linjc16/ctgov huggingface dataset:
A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
To determine the MTD and dose-limiting toxicities of recombinant interleukin-2 (aldesleukin; Proleukin) administered subcutaneously in HIV-seropositive patients. To identify a tolerable subcutaneous regimen that will replicate the immunologic improvement demonstrated in the outpatient polyethylene glycolated IL-2 and high-dose continuous infusion IL-2 studies. To evaluate the incidence and level of anti-IL-2 antibody formation to subcutaneously administered Proleukin in this patient population.

Detailed Description
-----------------
Patients will receive subcutaneous Proleukin, and the MTD will be determined.

Official Title
-----------------
A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Aldesleukin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Documented HIV infection by ELISA and Western blot. CD4 count > 200 cells/mm3. Required: FDA-approved antiretroviral therapy for at least 2 months prior to study entry.

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


Arms and Interventions

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

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
-----------------
Interleukin-2, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer

Study Overview
=================
Brief Summary
-----------------
The scope of the trial is to assess the free progression rate at 2 months for each group of patients.

Official Title
-----------------
A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: CYCLOPHOSPHAMIDE
* Drug: MEGESTROL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > or = 18 PS-WHO < or = 1 Histologically proven cancer No other therapeutic proposal Treatment can be orally taken Radiologic proof of evolutive character of the disease Effective contraception Exclusion Criteria: Hypercalcemia ( Ca > 2.65 mmol/l) Breast cancer Thrombosis or pulmonary embolism Dysphagia, malabsorption Polynuclear neutrophil leukocytes < 1000/mm3 Treatment with Tegretol Active and uncontrolled infection Evolutive psychiatric disease Pregnant or lactating woman

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CYCLOPHOSPHAMIDE<br> | Drug: CYCLOPHOSPHAMIDE<br>* 50 mg x 2 /day , per os, nonstop until disease progression or toxicity or patient decision<br>|
| Active Comparator: MEGESTROL<br> | Drug: MEGESTROL<br>* 320 mg/day, per os, 2 pills of 160 mg one time, nonstop until disease progression or toxicity or patient decision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival rate at 2 months |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival rate and objective response (RECIST) at 2, 4 and 6 months |  | After 2, 4 and 6 months of treatment | 
| Toxicity according to NCI scale v3.0 |  | During study treatment | 
| Biological markers |  | the 2 first months of treatment | 
| Overall survival |  | Until death of the patient or until study analysis | 
| Median time between the beginning of treatment and hospitalization due to progression or toxicity |  | time of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, palliative treatment
Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of gastroesophageal reflux disease (GERD) treatment in primary care setting on symptom control and daily life in symptomatic GERD patients, using both GERD questionnaire and clinical symptoms assessment

Detailed Description
-----------------
A prospective, observational study to describe symptom control and impact on daily life in patients with gastroesophageal reflux disease (GERD)

Official Title
-----------------
A Prospective, 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 known or newly diagnosed with GERD Patients with typical GERD symptoms as heartburn and regurgitation for ≥2 days in the previous week Patients, currently not treated with a proton pump inhibitor Exclusion Criteria: Patients who have been receiving treatment with non-steroidal antiinflammatory drugs within two weeks prior the inclusion in the study Patients with medical history of surgery of the esophagus, stomach or duodenum Pregnant or nursing females

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 |
| --- | --- | --- |
| Percent change in intensity and frequency for each of typical GERD symptoms from baseline to week 4-6 |  | Day 0 to week 4-6 | 
| Changes in GERD questionnaire(GERD-Q) scores from baseline to week 4-6 |  | Day 0 to week 4-6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the correlation between GERD-Q scores and symptom scores |  | two times | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastroesophageal reflux disease, GERD questionnaire, primary care setting
Effect of 4 Weeks Treatment With Acipimox in Patients With Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate whether metabolic modulation improves left ventricular function, work capacity, insulin sensitivity and modifies substrate metabolism in chronic heart failure

