linjc16/ctgov huggingface dataset:
Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of feeding frequency on glucose and insulin metabolism and substrate partitioning.

Official Title
-----------------
Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning

Conditions
-----------------
Insulin, Glucose Metabolism

Intervention / Treatment
-----------------
* Dietary Supplement: low feeding frequency (3x)
* Dietary Supplement: High feeding frequency (14x)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI: 18.5-25 kg/m2 (lean) Gender: Male Age: subjects has to be older than 18 and including 35 years old Caucasian Exclusion Criteria: Metabolic abnormalities such as: Lactose intolerant Diabetes Mellitus Hypertension Hypotension Cardiovascular diseases Asthma and other obstructive pulmonary diseases Elevated fasting blood glucose level

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low feeding frequency (3x)<br> | Dietary Supplement: low feeding frequency (3x)<br>* 3 meals a day<br>|
| Experimental: High feeding frequency (14x)<br> | Dietary Supplement: High feeding frequency (14x)<br>* 14 meals a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose and insulin metabolism |  | 24 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substrate partitioning and metabolic markers |  | 24 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
feeding frequency, insulin metabolism, glucose metabolism, substrate partitioning
Safety and Efficacy of ART-123 in Subjects With Sepsis and Disseminated Intravascular Coagulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if ART-123 (recombinant human soluble thrombomodulin) decreases the number of people who die as a result of Disseminated Intravascular Coagulation (DIC) complication of sepsis.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Phase-2B Study to Assess the Safety and Efficacy Effects of ART-123 on Subjects With Sepsis and Disseminated Intravascular Coagulation

Conditions
-----------------
Sepsis, Disseminated Intravascular Coagulation

Intervention / Treatment
-----------------
* Drug: ART-123
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infection or suspected infection resulting in sepsis and DIC Exclusion Criteria: Unable to provide informed consent, or lack of consent from an acceptable surrogate Subjects < 18 years of age Known conditions that could confound the diagnosis of DIC due to sepsis Known conditions that increase the risk of bleeding Known medical condition associated with a hypercoagulable state Known or suspected severe liver disease History of solid organ (excluding uncomplicated kidney), bone marrow or stem cell transplantation Renal failure

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ART-123<br>6 mg/ml ampule solution for injection | Drug: ART-123<br>* 6mg/ml ampule solution for injection @ .01mg/kg<br>|
| Placebo Comparator: Placebo<br>6 mg/mlampule of solution for injection | Drug: placebo<br>* 6 mg/ml ampule solution for injection at .01mg/kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-Day All-cause mortality |  | 28 day |
Patency and Safety of the Drug Eluting Covered Biliary Stent Comparing to the Common Covered Biliary Stent

Study Overview
=================
Brief Summary
-----------------
Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common Covered Metallic Biliary Stent.

Detailed Description
-----------------
Paclitaxel covered metal biliary stent(Mira-Cover Biliary Stent) extents their patency rate comparing to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent.

Official Title
-----------------
Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent(Niti-S Mira-Cover Biliary Stent ) to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent)

Conditions
-----------------
Biliary Stricture, Malignant Neoplasms

Intervention / Treatment
-----------------
* Device: Biliary stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who is inoperable and/or unresectable cases of pancreatic cancer and/or biliary cancer with mid or distal CBD invasion Among patient of a.,Patient who previously had surgical biliary drainage of plastic stent have eligibility Exclusion Criteria: Patient who have life expectancy under 3 months Patient who have severe metastasis of Liver or whole body Patient who previously had surgical biliary drainage

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel ElutingCovered Metal Stent<br> | Device: Biliary stent<br>* palliative treatment for malignant patients<br>* Other names: Niti-S Biliary Stent;|
| Active Comparator: Covered Metal Stent<br> | Device: Biliary stent<br>* palliative treatment for malignant patients<br>* Other names: Niti-S Biliary Stent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accumulative Patency Rate |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accumulative Survival Rate |  | 6 months | 
| Complications |  | 6 months | 
| Possibility of Other Treatment after Obstruction |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
paclitaxel, drug eluting stent
Screening for Barrett's Esophagus in Otolaryngology Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to develop an accurate method to identify patients that suffer from acid reflux, but may not present with classic reflux symptoms (such as heart burn). Additionally, it is the purpose of this project to utilize the Unsedated Small-caliber Endoscopy (USE) to assess the prevalence of Barrett's esophagus in a population of patients with laryngopharyngeal reflux (LPR) symptoms and to define normal patterns of LPR. Laryngopharyngeal reflux (LPR) is when a small amount of stomach contents and acid are pushed up through the esophagus and may affect the vocal cords and upper respiratory tract. It is suspected that patients with LPR symptoms may have a prevalence of Barrett's esophagus similar to that found in a population with typical reflux symptoms. We propose to systematically test this hypothesis using the USE. This project is designed to improve the methods of identifying patients with a form of acid reflux that is often undetected, and thus untreated. If this project is successful then more patients with Barrett's esophagus will be identified; furthermore, screening and treatment for this pre-cancerous condition will be improved.

