linjc16/ctgov huggingface dataset:
Sibutramine Versus Continuous Positive Airway Pressure (CPAP)in Obstructive Sleep Apnea (OSA) Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to observe if Sibutramine is effective in improving the symptoms and signs of sleep apnea in obese patients. The secondary objectives are to document the effects of Sibutramine on heart rate variability and 24-h arterial pressure values. We hypothesized that sibutramine will improve sleep disordered breathing, cardiac autonomic function and systemic blood pressure in obese patients with obstructive sleep apnea (OSA).

Official Title
-----------------
Efficacy of Sibutramine-induced Weight Loss vs. Continuous Positive Airway Pressure (CPAP) in the Treatment of Obese Patients With Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea, Obesity, Hypertension

Intervention / Treatment
-----------------
* Drug: Sibutramine
* Device: CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible participants with non-treated OSA syndrome were aged between 18 to 65 years, with a body-mass index (BMI) ≥ 30 kg/m2 or ≥ 27 kg/m2 in the presence of other risk factors such as controlled systemic hypertension, type 2 diabetes, dyslipidemia and/or visceral obesity (as defined by a waist circumference ≥ 102 cm in men and ≥ 88 cm in women). Exclusion Criteria: Exclusion criteria were uncontrolled systemic hypertension defined as blood pressure > 145/90 mm Hg, previous pharmacological or surgical treatment for weight loss, had already used CPAP or had severe diurnal hyper somnolence requiring immediate treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>The first group received sibutramine 10 mg for the first 4 weeks, at which time consideration of increasing dosage to 15 mg was re-evaluated in the case of insufficient weight loss (< 1.8 kg) over the first month of treatment. | Drug: Sibutramine<br>* The first group received sibutramine 10 mg for the first 4 weeks, at which time consideration of increasing dosage to 15 mg was re-evaluated in the case of insufficient weight loss (< 1.8 kg) over the first month of treatment.<br>|
| Active Comparator: 2<br>A standard reference group, which was paired according to age and BMI, received CPAP as a treatment for OSA. | Device: CPAP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
EUS for Gastrointestinal Disorders: a Registry

Study Overview
=================
Brief Summary
-----------------
The aim of the EUS registry is to record information about Endoscopic Ultrasound (EUS) on the management of gastrointestinal disease. The registry will evaluate efficacy, safety and technical success of the Endoscopic Ultrasound (EUS). Design is retrospective and prospective registry study.

Official Title
-----------------
EUS for Gastrointestinal Disorders: a Registry

Conditions
-----------------
GI Tract Disorders, Pancreatic Disorders, EUS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients submitted to EUS, Informed consent. Exclusion Criteria: Age less than 18 y Patient who did not give the consent to the processing of personal data.

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 |
| --- | --- | --- |
| Number of participants with treatment-related adverse events | Documentation of adverse events. | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yied of elastography during EUS | sensitivity and specificity of EUS with elastography | 0 Day | 
| Diagnostic yied of Contrast-Enhanced Endoscopic Ultrasonography | sensitivity and specificity contrast medium | 0 Day | 
| Tissue acquisition during EUS | sensitivity and specificity of tissue acquisition | 0 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EUS
Randomised Study to Compare the Effect of r-Hu-EPO Administration With Transfusion of Red Blood Cell Concentrates and Also With the Administration of Polyvitamins in Anemic and Tired Patients Presenting a Bad Prognostic in Middle Course

Study Overview
=================
Brief Summary
-----------------
Randomised study to compare the effect of r-Hu-EPO administration with transfusion of Red Blood cell concentrates and also with the administration of polyvitamins in anemic and tired patients presenting a bad prognostic in middle course.

Official Title
-----------------
Randomised Study to Compare the Effect of r-Hu-EPO Administration With Transfusion of Red Blood Cell Concentrates and Also With the Administration of Polyvitamins in Anemic and Tired Patients Presenting a Bad Prognostic in Middle Course

Conditions
-----------------
- Medico-Economic Aspects (Evaluation of Medical Costs Related to the Three Strategies and Evaluation of Cost/Efficacy)

Intervention / Treatment
-----------------
* Drug: Erythropoiétine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both sexes 18-70 yrs metastatic or locally advanced cancer Life expectancy > 3 months hemoglobin between 7 and 10 g/100ml no contraindication to r-Hu-EPO with written informed consent at entry time

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Erythropoiétine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life, in particular when related to tiredness (FACT F) |  |  |
Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects And Subjects With Chronic Liver Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the pharmacokinetics of neratinib and to assess the safety and tolerability of neratinib in healthy subjects and subjects with chronic liver disease.