Official Title
-----------------
Effect of 4 Weeks Treatment With Acipimox on Left Ventricular Function, Work Capacity, Insulin Sensitivity and Substrate Metabolism in Patients With Chronic Heart Failure

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

Intervention / Treatment
-----------------
* Drug: acipimox
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: EF<40 % IHD NYHA-class II-III. Exclusion Criteria: pregnancy severe renal failure new brady- or tachyArrhythmia Severe stenotic valvular disease myocardial infarction within last 6 weeks insulin treated diabetes mellitus peptic ulcer pregnancy or lactating women allergy towards tested medicine

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: acipimox<br>* capsule, 250 mg, 4 times daily for 28 days<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* capsule, 250 mg, 4 times daily for 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular ejection Fraction |  | 4 weeks | 
| exercise capacity |  | 4 weeks | 
| muscular metabolism |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| regional left ventricular function |  | 4 weeks | 
| insulin resistance |  | 4 weeks | 
| full body metabolism |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure
Epidemiology of Carotid IMT Progression in MESA - Ancillary Study

Study Overview
=================
Brief Summary
-----------------
To determine the factors associated with progression of sub-clinical atherosclerosis and to evaluate the associations between the progression of sub-clinical atherosclerosis and the development of clinically manifest atherosclerosis.

Detailed Description
-----------------
BACKGROUND: Cardiovascular disease remains the leading cause of death in the United States and one of the leading causes of morbidity. New technology recently has allowed the non-invasive investigation of the extent of atherosclerosis in different vascular beds. Unfortunately, the clinical implications and significance of this new technology have not yet been fully examined nor has the interrelationship between these various measurements of clinical and sub-clinical atherosclerosis. The study is ancillary to the Multi-Ethnic Study of Atherosclerosis (MESA), an NHLBI-supported epidemiological study of atherosclerosis in several ethnic groups. DESIGN NARRATIVE: A longitudinal assessment of the carotid intima media thickness (IMT) will be added to the scheduled follow-up visits in MESA subjects in order to study the relationship between carotid IMT and a measure of calcium burden in the coronary vessels. In addition, studies will be conducted on how these two non-invasive markers of atherosclerosis relate to cardiovascular disease risk factors and clinical events.The study will utilize the MESA cohort involving 6500 subjects who will have baseline and four follow-up examinations. coronary artery calcification (CAC) and IMT are being obtained at baseline, with CAC determinations also scheduled at follow-up. IMT determinations will be added in conjunction with the CAC studies in the second and third exams and detailed analyses will be carried out on these two measures of atherosclerotic burden that may reflect different biologic processes.

Conditions
-----------------
Atherosclerosis, Cardiovascular Diseases, Heart Diseases, Carotid Artery Diseases, Coronary Arteriosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Members of MESA study

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 84 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 |
| --- | --- | --- |
| Common carotid artery intima-media thickness |  | randomly selected at 2 years or 4 years in 1/2 of the cohort | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Common carotid artery diameter |  | randomly selected at 2 or 4 years for each 1/2 of the cohort |
Weight-reduction Intervention in Asthmatic Children With Overweight/Obesity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of a multifactorial intervention with weight reduction, behavioural therapy, and physical exercise on the severity and control of asthma in obese children.

Official Title
-----------------
Secondary Prevention of Asthma in Overweight/Obese Children by a Combined Dietary-behavioural-physical Activity Intervention

Conditions
-----------------
Asthma, Overweight, Obesity

Intervention / Treatment
-----------------
* Behavioral: Multifaceted intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 6-16 years BMI in the overweight/obesity range according to data of Cole et al. Asthma diagnosis Exclusion Criteria: Children with a normal weight according to data of Cole et al. Children without any provable asthmatic complaints Congenital malformations of the airways or other chronic lung diseases like cystic fibrosis (CF) Mental retardation or syndromes Heart disease

