linjc16/ctgov huggingface dataset:
Study in EpCAM Positive Patients With Symptomatic Malignant Ascites Using Removab Versus an Untreated Control Group

Study Overview
=================
Brief Summary
-----------------
The study will be performed to obtain further efficacy and safety data in order to obtain a marketing authorization (pivotal study). In addition, health economic data are to be collected.

Official Title
-----------------
Two-Arm, Randomized (2:1), Open-Label Phase II/III Study in EpCAM Positive Cancer Patients With Symptomatic Malignant Ascites Using the Trifuncitonal Bispecific Antibody Removab (Anti-EpCAM x Anti-CD3) Versus an Untreated Control Group

Conditions
-----------------
EpCam Positive Tumor (e.g.Ovarian, Gastric, Colon, Breast), Malignant Ascites

Intervention / Treatment
-----------------
* Biological: Catumaxomab (Removab)
* Procedure: paracentesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histological confirmed diagnosis cancer symptomatic malignant ascites EpCAM positive tumor EOCG 0-2 negative pregnancy Exclusion Criteria: acute or chronic infection exposure to investigational product, cancer chemo- or radiotherapy within the last 28 days previous treatment with mouse monoclonal antibodies known or suspected hypersensitivity to Removab or similar antibodies inadequate renal function inadequate hepatic function (AST, ALt, GTP,< x ULN; bilirubin <1.5xULN) Platelets > 80000 cells/mm3; absolute neutrophil count (ANC) < 1500 cells/mm3 BMI < 17 Patients with reduced nutritional status Ileus within the last 30 days Brain metastases in cancer history Pregnant and nursing women history of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia within previous 3 months inadequate respiratory function in option of investigator

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Catumaxomab<br>Patient received Catumaxomab and paracentesis | Biological: Catumaxomab (Removab)<br>* Puncture free survival<br>* Other names: Removab;Procedure: paracentesis<br> <br> |
| No Intervention: 2:<br>Patient treated by paracentesis alone, but after the second paracentesis the patient is able to cross-over in the Catumaxomab-arm | |

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
-----------------
EpCAM positive tumor, malignant ascites, intraperitoneal
Effects of Whole Body Vibration Exercise on Metabolic Systems in Latino Boys

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if whole body vibration exercise improves insulin/glucose dynamics and bone metabolism in Latino Boys.

Official Title
-----------------
Effects of Whole Body Vibration Exercise on Metabolic Systems in Latino Boys

Conditions
-----------------
Effects of Whole Body Vibration Exercise on Metabolic Systems

Intervention / Treatment
-----------------
* Other: Exercise intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boy 8-10 years of age Tanner Stage I Age and gender BMI > 85th percentile Hispanic descent( all four grandparents of Hispanic descent) Exclusion Criteria: Acute or chronic illness Any condition known to influence body composition, or insulin/glucose dynamics Musculoskeletal disease, injury, or orthopedic condition that would prevent exercise

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 10 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>A group that continues with their normal daily activities for the duration of the study | |
| Experimental: Exercise Group<br>This group exercises 3 times each week | Other: Exercise intervention<br>* Whole body vibration exercise 3 times per week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood insulin | Change in basal insulin levels | Baseline and week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Density | Change in bone mineral density | Baseline and week 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Latino, Hispanic, Boys
Trauma Informed Guilt Reduction Therapy

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to determine if a 6-session psychotherapy intervention will help Veterans feel less deployment-related guilt and less distress related to their guilt. Half of the participants will receive the guilt focused intervention and half will receive a supportive intervention. A supplemental pilot study added in FY2021 will examine the intervention for pandemic-related guilt events.

Official Title
-----------------
Trauma Informed Guilt Reduction Therapy

Conditions
-----------------
Guilt, Shame, Post-traumatic Stress Disorders

Intervention / Treatment
-----------------
* Behavioral: Trauma Informed Guilt Reduction Therapy
* Behavioral: Supportive Care Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant Served in OEF/OIF/OND, has post-traumatic guilt related to deployment event (for pandemic supplement in 2021, has guilt related to pandemic event) Exclusion Criteria: Moderate or severe cognitive impairment, acute suicidality, current severe substance use disorder, unmanaged psychosis or mania

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
Interventional Model Description: 188 enrollment goal for primary study, 75 enrollment goal for 2021 pandemic guilt supplement study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trauma Informed Guilt Reduction Therapy<br>6-session psychotherapy intervention | Behavioral: Trauma Informed Guilt Reduction Therapy<br>* Trauma focused therapy<br>|
| Active Comparator: Supportive Care Therapy<br>6-session psychotherapy intervention | Behavioral: Supportive Care Therapy<br>* Supportive therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Trauma Related Guilt Inventory - Guilt Severity |  | baseline to 8 months (for supplemental study of pandemic guilt in 2021, timeframe is baseline to 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinician Administered post traumatic stress disorder (PTSD) Scale |  | baseline to 8 months | 
| Change in Patient Health Questionnaire - 9 |  | baseline to 8 months | 
| Internalized Shame Scale |  | up to 6-months post-treatmetn follow-up | 
| Change in World Health Organization Quality of Life - Brief |  | baseline to 8 months | 
| Change in Brief Symptom Inventory-18 |  | baseline to 8 months |
Bringing Life to Those Near Death

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether virtual reality technology can reduce anxiety, depression, and emotional distress screening scores in palliative care patients.

