linjc16/ctgov huggingface dataset:
Trial to Assess Vagus Nerve Stimulation Therapy in Children With Lennox-Gastaut Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve stimulatior in children with Lennox-Gastaut Syndrome.

Official Title
-----------------
The Clinical Research on PINS Vagus Nerve Stimulator for Treatment of Lennox-Gastaut in Children

Conditions
-----------------
Lennox-Gastaut Syndrome

Intervention / Treatment
-----------------
* Device: PINS Vagus Nerve Stimulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 3-14 year Lennox - Gastaut syndrome diagnostic standard Regular drug treatment is invalid Antiepileptic drug stability in recent 3 months Good health except epilepsy Patients or his(her) familyscould understand this method and sign the informed consent Patients with good compliance and could complete postoperative follow-up. Exclusion Criteria: Results of MRI remind epilepsy caused by intracranial space-occupying lesions Had epileptic foci excision surgery or corpus callosum The vagus nerve lesion and damage Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma， mental disease，peptic ulcer，diabetes Type 1，bad health etc, and other surgical contraindication Participated in other clinical drug test subjects within three months The researchers think that is not suitable for participants'

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 14 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: Vagus nerve Stimulation is on<br> | Device: PINS Vagus Nerve Stimulator<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in seizure frequency from baseline to the seizure count evaluation period 6 month |  | 6 month of stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in seizure frequency from baseline to the seizure count evaluation period |  | 1,3,6,months of stimulation | 
| Change from Baseline in the Engel and McHugh description |  | At 1,3,6 months | 
| Overall WISC Score in Patients from Baseline |  | Mean change from baseline WISC Overall Score at 1,3,6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PINS Vagus Nerve Stimulator
V-Flex Plus PTX Drug Eluting Coronary Stent

Study Overview
=================
Brief Summary
-----------------
The study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.

Official Title
-----------------
ELUTES III - V-Flex Plus PTX Drug Eluting Coronary Stent

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

Intervention / Treatment
-----------------
* Device: drug eluting coronary stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery. Patient must be an acceptable candidate for coronary artery bypass surgery Patient or legal guardian must have given informed consent Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status, an IVUS examination and a diagnostic angiogram. Exclusion Criteria: Patient must be less than 18 years old Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions. Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study. Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye. Women of child bearing potential. Patient has other medical condition that any cause non-compliance with the protocol, confound the results or is associated with limited life expectancy.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: drug eluting coronary stent|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation by IVUS of % diameter stenosis at follow up. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse events |  |  | 
| Target lesion revascularization |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery, restenosis, patency, drug eluting, stent
Ischaemic Stroke and Sleep Apnea in Northern Part of Finland

Study Overview
=================
Brief Summary
-----------------
Obstructive sleep apnoea is a risk factor for ischaemic stroke. study hypothesis: In prospective study the investigators want to know how many ischaemic stroke patients have sleep apnoea and does thrombolysis play a role in severity of osa in six months follow up.

Detailed Description
-----------------
In prospective study the investigators include all over 18 years old patients who came to emergency room for ischaemic stroke. Exclusion criteria is not able to co-operate or need for intensive care unit.The investigators shall take 100 control patients who have ischaemic stroke and no thrombolysis and 100 study patients who will have thrombolysis. The investigators do sleep registration during hospital staying within 2 days after patients have felt ill.Follow-up registration will be done after 6 months at home.

Official Title
-----------------
Obstructive Sleep Apnea as a Risk Factor for Ischaemic Stroke , a Prospective Study

Conditions
-----------------
Sleep Apnoea, Cerebral Palsy

Intervention / Treatment
-----------------
* Device: Nasal CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years old patients that have cerebral palsy and are able to participate to the study. Exclusion Criteria: no co-operation and need for intensive care unit

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 |
| --- | --- |
| Nasal CPAP<br>We want to study the nasal-cpap treatment and it's compliance in sleep apnea patients with ischaemic stroke. | Device: Nasal CPAP<br>* Nasal CPAP treatment for obstructive sleep apnoea<br>|
| no Nasal CPAP<br>No nasal-cpap in sleep apnea patients with ischaemic stroke. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral palsy events and severity of osa | in prospective study outcome measure is severity of osa in 6months follow-up | from six months to twenty four months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osa, cerebral palsy, thrombolysis in cerebral palsy, sleep registration
Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue

Study Overview
=================
Brief Summary
-----------------
The investigators compare the effects of two interventions, an endurance exercise program and a cognitive behavioural therapy, on the fatigue, quality of life, mood and physical performance of patients with a cancer-related fatigue syndrome. The intervention will be carried out for 4 weeks. Tests will be carried out at the beginning and at the end of the study.

Official Title
-----------------
Effects of a Brief Endurance Exercise Program and of a Cognitive Behavioural Therapy on Patients With Cancer-related Fatigue

Conditions
-----------------
Fatigue, Mood, Maximal Oxygen Uptake

Intervention / Treatment
-----------------
* Behavioral: Exercise
* Behavioral: Cognitive behavioural therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 Histologically confirmed neoplastic disease Treatment (chemotherapy or radiation) completed. No treatment in the previous 4 weeks Ability to understand written German Exclusion Criteria: Health conditions which can be aggravated by exercise

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive behavioural therapy<br> | Behavioral: Cognitive behavioural therapy<br>* Teaching of techniques to reduce fatigue and to improve stamina<br>|
| Experimental: Exercise<br>Endurance training (walking on a treadmill) 3 x weekly for 4 weeks | Behavioral: Exercise<br>* Endurance exercise 3 times weekly for 45 minutes, 4 weeks long<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue scores on the Brief Fatigue Inventory (BFI) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal oxygen uptake (VO2max) on a treadmill stress test. |  | 4 weeks | 
| Scores on the HADS (Hospital Anxiety and Depression Scale) |  | 4 weeks |
Non Invasive Ventilation During Physical Training in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Patients with cystic fibrosis older than 18 years will performance a Bruce test with non invasive ventilation (once) after 30 minutes they perform the same test with oxygen supplementation. Measurements: Transcutaneous level off carbon dioxide, saturation, puls and dyspnea scale.

Detailed Description
-----------------
measurements before and after the test: transcutaneous level off carbon dioxide, saturation, respiratory rate, dyspnea scale.

Official Title
-----------------
Physiotherapist in Charge of the Study

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Device: Non invasive ventilation
* Device: Oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with Cystic Fibrosis at Stockholm Cystic Fibrosis center > 18 years of age Forced expiratory volume in one second (FEV1) between 20 and 69% of predicted value Developed alveolar hypoventilation at the physical performance test Use oxygen supplementation during aerobic training Exclusion Criteria: Symptomatic upper airway infection characterized by fever less than 1 month before entering the study Cognitive dysfunction Cardio-respiratory instability Infection with Burkholderia cepacia complex Gastroesophageal reflux History of pneumothorax Massive hemoptysis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Non invasive ventilation<br>Patients perform physical test with non invasive ventilation | Device: Non invasive ventilation<br>* Training on treadmill with Non invasive ventilation<br>|
| Active Comparator: Oxygen<br>Patients perform physical test with oxygen with mask | Device: Oxygen<br>* Training on treadmill with oxygen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcutaneous level carbon dioxide | Physiological parameter | 10 min measurement |
iStent Inject Trabecular Micro-Bypass System Continuation Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
Long term follow up of subjects in the IDE study for iStent Inject to monitor safety

Detailed Description
-----------------
To evaluate the long -term rate of clinically relevant complications associated with iStent inject® placement and stability in subjects who have completed participation of the IDE clinical trial (GC-008).

