linjc16/ctgov huggingface dataset:
NOMAC : New Tools for Managing the Fate of Cereal Nutrients in the Gut : Effects of Amylose Content on Glycemic Index.

Study Overview
=================
Brief Summary
-----------------
The consumption of cereals-based foods with low glycemic indexes, high micronutrients and fibers contents are highly recommended. The target of this work is to provide new solutions for cereal based foods: the knowledge and understanding on the in vivo fate will be used to define structural features to gain in foods.

Official Title
-----------------
NOMAC : New Tools for Managing the Fate of Cereal Nutrients in the Gut : Effects of Amylose Content on Glycemic Index.

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

Intervention / Treatment
-----------------
* Other: 20% amylose bread
* Dietary Supplement: 10% amylose bread
* Dietary Supplement: Carbohydrates


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individual, Age between 19-65 years With normal food habits with at least 2 main meals per day Non smoking Having filled the consent form Exclusion Criteria: BMI > 25 kg/m2, Diabetes or any illness susceptible to alter Coeliac disease Past history of intestinal diseases. Treatment susceptible of modifying glycemia. Allergy

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bread with 20% amylose content<br>Bread with 20% amylose content | Other: 20% amylose bread<br>* 20% amylose bread<br>|
| Experimental: Bread with 10% amylose content<br>Bread with 10% amylose content | Dietary Supplement: 10% amylose bread<br>* 10% amylose bread<br>|
| Experimental: carbohydrates<br>50g of carbohydrates ingested with 400 ml of water | Dietary Supplement: Carbohydrates<br>* 50g of carbohydrates ingested with 400 ml of water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic index for each bread | To compare the glycemic index of breads made with different amylose content. (S1 to S6) A total of 6 visits. In each visit, blood samples will be taken for measurement of glycemia and insulinemia over 2 hours after ingestion of 50 of carbohydrates ingested with 400 ml of water. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC for insulinemia for the 2 hours following the ingestion of each bread. | To compare the AUC for insulinemia for the 2 hours following the ingestion of each bread. | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glycemic index
The RestEaze Ambulatory Sleep Monitor for Detection of Leg Movements During Sleep in Adults and Children With a Sleep Disturbance

Study Overview
=================
Brief Summary
-----------------
This observational study will test and evaluate the RestEaze ambulatory sleep monitor for the detection and classification of leg movements during sleep (LMS) and other sleep measures.

Official Title
-----------------
The RestEaze Ambulatory Sleep Monitor for Detection of Leg Movements During Sleep in Adults and Children With a Sleep Disturbance

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Diagnostic Test: RestEaze


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages between 5 -75 General good health and ambulatory Sleep complaint or other diagnosis that affects sleep (e.g. ADHD) with likely concomitant abnormal LMS requiring either HST or PSG Reports no significant problems sleeping in a new bed and bedroom away from home (If applicable) Parent or guardian available to spend the night with the child during the sleep study Exclusion Criteria: • Amputation that would preclude use of wrist actigraph or the RestEaze device

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: RestEaze|Wearable band to detect leg movements of sleep|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Algorithm | Development of analysis tools to validate RestEaze as a biomarker of leg movements of sleep | 1 year |
Acute Effects of a Non Excitatory Cardial Stimulation

Study Overview
=================
Brief Summary
-----------------
Electric stimulation by cardial contractility modulation (CCM)to improve contractility and physical capacity

Official Title
-----------------
Acute Neurotrophic Effects of a Non Excitatory Cardial Stimulation by Optimizer III System in Patients With Heart Failure

Conditions
-----------------
CCM Implantation

Intervention / Treatment
-----------------
* Other: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned CCM Implantation systolic left ventricular dysfunction despite of adequate therapy of heart failure (NYHA II, III, IV) implanted pacemaker, defibrillator or pacemaker during CS intubation written informed consent open entryways Exclusion Criteria: anemia Hemoglobin (HB)<8 mg/dl lying coronary sinus (CS) tube or CS being not able to intubate chronic atrial fibrillation or flutter mechanic tricuspid valve prothesis no access via subclavian vein patients with VVI pacemaker being stimulated 110% idiopathic hypertrophic cardiomyopathy, restrictive constrictive cardiomyopathy or heart failure because of known inflammatory or infiltrative illnesses or constrictive illness acute myocardial ischemia presented by angina pectoris or ECG changes under load patients being hospitalized because of heart failure during the last month and have to be treated with intravenous diuretics or inotropic substances acute coronary syndrome should not be implanted for at least 3 month patients with mechanic aortic or tricuspid valve patients after heart transplantation patients with clinical significant ectopy, defined by > 8.900 PVCs during 24 hours at beginning Holter monitoring patients after hypertensive crisis patients with acute renal failure Ejection Fraction (EF) > 35 patients after left ventricular pacemaker electrode pregnant or breast feeding women patients with heart failure after sepsis

