linjc16/ctgov huggingface dataset:
Measuring Quality of Decisions About Treatment of Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized controlled trial is to examine the impact of a patient decision aid on the quality of decisions about managing symptoms of depression. In particular, we will examine whether the decision aid increases knowledge about depression/managing depression symptoms and concordance between goals and treatment choices.

Official Title
-----------------
Measuring Quality of Decisions About Treatment of Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: DVD/Booklet: Coping with Symptoms of Depression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18+ In the last 12 months, talked to a health care provider about starting or stopping a treatment (prescription medicine for depression or counseling) Exclusion Criteria: none

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision Aid<br>Group receiving the decision aid (DVD/booklet) | Behavioral: DVD/Booklet: Coping with Symptoms of Depression<br>* DVD and booklet that provides information about treatment choices for depression symptoms<br>* Other names: Shared decision making programs;|
| No Intervention: Control<br>Group not receiving the decision aid (DVD/booklet) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Knowledge | Total knowledge score from factual questions about depression and methods for managing depression symptoms. Score is the percent of knowledge items answered correctly (0 - 100%). | 2 weeks, on average | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value Concordance | Measure of how concordant respondents' actual decisions about treatment for their depression are with their stated beliefs | 2 weeks, on average | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Depressive disorder, Decision Making, Decision Aids, Decision Quality Instrument
Wearable Devices for Secondary Prevention of Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
Ischemic stroke is an important cause of death and disability in Western countries. Different risk factors have been identified such as hypertension, diabetes, dyslipidemia, smoke, atrial fibrillation, obesity, and sedentary. The aim of this study is to evaluate the feasibility of an approach based on the use of wearable devices for the identification and reduction of risk factors in patients with previous history of ischemic stroke or transient ischemic attack.

Official Title
-----------------
Wearable Devices for Secondary Prevention of Ischemic Stroke

Conditions
-----------------
Stroke, Ischemic, Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Wearable devices for identifying and measuring risk factors for ischemic stroke
* Other: Standard of care monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal 50 years Recent transient ischemic attack or minor stroke Exclusion Criteria: Patients with significant cognitive impairment Patients dependent in the instrumental activities of daily life Patients not able to respect the frequency of monitoring program Patients with history of atrial fibrillation

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearable Devices Monitoring<br>Patients will be provided with wearable devices for at-home monitoring heart rhythm and rate, blood pressure, pulse oximetry, quality and quantity of sleep, and pace counting. | Device: Wearable devices for identifying and measuring risk factors for ischemic stroke<br>* Identifying and monitoring cerebrovascular risk factors using wearable devices<br>|
| Active Comparator: Standard of Care Monitoring<br>Patients will be evaluated by periodical clinical visits. | Other: Standard of care monitoring<br>* Periodical medical examinations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance of patients to at-home follow-up by means of wearable devices | Number of measurements actually performed in comparison to number of expected measurements | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation Detection Rate | Percentage of subjects with atrial fibrillation detected within 1 month of follow-up | 1 month | 
| Prevalence of Recurrent Stroke or Transient Ischemic Attack | Prevalence of subjects with recurrent stroke or Transient Ischemic Attack within 1 month of follow-up | 1 month |
Omalizumab Treatment in Venom Immunotherapy With Systemic Reactions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to systemic reactions.

Detailed Description
-----------------
Some honey bee venom allergic patients cannot be treated with venom immunotherapy due to systemic reactions during immunotherapy - immunotherapy failure due to systemic reactions. High basophil allergen sensitivity is a risk factor for venom immunotherapy failure due to systemic reactions. Omalizumab decreases basophil sensitivity. Venom immunotherapy failure patients will be co-treated with omalizumab during another attempt of immunotherapy introduction. Patients will be clinically and immunologically followed up after the introduction.