Official Title
-----------------
An Open-Label, Single-Dose, Parallel-Group Study Of The Pharmacokinetics And Safety Of Neratinib In Subjects With Chronic Hepatic Impairment And In Matched Healthy Adults

Conditions
-----------------
Hepatic Insufficiency

Intervention / Treatment
-----------------
* Drug: Neratinib (HKI-272)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women of nonchildbearing potential (WONCBP) aged 18 to 65 years inclusive at screening. WONCBP may be included if they are either surgically sterile (hysterectomy or oophorectomy) or postmenopausal for =1 year (with follicle-stimulating hormone [FSH] level =38 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. 2-Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay. 3-Have a high probability for compliance with and completion of the study Exclusion Criteria: Family history of QT prolongation, syncope, seizure, or unexplained cardiac-related death. 2-Presence or history of any disorder that may prevent the successful completion of the study. 3-History of drug abuse within 1 year before study day 1.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Neratinib (HKI-272)<br>* Neratinib 40-mg oral tablets. SINGLE DOSE of 120-mg (3 x 40-mg tablets)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of neratinib in healthy volunteers compared to hepatically impaired patients through analysis of blod samples collected after neratinib administration in these 2 populations. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests. |  | 4 weeks |
Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
To evaluate long-term safety of growth hormone replacement in adult patients with growth hormone deficiency

Official Title
-----------------
Extended Clinical Study of LY137998 [Somatropin (Recombinant DNA Origin)] in Adults With Growth Hormone Deficiency

Conditions
-----------------
Adult Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: Somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having completed the preceding long-term study of growth hormone replacement in adult patients diagnosed with growth hormone deficiency. Other pituitary hormone deficiencies being replaced if appropriate Exclusion Criteria: With severe impairments of cardiac, pulmonary, renal or hepatic functions With severe psychological disorders With malignant cancer With hypertension uncontrolled With diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Somatropin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety of growth hormone replacement in adult patients with growth hormone deficiency |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of efficacy of growth hormone replacement, measured by lean body mass, which is achieved in the previous trial in adult patients wtih growth hormone deficiency |  |  |
Pilot Study of Vestibular Rehabilitation Training for Panic Disorder With Vestibular Dysfunction

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate whether vestibular rehabilitation training is of value in reducing anxiety symptoms in patients with panic disorder with or without agoraphobia who have vestibular dysfunction as identified by clinical vestibular tests.

Detailed Description
-----------------
PROTOCOL OUTLINE: During the first 4 weeks of study, patients meet with a clinical nurse specialist once a week for approximately 1 hour. During this time, the nature of the anxiety disorder is explained and exposure to previously feared situations is encouraged. Only patients who remain symptomatic at a stable level following self-exposure will proceed with rehabilitation training. Patients meet with a physical therapist once a week for 4 weeks to further evaluate the extent of problems associated with balance. Then, patients undergo weekly 1 hour exercises for 8 weeks with the physical therapist, focusing on sensation, head and eye coordination, movement with eyes opened and closed, and gait. Concurrently, patients meet with the clinical nurse specialist every 4 weeks during and after physical therapy to evaluate the effects of vestibular treatment on anxiety symptoms. Training is continued if patient is symptomatic; otherwise, patient is discharged from study.

Conditions
-----------------
Vestibular Diseases, Agoraphobia, Panic Disorder

Intervention / Treatment
-----------------
* Procedure: Physical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Diagnosed panic disorder with or without agoraphobia Vestibular dysfunction, as defined by abnormalities in the caloric and/or rotational tests Continued symptomatology after general instructions of the importance of exposure to feared situations Absence of acute symptoms of anxiety or depression assessed to need immediate clinical care

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Physical therapy|nan|

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
-----------------
agoraphobia, anxiety disorder, disease-related problem/condition, neurologic and psychiatric disorders, panic disorder, rare disease, vestibular diseases
Chronic Total Occlusion Registry

Study Overview
=================
Brief Summary
-----------------
This study evaluated the long-term outcome of patients with chronic total occlusion treated with percutaneous coronary intervention, medical treatment or coronary artery bypass grafting.

Detailed Description
-----------------
This study is connected with Decision-CTO trial(NCT01078051). Randomized subjects and registry group subjects from Decision-CTO trial continue 10 years follow-up on this study.