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CCM aggregate<br>Taking of 10 blood samples | Other: Blood sample<br>* Taking of blood sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive inotropic effects by CCM stimulation |  | 15 minutes |
Validation of a High-risk Versus Low-risk Referral Model in Suspected Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
In Emergency Departments patients admitted with chest pain may suffer from non-significant to lifethreatening conditions. The aim of the present study is to develop and validate a referral model in chest pain patients which divide the patients with non- significant ECG changes into high risk and low risk groups for acute coronary syndrome.

Conditions
-----------------
Acute Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 15 years old Exclusion Criteria: Patients with ST-elevations in ECG

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |
| Acute Myocardial Infarction |  | 24 hours after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac event |  | 1 year after admission |
STYLE - Symbicort Single Inhaler Therapy vs Conventional Therapy in Treatment of Persistent Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma

Official Title
-----------------
A Comparison of the Efficacy of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5 mg 1 Inhalation b.i.d. Plus As-needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26 Weeks, Randomised, Open-label, Parallel-group, Multicentre Study

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Diagnosis of asthma ³ 3 months Prescribed daily use of glucocorticosteroids at a dose > 320 mcg/ day for at least 3 months prior to Visit 1 Exclusion Criteria: Smoking history > 10 pack-years Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion Any significant disease or disorder that my jeopardize the safety of the patient. Additional inclusion and exclusion criteria will be evaluated by the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first severe asthma exacerbation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of asthma exacerbations |  |  | 
| Mean use of as-needed medication |  |  | 
| Prescribed asthma medication |  |  | 
| Asthma Control Questionnaire |  |  | 
| Asthma related costs (direct asthma medication, direct non-medication costs and indirect costs) |  |  | 
| Safety: Serious Adverse Events and discontinuations due to adverse events |  |  | 
| All variables assessed over the 6 months treatment period |  |  |
A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).

Official Title
-----------------
ARMOR3-SV: A Phase 3, Randomized, Open Label, Multi-Center, Controlled Study of Galeterone Compared to Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic (M1) Castrate Resistant Prostate Cancer (CRPC)

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Galeterone
* Drug: Enzalutamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Progressive metastatic (M1) disease on androgen deprivation therapy Detectable AR-V7 from circulating tumors (CTCs) ECOG performance status 0 or 1 Exclusion Criteria: Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide) Prior treatment with chemotherapy for CRPC

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

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

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: Galeterone<br> | Drug: Galeterone<br>* 2550 mg galeterone tablets once daily PO<br>* Other names: TOK-001;|
| Active Comparator: Enzalutamide<br> | Drug: Enzalutamide<br>* 160 mg enzalutamide capsules once daily PO<br>* Other names: Xtandi®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Progression-free survival |  | ≥ 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | ≥ 8 months | 
| Time to Initiation of Cytotoxic Chemotherapy |  | ≥ 8 months |
One-Year Follow-up Safety Study in Subjects Previously Implanted With VC-01™

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to evaluate the long-term safety in subjects previously implanted with VC-01™ combination product.

Official Title
-----------------
A One-Year, Multicenter, Observational, Follow-up Safety Study in Subjects Previously Implanted With VC-01™ Combination Product

Conditions
-----------------
Type 1 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous implantation of VC-01™ combination product with subsequent explantation of all VC-01 units. Exclusion Criteria: There are no exclusion criteria for this trial.
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 |
| --- | --- | --- |
| Incidence of adverse events reported during the study. |  | 12 months |
Extension Study of MT-1303 in Subjects With Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The primary objectives of the study are: -To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）

Official Title
-----------------
A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Who Have Completed the MT 1303-E13 Study

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: MT-1303


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject completed 14 week Treatment Period in the double blind MT-1303-E13 study as per Protocol. Exclusion Criteria: Permanent discontinuation of study medication prior to the end of treatment Visit in MT-1303-E13

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-1303<br> | Drug: MT-1303<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects with Adverse Events |  | 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's Disease
Effects of Exercise Modality on Abdominal Obesity and Health Risk Factors in Older Men and Women

