linjc16/ctgov huggingface dataset:
MSC for Severe aGVHD

Study Overview
=================
Brief Summary
-----------------
Steroid-resistant acute graft-versus-host disease (aGVHD) is one of the most severe complications in the setting of allogeneic hematopoietic stem cell transplantation (HSCT), which cannot be significant benefit from the second-line therapies.The mesenchymal stem cells (MSCs) possess extensive immunomodulatory properties and are very promising to rescue the refractory aGVHD.This study aims to assess the efficacy and safety of MSCs for the treatment of the refractory aGVHD.

Official Title
-----------------
Treatment of Steroid-resistant Severe Acute Graft-versus-host Disease With Mesenchymal Stem Cells

Conditions
-----------------
Steroid-resistant Severe aGVHD

Intervention / Treatment
-----------------
* Biological: MSCs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Aged <65 years Patients with steroid-resistant severe aGVHD Cardiac: Left ventricular ejection fraction ≥ 50% Adequate renal and hepatic function Performance status: Karnofsky ≥ 70% Exclusion Criteria: Pregnant or lactating females. Any co-morbidity precluding the administration of MSCs.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSCs treated<br> | Biological: MSCs<br>* mesenchymal stem cells therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete and partial response rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events that are related to treatment |  | 1 year |
Injury Incidence in Professional Soccer

Study Overview
=================
Brief Summary
-----------------
The winter break within the German Professional Football Leagues will be shortened as for the season 2009/2010 from 6.5 to 3.5 weeks. That might have repercussions on injury incidence in either way, positive or negative. On the one hand, recovery time during the winter will be shorter, which might lead to an increased risk of injury. On the other hand, it will allow a better spread of games in the second round, thus reducing the amount of the so-called English weeks, which in turn could reduce the number of injuries. This study compares injury incidence between the season 2008/2009 (long winter break) and the season 2009/2010(short winter break) via questionnaires in accordance with UEFA/FIFA injury evaluation criteria.

Official Title
-----------------
Repercussions of a Shortened Winter Break on Injury Incidence Within the German Professional Soccer Leagues

Conditions
-----------------
Injury

Intervention / Treatment
-----------------
* Other: shortened winter break


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: German professional male soccer players Exclusion Criteria: Loss of professional status as a soccer player

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Soccer Players<br>German professional soccer players | Other: shortened winter break<br>* winter break shortened by 3 weeks (from 6.5 to 3.5) within the German Professional Soccer League in season 2009/2010<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| injury incidence |  | 2 seasons | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| types of injury |  | 2 seasons | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
injury incidence, male professional soccer, Change of injury incidence in professional soccer
A Sub Study of the Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)

Study Overview
=================
Brief Summary
-----------------
This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)

Detailed Description
-----------------
This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH). All patients who participated in the current study (CORT118335-861) or the Corcept Phase 2a NASH study (CORT118335-860), and who received at least one dose of miricorilant will be eligible for participation in an observational follow-up study; this includes patients who either terminated early or are study completers.

Official Title
-----------------
A Phase 1b, Open-Label Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Adult Patients With Presumed Nonalcoholic Steatohepatitis (NASH)

Conditions
-----------------
Nonalcoholic Steatohepatitis (NASH)

Intervention / Treatment
-----------------
* Other: MRI-PDFF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have participated in either Study CORT118335-861 (current study) or Study CORT118335-860 (Corcept Phase 2a NASH study) and received at least one dose of miricorilant; this includes patients who terminated early from the study or completed the study. Have not participated in any other clinical trial following study completion in either Study CORT118335-861 or Study CORT118335-860.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CORT118335-860 Participants<br>This group will include patients who participated in CORT118335-860 study and received at least one dose of miricorilant. | Other: MRI-PDFF<br>* Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a MRI-based diagnostic imaging biomarker of the liver.<br>|
| CORT118335-861 Participants<br>This group will include patients who participated in CORT118335-861 study and received at least one dose of miricorilant. | Other: MRI-PDFF<br>* Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a MRI-based diagnostic imaging biomarker of the liver.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liver-fat content assessed by MRI-PDFF after the last dose of study drug. |  | Baseline Day 1 up to Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nonalcoholic Steatohepatitis, NASH, Nonalcoholic Fatty Liver Disease
Motor Development and Orthoses in Spinal Muscular Atrophy (SMA)

Study Overview
=================
Brief Summary
-----------------
Spinal Muscular Atrophy (SMA) is neurodegenerative disease of anterior horn cells of spinal cord and represents the second more frequent pathology in childhood. According to the age of onset and the maximum motor function the disorder is classified in 4 types. Patients with SMA II and SMA III often use orthoses to achieve postural and dynamic functions. In this retrospective observational study the investigators describe the characteristics of sitting position, standing and walking correlated to type and time of orthoses used.

