linjc16/ctgov huggingface dataset:
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.

Official Title
-----------------
SJ4 Post Approval Study

Conditions
-----------------
Tachyarrhythmias, Sudden Cardiac Death, Heart Failure

Intervention / Treatment
-----------------
* Device: SJ4 connector and RV high voltage SJ4 lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have an approved indication per ACC/AHA/HRS guidelines for implantation of heart failure or life-threatening ventricular tachyarrhythmias and will be implanted with a St. Jude Medical SJ4 system. Have the ability to provide informed consent for study participating and be willing and able to comply with the prescribed follow-up test and schedule of evaluations. Exclusion Criteria: Be currently participating in a clinical investigation that includes an active treatment arm. Have a life expectancy of less than 6 months due to any condition. Be less than 18 years of age.

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 |
| --- | --- |
| No treatment: ICD/CRTD-indicated<br> | Device: SJ4 connector and RV high voltage SJ4 lead<br>* Standard of care implantation of SJ4 device system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right Ventricle (RV) Bipolar Capture Thresholds |  | 5 years | 
| Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD, CRTD, Heart Failure, DF4
A Study of Gaboxadol in Primary Insomnia

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and tolerability of gaboxadol in primary insomnia.

Detailed Description
-----------------
To obtain long-term safety and tolerability data with gaboxadol.

Official Title
-----------------
A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Study of Gaboxadol in Primary Insomnia

Conditions
-----------------
Primary Insomnia

Intervention / Treatment
-----------------
* Drug: Gaboxadol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with Primary insomnia

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety in gaboxadol. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary insomnia
Ranibizumab for Myopic Neovascularization

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).

Detailed Description
-----------------
Twenty consecutive patients (30 eyes) with subfoveal PM-CNV, 9 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 0.5mg ranibizumab. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. IVTs were repeated only in case of persistent angiographic leakage and if OCT scans showed retinal thickening or edema and serous retinal detachment. The follow-up period was at least 6 months.

Official Title
-----------------
Ranibizumabe Intravitreal Injection for Myopic Choroidal Neovascularization

Conditions
-----------------
Myopic Choroidal Neovascularization

Intervention / Treatment
-----------------
* Drug: ranibizumab injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myopic and CNVM Exclusion Criteria: Patients with poor compliance Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (< one year). (Physician clearance was obtained for all patients). Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved. Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery. Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods. Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR. Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranabizumab<br>Myopic eyes with retinal neovascularization | Drug: ranibizumab injection<br>* Ranibizumab intravitreal injection of 0,5 mg ( 0.05mL)<br>|

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
-----------------
Ranibizumab, Myopia, Complications, Neovascularization, OCT
Effect of Light Meal on Pharmacokinetic and Pharmacodynamics of Aliskiren in Patients With Mild to Moderate Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of a light meal on the pharmacokinetics and pharmacodynamics of aliskiren in patients with mild to moderate hypertension.

Official Title
-----------------
A Randomized, Single-blind, Parallel Group, Multiple Oral Dose Study to Evaluate the Effect of a Light Meal on the Pharmacokinetics and Pharmacodynamics of Aliskiren Using Market 300 mg Tablet Formulation in Subjects With Mild to Moderate Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Aliskiren
* Drug: Aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatients, 18 to 65 years of age with mild to moderate hypertension Patients who are eligible and able to participate in the study Exclusion criteria: Severe hypertension Secondary form of hypertension. Type 1 or type 2 diabetes mellitus Serum potassium out side laboratory reference range Any history of hypertensive encephalopathy or cerebrovascular accident Other protocol-defined inclusion/exclusion criteria may apply

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fed Group<br> | Drug: Aliskiren<br> <br> |
| Active Comparator: Fasted group<br> | Drug: Aliskiren<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare PK (AUC & Cmax) and PD, i.e. PRA (Plasma Renin Activity, AUE) of aliskiren when given with and without light meal. |  | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effect of Plasma Renin Concentration (PRC) and angiotensin II of aliskiren when given with and without light meal |  | 28 Days | 
| Assess safety and tolerability of aliskiren when given with and without light meal |  | 28 days | 
| Evaluate the effect on mean sitting systolic and diastolic blood pressure of aliskiren when given with or without a light meal |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aliskiren,, hypertension,, renin-angiotensin-aldosterone system,, pharmacokinetics,, pharmacodynamics
Melatonin for Prevention of Post Stroke Delirium

Study Overview
=================
Brief Summary
-----------------
Post stroke delirium is prevalent in 10-30% of all stroke patients. We aimed to investigate wether Melatonin 2mg may prevent post stroke delirium.

