linjc16/ctgov huggingface dataset:
Study to Assess the Safety and Pharmacokinetic (PK) of CTP-692 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and pharmacokinetic (PK) profile of single ascending doses of CTP-692 in healthy volunteers.

Official Title
-----------------
A Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of CTP-692 in Fed and Fasted Conditions in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: CTP-692
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult males and females between 18 and 55 years of age, inclusive Body weight ≥ 55 kg and BMI within the range of 18 to 32 kg/m2, inclusive Exclusion Criteria: Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions Positive drug or alcohol test at screening or prior to the first dose of study drug

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTP-692<br> | Drug: CTP-692<br>* Single oral dose<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Single oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety |  | 48 hours | 
| Measurement of CTP-692 exposure in plasma under fasted conditions |  | 48 hours | 
| Measurement of CTP-692 exposure in plasma under fed conditions |  | 48 hours |
Thoracoscopic Vascular Rings Chart Review

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to review the use of diverticulopexy, and collect data regarding the ease of the procedure and the overall outcome.

Detailed Description
-----------------
In addition to dividing the vascular ring, some surgeons stress the importance of performing a diverticulopexy (an additional stitch which holds the ring open and prevents recurrence). This is a difficult step to perform through the thoracoscope. We plan to review the use of this step, the diverticulopexy, and collect data regarding the ease of the procedure and the overall outcome. Once we have accomplished this, we hope to present our initial results of this new procedure.

Official Title
-----------------
Thoracoscopic Vascular Rings Chart Review

Conditions
-----------------
Cardiovascular Abnormalities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing vascular ring division at Children's Healthcare of Atlanta at Egleston Hospital between 2001 and 2004
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
-----------------
Children's Healthcare of Atlanta, pediatric, Thoracoscopic Vascular ring, diverticulopexy, Vascular Ring Division
Blood Lipid-lowering Effect of Brown Alga Ecklonia Cava

Study Overview
=================
Brief Summary
-----------------
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Ecklonia cava extract on hyperlipidemia.

Detailed Description
-----------------
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Ecklonia cava extract on hyperlipidemia. The investigators measured improvement of lipid profile, including total cholesterol, triglyceride, HDL-cholesterol, and LDL-cholesterol.

Official Title
-----------------
Blood Lipid-lowering Effect of Brown Alga Ecklonia Cava Extract in Hypercholesterolemic Korean Subjects: a Randomized Double-blind, Placebo-controlled Clinical Trial

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

Intervention / Treatment
-----------------
* Dietary Supplement: ECE (Ecklonia cava extract)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild hypercholesterolemic subjects(≥200mg/dL of total cholesterol or ≥110mg/dL of LDL-cholesterol) Exclusion Criteria: Self-reported pregnancy, lactation Prevalent heart disease, cancer, renal disorder, or diabetes mellitus, and use of lipid-lowering drugs

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECG (Ecklonia cava extract)<br>ECE 200mg, twice a day | Dietary Supplement: ECE (Ecklonia cava extract)<br>* ECE 200mg, twice a day<br>|
| Placebo Comparator: Placebo<br>Placebo 200mg, twice a day | Dietary Supplement: Placebo<br>* Placebo 200mg, twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in total cholesterol |  | 12 weeks | 
| Changes in LDL-cholesterol |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in triglyceride |  | 12 weeks | 
| Changes in HDL-cholesterol |  | 12 weeks | 
| Changes in waist to hip ratio |  | 12 weeks |
Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the evaluation of a bioimpedance method for determination of dry weight in dialysis patients. Additionally normal tissue hydration in non-Dialysis patients is investigated in healthy subjects and patients with chronic kidney disease in stages K/DIGO I-IV

Official Title
-----------------
Study for the Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients

Conditions
-----------------
Renal Insufficiency, Chronic

Intervention / Treatment
-----------------
* Device: Bioimpedance Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically stable on dialysis within the last three months signed written informed consent Exclusion Criteria: acute myocardial infarction or stroke within the last six months heart failure stage NYHA IV concommitant participation in other interventional trials psychiatric conditions that prevent subject from following the study procedures / protocol pregnancy or lactation limb amputation cardiac pacemaker joint implants implantable pumps and other metallic implants For healthy subjects and CKD patients in stages K/DIGO I-IV the above mentioned criteria other than the first mentioned are applicable respectively.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Bioimpedance Analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioimpedance Dry weight |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resistance |  |  | 
| Resistivity |  |  | 
| Blood pressure |  |  | 
| LV Diameter |  |  | 
| Shortening Fraction |  |  | 
| Wall thickness LA, LV |  |  | 
| Quality of Life |  |  | 
| EPO-Dose |  |  |
The Study to Describe Symptom Control and Impact on Daily Life in Gastroesophageal Reflux Disease (GERD) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate symptoms control and impact on daily life from patients perspective using specific GERD Impact Scale(GIS) questionnaire. The another objective is to obtain local epidemiological data for Bosnia and Herzegovina regarding GERD treatment in primary care.