Detailed Description
-----------------
We collect data from patients with SMA II and SMA III referred to UDGEE from jan. 1995 to dec. 2008. We estimate to achieve informations about 50-70 patients.

Official Title
-----------------
Assessment of Motor Development Related to Use of Orthoses in SMA II and III

Conditions
-----------------
Spinal Muscular Atrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical and genetics diagnosis of SMA II and SMA III Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SMA II and SMA III<br>patients with SMA II and SMA III | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time and percentage of sitting, standing, walking achievement in SMA II and SMA III |  | aug.2009- nov.2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| characteristics and percentage of orthoses for postural sitting control , standing and walking in SMA II and SMA III |  | aug. 2009 - dec.2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal muscular atrophy, motor development, orthoses
The Effects of Administration of Combined Docosahexaenoic Acid and Vitamin E Supplements on Spermatogram and Seminal Plasma Oxidative Stress in Infertile Men With Asthenozoospermia

Study Overview
=================
Brief Summary
-----------------
Since docosahexaenoic acid (DHA) level in sperm membrane has been shown to be decreased in asthenozoospermic men, the investigators hypothesized that DHA supplementation may improve it. Furthermore, the investigators added vitamin E to it to protect its unsaturated bonds which are susceptible to oxidation and production of free oxygen radicals.

Conditions
-----------------
Asthenozoospermia

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin E
* Dietary Supplement: DHA
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Willing to participate in the study and filling out the informed consent form should be infertile (no conception after 12 months intercourse without any contraception) age 20-45 y.o, idiopathic asthenospermia according to WHO criteria normal hormonal profile Exclusion criteria: any infection in genitourinary (GU) tract any anatomical abnormality in GU tract any chronic disease during last 3 months any surgery in GU tract consumption of omega-3 fatty acids and/or vitamin E supplements during last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHA plus vitamin E<br>Cap DHA 460mg plus vitamin E 600mg per day | Dietary Supplement: vitamin E<br> <br> Dietary Supplement: DHA<br> <br> |
| Active Comparator: VitaminE plus placebo<br>vitamin E 600 mg plus placebo | Dietary Supplement: vitamin E<br> <br> Other: placebo<br> <br> |
| Placebo Comparator: placebo plus placebo<br>DHA shaped placebo plus vitamin E shaped placebo | Other: placebo<br> <br> |
| Active Comparator: DHA plus placebo<br>460 mg DHA plus placebo | Dietary Supplement: DHA<br> <br> Other: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sperm motility | spermatogram | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sperm count | spermatogram | 12 weeks | 
| seminal oxidative stress | ELISA | 12 weeks |
Health Values and Spirituality in Veterans With HIV/AIDS

Study Overview
=================
Brief Summary
-----------------
We have previously shown that: 1) time tradeoff utilities for current health are high, indicating that patients have a strong will to live; 2) half of patients felt that their life was better now than before they were HIV-infected; and 3) certain non-health-related factors such as spirituality and concern and love for one�s children correlated with health values and a sense that life has improved.

Detailed Description
-----------------
Background: We have previously shown that: 1) time tradeoff utilities for current health are high, indicating that patients have a strong will to live; 2) half of patients felt that their life was better now than before they were HIV-infected; and 3) certain non-health-related factors such as spirituality and concern and love for one�s children correlated with health values and a sense that life has improved. Objectives: 1) To assess health values of veterans and non-veterans with HIV/AIDS; 2) To characterize spirituality in patients with HIV/AIDS; 3) To derive a power function relating health ratings to utilities; and 4) To assess whether society assigns higher values to health states for veterans than for non-veterans. Methods: We interviewed 100 representative veterans with HIV/AIDS from the Cincinnati and Pittsburgh VAMCs and, concurrently, 350 non-veterans with HIV/AIDS from Cincinnati and Washington, DC, twice over 12-18 months. The patient questionnaire included clinical and demographic data; health values measures; a question comparing life now with life before being infected with HIV; and measures of health status/health concerns, HIV symptoms, depressive symptoms, spirituality/religion, adherence, social support, self-esteem, and optimism. We also assessed how medical house officers rate and value the health state of a hypothetical patient with congestive heart failure, identified either as a 72-year-old veteran or merely as a 72-year-old male. Status: Data collection completed ahead of schedule. Several manuscripts published with others to be submitted soon.