Official Title
-----------------
Melatonin for Prevention of Post Stroke Delirium

Conditions
-----------------
Post Stroke Delirium

Intervention / Treatment
-----------------
* Drug: Melatonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with stroke, TIA or ICH admitted to our stroke unit or intemdiate care unit Stroke / ICH /TIA onset <= 48h Exclusion Criteria: RASS <=4 severe dementia, psychosis or depression

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Melatonin versus standard care<br>Melatonin is tested versus standard care | Drug: Melatonin<br>* Melatonin for prevent post stroke delirium<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of delir prevalence |  | 3months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of hospital stay |  | 3months | 
| Change of antipsychotic drug administration |  | 3 months | 
| Changed stay on stroke unit and/or intermediate care |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melatonin
Validation of ICG to Identify the Urethra During Rectal Surgery

Study Overview
=================
Brief Summary
-----------------
This is an open-label feasibility study utilising direct instillation of ICG into the urethra during surgery for low rectal cancers. The trial involves a single intervention taking place during the patient's operation. Participants will be included in the study for around 2 months with time either side of the intervention to collect background data.

Official Title
-----------------
Validation of ICG to Identify the Urethra During Rectal Surgery

Conditions
-----------------
Urethra Injury, Rectal Cancer, Surgery

Intervention / Treatment
-----------------
* Drug: Indocyanine Green Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Male, aged 18 years or above. Undergoing low rectal surgery where the operating field will be close to the urethra Exclusion Criteria: Participant has an allergy to iodine or ICG Known liver failure

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urethral instillation of ICG<br>Urethral instillation of indocyanine green (ICG) | Drug: Indocyanine Green Solution<br>* Urethral instillation of ICG (Indocyanine Green) mixed with urethral lubricant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of urethras identified under white light and fluorescence |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal to background ratios between cohorts of patients with varying doses of ICG |  | 1 day | 
| Subjective assessment of usefulness of technology during operative procedure |  | 1 day | 
| Length of time of interruption in operative procedure to perform trial intervention |  | 1 day | 
| Number of adverse events related to trial intervention |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluorescence
Study of Vanadium Supplement in Patients With Impaired Glucose Tolerance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate if the vanadium can improve the insulin sensitivity in patients with impaired glucose tolerance. Secondary purpose of this study was to assess changes on metabolic profile, weight and blood pressure.

Official Title
-----------------
Effect of Vanadium on Insulin Sensitivity in Patients With Impaired Glucose Tolerance

Conditions
-----------------
Prediabetic State

Intervention / Treatment
-----------------
* Dietary Supplement: Vanadyl sulfate
* Other: Magnesium oxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of impaired glucose tolerance Body mass index from 25 to 35 kg/m2 History of type 2 diabetes mellitus in the first branch Exclusion Criteria: Taking medication with known effects on carbohydrate or insulin metabolism Thyroid diseases Hepatic diseases

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 50 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Dietary Supplement: Vanadyl sulfate<br>* 50 mg twice daily orally for a period of 4 weeks<br>* Other names: Vanadyl sulphate hydrate;|
| Placebo Comparator: 2<br> | Other: Magnesium oxide<br>* Validation of similar appearance and weight to the intervention component orally 1 unit (<50 mg) twice daily for a period of 4 weeks<br>* Other names: Magnesia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on insulin sensitivity assessed with a euglycemic-hyperinsulinemic clamp technique |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on metabolic profile |  | 4 weeks | 
| Changes on anthropometrical measures |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vanadium, insulin sensitivity, impaired glucose tolerance, triglycerides
Exploratory Study on Two Different Doses of VML-0001 on the Effects on Vaginal pH in Healthy Post-Menopausal Women

