linjc16/ctgov huggingface dataset:
Efficacy Study of Low-dose Glucocorticoid Prophylaxis for Acute Graft-versus-host Disease(GVHD)

Study Overview
=================
Brief Summary
-----------------
Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia. However, GVHD rate was still high after haploidentical HSCT. It was found in our previous study that CD4/CD8>=1.16、CD56bright NK>1.9×106/kg in the graft was associated with higher risk of developing acute Graft-versus-host Disease (GVHD). The study hypothesis: Risk stratification-directed low-dose glucocorticoid prophylaxis for acute GVHD after unmanipulated haploidentical blood and marrow transplantation can reduce the incidence of acute GVHD

Detailed Description
-----------------
patients undergone haploidentical HSCT following day 5 post transplant were randomized to treated group(low-dose glucocorticoid) and controlled group(no intervention).

Official Title
-----------------
Risk Stratification-directed Low-dose Glucocorticoid Prophylaxis for Acute GVHD After Unmanipulated Haploidentical Blood and Marrow Transplantation--a Randomized, Controlled, Clinical Trial

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Drug: low-dose glucocorticoid Methylprednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no severe diarrhea no serious infection Exclusion Criteria: serious diarrhea active,uncontrolled infection

Ages Eligible for Study
-----------------
Maximum Age: 60 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: low-dose glucocorticoid<br>drug | Drug: low-dose glucocorticoid Methylprednisolone<br>* patients receive low-dose glucocorticoid from day 5 post transplant<br>* Other names: Methylprednisolone;|
| Other: no intervention after transplant<br> | Drug: low-dose glucocorticoid Methylprednisolone<br>* patients receive low-dose glucocorticoid from day 5 post transplant<br>* Other names: Methylprednisolone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of acute graft-versus-host disease | number of participants with acute graft-versus-host disease at 100 days | paticipants will be followed for the duration of hospital stay,an expected average of 100 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of infection | number of participants with infection (including bacterium,EB virus, cytomegalovirus and fungus ) at 100 days | participants will be followed for the duration of hospital stay,an expected average of 100 days |
Project Fit:a School- and Community-based Obesity Intervention

Study Overview
=================
Brief Summary
-----------------
Project FIT is a collaboration between the public school system, local health systems, physicians, neighborhood associations, businesses, faith-based leaders, community agencies and university researchers to develop a multi-faceted approach to promote physical activity and healthy eating toward the general goal of preventing and reducing childhood obesity among children in Grand Rapids, MI, USA. There are four overall components to Project FIT: school, community, social marketing, and school staff wellness - all that focus on: 1) increasing access to safe and affordable physical activity and nutrition education opportunities in the schools and surrounding neighborhoods; 2) improving the affordability and availability of nutritious food in the neighborhoods surrounding the schools; 3) improving the knowledge, self-efficacy, attitudes and behaviors regarding nutrition and physical activity among school staff, parents and students; 4) impacting the 'culture' of the schools and neighborhoods to incorporate healthful values; and 5) encouraging dialogue among all community partners to leverage existing programs and introduce new ones.

Official Title
-----------------
Project Fit:a School- and Community-based Intervention to Address Physical Activity and Healthy Eating Among Low-income Elementary School Children

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Project Fit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: enrolled in participating school district in grades 1-5. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 14 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: physical activity and nutrition<br> | Behavioral: Project Fit<br>* physical activity and nutrition education<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity measured by pedometer. | Physical activity will be measured with a pedometer worn for 7-day period at the beginning and end of the intervention. | 2 years | 
| Healthy eating index quantified by the Food Frequency Questionnaire. | The healthy eating index is a composite measure of diet quality. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical inactivity, poor diet
Prevention of Asthma Relapse After Discharge From Emergency

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the Symbicort® Turbuhaler® to both Pulmicort® Turbuhaler® and Bricanyl® Turbuhaler® for the treatment of asthma after discharge from the emergency room

Official Title
-----------------
A Comparison of Budesonide/Formoterol Turbuhaler® 160/4.5 µg 2 Inhalations BID Plus as Needed to Budesonide Turbuhaler® 320 µg 2 Inhalations BID Plus Terbutaline Turbuhaler® 0.4 mg as Needed for the Prevention of Asthma Relapse

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

Intervention / Treatment
-----------------
* Drug: Budesonide/formoterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 65 years of age Presenting at a study emergency department with an asthma exacerbation Exclusion Criteria: Admission to hospital Patients receiving more than 2000 µg/day of beclomethasone equivalent inhaled corticosteroids (1000 µg/day fluticasone or 1600 µg/day budesonide)

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Budesonide/formoterol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first asthma relapse |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean use of reliever medication |  |  | 
| Asthma Control Questionnaire (ACQ) score |  |  | 
| Complete AE and SAE collection |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma Reoccurrence, Acute Asthma, Patient Discharge, Emergency Service, Hospital, Asthma Exacerbation, Asthma Relapse
Pharmacokinetics and Excretion of Albendazole and Its Metabolites in Saliva

Study Overview
=================
Brief Summary
-----------------
This project will develop and assess the feasibility and acceptability of a salive-based assay to monitor adherence to Mass Drug Administration (MDA) campaigns within Soil-transmitted helminthiasis (STH) control programs, evaluating the salive and serum pharmacokinetics of ALBENDAZOLE (ABZ) and its metabolites.The final goal is to obtain a field ready tool for the measurement of adherence to anthelmintic treatment at a community level that serves as a coverage/adherence indicator and a reference standard for other monitoring tools.

