linjc16/ctgov huggingface dataset:
Dilator Muscle Activity in Health and Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The role of control of peri-pharyngeal muscle tone in the pathogenesis of obstructive sleep apnea (OSA) is obvious: pharyngeal obstruction occurs only during sleep; and pharyngeal collapse occurs in almost all healthy subjects during anesthesia. Better understanding of these control mechanisms may help identifying the central components of the pathogenesis of OSA.

Detailed Description
-----------------
Study plan: Subjects will be studied first during wakefulness, while breathing against external resistors, to evaluate how are the peri-pharyngeal muscles recruited and activated to prevent pharyngeal collapse in the presence of negative intra-pharyngeal pressures. Thereafter, the same parameters will be evaluated during sleep, to assess muscle recruitment during intra-pharyngeal obstruction. The investigaors will record the electromyogram (EMG) of several dilator muscles, as well as the pressures above and below the area of pharyngeal collapse, and airflow.

Official Title
-----------------
Upper Airway Dilator Muscle Activity in Healthy Subjects and Patients With Obstructive Sleep Apnea During Wakefulness and Sleep

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Other: patients with OSA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. subjects that underwent regular sleep studies and found to have either moderate/severe OSA, or no OSA. - Exclusion Criteria: hemophilia use of anti-coagulants -

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with OSA<br>Subjects that underwent regular sleep studies (PSG) and found to have moderate/severe obstructive sleep apnea | Other: patients with OSA<br>* Sleep study<br>|
| subjects without OSA<br>Subjects that underwent regular PSG and found not to have sleep apnea | Other: patients with OSA<br>* Sleep study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EMG activity of peri-pharyngeal muscles during wakefulness and sleep | EMG of peripharyngeal muscles will be measured during wakefulness (on external resistors) and sleep (during flow limitation), patients with OSA. EMG data will be presented as %max (0-100%). | 4 hours |
Trial of Post-Dated Delayed Antibiotic Prescriptions

Study Overview
=================
Brief Summary
-----------------
Delayed prescriptions have been shown to lower antibiotic use for upper respiratory tract infections (which are mostly viral). This trial will test the hypothesis that if the clinician post-dates the delayed prescription by 2 days, rather than dating it on the day the patient is seen, there will be a further drop in the rate of antibiotic use.

Detailed Description
-----------------
6 family doctors and 2 nurse practitioners in a small rural town will issue delayed antibiotic prescriptions to adult patients with new acute respiratory tract infections. The delayed prescriptions will be randomly dated for either the day of the office visit, or 2 days later. The 2 local pharmacies will note whether the prescription is cashed, and when. It is hypothesised that post-dating the prescription will result in a reduced cashing rate. Each arm of the study (Usual v Post-Dated) will contain 75 subjects. This sample will have the power to detect a 25% change in prescription use.

Official Title
-----------------
Post-Dated Versus Voluntary Delayed Antibiotic Prescriptions for Acute Respiratory Infections in Primary Care: A Randomized Trial

Conditions
-----------------
Acute Upper Respiratory Tract Infections

Intervention / Treatment
-----------------
* Other: A delayed prescription dated 2 days after clinical office visit
* Drug: Usual Dated


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 years or older Adults with an untreated upper respiratory tract infection Adults presenting for the first time to a family physician or a nurse practitioner Exclusion Criteria: Less that 18 years Having a clear indication for antibiotic therapy

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Post-Dated Prescription<br>a delayed prescription dated 2 days after clinical office visit | Other: A delayed prescription dated 2 days after clinical office visit<br> <br> |
| Other: Usual<br>usual date | Drug: Usual Dated<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Filled a Prescription in 20 Days | Prescriptions | 20 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory infections, Primary care, Antibiotics, Delayed prescriptions
Exercise and Baseline Respiratory Functional Tests Among Obese Teenagers

Study Overview
=================
Brief Summary
-----------------
In obese adolescents, the severity of obesity should not influence the outcome of resting PFT. The amplitudes of the rest PFT should make it possible to predict the performance achieved while exercising on a cycloergometer. We wish to highlight the presence of a significant correlation, probably low, between some respiratory parameters at rest, and cardio-vascular parameters at the exercise.

