteria for 20% improvement in RA (ACR20) at Week 24. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare efficacy of SMP-114 versus placebo after 24 weeks in terms of ACR50, ACR70, DAS28 and EULAR response. |  |  | 
| To compare the efficacy of SMP-114 versus placebo in terms of change in core variables, time to response, Quality of Life, radiological measurements of joint damage, assessment of safety and tolerability, and PK measurements |  |  |
Alcohol and Tobacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, interventional, randomized study for preventive and therapeutic strategies for patients with head and neck or Lung cancer; contribution of an addiction support

Official Title
-----------------
Alcohol and TObacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support

Conditions
-----------------
Head and Neck Cancer, Lung Cancer

Intervention / Treatment
-----------------
* Other: Addiction support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first head and neck or lung cancer first support 18 ≤ age ≤ 60 lives in Lille Metropolis having an addiction to alcohol and tobacco covered by health insurance signed informed consent Exclusion Criteria: prior cancer mesothelioma and oesophageal cancer unable to undergo trail medical follow up (geographical, social and psychological reasons) pregnant or nursing woman patient under guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Other: Addiction support<br>* one consultation with an addiction specialist<br>|
| No Intervention: Group B<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systematic addiction consultation | difference between abstinence in group A and abstinence in group B | 12 months after diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | median time between date of inclusion and date of first progression | 24 months after diagnosis | 
| overall survival | median time between date of inclusion and date of death | 24 months after survival | 
| alcohol and tobacco consumption | frequency of tobacco and alcohol consumption questionnaire : Fagerström, Alcohol Use Disorders Identification Test (AUDIT), Cut Down Annoyed Guilty Eye-Opener (CAGE-DETA), Cannabis abuse screening test (CAST), M.I.N.I. | baseline, 3 months, 6 months and 12 months after diagnosis | 
| alcohol + tobacco withdrawal and addiction support | difference between abstinence of group A and abstinence group B | 12 months after diagnosis | 
| addiction follow up | percentage of patient with a first addiction consultation, and willing to have a long term follow up | 24 months after diagnosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
addiction support, addiction specialist, lung cancer, head and neck cancer
Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to investigate the safety, efficacy and clinical utility of the Occlutech PDA device for closure of patent ductus arteriosus of all types.

Official Title
-----------------
Phase 1 Study for Safety and Effectiveness of the New Occlutech PDA Occluder, for Non Surgical Closure of Patent Ductus Arteriosus

Conditions
-----------------
Patent Ductus Arteriosus

Intervention / Treatment
-----------------
* Device: Occlutech PDA occluder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a demonstrated patent ductus arteriosus Female or male Belonging to any ethnic group Age between > 6 months and 70 years Body weight > 6 kg < 120 kg Exclusion Criteria: Associated congenital cardiac anomalies, Body weight < 6 Kilograms General exclusion criteria presence of a known coagulation disorder thrombus at the position allocated for the implantation a vein thrombosis in the blood vessels chosen for the introducing system an active infection Nitinol intolerance (nickel or titanium) contrast medium intolerance patients who have a vascular system which is too small to admit the required sheath patients with pulmonary hypertension and pulmonary-vascular resistance of >8 Woods Units or a lung - / systemic resistance (PR/SR) of >0.4.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PDA Occluder<br>single arm | Device: Occlutech PDA occluder<br>* Four different sizes of Occluders will be evaluated based on pre-assessment of PDA size.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful closure of patent ductus arterious without evidence of any complication assessed by echocardiongram, ECG and X-ray 30 and 90 days after implant. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful closure without evidence of residual shunt after 1 year confirmed by echocariodgram. Safety: freedom of major adverse events i.e periherial embolism or endocarditits. |  | 30, 90, 180 and 360 days after implant |
Ultrasound Image Quality of the Brachial Plexus at the Interscalene Space Before and After Shoulder Arthroscopy

Study Overview
=================
Brief Summary
-----------------
Ultrasound guided interscalene nerve blockade with local anesthesia is a standard regional anesthetic technique for providing postoperative analgesia during shoulder arthroscopy and wide variety of shoulder procedures. There is a paucity of data regarding the effects of shoulder arthroscopy on ultrasound image quality, including the effects of muscle mobilization and the use of large volume irrigation and subsequent tissue absorption, though increased neck circumference and airway edema are known complications of arthroscopic shoulder procedures. The objective of the study is to determine if there is a difference in ultrasound image quality of the interscalene block anatomy, by Likert scale, pre- versus post-operatively in a cohort of patients undergoing shoulder arthroscopy who routinely receive blockade of the brachial plexus for postoperative analgesia. Further, if there are differences in imaging quality, correlations with surgical and patient factors will be studied.