Official Title
-----------------
Pharmacokinetics and Excretion of Albendazole and Its Metabolites in Saliva in Healthy Volunteers

Conditions
-----------------
Pharmacological Action

Intervention / Treatment
-----------------
* Drug: Albendazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index: 18 to 25. Physical exam without significant abnormal findings. Exclusion Criteria: Pregnancy Lactation Use of ABZ or other benzimidazole drugs in the previous 30 days History of intolerance to ABZ Malabsorption and/or other gastrointestinal conditions that might compromise ABZ absorption.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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: Albendazole<br>400 mg po single dose | Drug: Albendazole<br>* tablet administration after a meal contaning approximate 15 g of fat<br>* Other names: Albendazole tablet, Albendazole 400mg po;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salive albendazole levels | Albendazole and its metabolites will be measured in salive samples through high performance liquid chromatography (HPLC). | 72 hours |
Influence of Pregnenolone on Exposure Therapy in Obsessive-compulsive Disorder

Study Overview
=================
Brief Summary
-----------------
Characterization of the influence of pregnenolone vs. placebo on subjective distress and autonomic functioning during cognitive-behavioral exposure therapy in patients with obsessive-compulsive disorder.

Detailed Description
-----------------
Main out-come parameters: Inter-session habituation as per SUD (100 mm VAS), Y-BOCS Secondary out-come parameter: HF/LF of HRV, Salivary epinephrine

Official Title
-----------------
Influence of Pregnenolone on Distress and Autonomic Parameters During Cognitive-behavioral Exposure Therapy in Patients With Obsessive-compulsive Disorder

Conditions
-----------------
Obsessive-compulsive Disorder (OCD)

Intervention / Treatment
-----------------
* Behavioral: Exposure therapy with pharmacological facilitation
* Behavioral: Exposure therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -OCD according to DSM-IV criteria. Exclusion Criteria: Acute suicidality psychotic disorders, bipolar disorder substance dependency organic brain disorder pregnancy lactation tuberculosis gastric/duodenal ulcer diabetes mellitus acute inflammation autoimmune disorders arterial hypertension therapy with glucocorticoids (up to 4 weeks ago)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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: Nutritional supplement Pregnenolone<br>Exposure therapy, exposure with response prevention and pharmacological facilitation (nutritional supplement pregnenolone), orally two hours before exposure therapy. | Behavioral: Exposure therapy with pharmacological facilitation<br>* Exposure with response prevention and pharmacological facilitation<br>|
| Placebo Comparator: Placebo<br>Exposure therapy, exposure with response prevention without pharmacological facilitation (Placebo), orally two hours before exposure therapy. | Behavioral: Exposure therapy<br>* Exposure with response prevention without pharmacological facilitation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective units of distress (SUD) |  | During exposure therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low/high frequency index of heart rate variability (L/HFI) |  | During exposure therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obsessive-compulsive disorder (OCD), Exposure therapy, Extinction learning, Pregnenolone
Acupuncture for the Prevention of Postdates Pregnancy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess if acupuncture can shorten the time to delivery for women who are experiencing their first, full-term pregnancy.

Detailed Description
-----------------
There are certain medical conditions that can complicate pregnancies after 40 weeks gestation. However, it is not always safe or easy to put these women into labor. Acupuncture has been used in Asia for hundreds of years to induce contractions and begin the labor process. Acupuncture is not typically used in the United States to induce labor, however. The purpose of this study is to determine whether a series of up to five acupuncture treatments can prevent postdates pregnancy.

Official Title
-----------------
A Randomized Controlled Trial of Acupuncture to Prevent Postdates Pregnancy

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Procedure: Acupuncture
* Procedure: Sham comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first, full-term pregnancy 38-41 weeks gestation English or Spanish speaking Bishop score of 7 or less Exclusion Criteria: uncertain pregnancy dating transportation difficulties previous inability to tolerate acupuncture age less than 18

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

Sexes Eligible for Study
-----------------
Female

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br> | Procedure: Acupuncture<br> <br> |
| Sham Comparator: Sham Acupuncture<br> | Procedure: Sham comparator<br> <br> |
| No Intervention: Usual care only<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevention of inpatient induction of labor |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of cesarean delivery |  |  | 
| rates of chorioamnionitis |  |  | 
| length of maternal hospital stay |  |  | 
| rates of assisted delivery |  |  | 
| neonatal outcomes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, acupuncture
Genomic and Proteomic Analysis of Disease Progression in Idiopathic Pulmonary Fibrosis (IPF)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to identify genetic and biologic markers that may predict the loss of lung function due to idiopathic pulmonary fibrosis. The studies will compare genetic and biologic markers of samples to changes in symptoms. The ultimate goal is to predict if or when patients are likely to experience a rapid decline in lung function due to disease progression.