Official Title
-----------------
Influence of Omalizumab Co-treatment on Honey-bee Venom Immunotherapy Failure Due to Systemic Reactions

Conditions
-----------------
Allergy, Bee Venom, Immunotherapy, Omalizumab

Intervention / Treatment
-----------------
* Drug: omalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe anaphylactic reaction after honey-bee sting (Mueller grade III or IV) confirmed sensitization to honey-bee venom, honey-bee venom immunotherapy treatment failure due to systemic reactions. Exclusion Criteria: systemic mastocytosis, pregnancy, use of beta-adrenergic blocking agents.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEVIT<br>Co treatment with omalizumab during another attempt of immunotherapy introduction | Drug: omalizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of systemic reactions during ultra rush immunotherapy build up phase and maintenance phase followed by omalizumab co-treatment. |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in basophil sensitivity during omalizumab co-treatment |  | 2 years |
REWARDS Premier Taxus-Liberte vs Xience V

Study Overview
=================
Brief Summary
-----------------
Multicenter, retrospective registry to collect baseline, clinical, procedural, in hospital and 9-12 month follow-up data to compare major adverse cardiac events in patients receiving Promus Premier drug eluting stent to data already collected from the REWARDS-TLX Registry in which patients received either the Taxus Liberte or XIENCE V drug eluting stent.

Official Title
-----------------
REWARDS-Premier TLX (Registry Experience at the WAshington Hospital CenteR, DeS - Premier Taxus-Liberte vs Xience V)

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

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older Underwent PCI with Promus Premier (alone) DES Exclusion Criteria: Underwent PCI with a non-Promus Premier DES during the same index procedure Patients not taking, or unable to take, dual antiplatelet therapy (aspirin plus clopidogrel, prasugrel, or ticagrelor)

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 |
| --- | --- |
| Promus Premier<br>observational data | Other: Observational<br>* compare data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac event | composite of all-cause death, Q-wave myocardial infarction, and target vessel revascularization | 1 year |
Normothermia Protocol for Traumatic Brain Injury Patients

Study Overview
=================
Brief Summary
-----------------
Comparison between a normothermia protocol and current protocol (acetaminophen plus blankets) Normothermia Protocol is successful in achieving and maintaining normal temperature in moderate to severe Traumatic Brain Injury (TBI) patients.(using Arctic Sun for 96 hrs from admission to Neuro ICU) Normothermia is translated into improved neurologic Outcome and survival compared to standard of care (Physician management)

Official Title
-----------------
Normothermia Protocol for Traumatic Brain Injury Patients: An Outcome Study

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe TBI patients(GCS 3-9) admitted to ICU Exclusion Criteria: Less than 18 years OLD. Bleeding disorders. Pregnancy/Breastfeeding. Hepatic Encephalopathy. Spinal cord injury (know or new) Fever >100 F prior to randomization. Blood Alcohol level >80 Participation in other Research trial. Inability/unwilling to obtain Informed consent. Terminal illness(not expected to survive 3-6 months) Not expected to survive 24 hrs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Current protocol group<br>Patients treated with current standards based on physician discretion. | |
| Normothermia group<br>Normothermia protocol, using Hydrogel cooling Pads(Arctic Sun) applied for 96 hrs starting upon admission to the ICU | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the Normothermia protocol | Number of times patient's temp was above 37°C during this 96 hr period | 5 days | 
| Temperature vs ICP | Number of times ICP > 20 in patients with ICP monitors | 5 days | 
| Neurologic Outcome of the 2 patient populations | Modified Rankin Scale at Hospital discharge, 3 months, and 6 months | 1month, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | In-Hospital mortality, 3 - 6 month mortality | 5 days, 3 months, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Normothermia, fever control, Outcome study
Acid Suppressing Drug Seizure Epidemiology Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the incidence of seizure in the general population and stratified by epilepsy status To estimate the relative risk of seizure associated with use of proton pump inhibitors and histamine 2 receptor antagonist and stratified by epilepsy status

Detailed Description
-----------------
A cohort study with a nested case control analysis on the association between acid-suppressing drugs and seizures using THIN database in the UK

Official Title
-----------------
A Cohort Study With a Nested Case Control Analysis on the Association Between Acid-suppressing Drugs and Seizures Using THIN Database in the UK