Official Title
-----------------
Screening for Barrett's Esophagus in Otolaryngology Patients

Conditions
-----------------
Extraesophageal Symptoms, Cough, Throat Clearing, Hoarseness, Difficulty Swallowing

Intervention / Treatment
-----------------
* Diagnostic Test: Screening for Barrett's Esophagus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: Prior anti-reflux surgery, laryngeal surgery, trauma to larynx Esophageal diverticulum Pregnancy Anticoagulation therapy Esophageal varices ENT malignancy History of recurrent epistaxis

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening for Barrett's Esophagus<br> | Diagnostic Test: Screening for Barrett's Esophagus<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary aim of the study is to establish that patients with symptoms of LPR who are referred to an otolaryngology clinic have a prevalence of Barrett's metaplasia equivalent to that of a population with GERD symptoms. |  | One time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laryngopharyngeal reflux, extraesophageal reflux symptoms
Brain Function in Adolescent Eating Disorders and Healthy Peers

Study Overview
=================
Brief Summary
-----------------
This study of adolescent eating disorders (ED) will examine the association of temperament-based classifications, brain activation during incentive processing, and ED symptoms at time of scan and 1 year later to better understand the neurobiology and symptoms of ED. We will recruit 150 females currently ill with an ED and 50 controls ages 14-17 to investigate how temperaments reflecting greater inhibition, impulsivity, or effortful control correspond to 1) clinical symptoms and 2) the brain's response to anticipation and outcome of salient stimuli, and 3) by collecting follow-up clinical data one year later, identify how temperament-based subtypes predict ED symptom change (e.g., clinical prediction). Data collection will rely on a technology called functional magnetic resonance imaging (fMRI).

Official Title
-----------------
Neurocircuitry of Temperament and Motivated Behavior in Adolescent Eating Disorders

Conditions
-----------------
Eating Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Meet DSM-V criteria for an Eating Disorder or Never met criteria for an Eating disorder Medically stable Post-Pubertal (must have started menses, but subsequent loss of menses secondary to ED is fine). Exclusion Criteria: Psychotic illness/other mental illness requiring hospitalization Current dependence on drugs or alcohol Physical conditions known to influence eating or weight (e.g, diabetes mellitus, pregnancy). On psychoactive medication Organic brain syndromes, delirium, psychotic disorders, or intellectual disability Neurological or medical disorders such as seizure disorder Any contraindication to undergoing an MRI Major depressive disorder Left handed

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 17 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 |
| --- | --- |
| Adolescents with an Eating Disorder<br>Females between the ages of 14-17 currently diagnosed with an eating disorder (including ARFID, Anorexia Nervosa, Bulimia Nervosa, OSFED) | |
| Healthy Controls<br>Females between the ages of 14-17 with no psychiatric conditions | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain function | Functional Magnetic Resonance imaging will be used to assess brain activation associated with inhibition, impulsivity, and control | 1 year (fMRI Scan) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adolescents, healthy controls
A Four Month Home Based tDCS Study on Patients With Alzheimer's Disease.

Study Overview
=================
Brief Summary
-----------------
The study is an open label study on patients with Alzheimer's dementia using home based transcranial direct current (tDCS) stimulation. Aims of the study is to investigate applicability and effect of treatment.

Detailed Description
-----------------
Active tDCS of 2mA is applied via surface based electrodes daily for 30 minutes over a 4 month period. Anodal electrode is placed over the left temporal lobe. Participants is followed up by home visit and phone calls. Cognitive tests are performed prior to the treatment period, right after finishing 4 months of treatment and 4 months after treatment is terminated.

Official Title
-----------------
A Four Month Home Based tDCS Study on Patients With Alzheimer's Disease.