Official Title
-----------------
iStent Inject Trabecular Micro-Bypass System Continuation Post-Approval Study

Conditions
-----------------
Glaucoma, Open-Angle

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Randomized subject followed for 24 months in the GC-008 study Able to understand study requirements Willing to attend scheduled follow-up exams for 5 years post-operatively Able and willing to provide written informed consent on the IRB approved Informed Consent Form Exclusion Criteria: None
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 |
| --- | --- | --- |
| iStent inject Placement and Stability | Rate of clinically relevant complications associated with iStent inject placement and stability. | 60 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sight-Threatening Adverse Events | Rate of occurrence of sight-threatening adverse events | 60 Months |
To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fed conditions.

Official Title
-----------------
A Single-Dose Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions

Conditions
-----------------
Epilepsy, Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
* Drug: Depakote 500 mg DR Tablets (Abbott Laboratories, USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 47 Years

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

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

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: 1<br>Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA) | Drug: Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)<br> <br> |
| Active Comparator: 2<br>Depakote 500 mg DR Tablets (Abbott Laboratories, USA) | Drug: Depakote 500 mg DR Tablets (Abbott Laboratories, USA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment of Epilepsy and Bipolar Disorder
Effects of Flaxseed Supplementation in Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of flaxseed supplementation on fasting blood sugar, lipid profile and anthropocentric measurements in subjects with metabolic syndrome, in a randomized, open-labeled, controlled pilot study, 44 subjects with metabolic syndrome will be received 30g/d flaxseed with lifestyle modification or lifestyle modification alone for 12 weeks. Both groups will be advised to follow an energy balanced diet and physical activity recommendations. Parameters related to metabolic syndrome will be measured at the baseline and at the end of the study.

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: flaxseed
* Behavioral: lifestyle modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older having three of the following five features: Increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated TG (≥150 mg/dl), reduced HDL-C (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm Hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the National Cholesterol Education Program Adult Treatment Panel III report Exclusion Criteria: history of allergy or high consumption of nuts, flaxseed, or sesame seeds clinically diagnosed renal, liver, heart, pituitary, thyroid, or psychiatric disorders impairing the patient's ability to provide written informed consent history of cardiovascular diseases, cancers, alimentary tract disorders affecting absorption pregnancy, lactation, and lack of effective birth control in women of child-bearing potential

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flaxseed<br>30 g milled brown flaxseed + lifestyle modification | Dietary Supplement: flaxseed<br> <br> Behavioral: lifestyle modification<br> <br> |
| Active Comparator: control<br>lifestyle modification including dietary and physical activity recommendation | Behavioral: lifestyle modification<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance index (HOMA-IR) | The homeostatic model assessment (HOMA) | 12 weeks |
Evaluation of a Male-focused Intervention to Prevent Intimate Partner Violence in a Conflict-affected Setting

Study Overview
=================
Brief Summary
-----------------
Cluster randomized controlled trial to evaluate a male-focused primary prevention programme which used a men's only group discussion format to prevent intimate partner violence against women & girls through fostering knowledge and behaviour changes by: (1) increasing men's knowledge on the impact of violence against women; (2) promoting gender equitable beliefs/behaviours within relationships; and (3) developing anger management techniques.

Official Title
-----------------
Evaluation of a Male-focused Primary Prevention Intervention to Prevent Intimate Partner Violence in a Conflict-affected Setting: A Cluster Randomized Controlled Trial in Cote d'Ivoire

Conditions
-----------------
Domestic Violence

Intervention / Treatment
-----------------
* Behavioral: Male-focused group violence prevention intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 15+ years old males: participant in group intervention or selected as control females: female intimate partner of males in intervention or selected as control capable of completing face-to-face interview independently and without causing undue psychological distress Exclusion Criteria: lack of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral intervention<br>Male-focused group violence prevention intervention | Behavioral: Male-focused group violence prevention intervention<br> <br> |
| No Intervention: Control communities<br>Communities in which male-focused group prevention activities will not be conducted | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Past 12 months victimisation/perpetration of physical or sexual intimate partner violence |  | 1 year after intervention completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intimate partner violence, gender, primary prevention intervention, conflict, Cote d'Ivoire, Ivory Coast