linjc16/ctgov huggingface dataset:
An Ischaemic Stroke Observational Study

Study Overview
=================
Brief Summary
-----------------
A non-interventional observational clinical study to document the clinical course of patients at 12 months or more following an ischaemic stroke

Detailed Description
-----------------
Primary objective: To document and better define the prognostic characteristics of residual disability 12 months or more following an ischaemic stroke in patients that originally participated in the preceding clinical study RN-CS-0001. Other objective: To inform the design of efficient Phase 2/3 studies when screening potentially efficacious interventions for signals of activity which merit further development.

Official Title
-----------------
A Non-interventional Observational Clinical Study to Document the Clinical Course of Patients 12 Months or More Following an Ischaemic Stroke

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Capacity to give informed consent or witnessed informed consent in the event that the patient is unable to sign informed consent due to physical impairments. Participation in the preceding study RN-CS-0001 Completion of at least one of the 4 functional assessment tests (ARAT, BI, NIHSS, mRS) at any time point on the previous study RN-CS-0001 Ability to participate in all assessments and attend all visits Exclusion Criteria: Any additional incidence of stroke (Ischaemic or Haemorrhagic) since participation in the previous study RN-CS-0001 (since the last CS-0001 assessment visit date). Incidence of significant other disease that judged by the investigator would confound completion of all functional assessments (not excluding patients that can complete at least one functional assessment with no confounding factor from significant other disease).
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare functional assessment scores collected in this study with the preceding RN-CS-0001 study | Compare functional assessment scores collected in RN-CS-0002 with the preceding RN-CS-0001 study to better understand stroke symptom recovery and progress | 12-months |
Anaerobic Power and Salbutamol

Study Overview
=================
Brief Summary
-----------------
Athletes using inhaled β2-adrenoreceptor agonists (IBAs) win a disproportionate number of medals. However, most previous research has shown that β2 agonists do not improve exercise performance in either asthmatic or non-asthmatic athletes. Although the majority of these studies do not show an ergogenic effect, the small number of studies with extended exercise bouts ( 60 minutes) do show an advantage. The investigators believe that a controlled yet sport-specific exercise protocol will elucidate this ergogenic effect. Because IBAs may have different effects on these two groups of athletes, the investigators will measure exercise performance in both female and male elite cyclists. The investigators hypothesize that athletes will perform better during a combination steady-state/sprint exercise task following salbutamol administration.

Official Title
-----------------
The Effects of High-dose Salbutamol on Anaerobic Cycling Power

Conditions
-----------------
Ergogenic Athletic Performance

Intervention / Treatment
-----------------
* Other: Cycling Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: maximal oxygen consumption of ≥60 and ≥55 mL⋅kg-1⋅min-1 or ≥5⋅L⋅min-1 and ≥4⋅L⋅min-1 for men and women Exclusion Criteria: pregnant women any history of uncontrolled respiratory or cardiac disease smokers diabetics

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salbutamol inhalation<br>Study participants will be exposed to 1600ug salbutamol 30min prior to exercise | Other: Cycling Exercise<br> <br> |
| Experimental: Placebo inhalation<br>Study participants will be exposed to 1600ug salbutamol 30min prior to exercise | Other: Cycling Exercise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Power Output |  | peak power output of the final 30 seconds of the cycling bout will be assessed. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
salbutamol, exercise-induced bronchoconstriction, anaerobic power
PCI Suite: Road Map Fusion Imaging in Coronary Diagnostics and Therapy

Study Overview
=================
Brief Summary
-----------------
The PCI Suite is developed by Philips Medical Systems, a Philips Healthcare company. The proposed PCI Suite is a new software package which can be used during coronary interventions. The software package includes two sub-packages, known as StentBoost and Cardiac Roadmapping. The patient will undergo standard of care medical treatment for his or her cardiac condition. During the procedure, the physician may make angiograms for diagnosis and as reference for device navigation as part of the standard care. These angiograms will be automatically processed in PCI Suite and displayed on fluoroscopy for navigation support. In case a balloon catheter is inserted into the coronary arteries, the physician may take cine images as part of the standard care. These images can be automatically enhanced in PCI Suite. The primary objective of this prospective, mono-center, randomized clinical trial is to evaluate the amount of contrast medium used during percutaneous coronary intervention.