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Device: transcranial direct current stimulation (tDCS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 60-85. Fulfil diagnostic criteria of probable Alzheimer's dementia. Participants has to live with a caregiver. If medicated with cholinesterase inhibitors or memantine, a stable dose the last three months before inclusion is required. Exclusion Criteria: Implant in head Seizure history Severe illness, Psychosis or depression measured with a cornell score over 11. Mini mental status (MMSE) score<17.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 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
Interventional Model Description: Treatment study, open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with tDCS<br>Home based treatment with tDCS for four months | Device: transcranial direct current stimulation (tDCS)<br>* Apply 30min low dose (2mA) transcranial current stimulation on the scalp every day for four months.<br>* Other names: tDCS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate adverse effects of the treatment | Investigation of tolerability of long term home based tDCS to patients with Alzheimer's by using the Adverse effect questionnaire for tDCS | 4 months | 
| To investigate effect of the treatment | Investigate possible change in cognitive tests (Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Mini Mental Status Examination ( MMSE), Clock drawing test, Trail making test A & B) after 4 months treatment and change 4 months after end of treatment | 8 months |
Survey of Adolescent Living in Vestmanland

Study Overview
=================
Brief Summary
-----------------
The interaction of MAO-A genotype and psychosocial risk, in relation to male adolescent criminality The interaction of 5-HTTLPR genotype and psychosocial risk in relation to excessive adolescent alcohol consumption The interaction of 5-HTTLPR genotype and psychosocial risk in relation to depressive symptoms among adolescents The interaction of MAO-A genotype and psychosocial risk, in relation to female adolescent criminality

Official Title
-----------------
Risk Factors for Alcohol Abuse and Deviant Behaviour - Biochemical and Molecular Studies in Adolescents From Swedish County

Conditions
-----------------
Alcohol Abuse, Criminalism, Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All students present in school class during survey

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 19 Years

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent, Alcohol, Criminology, Genes, Environment, Mono amine Oxidase, Serotonin, Social Support
PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy

Study Overview
=================
Brief Summary
-----------------
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. Using a medical device like a pacemaker or a defibrillator can help the heart to pump in regular beats. However, not all patients do better with a device. Currently, there is not a way to identify which patients will benefit from the device. The purpose of this study is to determine if using medical tests, Echocardiogram, can help in predicting which patients will improve. The types of patients needed for this study are those who have been diagnosed with moderate or severe heart failure.

Official Title
-----------------
Predictors of Response to Cardiac Re-Synchronization Therapy

Conditions
-----------------
Heart Failure, Congestive Heart Failure, Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe heart failure Ejection Fraction ( measurement of blood pumped out of the heart) less than 35% Wide (greater than 130 milliseconds) QRS duration for US patients only. May include patients with less than 130 millisecond QRS duration if they have mechanical dyssynochrony (uncoordinated heart contractions) in Europe. All patients enrolled should be stable on medications that include at least an ACE inhibitor or Angiotensin Receptor Blocker (ARB) and at optimal level for at least one month prior to surgery Exclusion Criteria: Patients that are not eligible for this study are those that have a mechanical right heart valve or are experiencing the following medical conditions within the last 3 months: Chest pain / unstable angina Acute heart attack Chronic or permanent atrial arrhythmias such as atrial fibrillation Contrary artery bypass graft (CABG) Percutaneous transluminal coronary angioplasty (PTCA) Patients who have had intermittent or continuous Inotropic drug therapy are not eligible for this study. Patients who have had heart transplant or a prior Cardiac Resynchronization Therapy device are not eligible for this study. Patients who are pregnant or are of child-bearing potential are not on a form of birth control may not participate in this study.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Congestive Heart Failure, Fluid overload, Left sided heart failure, Pacemaker, Defibrillator
A Pilot Study on Whey Protein Supplementation in Non Alcoholic Fatty Liver Disease

Study Overview
=================
Brief Summary
-----------------
An increase in dietary protein intake has been shown to blunt the increase in intrahepatic fat induced by high fat feeding in healthy individuals. The purpose of this study is to determine if a protein supplementation decreases intrahepatic fat in obese patients with non-alcoholic fatty liver disease.

Detailed Description
-----------------
12 obese patients will be be treated with a dietary whey protein supplementation over 4 weeks. Their intrahepatic fat content, glucose tolerance, and body weight will be evaluated before and after 4 weeks of supplementation.

Official Title
-----------------
Effect of a Whey Protein Supplementation on Intrahepatic Lipids in Obese Patients With Non-alcoholic Fatty Liver Disease

Conditions
-----------------
Non-alcoholic Fatty Liver Disease, Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: ProWHEY 94 CFM, SponserR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI higher than 35 kg/m2 age 18-50 years sex male or female ASAT/ALAT > 1.8 Exclusion Criteria: treatment with hypolemic or antidiabetic agents blood glucose > 7 mmol/l alcohol intake > 20g/day creatinin > 120 umol/l) contra-indications to Magnetic resonnance imaging

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Dietary Supplement: ProWHEY 94 CFM, SponserR<br>* 3 times 20g per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intrahepatic fat |  | before and after 4 weeks of whey protein supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose metabolism |  | 4-hour oral glucose tolerance test with indirect calorimetry | 
| body weight and body fat |  | before and after 4 weeks whey protein supplementation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intrahepatic fat, obesity, body fat, impaired glucose tolerance