Study Overview
=================
Brief Summary
-----------------
The prevalence of abdominal obesity in the elderly is increasing at alarming rates and thus, requires immediate attention. By comparison to younger adults, obesity reduction in the elderly presents a unique challenge and requires an innovative approach. We propose a novel approach to investigate the effects of different exercise types as independent treatment strategies for the reduction of obesity and related health risk factors in older men and women. We propose that exercise without caloric restriction will be associated with modest weight loss (3-5%), that in turn will be associated with significant reduction in abdominal obesity, insulin resistance, and a corresponding increase in skeletal muscle mass and function. We will determine the separate effects of resistance and aerobic exercise on these primary outcome variables, and, whether a treatment strategy that combines the two is optimal.

Official Title
-----------------
Effects of Exercise Modality on Abdominal Obesity and Health Risk Factors in Older Men and Women

Conditions
-----------------
Abdominal Obesity

Intervention / Treatment
-----------------
* Other: Resistance Exercise (RE)
* Other: Aerobic Exercise (AE)
* Other: Resistance and Aerobic Exercise (RAE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women between 65 and 80 years of age. Men and women are self-sufficient, sedentary, abdominally obese (BMI between 27 and 34.9 kg/m2; waist circumference greater than 88 cm in women and 102 cm in men), weight stable (± 2 kg) for 6 months prior to the beginning of the study, be non-smokers, and not diabetic. We will study elderly women who are not taking hormone replacement therapy to create a homogeneous population in whom the effect of exercise on the principal outcome variables can be evaluated with minimal confounding. Exclusion Criteria: Smokers and diabetics. Women taking hormone replacement therapy.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 Years

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: C<br> | |
| Active Comparator: RE<br>Resistance Exercise | Other: Resistance Exercise (RE)<br> <br> |
| Active Comparator: AE<br>Aerobic Exercise | Other: Aerobic Exercise (AE)<br> <br> |
| Active Comparator: RAE<br>Resistance and Aerobic | Other: Resistance and Aerobic Exercise (RAE)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal obesity |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Resistance |  | 6 Months |
Trial to Investigate the Influence of the Homeopathic Remedy Naja-comp on Stroke Therapy in Geriatric Rehabilitation

Study Overview
=================
Brief Summary
-----------------
The homeopathic remedy 'naja-comp' will improve functional outcome measured by the Barthel-Index. The homeopathic remedy 'naja-comp' will decrease complications during geriatric rehabilitation measured by rate of unplanned discharge to hospital.

Detailed Description
-----------------
Secondary outcome for functional improvement are Scandinavian Stroke Scale, 4D+S-Scale and Timed-Up&Go-Test.

Official Title
-----------------
Multicenter Randomized Controlled Trial to Investigate the Influence of the Homeopathic Remedy 'Naja-comp' on Stroke Therapy in Geriatric Rehabilitation

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

Intervention / Treatment
-----------------
* Drug: Naja-comp.
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stroke within 60 days after onset Exclusion Criteria: stroke by injury or tumor stroke older than 60 days missing consent for participation participation at other clinical trials

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naja-comp.<br>s.c. injection of naja comp (homeopathic remedy) three times a week | Drug: Naja-comp.<br>* homeopathic remedy<br>* Other names: Naja compositum;|
| Placebo Comparator: Placebo<br>s.c. injection of placebo (NaCl-solution) three times a week | Drug: Placebo<br>* s.c. injection of NaCl-solution three times a week<br>* Other names: NaCl 0.9%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| barthel-index |  | baseline, 21st day of rehabilitation | 
| rate of unplanned discharge to hospital care |  | until day 21 of rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scandinavian Stroke Scale, 4D+S-Scale, Timed-Up&Go-Test |  | baseline, 21st day of rehabilitation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke rehabilitation, outcome, barthel-index, geriatrics, elderly
Bacterial Contamination of Anaesthetists' Hands by Personal Mobile Phones Used in the Operating Theatre

Study Overview
=================
Brief Summary
-----------------
The use of mobile phones in the operating room (OR) has become widespread, because of the lack of reports on serious problems. Since mobile phones are used in close body contact and since, as for most non-medical electronic equipment, there are no cleaning guidelines that meet hospital standards, the hygiene risk involved in using mobile phones in the OR has not yet been determined.

Conditions
-----------------
Environmental Microbiology, Equipment Contamination, Personnel, Hospital

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anaesthetist working in the OR
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |