linjc16/ctgov huggingface dataset:
The Relative Effects of Olmesartan Medoxomil, Irbesartan and Valsartan on the Activity of the Blood Pressure Control System in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To assess the effects of 3 blood pressure drugs, called angiotensin receptor blockers, on the blood pressure control systems in healthy subjects.

Official Title
-----------------
The Relative Effects of Single Doses of Olmesartan Medoxomil, Irbesartan and Valsartan at High Dosage Levels on the Renin-Angiotensin-Aldosterone System in Healthy Normal Subjects

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

Intervention / Treatment
-----------------
* Drug: Olmesartan medoxomil
* Drug: Irbesartan
* Drug: Valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women between the ages of 18 to 65 In good health Exclusion Criteria: Any serious health problems Positive test for HIV, Hepatitis B and C History of drug and alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Olmesartan medoxomil|nan|
|Drug: Irbesartan|nan|
|Drug: Valsartan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the plasma renin activity (PRA) and urinary aldosterone response patterns to single doses of olmesartan medoxomil, irbesartan, and valsartan compared to placebo in normal volunteers. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
olmesartan, valsartan, irbesartan, renin-angiotensin-aldosterone system
The Stanford Integrated Psychosocial Assessment for Transplant (SIPAT)

Study Overview
=================
Brief Summary
-----------------
Given the extremely limited availability of donated organs, transplant candidates must be carefully evaluated and selected to ensure the success of the transplant and value of the organ to the recipient. Medical criteria for pre-transplant evaluation of patients is well established, however, listing criteria for psychosocial risk factors (e.g., understanding of illness and transplant process, psychiatric history, support system, compliance, etc) is less standardized. The purpose of this research is to study the psychometric properties (e.g., predictive validity) of the new pre-transplant Stanford Integrated Psychosocial Assessment for Transplant (SIPAT) examination in patients who received heart, kidney, liver, or lung transplant and underwent the SIPAT evaluation before treatment. This new screening tool was designed to standardize the evaluation process of psychosocial risk factors and their severity, in order to enhance predictions of medical and psychosocial outcomes of patients post-transplant. If the SIPAT is used for standard, pre-transplant assessment, risk factors that may be amenable to clinical intervention could be identified. In turn, this may assist in developing a comprehensive psychosocial treatment plan for each individual, with the ultimate goal of minimizing preventable problems, mitigating risk, and optimizing graft survival, patient function, and quality of life.

Official Title
-----------------
The Stanford Integrated Psychosocial Assessment for Transplant (SIPAT): Psychometric Characteristics of a New Scale for the Prediction of Post-transplant Psychosocial and Medical Outcomes.

Conditions
-----------------
Organ Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients identified through chart review who were transplanted with heart, kidney, liver, and lung between 6/1/2008 and 7/31/2011 and underwent the SIPAT evaluation before treatment. Exclusion Criteria: Patients identified through chart review who were transplanted with heart, kidney, liver, and lung between 6/1/2008 and 7/31/2011, who did not undergo the SIPAT evaluation before treatment.

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 |
| --- | --- | --- |
| Graft survival |  | Assessed at any given time post initial transplantation (up to 15 minutes to assess) | 
| Patient survival |  | Assessed at any given time post initial transplantation (up to 15 minutes to assess) |
Effects of an Amino-acid Supplement on Hepatic Lipid Metabolism

Study Overview
=================
Brief Summary
-----------------
10 healthy male volunteers will be studied after a 6 day weight maintenance, balanced diet a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body weight/day a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body weight/day and 20g amino-acids per day At the end of each 6 days period, the following measurements will be obtained intrahepatic lipids (1H-MRS) metabolic effects of fructose ingestion (measurement of substrate oxidation, gluconeogenesis from fructose, palmitate synthesis from fructose, plasma VLDL-kinetics) This is a randomized, double blinded study

Official Title
-----------------
Effects of a Supplementation With Amino-acids on Hepatic Lipid Metabolism

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Fructose+maltodextrin placebo
* Dietary Supplement: amino-acid + fructose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-30 years sex: males BMI between 19 and 25 kg/m2 less than 3 30min- exercise session/week Exclusion Criteria: smokers alcohol consumption more than 50g/week consumption of drugs history of diabetes in first degree relatives presence of ferro-magnetic prosthesis, cardiac pacemakers, or any contra-indication to NMR

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: weight maintenance diet<br> | |
| Placebo Comparator: weight maintenance + fructose<br> | Dietary Supplement: Fructose+maltodextrin placebo<br> <br> |
| Experimental: weight maintenance diet + fructose and amino-acid<br> | Dietary Supplement: amino-acid + fructose<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intrahepatic lipids |  | after 6 days on each controlled diet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 13C palmitate synthesis |  | after 6 days on each controlled diet | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatic fat content, hepatic de novo lipogenesis
Cisplatin for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
To assess the effect and toxicity of intrapleural administration of hypertonic cisplatin for malignant pleural effusion in patients with non-small-cell lung cancer.

Detailed Description
-----------------
The lung was fully expanded by a thoracostomy using a chest tube with a double lumen, and then the patients were enrolled into the trial.First, premedication including antiemetics and hydration were performed. Thereafter, 75 mg of body surface area of cisplatin in 50 ml of distilled water was injected through a chest tube.The patients were asked to change position (supine and bilateral decubital) from time to time for 30 minutes. The chest tube was clamped for 48 h and then the tube was declamped and allowed to drain. When the drainage effusion was less than 100 ml a day, the chest tube was removed. Any patient whose drainage effusion continued for over 2 weeks was withdrawn from the trial and was also judged to be a nonresponder.

Official Title
-----------------
Intrapleural Hypertonic Cisplatin Treatment for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer.

Conditions
-----------------
Pleural Effusion, Malignant

Intervention / Treatment
-----------------
* Drug: cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cytologically proven and previously untreated malignant pleural effusion of Non-small-cell Lung Cancer; An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1; A leucocyte count of≥4000µl; A platelet count of≥100000µl; A normal creatinine level; Serum glutamic oxaloacetic transaminase/glutamic pyruvic transaminase levels of no more than twice the upper limit of normal; Survival time ≥12 weeks. Exclusion Criteria: Previously treated malignant pleural effusion; Pericardial effusion； Pregnant； Uncontrolled hypertension or diabetes； Liver cihrosis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cisplatin<br>75 mg of body surface area of ciplatin in distilled water is injected in to the chest through a chesttube. | Drug: cisplatin<br>* ciplatin in distilled water is injected into the chest for 48 h.<br>* Other names: cisplatinum;|
| No Intervention: Control<br>No intervention was applied. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | one month |
The Effect of Acupressure (GB30) on Ventrogluteal Intramuscular Injection Pain

Study Overview
=================
Brief Summary
-----------------
Acupressure is an ancient manual therapy which fingers are used to press key points on the body. These points are the same with acupuncture points but in contrast to acupuncture, acupressure uses gentle but firm pressure with fingers and hands. The purpose of this study is to investigate effect of acupressure onto GB30 poin for ventrogluteal intramuscular injection pain.The study was designed as a prospective, single-blind, crossover study. The study included 72 volunteer students attending Faculty of Health Sciences, Nursing Department.

Official Title
-----------------
The Effect of Acupressure (GB30) on Ventrogluteal Intramuscular Injection Pain - A Crossover Randomized Single-blind Study

Conditions
-----------------
Injection, Acute Pain, Needle Phobia

Intervention / Treatment
-----------------
* Procedure: Acupressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI) of 18.5 to 29.9kg/m2 Voluntariness Exclusion Criteria: history of IM injection within 2 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupressure<br>Acupressure is applied before injection | Procedure: Acupressure<br>* Acupressure was performed before the injection onto GB30 point<br>|
| No Intervention: Control group<br>acupressure is not applied before injection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pain during intramuscular injection with 10 cm VAS (Visual Analog Scale) | Assessment of pain during intramuscular injection will be marked on 10 cm VAS scale 0-10 ( 0:no pain 10:Worst possible pain ) by the patient and will be measured | 2 minutes |
Prospective Observational Study of Disease Progression in Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the progression of chronic hepatitis C patients infected by paid plasma donation,and explore the possible pathogenic mechanisms of disease progression in chronic hepatitis C.

Official Title
-----------------
Observational Study of Disease Progression and Risk Factors in Chronic Hepatitis C Caused by Plasma Donation

Conditions
-----------------
Liver Cirrhosis, Hepatitis C, Chronic, Disease Progression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All these patients had a definite history of regular plasma donations with repeated blood cell re-transfusions. The Hepatitis C Virus antibody was positive. All patients did not receive interferon therapy before being recruited. Exclusion Criteria: Patients with evidences for other forms of liver diseases. The coinfection with hepatitis B virus or other virus.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Healthy volunteers<br> | |
| Chronic hepatitis C<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibrosis progression rate |  | 20 years | 
| The incidence of cirrhosis |  | 20 years | 
| Risk factors for the occurrence of cirrhosis |  | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of hepatocellular carcinoma |  | 20 years | 
| Number of participants with chronic hepatitis C-related complications |  | 20 years |
ECG Signal Collection From Long QT Syndrome, Wide QRS Complexes, Heart Failure, and Cardiac Resynchronization Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect surface electrograms from standard and several non-standard configurations in patients with long QT syndrome, heart failure, cardiac resynchronization therapy or wide QRS during a routine outpatient assessment. The ECGs collected will be used as test signals by the sponsor for the development of a subcutaneous implantable defibrillator

Detailed Description
-----------------
The objective of this study is to record standard ECG signals is each of the 4 patient populations together with signals from 4 non-standard surface positions when these patients attend the outpatient department for follow-up. The non-standard electrode positions mimic the positions of the subcutaneous electrodes of the subcutaneous implantable defibrillator (S-ICD) system in development by Cameron Health. The collection of these signals will allow bench testing of the algorithms proposed for the S-ICD system. Additionally, it will allow a comparison of the response of different defibrillators to these same signals to asses how each would treat a particular rhythm.

Official Title
-----------------
Further Research on Human Feasibility of a Subcutaneous Implantable Defibrillator (S-ICD)- ECG Signal Collections From Various Patient Groups Whilst Attending Outpatient Follow-up

Conditions
-----------------
Long QT Syndrome, Wide QRS Complexes, Heart Failure, Cardiac Resynchronisation

Intervention / Treatment
-----------------
* Device: subcutaneous ICD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients attending the outpatient for routine follow-up for their cardiac disease or to have an implanted device follow-up Exclusion Criteria: Patients unable or unwilling to provide informed consent Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study

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 |
| --- | --- |
| LQTS<br>Long QT syndrome | Device: subcutaneous ICD<br> <br> |
| HF<br>Heart Failure | Device: subcutaneous ICD<br> <br> |
| CRT<br>Cardiac Resynchronization Therapy | Device: subcutaneous ICD<br> <br> |
| Wide QRS<br>QRS > 120 milliseconds | Device: subcutaneous ICD<br> <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
-----------------
S-ICD, ICD, ECG signals, Resting
Pulmonary Function and Neuromuscular Disease

Study Overview
=================
Brief Summary
-----------------
This study aims to describe the evolution of pulmonary function in 3 neuromuscular diseases : Duchenne muscular dystrophy, Werdnig-Hoffinann disease, congenital myopathy, monitored in Besançon university hospital.

Official Title
-----------------
Pulmonary Function and Neuromuscular Disease

Conditions
-----------------
Neuromuscular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neuromuscular disease Followed-up in Besançon University Hospital With at least 2 Pulmonary Function Tests previously performed Exclusion Criteria: Mental deficiency Facial expressions disorders

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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 |
| --- | --- | --- |
| FVC (Forced Vital Capacity) | Percentage of decrease of FVC sitting or lying down | Year 12 |
Long Term Metabolic Safety of Norditropin® Treatment of Small for Gestational Age (SGA) Subjects

Study Overview
=================
Brief Summary
-----------------
The study is conducted in Europe. The primary aim of this observational study is to compare the insulin sensitivity in small for gestational age (SGA) subjects treated with Norditropin® with untreated small for gestational age (SGA) subjects and with average for gestational age (AGA) subjects.

Official Title
-----------------
Comparison of Safety in Small for Gestational Age (SGA) Subjects Treated With Norditropin® (Somatropin) 5 Years Ago With Untreated SGA Subjects and With Normal Average for Gestational Age (AGA) Subjects

Conditions
-----------------
Foetal Growth Problem, Small for Gestational Age

Intervention / Treatment
-----------------
* Drug: somatropin
* Drug: No treatment given
* Drug: No treatment given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Norditropin® treated small for gestational age (SGA) group: Treated with Norditropin® for at least three years in the IUGR-1 or IUGR-2 trials Untreated small for gestational age (SGA) group: Birth length and/or weight less than -2 SDS for gestational age Average gestational age (AGA) group: Birth length and/or weight larger than -2 SDS for gestational age Exclusion Criteria: Growth hormone deficiency defined as a peak growth hormone (GH) less than 20 mU/l Insulin like growth (IGF)-1 level less than -2 SDS Receipt of any investigational drug within four weeks prior to the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 24 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 |
| --- | --- |
| A<br> | Drug: somatropin<br>* SGA previously treated with Norditropin®<br>* Other names: GHLIQUID;|
| B<br> | Drug: No treatment given<br>* Untreated SGA<br>|
| C<br> | Drug: No treatment given<br>* AGA (Average gestational age)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity |  | Index 5 years after end of GH treatment compared to controls | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disposition index, glucose effectiveness and acute insulin response compared to controls |  | 5 years after end of Norditropin treatment |