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 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: Multifaceted intervention<br>Multifaceted intervention:physical exercise, nutrition, and behavioural intervention. | Behavioral: Multifaceted intervention<br>* multifaceted family-based, physical exercise, nutrition, and behavioural intervention study for 18 month, in children aged 6-16 years with asthma and overweight/obesity.<br>* Other names: MIKADO;|
| No Intervention: Control<br>standard usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in the first second (FEV1 %) predicted value |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway inflammation |  | 2 years | 
| Symptom-free days, exacerbations |  | 2 years | 
| Need for beta-2 agonists/anti-inflammatory medication |  | 2 years | 
| Weight, height, body mass index (BMI) |  | 2 years | 
| Levels of serum adipokines |  | 2 years | 
| aerobic capacity | VO2max measured with an maximal ergometry test | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, overweight, obesity, children
Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects

Study Overview
=================
Brief Summary
-----------------
This prospective randomized double-blinded study was conducted to compare the antishivering effects of two different types of intrathecal administration.

Detailed Description
-----------------
This prospective randomized double-blinded study was conducted to compare the antishivering effects of two different types of intrathecal administration.Group Control:traditional intrathecal administration; Group Diluting:Diluting with cerebrospinal fluid

Official Title
-----------------
Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects

Conditions
-----------------
Antishivering Effects

Intervention / Treatment
-----------------
* Procedure: bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status Ⅰ or Ⅱ who were scheduled for elective surgery under spinal anesthesia were enrolled. Exclusion Criteria: Patients with pre-operative fever (>38℃), diabetes, , Parkinson's disease, hypo or hyperthyroidism, Raynaud's syndrome, obese patients (weight >100 kg), patients shorter than 152 cm, those with a history of allergy to the study medications, and patients receiving vasodilators were excluded from the study.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group Control<br>Hyperbaric bupivacaine 0.5% 2.5 mL was administered intrathecally in 30 seconds. | |
| Experimental: Group Diluting with cerebrospinal fluid<br>Hyperbaric bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid was administered intrathecally in 30 seconds | Procedure: bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid<br>* Hyperbaric bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid was administered intrathecally in 30 seconds<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antishivering effects of two different types of spinal anesthesia | antishivering effects of two different types administration of spinal anesthesia | time point 1: 15 minuntes after spinal anesthesia and time point 2 : when patiets were sent to postoperation care unit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shivering spinal anesthesia
Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to accumulate and quantitatively analyze data on the microbiome, serotonin signaling and genetics, and inflammatory cytokines from patients with Autism Spectrum Disorder and Fragile X Syndrome. Computational analysis of multi-dimensional datasets will be used to establish a Diagnostic and Therapeutic Index - an objective set of tools that can help differentiate subtypes of Autism Spectrum Disorder and develop more accurate methods of diagnosis and response to treatment.

Official Title
-----------------
Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome

Conditions
-----------------
Autism Spectrum Disorder, Fra(X) Syndrome

Intervention / Treatment
-----------------
* Other: specimen collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early childhood (pre-diagnosis) OR existing ASD diagnosis (Moderate to Severe) Existing FXS diagnosis Exclusion Criteria: Hospitalization Enrolled in another clinical study

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 21 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 |
| --- | --- |
| Autism Spectrum Disorder (ASD)<br>Early childhood (pre-diagnosis) OR existing diagnosis of moderate/severe ASD | Other: specimen collection<br>* participants will submit at minimum two of four required samples: fecal, urine, finger/toe-prick blood, and cheek swab, collected at home via commercially available kits<br>|
| Fragile X Syndrome (FXS)<br>Existing diagnosis of Fragile X Syndrome | Other: specimen collection<br>* participants will submit at minimum two of four required samples: fecal, urine, finger/toe-prick blood, and cheek swab, collected at home via commercially available kits<br>|
| Healthy Controls<br>No diagnosed chronic conditions | Other: specimen collection<br>* participants will submit at minimum two of four required samples: fecal, urine, finger/toe-prick blood, and cheek swab, collected at home via commercially available kits<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbial diversity profile | genetic analysis of microbial species in fecal samples | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences in serotonin levels | molecular analysis of blood/urine/fecal samples | 2 years | 
| differential expression of serotonin-related signaling molecules | genetic analysis of cheek swabs | 2 years |