Official Title
-----------------
Exercise and Baseline Respiratory Functional Tests Among Obese Teenagers

Conditions
-----------------
Obesity, Childhood

Intervention / Treatment
-----------------
* Other: Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged >12 y.o and <18 y.o BMI > 30 with a previous pulmonary function test (PFT) available in the medical record

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese teenagers<br> | Other: Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise<br>* Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise | Correlation between resting respiratory parameters: total lung capacity (TLC), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and cardio-respiratory parameters at exercise: maximal oxygen uptake (VO2 max), power achieved during incremental testing (Pmax), blood gas, at the time of the pulmonary function test. | Day 1 |
Canadian Ticagrelor Survey

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the effectiveness of the current ticagrelor risk minimisation strategy in Canada through a prescriber knowledge and understanding (KAU) survey of selected important identified safety concerns (i.e., bleeding, dyspnea and drug interactions) and ASA dosage.

Detailed Description
-----------------
Effectiveness of risk minimisation interventions for ticagrelor in Canada

Official Title
-----------------
Effectiveness of Risk Minimisation Interventions for Ticagrelor in Canada

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - N/A (All prescribers will be contacted for participation) Exclusion Criteria: - Participation in a previous wave of the survey.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prescribers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KAU Questionnaire: Knowledge of the 4 key safety issues pertaining to ticagrelor (adequate or inadequate for each safety issue) |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KAU Questionnaire: Practice characteristics |  | 2 months | 
| KAU Questionnaire: The difference in knowledge of understanding across the key safety concerns |  | 2 months | 
| KAU Questionnaire: Association between prescribers' characteristics and knowledge and understanding of the key safety concerns. |  | 2 months |
Asthma Self-Management in Older Adults

Study Overview
=================
Brief Summary
-----------------
Asthma self-management is an effective way to improve the outcomes of patients with asthma. However, to be most effective these interventions should be targeted and designed toward a specific population or group. There is currently no asthma self-management intervention directed towards older adults. The hypothesis is that a 6-session asthma self-management intervention will improve the outcomes of older patients with asthma.

Official Title
-----------------
Asthma Self-Management in Older Adults

Conditions
-----------------
Asthma, Aged

Intervention / Treatment
-----------------
* Behavioral: Self management intervention
* Behavioral: placebo group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:: Age over 65, physician diagnosed asthma, need for daily asthma control medication, access to a telephone. - Exclusion Criteria: Smoking history greater than 40 pack years, current smoker, mental impairment that would preclude participation in the asthma self management program -

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Management Intervention<br>Will receive 6 asthma self-management group or individual session over a 7 week period | Behavioral: Self management intervention<br>* Intervention arm will receive 6 group or individual sessions over a 7 week period<br>|
| Placebo Comparator: Control<br>Group will receive 3 phone calls not related to asthma self management over a 7 week period | Behavioral: placebo group<br>* 3 phone calls not related to asthma self-management<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Quality of Life Questionnaire |  | 3 months, 6 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Questionnaire |  | 3 months, 6 months, 12 months | 
| Health Care Utilization |  | 3 months, 6 months, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, aged, self care
Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the effect of IgPro10 on the prevention of serious bacterial infections in patients with primary immunodeficiency. As secondary endpoints the rate of overall infections, the tolerability and safety of IgPro10 are studied. A part of the patients are participating in a pharmacokinetic substudy.