Detailed Description
-----------------
People who are diagnosed with idiopathic pulmonary fibrosis are asked to participate in this study. The subject must be treated at the Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease. Subjects, if consented, are required to perform tests so that research data can be collected. At the initial visit, patients are subject to having a blood draw, pulmonary function testing, echocardiograms, and CT scans as well as completing several questionnaires designed to measure how the patient is feeling. Follow up visits are then scheduled in 3-4 month intervals. Every 3-4 months blood samples will be collected while every 6-8 months the questionnaires will administered. If the patient enters a stage of accelerated decline in lung function, a bronchoscopy will be performed to collect residual bronchoalveolar lavage fluid for testing. All of the results of clinical and laboratory testing will be placed into the subjects research file.

Official Title
-----------------
Genomic and Proteomic Analysis of Disease Progression in Idiopathic Pulmonary Fibrosis

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are 18 or older Diagnosis of Idiopathic Pulmonary Fibrosis Treated at the Simmons Center Exclusion Criteria: Other Lung Illness

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
-----------------
Lung, Fibrosis, Idiopathic, Biomarkers, Genomics, Longitudinal
Study of TRM-1 (TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, efficacy and exposure to TRM-1 in subjects with relapsed or refractory Non-Hodgkin's Lymphoma (NHL).

Official Title
-----------------
A Multi-Center, Open-Label, Dose-Escalation Study to Evaluate the Safety, Efficacy, and Exposure to TRM-1 (Fully Human Monoclonal Antibody to the TRAIL-R1) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma

Conditions
-----------------
Lymphoma, Non-Hodgkin

Intervention / Treatment
-----------------
* Drug: TRAIL-R1 mAb (TRM-1; HGS-ETR1)


Participation Criteria
=================
Eligibility Criteria
-----------------
Primary Inclusion Criteria: Relapsed or refractory histologically confirmed Non-Hodgkin's Lymphoma Previously treated with at least 1 therapeutic regimen and relapsed or progressed or failed to achieve a response after the last regimen 18 years of age or older Primary Exclusion Criteria: Received a non-FDA approved investigational agent within the last 4 weeks Received cancer therapies (chemotherapy, biological therapy [including hormonotherapy], radiation therapy or immunosuppressants within the last 3 weeks, 8 weeks for monoclonal antibodies, radioimmunotherapy or nitrosourea Eligible for a hematopoietic stem cell transplant (HSCT) or have had an autologous HSCT within the last 16 weeks Prior history of an allogeneic HSCT HIV, AIDS-related lymphoma, central nervous system (CNS) lymphoma, Hepatitis-B or Hepatitis-C Infection requiring antibiotics within the last 4 weeks Major surgery within the last 4 weeks Pregnant or breast-feeding women History of other cancers within the past 5 years

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TRAIL-R1 mAb (TRM-1; HGS-ETR1)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant

Study Overview
=================
Brief Summary
-----------------
Use of the EnSite NavX system to map the coronary vasculature during CRT implant

Detailed Description
-----------------
Objective(s): To determine the feasibility of CS mapping with NavX during Biventricular Implantable Cardioverter Defibrillator (BiV ICD) implantation. Inclusion Criteria: Subject is between the age of 18 and 75 years Subject is willing and able to sign a study specific informed consent Subject is able to fulfill study requirements Meet the conventional criteria for implant of a BiV ICD, including; LVEF of ≤35%, QRS ≥ 120 ms and NYHA III-IV Have persistent CHF symptoms despite contemporary CHF medical therapy Stable and optimal medical therapy (stability is no changes in past 3 months). Documented history of ischemic or non-ischemic cardiomyopathy. Exclusion Criteria: Have any standard device exclusions including tricuspid valve prosthesis/ replacement. Have a positive urine or serum pregnancy test (if female and of childbearing potential) Be currently participating in an IDE or IND study.

Official Title
-----------------
Mapping in the Coronary Sinus During Implant of a Bi-Ventricular Implantable Cardioverter Defibrillator Utilizing the NavX Mapping System

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Other: EnSite NavX System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet criteria for CRT implant including EF<35%, QRS>120ms, NYHA class III or IV Persistent CHF symptoms despite optimization Stable/optimal medical therapy History of ischemic or non-ischemic cardiomyopathy Exclusion Criteria: Any standard device exclusion including TVR Positive pregnancy test Currently participating in IDE/IND study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: EnSite NavX System|EnSite NavX system is a 3D Mapping system|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine feasibility of CS mapping with EnSite NavX during CRT implant |  | Procedural |