Official Title
-----------------
An Epidemiological, Observational Study to Describe Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease (GERD)

Conditions
-----------------
Gastroesophageal Reflux Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients previously diagnosed with GERD (disease duration =3 years) or newly diagnosed patients that are currently not treated with proton pump inhibitor, for whom specialist or General Practionaire (GP) have previously decided to initiate or change treatment for GERD; Patients should be treated for GERD according to current practice Exclusion Criteria: Females of childbearing potential should not be pregnant or nursing

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years |  | Maximum of 14 weeks, with 3 visits in total | 
| Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years |  | Visit 1 (enrolment) | 
| Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years |  | Visit 2 (4-6 weeks after Visit 1) | 
| Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years |  | Visit 3 (8-14 weeks after Visit 1). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of GERD Impact Scale (GIS questionnaire) as a useful tool for initial and long term management of GERD patients |  | Maximum of 14 weeks, with 3 visits in total: Visit 1 (enrolment), Visit 2 (4-6 weeks after Visit 1) and Visit 3 (8-14 weeks after Visit 1). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroesophageal reflux disease, GERD Impact Scale
Care-related Pain and Discomfort in People With Motor Disorder

Study Overview
=================
Brief Summary
-----------------
The combination of motor disabilities, chronic pain, cognitive disabilities limiting the possibilities of communications and repeated potentially painful rehabilitation, exposes patients with motor disabilities to a high risk of induced pain in the specialized establishments. Induced pain is difficult to detect and is therefore little assessed and treated. Currently, little is known about the prevalence and conditions of occurrence of such induced pain as the clinical characteristics of patients (children, adults, severity of disability), the types of care and the nature of the institutional admission (medical or medico-social). Secondary objectives are to identify risk factors related to the induced pain and patient characteristics, as well as to create an easy-to-use weekly continuous pain assessment tool in a routine clinical set-up. All daily life procedures or treatment carried out in children and adults with motor disability are collected for 5 days and 1 night. Collected data are clinical and demographic characteristics of patients, the intensity of the pain assessed by the care professional (FLACC-r) or the patient himself (VAS). Clinically, the uncomfortable and painful procedures and risk factors for pain identified by this study will help the development of targeted preventive measures within institutions. Meanwhile, the study should sensitize Breton teams involved with regards to the induced pain, leading them to observe the behavior of patients, to admit any pain related to an act of daily life, and to ask for the medical profession to anticipate the painful experience.

Official Title
-----------------
Care-related Pain and Discomfort in Children and Adults With Motor Disorder in Medical Establishments

Conditions
-----------------
Motor Disorders, Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: motor disorder institutionalized Exclusion Criteria: chronical pain

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 80 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 |
| --- | --- |
| children<br>aged from 1 to 18 years with motor disorder | |
| adults<br>aged from 18 to 80 years with motor disorder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain related to care-activities assessed with the Face, Legs, Activity, Cry, Consolability (FLACC-r) scale |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain related to care-activities assessed with the Visual Analog Scale (VAS). |  | 5 days |
Antihypertensive Effectiveness of the Associations of Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril

Study Overview
=================
Brief Summary
-----------------
The majority of hypertensive patients require antihypertensive associations to control their blood pressure. Most of clinical trials don't compare different associations using Hydrochlorothiazide 25 mg as the standard initial therapy and compare the associations using doses that are not equivalent. This randomized trial where patients and investigators are blinded and compares the effectiveness two associations: Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril.