Official Title
-----------------
Bringing Life to Those Near Death: Assessing the Use of Virtual Reality Technology in Palliative Care

Conditions
-----------------
Palliative Care

Intervention / Treatment
-----------------
* Behavioral: Virtual Reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria; A terminal or end-stage condition with an expected prognosis of a year or less. An established palliative care patient. English-speaking. Able to wear virtual reality equipment (goggles, etc.). Subject or Caregiver able to provide consent. Exclusion Criteria: Older than 65 years of age. Lack of a prognosis of 1 year or less.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality intervention in palliative care patients<br>Palliative care patients with a limited life expectancy will participate in a virtual reality experience for 10-30 minutes | Behavioral: Virtual Reality<br>* Simulated travel destination or activity of the participants choosing that would otherwise be inaccessible<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety | Measured using the self-reported Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Subjects rank how often they have been bother by specific problems within the last 2 weeks on a scale of 0 being not at all and 3 being nearly every day. Total scores range from 0-20, with higher scores indicating more anxiety severity. | Baseline, post-intervention approximately 30 minutes | 
| Change in emotional distress | Measured using the self-reported Distress from Death and Dying Survey. Subjects rank their distress on a scale or 0-10, 0 being no distress at all, and 10 being completely distressed. Total scores range from 0-130, with higher scores indicating more distress severity. | Baseline, post-intervention approximately 30 minutes |
Max COVID19- Study

Study Overview
=================
Brief Summary
-----------------
In view of the increasing cases of COVID-19 in India and the possibility of the exponential rise of the cases, this study has been designed to collect data of the healthcare workers of Max Hospital and the general population. Our objective is to identify individuals with flu-like symptoms in suspicion of COVID-19 and follow them weekly up to 8 weeks until the pandemic resolves. The data will be collected through an online questionnaire circulated via Emails or WhatsApp.

Detailed Description
-----------------
The primary objective of this study is to screen and identify individuals with flu-like symptoms and follow-them up weekly. In the study, baseline data will be collected online and then weekly follow up will be done with the participants for 4 weeks via opted communication method. There will be no physical contact and we are also avoiding the use of papers so as to avoid possible transmission. Participation in this study will be entirely voluntary and the questionnaire will be accessible to the participants only when they mark Agree on the form. The data collection form is available in English and Hindi. The study questionnaire includes questions related to general health status, clinical symptoms, Food security, and job security.

Official Title
-----------------
A Prospective, Longitudinal, Observational Study of Healthcare Workers and the General Population to Watch for Flu-like Symptoms in Suspicion of COVID 19

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indian males and females currently living in India, OR All the employees of Max Super Speciality Hospital, New Delhi, India Exclusion Criteria: Anyone who has filled the questionnaire once per household

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| COVID-19 positive case | An individual identified with the clinical symptoms when tested positive for COVID-19 | 4-8 weeks |
Probiotics for Prevention of Ventilator-Associated Pneumonia (VAP)

Study Overview
=================
Brief Summary
-----------------
Hospitalized patients with ventilator are randomized to receive fermented dairy product containing L. casei shirota or nothing. The main outcome is development of ventilator-associated pneumonia (VAP)

Detailed Description
-----------------
Fermented dairy product containing L. casei shirota has bee shown to inhibit multi-drug-resistant bacteria. This study is conducted to determine if Fermented dairy product containing L. casei shirota can prevent ventilator-associated pneumonia.

