linjc16/ctgov huggingface dataset:
Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis C

Study Overview
=================
Brief Summary
-----------------
Acute cellular rejection is relatively common after liver transplantation, typically does not affect graft survival, and is not associated with the development of chronic rejection. Acute cellular rejection is diagnosed when liver enzymes and/or liver function tests are elevated when compared to baseline. The only means of differentiating acute rejection from other liver pathologies is with a liver biopsy. However, even with this invasive diagnostic procedure, it may be difficult to distinguish acute rejection from another disease process, such as injury caused by the hepatitis C virus (HCV) from the native liver. This study will evaluate whether certain patterns of biomarkers in the peripheral blood and/or liver tissue of a liver transplant recipient can be used to determine if the transplanted liver is being rejected by the recipient or sustaining HCV injury. Diagnostic biomarkers that are specific for acute rejection and informative of the severity of HCV recurrence could allow for modulation of immunosuppression therapy and treat the clinical condition without the need for invasive liver biopsies.

Official Title
-----------------
Development of Gene Expression Signatures for the Diagnosis of Liver Allograft Rejection and Recurrent Hepatitis C Disease (CTOT-07)

Conditions
-----------------
Liver Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Specimens derived from subjects enrolled in the ITN030ST study. Availability of adequate biopsy specimens with corresponding blood and/or serum collected within a 10 day window of a for-cause or protocol biopsy. Exclusion Criteria: Withdrawal of consent for the ITN030ST study. Absence of consent in the ITN030ST study for the collection and storage of samples of blood and tissue for future research studies.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-Immune/Non-Viral (NINV)<br>Patients enrolled in ITN030ST transplanted for liver failure resulting from non-viral, non-immune causes | |
| Hepatitis C Virus (HCV) positive<br>Patients enrolled in ITN030ST transplanted for liver failure resulting from HCV genotype 1 infection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression levels of mRNA and miRNA in peripheral blood cells, serum, and tissue at the time of for cause and protocol biopsies, and the diagnostic effectiveness of identified patterns | This assay study will analyze expression levels of mRNA and miRNA from NINV and HCV liver biopsy, whole blood, and/or serum samples from the ITN030ST study obtained within a +/- 10-day window of the biopsy. | +/- 10 day window from time of clinically indicated biopsy |
Study to Assess Effects of Age, Weight, and Body Composition on the Pharmacokinetics of IV Diclofenac Sodium

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers.

Detailed Description
-----------------
This study is an open label, single center, single-dose study to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers. This study will be conducted in two cohorts. The first cohort of subjects will be selected based on body mass index (BMI) and weight criteria. The second cohort of subjects will be selected based on age.

Official Title
-----------------
An Open-Label, Single-Dose Study to Assess the Effects of Age, Weight, and Body Composition on the Pharmacokinetic Profile, Safety, and Tolerability of Intravenous Diclofenac Sodium (DIC075V) in Adult Volunteers

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

Intervention / Treatment
-----------------
* Drug: Intravenous diclofenac sodium (DIC075V)
* Drug: Intravenous diclofenac sodium (DIC075V)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult volunteers over age 18 Exclusion Criteria: Known allergy or hypersensitivity to diclofenac, aspirin, or other NSAIDs or to any of the excipients of the study preparation History of previous and/or present cerebral hemorrhage, peptic ulceration, GI bleeding or any bleeding diathesis, positive for hepatitis B or hepatitis C or HIV antibodies

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Low dose Diclofenac | Drug: Intravenous diclofenac sodium (DIC075V)<br>* Low Dose Diclofenac<br>|
| Experimental: B<br>High dose Diclofenac | Drug: Intravenous diclofenac sodium (DIC075V)<br>* High dose Diclofenac<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers. |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult volunteers
A Study on the Effects of Soy Protein on Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
The objectives of the trial are to determine whether a non-commercial soy protein product, consumed as part of a low-saturated fat diet, reduces low-density lipoprotein cholesterol (LDL-C) concentrations in men and women with mild to moderate hypercholesterolemia, and affects other aspects related biomarkers.