Official Title
-----------------
PCI Suite: Road Map Fusion Imaging in Coronary Diagnostics and Therapy

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Device: PCI Suite Software
* Other: conventional PCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemodynamically relevant type A or B lesion Exclusion Criteria: hemodynamically relevant type C lesion NSTEMI/STEMI declined to participate

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PCI with PCI Suite Software<br> | Device: PCI Suite Software<br>* PCI with PCI Suite Software<br>|
| Other: conventional PCI<br> | Other: conventional PCI<br>* conventional PCI without PCI Software<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of contrast medium | Determination during PCI | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebrovascular events | Major adverse cardiac and cerebrovascular events (MACCE) are defined as occurence of myocardial ischemia, stroke, acute stent thrombosis, major bleeding | Baseline, after 6 months, after 12 months | 
| Procedural success | Defined by an open target vessel with a maximum of 20% residual stenosis and TIMI III flow | Baseline | 
| Procedure duration | Determination of duration of PCI | Baseline | 
| area dosage product | Determination during PCI | Baseline |
TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of TVTO™ and TVTSecur™ as surgical treatment for female urinary stress incontinence.

Official Title
-----------------
Comparative Study of TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Device: TVT-O
* Device: TVT-S


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical and urodynamic for stress urinary Exclusion Criteria: Detrusor overactivity (urodynamic study) Urodynamic changes suggesting reduced vesical capacity Associated neurological diseases Coagulopathies Pregnancy Foreign matter sensitiveness history Acute urinary tract infection Sequel from high ionizing radiation exposure Use of drugs that may result in high surgical risk and/or significant postoperative complication Anesthetic procedure contraindication Vulvovaginitis: presence of vaginal secretion with infection clinically or lab supported

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TVT-O<br>Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA). | Device: TVT-O<br>* Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).<br>* Other names: TVT-O™ (Gynecare™, USA).;|
| Active Comparator: TVT-S<br>Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA). | Device: TVT-S<br>* Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).<br>* Other names: TVT-Secur™ (Gynecare™, USA).;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the efficacy of employing the Gynecare TVT Secur™ with the traditional Gynecare TVT- O™ for treating female stress urinary incontinence. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TVTO, TVTSecur, Mini sling, stress urinary incontinence
CAEB071 Thorough QTc Study in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study has been designed in compliance with the ICH-E14 guideline 2005 to evaluate the QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.

Official Title
-----------------
A Randomized, Partially Blinded, 4-period, Crossover Study to Assess the Effects of Single-dose AEB071 Administration (300 and 900 mg) on Electrocardiographic QT Intervals Compared to Placebo in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: sotrastaurin
* Drug: sotrastaurin
* Drug: placebo to sotrastaurin
* Drug: Avelox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects age 18 to 50 years (including both) of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. Exclusion Criteria: Smokers and tobacco product users (in the previous 3 months). Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing. A marked baseline prolongation of QT/QTcF interval Presence of clinically significant illness Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AEB071 300 mg<br> | Drug: sotrastaurin<br> <br> |
| Experimental: AEB071 900 mg<br> | Drug: sotrastaurin<br> <br> |
| Placebo Comparator: Placebo to AEB071<br> | Drug: placebo to sotrastaurin<br> <br> |
| Active Comparator: Moxifloxacin<br> | Drug: Avelox<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the corrected QT interval (QTc) in healthy volunteers as compared to placebo. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in concentration of exposure-response AEB071 and AEE800 (a metabolite of AEB071) concentrations compared to cardiac repolarization intervals |  | 24 hours | 
| Tolerability of 300 and 900 mg of AEB071. |  | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteer, QT intervals, QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs, ECG
Effect of Passive Smoking on Orofacial Dysfunction Among a Group of Egyptian Children: A Cohort Study

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the orofacial dysfunction in children who are subjected to passive smoking and to correlate its results to their saliva cotinine levels

Detailed Description
-----------------
The participants will be recruited from the pedodontics outpatient clinic in the, Faculty of Oral and Dental Medicine, Ahram Canadian University, Egypt. The aim and the steps of the study will be explained to the guardian. After obtaining the informed consent, the investigator will fill an administrative questionnaire, which includes parents and child's personal data, medical and dental history, a question inquiring if one of the parents smokes in the house, the frequency of smoking, smoking type, and number of cigarettes (if present). Then, the examination of orofacial dysfunction will be evaluated by the investigator, using Nordic Orofacial Test - screen (NOT-S)