Official Title
-----------------
Health Values and Spirituality in Veterans With HIV/AIDS

Conditions
-----------------
Quality of Life, HIV, Spirituality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with HIV/AIDS Exclusion Criteria:

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 |
| --- | --- |
| Group 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Faith Leaders Advocating for Maternal Empowerment (FLAME)

Study Overview
=================
Brief Summary
-----------------
In 2015, the average Ethiopian woman had a 1 in 64 lifetime risk of death due to complications of childbirth and 87,414 newborns died before their 28th day of life. Demand for MNCH services, however, remains low in Ethiopia's rural communities most at risk with only 16% of women delivering in a health facility. The investigator's project responds to the challenge of creating demand for existing MNCH services in rural Ethiopia, which fell short of reaching Millennium Development Goal targets for reducing preventable maternal and neonatal deaths. This study addresses two strategic drivers to prevent maternal mortality identified by USAID including improving individual, household, and community behaviors and norms and increasing equity of access and use of services by the most vulnerable. The primary objective of the study is to determine the impact of a behavior change intervention that partners Ethiopian Orthodox priests with members of the Health Development Army (HDA) and trains them to conduct maternal health outreach to increase births attended by skilled health personnel among women who attend ≥1 ANC visits.

Official Title
-----------------
Faith Leaders Advocating for Maternal Empowerment (FLAME)

Conditions
-----------------
Prenatal Care, Maternal Health Services, Perinatal Care

Intervention / Treatment
-----------------
* Behavioral: FLAME


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women Willing to receive intervention counseling Exclusion Criteria: None
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized trial assigning facility catchment areas to intervention vs. standard of care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: FLAME<br>* The FLAME intervention trains pairs of faith leaders and community health workers and deploys them to conduct behavior change outreach in their communities.<br>|
| No Intervention: Standard of Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facility delivery | The proportion of births attended by skilled health personnel among the women who attended ≥1 ANC visits | Through study completion, an average of 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any ANC | Number of women who attended ≥1 ANC visits | Through study completion, an average of 18 months | 
| Complete ANC | Number of women who attended ANC 4 | Through study completion, an average of 18 months |
Mechanism of Growth Hormone Effects on Adipose Tissue

Study Overview
=================
Brief Summary
-----------------
Growth hormone treatment in humans has been shown to decrease body fat. This study aims to determine what adipose tissue depots are affected by GH and what is the mechanism.

Detailed Description
-----------------
Growth hormone (GH) replacement in GH deficient adults results in an improvement in metabolic status, an increase in lean body mass and a reduction in visceral adiposity. GH might also decrease visceral adiposity in obese adults that are not GH deficient. The objective of the study is to determine the effects of GH on the metabolic syndrome and visceral adiposity in men with low blood levels of IGF-1 and the durability of these effects after stopping GH therapy. We will use a double blind, placebo controlled 6 month intervention trial followed by a blinded follow-up period of 6 months. Thirty non-diabetic middle aged men with central adiposity (BMI > 27 kg/m2, waist circumference > 102 cm) will participate.

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

Intervention / Treatment
-----------------
* Drug: rhGH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, aged 40-70 Central obesity defined as waist circumference greater than 102 cm and BMI > 27 and < 35 kg/m2 No weight loss in last 12 months Total IGF-1 level < 241 ng/ml ( 25th percentile for the assay) Body habitus which permitted accurate CT scan acquisition and analysis. Exclusion Criteria: Significant neurologic, metabolic, endocrine, cardiac, respiratory or gastrointestinal disease Diabetes Known coronary heart disease Exercised more than 3 hours per week Unwilling or unable to abstain from alcohol for 72 hours prior to the measurements of energy expenditure and fasting blood work

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rhGH|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition at baseline, after 6 months of treatment and at the end of the followup period |  |  | 
| energy expenditure at baseline, after 6 months of treatment and at the end of the followup period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene expression in adipose tissue at baseline and after 6 months of treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
growth hormone, obesity, visceral adiposity