Official Title
-----------------
A Randomized, Controlled Parallel Study to Evaluate the Effects of a Non-Commercial Soy Protein Product on Fecal Bile Acids and Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Dietary Supplement: Soy protein; 25 grams/day
* Dietary Supplement: Control protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18-79 years of age Fasting LDL-Cholesterol level borderline to high range taking no cholesterol lowering medications otherwise judged to be in good health, willing to maintain a stable body weight and follow the TLC diet throughout the trial. Exclusion Criteria: CHD or CHD risk equivalent Pregnancy Food allergy or sensitivity to soy or milk protein Certain muscle, liver, kidney, lung or gastrointestinal conditions and medications Poorly controlled hypertension Cancer treated within prior 2 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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 |
| --- | --- |
| Active Comparator: Soy protein<br> | Dietary Supplement: Soy protein; 25 grams/day<br>* Soy protein<br>|
| Placebo Comparator: Milk protein<br> | Dietary Supplement: Control protein<br>* Milk protein<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in other lipid levels and other related biomarkers |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypercholesterolemia, cholesterol, soy
Effect of rHDL on Atherosclerosis - Safety and Efficacy: THE ERASE TRIAL

Study Overview
=================
Brief Summary
-----------------
Currently available therapies to treat Acute Coronary Syndromes(ACS) have several limitations including; the relatively long treatment duration required before apparent significant benefit; the inability to achieve reversal of the atherosclerotic process; and poor patient compliance due to chronicity of therapy. This study will assess the effects of rHDL compared with placebo on indices of atherosclerosis progression and regression as assessed with intravascular ultrasound (IVUS) in patients after acute coronary syndromes (ACS).

Official Title
-----------------
Regression of Coronary Atherosclerotic Lesions After rHDL Infusions in Acute Coronary Syndrome Patients as Assessed by Intravascular Ultrasound.

Conditions
-----------------
Acute Coronary Syndromes

Intervention / Treatment
-----------------
* Drug: rHDL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 30 - 75 years of age Recent acute coronary syndrome, defined as unstable angina, non-Q wave myocardial infarction, or ST elevation indicative of myocardial infarction, within the last 14 days Exclusion Criteria: >50% stenosis by visual angiographic estimation in the left main artery Renal insufficiency Severe liver disease Congestive heart failure as defined by the NYHA classification as functional Class III or Class IV Previous or planned coronary artery bypass surgery

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  |
Safety Study of GS-5806 to Treat Respiratory Syncytial Virus (RSV)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of GS-5806 in hospitalized infants with RSV.

Official Title
-----------------
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Ranging Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GS-5806 in Subjects < 24 Months of Age Hospitalized for Respiratory Syncytial Virus (RSV) Related Respiratory Infection

Conditions
-----------------
Respiratory Syncytial Virus Infections

Intervention / Treatment
-----------------
* Drug: GS-5806
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: <24 months of age Diagnosis of Respiratory Syncytial Virus (RSV) within 48 hours of screening Exclusion Criteria: Chronic or congenital heart disease Required ventilation or admission to any pediatric Intensive Care Unit Inadequate organ function

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 24 Months

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GS-5806<br>Single dose, oral liquid, .5 mL/kg | Drug: GS-5806<br>* Single dose, oral liquid, .5 mL/kg<br>|
| Placebo Comparator: Placebo<br>Single dose, oral liquid, .5 mL/kg | Drug: Placebo<br>* Single dose, oral liquid, .5 mL/kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | Safety and tolerability will be assessed by evaluating AE's, laboratory abnormalities and vital sign measurements. | 10 days from subject randomization to study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics effects of GS-5806 | Evaluation of GS-5806 on viral load related and symptom related endpoints. | 10 days from subject randomization to study drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory, Syncytial, Virus, RSV
Establishment of Social Skills Training Group in Adults With Autism Spectrum Disorder and Effectiveness Analysis

Study Overview
=================
Brief Summary
-----------------
This project aims to examine the effectiveness of social skill training group in adults with autism spectrum disorders.

Official Title
-----------------
Establishment of Social Skills Training Group in Adults With Autism Spectrum Disorder and Effectiveness Analysis

Conditions
-----------------
Social Skill Training Group

Intervention / Treatment
-----------------
* Behavioral: PEERS®: program for the education and enrichment of relational skills


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 18 to 45 years having relational problems having motivation to participate good chinese speaking having a healthy cargiver join together IQ > 70 (WAIS) Autism Spectrum Quotient > 26 Exclusion Criteria: ever had psychosis and neurological diseases visual and hiring impairment

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEERS<br> | Behavioral: PEERS®: program for the education and enrichment of relational skills<br>* providing evidence-based social skills treatment to preschoolers, adolescents, and young adults with autism spectrum disorder (ASD)<br>|
| Other: Controls<br> | Behavioral: PEERS®: program for the education and enrichment of relational skills<br>* providing evidence-based social skills treatment to preschoolers, adolescents, and young adults with autism spectrum disorder (ASD)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome analysis | Background characteristics, co-existing psychiatric conditions and dropout rates for the two groups are compared using χ2 tests. Differences between two groups' baseline measures are analyzed using two-sided independent t tests. The comparison will adopt an intention-to-treat principle. The missing data are substituted with last observation carried forward. To analyze the reasons for the attrition, the dropouts will also be compared to the completers on their clinical variables. Then, repeated-measures analyses of variance (ANOVAs) are used to calculate between- and within-group effects on all continuous variables. Treatment effect calculations (Cohen's d) will be calculated for each indicator. Differences between the interventions in CGI-I will be examined using a one-way ANOVA. Reported change in the follow-up survey was compared between the PEERS group and the controls using independent t tests. | after intervention 12 weeks |
Correlation of Chronic Pancreatitis Pathology Features With Endoscopic Ultrasound (EUS) Criteria