Conditions
-----------------
Seizure

Intervention / Treatment
-----------------
* Drug: Risk of seizure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary care physician for at least 2 years. Computerized prescription history of at least 1 year. Patients will have to be free of acid-suppressing drugs (PPI or H2RA) for at least one year. No diagnosis of cancer. No alcohol abuse or alcohol-related disease- No drug abuse. Exclusion Criteria: Patients with at least 1 prescription of PPI or H2RA in the year prior to start date. Cancer before start date. Alcohol abuse or alcohol-related disease before start date. Drug abuse before start date.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients newly prescribed PPI<br>All patients newly prescribed PPI | Drug: Risk of seizure<br>* Patients newly prescribed PPI and H2RA, respectively<br>|
| All patients newly prescribed H2RA<br>All patients newly prescribed H2RA | Drug: Risk of seizure<br>* Patients newly prescribed PPI and H2RA, respectively<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of seizure in the general population and stratified by epilepsy status. |  | Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years. | 
| Follow-up of safety outcomes: First recorded entry of seizure. |  | Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seizure, Acid-suppressing drugs, Epidemiology
Intestinal Barrier Function and Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Patients with liver cirrhosis have an increased risk to develop life-threatening complications such as spontaneous bacterial peritonitis (SBP). Impairment in the intestinal barrier, changes in numbers and composition of the intestinal microbiota and alterations in immune defenses have been suggested to be involved in liver cirrhosis and its complications. Dysfunction in the intestinal barrier for example results in the ongoing passage of toxic substances from the gastrointestinal tract that may damage the liver, leading to oxidative stress, inflammation and eventually liver cirrhosis. In addition, bacterial translocation is considered a key step in the development of spontaneous infections, mainly SBP, in patients with liver cirrhosis. The investigators hypothesize that patients with decompensated liver cirrhosis have a more impaired intestinal epithelial barrier and altered intestinal microbiota than patients with compensated liver cirrhosis.

Official Title
-----------------
The Role of the Intestinal Barrier Function in Liver Cirrhosis

Conditions
-----------------
Liver Cirrhosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver cirrhosis of any cause A score of greater-than or equal to 5 assessed according to the Child-Pugh classification Age between 18 and 65 years Exclusion Criteria: Known gastrointestinal diseases (such as inflammatory bowel disease and celiac disease), chronic renal disease (i.e. a glomerular filtration rate of less-than or equal to 60 ml/min per 173 m2 estimated from the Modification of Diet in Renal Disease (MDRD) equation) or Diabetes Mellitus Major abdominal surgery interfering with gastrointestinal function (except for uncomplicated appendectomy, cholecystectomy and hysterectomy, other surgery upon judgement of the principle investigator)

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Compensated liver cirrhosis<br> | |
| Decompensated liver cirrhosis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary aim is to study differences in small and large intestinal permeability between patients with compensated and decompensated cirrhosis by means of a sugar permeability test |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess tight junction structure and proteins in biopsy specimens of small and large intestine |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver cirrhosis, intestinal permeability, microbiota, complications
Exercise Duration Models, in Middle-aged Men

Study Overview
=================
Brief Summary
-----------------
Duration of exercise is an important factor among the medical guides for weight loss. However, there is still little knowledge about other its models in middle-aged and older men. The present study aimed to determine the effects of the interval training on weight loss and lipid profile, and to compare its efficiency with the continuous training.

Detailed Description
-----------------
Participants included sedentary men (age 45-75 years) with overweight or obesity (n= 82). They were randomly divided into two groups including continuous exercise, and interval exercise. The weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.

Official Title
-----------------
The Study of Various Models of Exercise Duration on Weight Loss and Lipid Profile in Sedentary Overweight/Obese Middle-aged Men

Conditions
-----------------
Weight Loss

Intervention / Treatment
-----------------
* Other: Continuous training
* Other: The interval training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sedentary lifestyle Good Health Weight stability Exclusion Criteria: Abnormality or history of Disease

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: continuous training group<br>With the continuous training program | Other: Continuous training<br>* Study group I (42 participants) received the continuous training.<br>* Other names: group I;|
| Experimental: interval training group<br>With the interval training program | Other: The interval training<br>* Study group II (40 participants) received the interval training.<br>* Other names: group II;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-item | weight, lipid profile (HDL, LDL, Cholesterol) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-item | weight, lipid profile (HDL, LDL, Cholesterol) | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Men, Caloric Restriction, Dietary Formulations, Exercise