Official Title
-----------------
A Multicenter, Prospective, Real World Observational Study for Chronic Total Occlusion

Conditions
-----------------
Coronary Occlusion, Coronary Artery Stenosis, Coronary Stenosis

Intervention / Treatment
-----------------
* Procedure: Percutaneous coronary intervention
* Procedure: Coronary Artery Bypass Grafting
* Drug: Medical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with angina or silent ischemia and documented ischemia Patients with De novo chronic coronary occlusion ≥ 3months and reference diameter ≥ 2.5 mm on coronary angiography Age > 18 years Exclusion Criteria: Refuse to participate in this study

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Chronic coronary occlusion patients<br>≥3 months chronic total occlusion on coronary angiography | Procedure: Percutaneous coronary intervention<br> <br> Procedure: Coronary Artery Bypass Grafting<br> <br> Drug: Medical treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite event of all cause death, myocardial infarction, stroke or all kinds of repeat revascularization |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event rate of all cause death |  | 10 years | 
| Event rate of acute myocardial infarction |  | 10 years | 
| Event rate of stroke |  | 10 years | 
| Event rate of repeat revascularization |  | 10 years | 
| Event rate of rehospitalization due to acute coronary syndrome |  | 10 years | 
| The rate change of left ventricular ejection fraction |  | 10 years | 
| Composite event of death, myocardial, stroke or repeat revascularization |  | 5 years | 
| Composite event of death, myocardial, stroke or repeat revascularization |  | 10 years | 
| Event rate of Procedural success | Procedural success is defined as < 30% final stenosis and the absence of in-hospital event including death, Q-wave myocardial infarction or urgent repeat revascularization. | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CTO, PCI, CABG, Medical treatment, Decision CTO
The Cutoff Point for Caval Index and Its Correlation With Central Venous Pressure and Plasma Lactate Level for Assessing Patients in Hypovolemic Hemorrhagic States

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the cutoff point for IVC collapsibility index (by Bedside Ultrasonographic technique) for cases in hypovolemic hemorrhagic shock with CVP measures less than 8 cmH2o.

Conditions
-----------------
IVC Collapsibility Index, Hemorrhagic Shock

Intervention / Treatment
-----------------
* Other: Measuring IVC collapsibility index by bedside ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypovolemic hemorrhagic subjects (class II or more)if they were more than 18 years old and CVC insertion was indicated for them. Exclusion Criteria: a history of Renal failure, Congestive Heart Failure, use of negative inotropic agents, presence of any contraindication for CVC insertion or failed ones and inability for measuring IVC by bUS were considered for exclusion.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Group B<br>CVP less than 8cmH2o | Other: Measuring IVC collapsibility index by bedside ultrasonography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IVC collapsibility index |  | within the first 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum lactate level |  | within the first 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVC, ultrasonography, IVC collapsibility index, IVC diameter
Evaluation to Assess the Long Term Safety of Tacrolimus Ointment for Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
To assess the long-term safety of tacrolimus ointment

Detailed Description
-----------------
To assess the long-term safety of tacrolimus ointment 0.03% or 0.1% in the treatment of subjects with atopic dermatitis under actual use conditions, including the risk of developing cutaneous or systemic malignancies. The FDA and EMEA approved Tacrolimus ointment, 0.03% in children and 0.1% and 0.03% in adults, for the treatment of atopic dermatitis. As part of the approval process, the FDA and EMEA requested a post-marketing commitment regarding the safety of long-term use of Tacrolimus ointment in pediatric atopic dermatitis subjects.

Official Title
-----------------
APPLES: A Prospective Pediatric Longitudinal Evaluation To Assess The Long Term Safety Of Tacrolimus Ointment For The Treatment Of Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has/had atopic dermatitis. Subject has applied tacrolimus ointment 0.03% or 0.1% for at least 6 weeks, continuously or intermittently. This may include subjects who have been enrolled in previous tacrolimus ointment studies and/or subjects with commercial product exposure prior to study enrollment. Subject age at the first tacrolimus ointment exposure is/was <16 years of age. Subject/Caregiver has given written informed consent and assent as required by state and/or governmental laws, including access to all relevant clinical and medication data, and the storage and analysis of these data. Subject/Caregiver agrees to comply with the program requirements including an annual physical exam and biennial dermatological exam and agrees to be contacted and provide information as described in this document to Primary Investigator Dr. Lamb and Covance Periapproval Services, Inc. Exclusion Criteria: Subjects who do not have/ have not had Atopic Dermatitis. Subjects must have used Tacrolimus ointment prior to age 16.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br> | Drug: Tacrolimus<br>* Participants will be followed for 10 years to study the effects of Tacrolimus.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The purpose of this study is to identify the long term effects of Tacrolimus in pediatric subjects |  | 10 Years |