Official Title
-----------------
Effect of Passive Smoking on Orofacial Dysfunction Among a Group of Egyptian Children: A Cohort Study

Conditions
-----------------
Smoking, Orofacial Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: Nordic Orofacial Test-Screen (NOT-S)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who are free from any systematic disease, or genetic disorders that Children whose families accept to participate in this study. Exclusion Criteria: Children whose parents quit smoking after the child was born.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 7 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 |
| --- | --- |
| passive smokers children group (study group)<br>children whose parents reported having one or more family members smokes indoors in the presence of the child | Diagnostic Test: Nordic Orofacial Test-Screen (NOT-S)<br>* screening tool to detect orofacial dysfunction<br>|
| non-passive smokers children group (control group)<br>children whose parents reported not to have one or more family members smokes indoors in the presence of the child | Diagnostic Test: Nordic Orofacial Test-Screen (NOT-S)<br>* screening tool to detect orofacial dysfunction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orofacial Dysfunction (measured using Nordic Orofacial Test-Screen) | deviation from normal functions of facial and oral structures | baseline record |
Alzheimer and Sleep

Study Overview
=================
Brief Summary
-----------------
The aim of the study is the analysis of two inhibitors of Ach-E: galantamine and donépézil in over 65 years' old patients suffering from Alzheimer disease (MMSE between 20 and 26) without Alzheimer's medication.

Detailed Description
-----------------
Feasibility study, open, randomized, controlled, cross-over study in 65 years old patients.

Official Title
-----------------
Effects of Galantamine and Donépézil on the Amount and the Quality oh the Sleep in Patients Suffering From Alzheimer Disease.

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Galantamine and Donepezil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 and over years old Patients suffering from Alzheimer disease Patient living with someone at home Written consent given Exclusion Criteria: Galantamine or Donepezil hypersensibility Patient living alone and in a medicalized structure Concomitant medication Chronical diseases

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Galantamine<br> | Drug: Galantamine and Donepezil<br>* the analysis of two inhibitors of Ach-E : galantamine and donézepil in over 65 years old patients suffering from Alzheimer's disease (MMSE between 20 and 26) without Alzheimer's medication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the percentage of paradoxical sleep recorded with polysomonography in 65 years old patients with administration of Galantamine or Donépézil |  | administration of galantamine or donépézil | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the iatrogenic modifications of rhythm and architecture of sleep. describe the iatrogenic modifications of rythm and architecture of sleep |  | during the iatrogenic modifications | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep, Alzheimer, old patients
Association Between Attention Deficit Hyperactivity Disorder and Bulimia Nervosa in Outpatients With Eating Disorders

Study Overview
=================
Brief Summary
-----------------
To understand whether a relationship exists between eating disorders and ADHD, we seek to clarify the prevalence of ADHD in individuals with eating disorders. To this end, we will estimate the prevalence of ADHD, and other neuropsychiatric disorders, in outpatients with history of an eating disorder diagnosis. Secondarily, we will identify patterns of cognitive deficits in outpatients with history of an eating disorder diagnosis. We will also examine whether ADHD in this population is associated with functional and familial correlates associated with ADHD.

Official Title
-----------------
Association Between Attention Deficit Hyperactivity Disorder and Bulimia Nervosa in Outpatients With Eating Disorders

Conditions
-----------------
Bulimia Nervosa, Eating Disorders, ADHD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female outpatients between, and including, 18 and 55 years of age with a history of eating disorder diagnosis. Exclusion Criteria: Any clinically unstable psychiatric conditions such as: acute psychosis, acute panic, acute obsessive compulsive disorder, acute mania, acute suicidality, acute substance use disorders (alcohol or drugs), and sociopathy. Any metabolic, neurological, hepatic, renal, cardiovascular, hematological, opthalmic, or endocrine disease that would confound ability to participate in valid assessments. Mental retardation (IQ <75). Organic brain disorders. Non-English speaking subjects will not be allowed into the study because the assessment instruments are unavailable and have not been adequately standardized in other languages.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Eating Disorders<br>Study subjects will be individuals with a history of eating disorder(s) diagnosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We will identify the lifetime rate of mental health conditions using structured clinical interviews in subjects with a lifetime history of eating disorders and compare the rate of these conditions to that of non-ED control subjects. |  | 1 time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bulimia Nervosa, Eating Disorder NOS, Attention Deficit Hyperactivity Disorder, ADHD