Official Title
-----------------
Randomized Controlled Trial of Fermented Dairy Product Containing L. Casei Shirota for Prevention of Ventilator-Associated Pneumonia

Conditions
-----------------
Drug Safety

Intervention / Treatment
-----------------
* Other: Probiotics
* Other: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age ≥ 18-year who received ventilator and agreed to participate by signing informed consent form Exclusion Criteria: Immunocompromised host (e.g. HIV infection, On immunosupressive agents, ANC ≤ 500 cell/ml), Pregnancy, History of congenital heart disease, rheumatic fever, previously infective endocarditis, prosthetic valve, Contraindication for enteral feeding, History of milk or milk-product allergy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>80 ml of fermented dairy product containing L. casei shirota via nasogastric tube once daily and 80 ml of fermented dairy product containing L. casei shirota oral rinse once daily | Other: Probiotics<br>* 80 ml of fermented dairy product containing L. casei shirota via nasogastric tube once daily and 80 ml of fermented dairy product containing L. casei shirota oral rinse once daily<br>* Other names: Yakult;|
| No Intervention: control<br> | Other: control<br>* usual oral care<br>* Other names: regular care;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with pneumonia | patient with pneumonia | up to 28 days |
Observational Study on Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The study is conducted in Europe. The aim of this observational study is to assess glycaemic control while using liraglutide under normal clinical practice conditions in Belgium.

Official Title
-----------------
A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Insufficiently controlled after 3 months of treatment with OADs (oral anti-diabetic drugs) Exclusion Criteria: Previously treated with liraglutide Hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections) Pregnant, breast feeding or have the intention of becoming pregnant
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: liraglutide<br>* Liraglutide will be prescribed and titrated (individually adjusted) by the treating physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with a decrease in HbA1c (glycosylated haemoglobin A1c) of at least 1% |  | month 12 | 
| Percentage of participants reaching the treatment target of a HbA1c (glycosylated haemoglobin A1c) decrease of at least 1% |  | month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | month 12 | 
| Fasting blood glucose (FBG) |  | month 12 | 
| Incidence of serious adverse events (SAEs) |  | months 0-12 | 
| Incidence of adverse drug reactions (ADRs) |  | months 0-12 | 
| Frequency of hypoglycaemic episodes (frequency of episodes with low blood sugar) |  | months 0-12 |
Losartan and Emotion Processing

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the effect of losartan (50mg, single dose) on the extinction of conditioned fear

Detailed Description
-----------------
In a double-blind, between-subject, placebo controlled design the effects of a single dose of losartan (50mg) on fear extinction in healthy male participants will be examined. Participants will initially undergo a Pavlovian fear conditioning procedure, followed by the administration of 50mg losartan or placebo. 90 minutes after treatment subjects will undergo the fear extinction procedure. Neural activity and psychophysiological indices of arousal will be assessed by the simultaneous acquisition of functional magnetic resonance imaging (fMRI) and skin conductance data.

Official Title
-----------------
Losartan Effects on the Extinction of Conditioned Fear in Humans

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

Intervention / Treatment
-----------------
* Drug: Losartan
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects without past or current psychiatric or neurological disorders Exclusion Criteria: history of head injury medical or psychiatric illness hypertension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Losartan group<br> | Drug: Losartan<br>* administration of losartan (50 mg) (oral)<br>* Other names: Cozaar Oral Tablet;|
| Placebo Comparator: Placebo group<br> | Drug: Placebo Oral Tablet<br>* administration of placebo (oral)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Losartan effects on neural activity during fear extinction | Neural activity will be measured by functional magnetic resonance imaging (fMRI). Effects of treatment will be evaluated by comparing extinction-related neural activity in the core extinction network (prefrontal cortex, limbic regions) between the active treatment and the placebo group. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Losartan effects on skin conductance responses during fear extinction | Effects of treatment will be evaluated by comparing extinction-related skin conductance responses between the active treatment and the placebo group. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Losartan, Fear extinction
Multi-center Registry for CCSVI Testing and Treatment

Study Overview
=================
Brief Summary
-----------------
Patients suspected of CCSVI (chronic cerebrospinal venous insufficiency) may be tested and if appropriate treated with catheter venoplasty by an interventional radiologist in their local community who has been credentialled either by the local hospital's IRB or a national IRB if the procedure is done in an outpatient facility. Catheter angioplasty is a long-established and accepted medical procedure, patients' insurance should but may not cover the testing or treatment.

Detailed Description
-----------------
more to follow

Official Title
-----------------
Multi-center Registry for CCSVI Testing and Treatment

Conditions
-----------------
CCSVI, Chronic Cerebrospinal Venous Insufficiency, Venous Malformations of CNS Draining Veins

Intervention / Treatment
-----------------
* Procedure: venous angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referral by patients primary treating physician for suspected CCSVI Exclusion Criteria: Abnormal kidney function Allergy to either or both of the imaging contrast agents Pacemaker or other implantable device Ferrous metal in or on the body Claustrophobia Pregnancy -

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CNS draining vein abnormalities<br> | Procedure: venous angioplasty<br>* catheter venous angioplasty via femoral vein approach<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-Form 36 (SF36) Quality of Life Instrument |  | Baseline and at 1, 6 and 12 months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neurodegenerative disease, neurovascular disease, fatigue, Hubbard Foundation, angioplasty