Study Overview
=================
Brief Summary
-----------------
The study is designed to determine the effect on vaginal pH and the duration of action measured on the ability of the base formulation to reduce the vaginal pH

Official Title
-----------------
A Phase II, Open-label, Single-Centre, Randomized, Cross-over, Exploratory Study on Two Different Doses of VML-0001, the Base Formulation of Viramal's pH Regulating and Vaginal Moisturizing Cream, on the Effects on Vaginal pH in Healthy Post-Menopausal Women

Conditions
-----------------
Vaginal Atrophy

Intervention / Treatment
-----------------
* Device: VML-0001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be greater than 45 years no positive findings on screening gynaecological examination negative smear test within the last 5 years Exclusion Criteria: has signs of vaginal infection has evidence of alcohol abuse has used hormonal replacement therapy in three months prior to study entry

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br> | Device: VML-0001<br>* Medical device<br>|
| Group B<br> | Device: VML-0001<br>* Medical device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the duration of action measured on the ability of VML-0001 (base formulation) to reduce vaginal pH. | The Vaginal pH will be measured daily for 7 days after single dose of VML-0001 using pH kits. | 7-14 days |
Study of Smoking Trajectory in Newly Diagnosis Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Understanding the smoking change patterns among the newly diagnosis lung cancer patients after cancer diagnosis. Explore the related factors of the smoking change patterns. The type of smoking trajectory impact on survival and quality of life.

Detailed Description
-----------------
This was a prospective longitudinal design study. The investigators used the structure questionnaires to collect the data from a consecutive sample of newly diagnosed lung cancer patients.

Official Title
-----------------
Smoking Trajectory in Newly Diagnosis Lung Cancer Patients

Conditions
-----------------
Newly Diagnosed Lung Cancer, Smoking, Cigarette, Survival, Quality of Life

Intervention / Treatment
-----------------
* Behavioral: smoking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 20 years old Newly diagnosed lung cancer Conscious clear and able to communicate Agreed to participate the study Exclusion Criteria: Consciously confused Cognitive or psychotic disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: smoking|smoking behavior|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes From Baseline Smoking Behavior at 1,2,3,4,5,6 Months | Self-reported smoking during the last 30 days was a dichotomous variable. | baseline, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes From Baseline Quality of Life at 1,2,3,4,5,6 Months | Functional Assessment of Cancer Therapy-Lung, Version 4 (FACT-L v. 4) was a 36-item ordinal scale, five-point scale from 0 (not at all) to 4 (very much). There were 5 domains: Physical, social/family, emotional, and functional well-being; lung cancer subscale (symptoms, cognitive function, regret of smoking). Subscale scores added to obtain total score, with higher scores indicating better quality of life. | baseline, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month | 
| Proportion of participants with Overall Survival up to 2 years | survival | follow up to one or two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Survival, Quality of life, Smoking, Lung cancer
An Extension of the CONCERT Protocol (DIM18)

Study Overview
=================
Brief Summary
-----------------
An open-label extension study of the CONCERT (DIM18) protocol evaluating the safety of dimebon (latrepirdine) in subjects with With Mild-to-Moderate Alzheimer's Disease on Donepezil.

Official Title
-----------------
An Open-Label Extension of the CONCERT Protocol (DIM18) Evaluating Dimebon (Latrepirdine) in Patients With Alzheimer's Disease

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

Intervention / Treatment
-----------------
* Drug: Dimebon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Successful completion of the 12 month DIM18 CONCERT study Mild-to-moderate Alzheimer's disease Probable AD, Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revised (DSM-IV-TR) Mini-Mental State Exam (MMSE) score between 12 and 24, inclusive Stable on donepezil for at least 6 months Exclusion Criteria: Other causes of dementia Major structural brain disease Unstable medical condition or significant hepatic or renal disease

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Dimebon<br> | Drug: Dimebon<br>* 20 mg orally three times daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | To evaluate the long-term safety and tolerability of dimebon (latrepirdine) in Alzheimer's disease (AD) patients who have completed 52 weeks of blinded treatment in the DIM18 (CONCERT) protocol. | Through study discontinuation |