Official Title
-----------------
Hydrochlorothiazide and Amiloride vs Hydrochlorothiazide and Enalapril: a Randomized Clinical Trial of Antihypertensive Effectiveness.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Amiloride 2,5/d or Enalapril/d 10 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who are using Hydrochlorothiazide 25mg/d at least in a four weeks treatment and had their office blood pressure not controlled (systolic or diastolic greater than 140 mmHg or 90 mmHg, respectively). Exclusion Criteria: Established cardiovascular disease Diabetics in use of insulin Impairment renal in renal function Contraindications for the study medications

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

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

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: Amiloride 2,5/d or Enalapril/d 10 mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean blood pressure measured with 24-hour ambulatory blood pressure monitoring after 12 weeks of follow-up |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who needed to double the dose of enalapril or amiloride in forth or eighth week or use propranolol in the eighth week follow-up visiting. |  |  | 
| Fasting blood glucose differences between the baseline and twelve-week follow-up visiting. |  |  | 
| Serum potassium differences between the baseline and twelve-week follow-up visiting. |  |  | 
| Serum total cholesterol, LDL- cholesterol, HDL- cholesterol and triglycerides differences between the baseline and twelve-week follow-up visiting. |  |  | 
| Serum uric acid differences between the baseline and twelve-week follow-up visiting. |  |  | 
| Urine microalbuminuria differences between the baseline and twelve-week follow-up visiting. |  |  |
Low-dose IL-2 ( Interleukin-2) Treatment in Macrophage Activation Syndrome（MAS）

Study Overview
=================
Brief Summary
-----------------
The investigators evaluate the effectiveness and safeness of low-dose Recombinant Human Interleukin-2 （rhIL-2） for MAS.

Detailed Description
-----------------
Autoimmune-associated macrophage activation syndrome (MAS), also known as secondary hemophagocytic lymphohistiocytosis (HLH), is a rapidly progressing life-threatening disease. VP16 (Etoposide) is a well-known standard therapy, but is associated with substantial adverse effects, especially myelosuppression and infections , while steroids and ciclosporin (CSA) are not always efficient in this disease. The investigators hypothesized that low- dose IL-2 could be a novel therapy in MAS. This clinical study will test the efficacy and safety of low dose IL-2 treatment in MAS. The investigators perform a single-centre pilot trial with rhIL-2 in MAS. The investigators evaluate the effectiveness and safeness of low-dose IL-2 for MAS.

Official Title
-----------------
Safety and Efficiency Study of Low-dose IL-2 Treatment in Macrophage Activation Syndrome

Conditions
-----------------
Macrophage Activation Syndrome

Intervention / Treatment
-----------------
* Drug: Interleukin-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Macrophage Activation Syndrome（MAS） MAS secondary to autoimmune disease, such as Adult onset still's disease (AOSD), juvenile rheumatoid arthritis (JRA) or Systemic Lupus Erythematosus (SLE). Exclusion Criteria: Primary MAS Secondary to neoplasia, lymphoma and virus infection pre-treatment with Cyclosporine A relevant cardiac, pulmonary, neurologic or psychiatric disease life-Vaccination within 4 weeks before begin with study medication pregnant or breast-feeding weight under 45kg or more than 80kg

Ages Eligible for Study
-----------------
Minimum Age: 16 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-does rhIL-2 therapy<br>Recombinant Human Interleukin-2 (RhIL-2) was administered subcutaneously at a dose of 1 million IU every other day for 4 weeks | Drug: Interleukin-2<br>* Recombinant Human Interleukin-2 (RhIL-2) was administered subcutaneously at a dose of 1 million IU every other day for 4 weeks.<br>* Other names: Recombinant Human Interleukin-2;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease activity on the HScore (a Score for the Diagnosis of Reactive Hemophagocytic Syndrome) | Examination of the therapeutic effects (improvement in HScore) of low dose IL-2 in patients with MAS | 1month |
Design and Implementation of the Pediatric Liver Transplantation Biobank

Study Overview
=================
Brief Summary
-----------------
The purpose of the pediatric liver transplant biobank is to systematically collect clinical specimens from pediatric end-stage liver disease. It is expected to contribute to the research and development of paediatric end-stage liver disease in the future.

Official Title
-----------------
Children's Hospital of Chongqing Medical University

Conditions
-----------------
Liver Diseases, Liver Transplant; Complications, Pediatric ALL

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children diagnosed with end-stage liver disease. Liver transplantation in our hospital. informed patient consent. long-term follow-up in our hospital. Exclusion Criteria: No fixed contact information, difficult to follow up the patients.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|There are no interventions because it is a protocol study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological sample bank | A repository of biological samples from patients who will join the project, will be organised at the biobank center of the Children's Hospital of Chongqing Medical University(CHCMU) under the responsibility of the experienced staff at the Department of Hepatic. | 2 years | 
| Integrated health data platform | Collect patient clinical test information and establish diagnostic database. | 2 years |