Official Title
-----------------
A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)

Conditions
-----------------
Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency

Intervention / Treatment
-----------------
* Drug: Immunoglobulins Intravenous (Human)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Patients with primary immunodeficiency Patients who have received stable IVIG therapy at 3- or 4-weekly intervals for at least 6 months Key Exclusion Criteria: Newly diagnosed PID Allergic reactions to immunoglobulins or other blood products Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs Concomitant diseases such as hypoalbuminemia, protein-losing enteropathies, kidney diseases with proteinuria, malignancies of lymphoid cells (e.g. lymphocytic leukemia), and recent history of migraine History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
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 |
| --- | --- |
| Experimental: IgPro10<br> | Drug: Immunoglobulins Intravenous (Human)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized rate of acute serious bacterial infections |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infections |  |  | 
| Number of days out of work / school due to underlying PID |  |  | 
| Adverse events temporally associated with study drug infusion |  |  | 
| Trough levels of total IgG serum concentrations |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunoglobulin Intravenous, Agammaglobulinemia, Hypogammaglobulinemia, Common variable immunodeficiency, Immunoglobulin G, Children
A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.

Study Overview
=================
Brief Summary
-----------------
The main objectives of this study are: to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed). to assess clinical outcome when treating a bleed with Optivate®. to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. . to assess FVIII inhibitor development during the study.

Official Title
-----------------
An Open Multicentre Phase III Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Severe Haemophilia A.

Conditions
-----------------
Haemophilia A

Intervention / Treatment
-----------------
* Biological: Optivate® (Human Coagulation Factor VIII)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children under the age of 6 years with a diagnosis of severe Haemophilia A. Subjects who required FVIII therapy and did not demonstrate inhibitors to FVIII. Children with history of inhibitors to FVIII or clinically significant renal or liver disease were not eligible to participate in the study. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 6 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optivate®<br>Optivate® (Human Coagulation Factor VIII) | Biological: Optivate® (Human Coagulation Factor VIII)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of FVIII |  | Day 0 to Week 26 |
FC Patch Comparator Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
Multi-center, Open, Randomized, Parallel Group Comparison of Cycle Control for Seven Cycles and Endometrial Safety in a Subgroup for Thirteen Cycles of Contraceptive Patch SH P00331F (0.9 mg Ethinylestradiol/1.9 mg Gestodene) vs. a Contraceptive Comparator Patch (0.6 mg Ethinylestradiol/6 mg Norelgestromin) in 400 Healthy Female Volunteers

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: BAY86-5016, SH P00331F
* Drug: SH P00331N


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female volunteer aged 18-35, smokers 18-30 Exclusion Criteria: Contraindications for using hormonal contraceptives

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: BAY86-5016, SH P00331F<br>* Drug amount per patch: 0.9 mg EE2 + 1.9 mg gestodene (GSD)<br>|
| Active Comparator: Arm 2<br> | Drug: SH P00331N<br>* Drug amount per patch: 0.6 mg EE2 + 6 mg NGM<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding pattern and cycle control |  | 13 cycles | 
| Number of pregnancies |  | 13 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events collection |  | 13 cycles | 
| Endometrial biopsy |  | 13 cycles | 
| Physical and gynecological exam |  | 13 cycles | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FC patch, comparator study
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease

Study Overview
=================
Brief Summary
-----------------
This prospective study aims to better characterize inner ear's perilymphatic structures with Magnetic Resonance Imaging using contrast media and delayed injection in patient's with Meniere's disease. MR Perfusion Imaging will be assess in both cochlea as well Primary auditory brain pathways will be evaluated through MR diffusion imaging

Official Title
-----------------
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease

Conditions
-----------------
Meniere's Disease

Intervention / Treatment
-----------------
* Drug: Gadolinium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major subjects of over 40 years (mean age of Meniere's disease 40 to 50 years) Informed consent signed Medical examination performed prior to participation in research Patients with clinical criteria of Meniere's disease according to the classification of the American Association of Otology (ie the combination of a sensorineural hearing loss at low frequencies, recurrent vertigo and tinnitus and / or clogged ear sensation) Recipient of a French social security scheme Exclusion Criteria: Patients minors Patients on a legal protection regime type guardianship Respiratory pathologies, cardiovascular, renal, diabetes Claustrophobia Contraindications to exposure to a magnetic field Contraindications to injecting Dotarem ®

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with Meniere's disease<br> | Drug: Gadolinium<br>* diffusion of gadolinium for a population with Meniere's disease in order to develop an imaging disease screening test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted-Imaging dynamic measurement |  | One MR scan (4 hours) |