Official Title
-----------------
Ultrasound Image Quality of the Brachial Plexus at the Interscalene Space Before and After Shoulder Arthroscopy: a Prospective Cohort Study

Conditions
-----------------
Pain, Postoperative

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is undergoing shoulder procedures involving arthroscopy Subject has consented to interscalene blockade for postoperative analgesia Exclusion Criteria: Patient refusal Contraindications to interscalene blockade, including significant pulmonary insufficiency, hemi-diaphragmatic paralysis, brachial plexus or degenerative neuropathy Allergy to proposed local anesthetic medication\ Severe cervical spine disease. BMI >40 kg/m2 Neck Circumference > 50cm Failed preoperative interscalene blockade Patients known to be currently pregnant or actively breastfeeding Patients where English is a language barrier

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Likert Scale | Ultrasound media will be scored using a Likert scale (from 1-5 based on quality of imaging) individually for pre-operative and post-operative scanning for each enrolled patient | 2-3 months |
Pergolide Treatment and Valvular Heart Disease

Study Overview
=================
Brief Summary
-----------------
In a blinded echocardiographic study we investigate the frequency of valvular abnormalities in a group of Parkinson patients treated with either ergot derived dopamine agonists (pergolide and cabergoline) or non-ergot derived dopamine agonists (pramipexole and ropinirole). The ability to detect patients with valvular abnormalities by clinical approach is examined.

Detailed Description
-----------------
Some case reports and a single study, which included 78 Parkinson patients, has found a correlation between treatment with the ergotamine derivative dopamine agonists (pergolide) and restrictive valvular heart disease. The mechanisms are thought to be the same as with the former used anorectikum, fenfluramine and other drugs stimulating the 5HT-2B receptor. In a blinded manner we make physiologic and echocardiographic examination on 160 Parkinson patients treated with either ergotamine or non-ergotamine derivative dopamine agonists (80 patients in each group) to see whether Parkinson patients treated with ergotamine derivatives have more heart valvular disease

Conditions
-----------------
Heart Valve Diseases, Parkinson's Disease, Pergolide, Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson patients who in the last year has been treated minimum 6 months with either ergotamine derivative or non-ergotamine derivative dopamine agonists (the latter included as controls) Informed contests Exclusion Criteria: Control patients will be excluded if the have been treated with ergotamine derivates in the last 12 months or if the prior to that have had ergotamine derivates for more than 6 months Patients with known valvular heart disease prior to the diagnosis of Parkinson
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pergolide, Ergotamine derivates, Valvular heart disease
Feasibility Study: Sleuth Monitoring System

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.

Official Title
-----------------
Pilot Clinical Study of the Sleuth Implantable ECG Monitoring System

Conditions
-----------------
Arrhythmia, Syncope

Intervention / Treatment
-----------------
* Device: Sleuth Implantable ECG Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > = 18 years at time of enrollment Either of the following: MI > 30 days prior to enrolment and LVEF < = 35% by echocardiography (or nuclear imaging as necessary) Syncope of unknown etiology Exclusion Criteria: Life expectancy < 12 months following enrollment Active infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Sleuth Implantable ECG Monitoring System|The study device provides monitoring only. It cannot provide intervention or treatment.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostically viable ECG signals |  | daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of device-related adverse events |  | 1, 6, and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac arrhythmia, syncope, ECG, implantable ECG monitor, ILR
Identification of Respiratory Profiles From Nasal Pressure Signals

Study Overview
=================
Brief Summary
-----------------
Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease caused by smoking and associated with significant morbidity due to recurrent exacerbations or even hospitalizations. It is one of the leading causes of death in rich countries. Early detection of exacerbations of the disease is thus an economic and public health issue in the world. Finding tools for automatic and early detection of an exacerbation is the subject of the study. A continuous analysis of the frequency and shape of the patients' breathing will be used. As a first step in this study, investigators want to measure the frequency and shape of breathing in healthy subjects as they execute standard activities. These activities include resting, drinking, coughing, speaking, breathing through the mouth, physical exercise and recuperation.

Official Title
-----------------
Identification of Respiratory Profiles From Nasal Pressure Signals

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Oxygen therapy simulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of majority Health volunteers Exclusion Criteria: Pregnancy Age of minority Protected adult Person deprived of liberty Respiratory pathology Non affiliation to the health care system

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy subjects<br>Subjects not presenting any pulmonary pathology that will follow the intervention Oxygen therapy simulation. | Other: Oxygen therapy simulation<br>* The intervention consists of reproducing oxygen therapy situations in healthy individuals by replacing oxygen bottles with bottles of air. A TeleOx® device will be placed on the circuit between the source and the nasal cannula for respiratory signals recording. The intervention will last 30 minutes, containing the following activities in the given order: rest (9 minutes); drinking water (1 minute); rest (1 minute); coughing (1 minute); rest (1 minute); reading aloud (1 minute); rest (1 minute); breathing by the mouth (1 minute); rest (1 minute); exercising (running) (3 minutes) and rest (10 minutes) Recordings will be retrieved after each test.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure | The monitoring device used records the nasal pressure from users at 10 Hz (one measure every 0.1 seconds). | 10 Hz for 30 minutes |