Study Overview
=================
Brief Summary
-----------------
In this research project the investigators intend to find out if Endoscopic Ultrasound (EUS) criteria for diagnosing chronic pancreatitis can be correlated with pathologic characteristics of tissues taken from pancreas of patients with suspected chronic pancreatitis. This will be a retrospective study which will examine results from biopsy specimens and endoscopic ultrasound findings in suspected chronic pancreatitis.

Official Title
-----------------
How Pathologic Features of Chronic Pancreatitis Corelate With Endoscopic Ultrasound (EUS) Criteria for Diagnosing Chronic Pancreatitis

Conditions
-----------------
Chronic Pancreatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: will include all patients who consented to have both EUS and had biopsy taken for tissue diagnosis. Exclusion Criteria: Will exclude patients who are less than 18 years

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| chronic pancreatitis<br> | |

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
-----------------
chronic pancreatitis
Characterization of Interventricular Conduction Measurements

Study Overview
=================
Brief Summary
-----------------
This study is an effort to use left ventricular (LV) lead based measurements to identify late electrical activation and avoid scar.

Detailed Description
-----------------
The aim of this study is to characterize how right ventricular (RV) to left ventricular (LV) conduction delays are altered by pacing site in patients with a cardiac resynchronization therapy (CRT) system. The study will be performed in conjunction with a CRT implant.

Official Title
-----------------
Characterization of Interventricular Conduction Measurements

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

Intervention / Treatment
-----------------
* Procedure: Cardiac Resynchronization Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is greater than 18 years of age. The patient or the patient's legally authorized representative is willing to give informed consent. CRT indicated guidelines. Patient is receiving a Medtronic IPG or ICD. Exclusion Criteria: Patients who are pregnant. Patient is in AF. Patient with 3rd degree AV block.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac Resynchronization Therapy (CRT)<br>Implanting device to measure delays between paced chambers in heart failure patients. | Procedure: Cardiac Resynchronization Therapy<br>* Implanting device to measure delays between paced chambers in heart failure patients.<br>* Other names: CRT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure how RV to LV conduction times are altered by pacing site in patients with a CRT system. | This procedure will take approximately 30 minutes prior to implant of a CRT system. At completion of this study the patient is not followed and will be transferred to another study if enrolled in a clinical or followed as a routine implant by the center. | 30 minutes |
Contrast Echocardiography in Non-ST Elevation Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
In patients with acute myocardial infarction, treatment logistics are primarily defined based upon ST segment shift in the electrocardiogram. While patients with ST elevation (STEMI) are forwarded to immediate coronary angiography and percutaneous coronary intervention, patients without ST elevation (NSTEMI) are initially medically treated and recommended coronary angiography within 48-72 hours. Early invasive treatment has been found cost-effective in intermediate and high-risk NSTEMI patients and current guidelines recommend use of the Thrombolysis in Myocardial Infarction (TIMI) risk score to identify patients who will benefit from early intervention due to high risk of new infraction and cardiovascular death. However, new research has suggested that TIMI risk score may not always identify patients with severe angiographic disease. The purpose of this study was to assess if contrast echocardiography could be used to identify NSTEMI patients with angiographically severe disease independent of their TIMI risk score.

Official Title
-----------------
Contrast Echocardiography in Assessment of Myocardial Perfusion in Patients With Non-ST Elevation Myocardial Infarction

Conditions
-----------------
Non-ST-Elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Other: Perflutren Lipid Microsphere ultrasound contrast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute non-ST elevation myocardial infarction Exclusion Criteria: hemodynamic unstable mechanical prosthetic heart valve severly reduced pulmonary function

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 |
| --- | --- |
| Contrast echocardiography<br>110 patients with acute non-ST elevation myocardial infarct were examined with contrast echocardiography prior to coronary angiography. | Other: Perflutren Lipid Microsphere ultrasound contrast<br>* Perflutren Lipid Microsphere ultrasound contrast 0.01 ml/kg administered as intravenous bolus<br>* Other names: Luminity;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |