linjc16/ctgov huggingface dataset:
LEAN Project: Weight Loss and Appetite Suppression

Study Overview
=================
Brief Summary
-----------------
The primary aim is to examine whether the intake of PhosphoLEAN is effective in aiding a cohort of women in losing weight. Participants taking the supplement will have significantly greater improvement in study outcomes than those taking the placebo.

Detailed Description
-----------------
Participants will be randomized to either a control or treatment group taking the dietary supplement containing a soy lecithin-derived N-oleoyl-phosphatidyl-ethanolamine (NOPE) and caffeine free Green Tea-derived epigallocathchin gallate (EGCG) whose trade name is PhosphoLean. The outcome is to determine the effects on indices of weight loss and appetite suppression. Participants will return at 6, 12, and 16 weeks for clinical measures.

Official Title
-----------------
The Effect of Soy Lecithin-derived N-oleoyl-phosphatidyl-ethanolamine (NOPE) and Green Tea-derived Epigallocatechin Gallate (EGCG) on Indices of Weight Loss and Appetite Suppression

Conditions
-----------------
Weight Loss

Intervention / Treatment
-----------------
* Drug: PhosphoLean


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30-45 years, women, overweight or obese class I, premenopausal, maintain current diet and exercise regimen Exclusion Criteria: pregnant or planning to become pregnant, currently have or history of cancer, heart disease, anemia, diabetes, depression

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss |  |  | 
| Appetite Suppression |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
green tea, weight, women
Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis

Study Overview
=================
Brief Summary
-----------------
ADDUP is an observational study of patients with alcoholic hepatitis. A structured interview is used to quantitatively estimate: Alcohol use Dietary intake Drug use (legal and illegal) in the weeks preceding onset of acute alcoholic hepatitis. After interview patients are followed up for 12 months with regard to response to therapy and survival. The study is intended to explore potential precipitants of alcoholic hepatitis.

Official Title
-----------------
Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis

Conditions
-----------------
Hepatitis, Alcoholic

Intervention / Treatment
-----------------
* Other: Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute alcoholic hepatitis aged over 18 years able to give informed consent Exclusion Criteria: evidence of other acute or chronic liver disease episode of alcoholic hepatitis in 6 months before admission severe hepatic encephalopathy delirium

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 |
| --- | --- |
| Alcoholic hepatitis<br>Individuals admitted to hospital with acute alcoholic hepatitis, defined as acute onset of jaundice in the context of recent hazardous alcohol use and the absence of other liver disease | Other: Interview<br>* Brief structured interview<br>|
| Hazardous alcohol use<br>Individuals admitted to hospital for any cause who drink hazardous quantities of alcohol but without evidence of alcoholic hepatitis or advanced liver disease | Other: Interview<br>* Brief structured interview<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in alcohol intake, dietary intake or drug use before illness | Behavior before admission (Brief structured interview) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival after admission (Brief structured interview) | Survival | 12 months | 
| Response to treatment (Brief structured interview) | Response to treatment (corticosteroids, pentoxifylline or supportive medical care) after 1 week, measured by Lille score | 1 week |
Ciprofloxacin in Drug-resistant Epilepsy

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the effect of a short-term prescription of ciprofloxacin on intestinal microbial pattern and seizure frequency of patients with drug-resistant epilepsy.

Official Title
-----------------
Effect of Ciprofloxacin on Seizure Frequency in Patients With Drug-resistant Epilepsy

Conditions
-----------------
Epilepsy Intractable

Intervention / Treatment
-----------------
* Drug: Ciprofloxacin Oral Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Drug-resistant epilepsy with frequency of at least 2 seizure/Week Acceptance of patients or his/her guardian (Signing informed consent) Exclusion Criteria: Hypersensitivity to ciprofloxacin or other fluoroquinolones History of tendon, renal, hepatic or cerebrovascular disease, organ transplantation or myasthenia gravis Usage of medications with interaction to ciprofloxacin No reliable contraception Pregnancy or breastfeeding Being under treatment with corticosteroid Usage of antibiotics in recent 2 months or need to use it during the study Patients who are candidate for epilepsy surgery or other nonmedical treatments Change in anti-seizure medications (ASMs) during recent month Patients who will need changes in ASMs dose during study

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 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 |
| --- | --- |
| Other: Ciprofloxacin<br> | Drug: Ciprofloxacin Oral Product<br>* The first stool sample will be taken before treatment and the second one will be taken in day 5 to 7 after treatment initiation. Treatment includes ciprofloxacin tablet 500mg twice a day for 5 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in seizure frequency registered in questionnaire | Comparison of seizure frequency in 4th week with the frequency at the start of the study. | 4 weeks | 
| Changes in quantity of microbial DNA extracted from stool samples by AccuPrep Stool DNA extraction Kit | Comparison of quantity of extracted microbial DNA in stool sample taken at day5-7 with the sample taken at the start of the study | 7 days | 
| Changes in microbial burden of stool samples using Absolute real time polymerase chain reaction (PCR) | Comparison of microbial burden of stool samples taken at day5-7 with the sample taken at the start of the study | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in seizure frequency registered in questionnaire | Comparison of seizure frequency in 12th week with the frequency at the start of the study | 12 weeks |
Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Multiple sclerosis (MS) is an inflammatory, demyelinating disease which affects the central nervous system (CNS). The etiology of MS is unknown, although the immune system appears to play a role. Many different infectious agents have been proposed as potential causes for MS, including Epstein-Barr virus, human herpesvirus 6, and coronaviruses. Recently Dr. Sriram at Vanderbilt University has found evidence for active Chlamydia pneumonia infection in the CNS of MS patients. These findings have been replicated in part by other laboratories. The purpose of the current study is to test whether antibiotic treatment aimed at eradicating Chlamydia infection will reduce the disease activity in MS. The primary outcome measure will be reduction in new enhancing MS lesions on brain MRI. Forty patients will be entered into the trial. To be eligible, patients must have evidence of chlamydia infection in their spinal fluid and enhancing lesions on their pre-randomization MRI scans. Patients who meet these criteria will be randomized to either placebo or antibiotic therapy, and followed for 6 months on treatment.

Official Title
-----------------
Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Rifampin
* Drug: Azithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with unequivocal diagnosis of multiple sclerosis and have evidence of C. pneumoniae infection in the cerebral spinal fluid

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: Treatment
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rifampin|nan|
|Drug: Azithromycin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison Study for Bioelectrical Impedance Device to Measure Human Body Composition

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance analyzer is comparable to a predicate device in measuring human body composition.

Detailed Description
-----------------
The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance analyzer is comparable to a predicate device in measuring human body composition under normal patient conditions. Specifically, the goal of this study is to compare impedance measurements (R and Xc) determined by using each bioelectrical impedance device and the estimated body compositional estimates [total body water (TBW); fat-free mass (FFM); and fat mass (FM)] calculated by using the same prediction equation (models) as the predicate device.

Official Title
-----------------
Comparison of Impedance Components and Estimated Body Composition Variables Determined by Using Bioelectrical Impedance Devices Manufactured by Akern SRL and RJL Systems

Conditions
-----------------
Body Composition Measurement

Intervention / Treatment
-----------------
* Device: Akern USA EFG
* Device: RJL Impedance analyzer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 90 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Akern EFG<br> | Device: Akern USA EFG<br>* Impedance measurement device<br>|
| Active Comparator: RJL device<br> | Device: RJL Impedance analyzer<br>* Impedance analyzer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resistance (R) - (ohms) |  | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Free Mass (FFM) |  | 5 minutes | 
| Total Body Water (TBW) |  | 5 minutes | 
| Extra Cellular Water |  | 5 minutes | 
| Fat Mass (FM) |  | 5 minutes |
Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the pathophysiology of nephrogenic fibrosing dermopathy (NFD)/nephrogenic systemic fibrosis (NSF).

Official Title
-----------------
Use of Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF) and Understanding Its Etiology

Conditions
-----------------
Nephrogenic Fibrosing Dermopathy, Nephrogenic Systemic Fibrosis

Intervention / Treatment
-----------------
* Procedure: Plasmapheresis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with NFD/NSF following a kidney transplant diagnosed with NFD/NSF following a liver transplant NFD/NSF and who have not had a kidney or liver transplant diagnosed with NFD/NSF and who have not had a kidney or liver transplant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>One to three 5-day course of plasma exchange (plasmapheresis) | Procedure: Plasmapheresis<br>* A course of 5 daily treatments of plasma exchange (plasmapheresis) for one to three courses<br>|
| Active Comparator: Group 2<br>One to three 5-day course of plasma exchange (plasmapheresis) | Procedure: Plasmapheresis<br>* A course of 5 daily treatments of plasma exchange (plasmapheresis) for one to three courses<br>|
| No Intervention: Group 3<br>No intervention taken | |
| Active Comparator: Group 4<br>One to three 5-day course of plasma exchange (plasmapheresis) | Procedure: Plasmapheresis<br>* A course of 5 daily treatments of plasma exchange (plasmapheresis) for one to three courses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve elasticity of skin, including increased range of motion of compromised joints due to leathery skin |  | Assessed two weeks after each monthly course of plasmapheresis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nephrogenic Fibrosing Dermopathy (NFD), Nephrogenic Systemic Fibrosis (NSF)
Intraoperative Near Infrared Spectroscopy of Kidney for Prediction of Acute and Sub-acute Kidney Injury in Partial Nephrectomy

Study Overview
=================
Brief Summary
-----------------
Intra-operative NIRS measurements of kidney during partial nephrectomy, after reperfusion, for monitoring ischemia and prediction of postoperative renal dysfunction.

Official Title
-----------------
Intraoperative Near Infrared Spectroscopy of Kidney for Prediction of Acute and Sub-acute Kidney Injury in Partial Nephrectomy

Conditions
-----------------
Kidney Injury

Intervention / Treatment
-----------------
* Device: near infrared spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidates for partial nephrectomy at Tel Aviv Medical Center who will consent to participate. Exclusion Criteria: Patients unable to give consent, Patients who were lost to follow up during the first 7 post-operative days.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: near infrared spectroscopy|near infrared spectroscopy monitoring on kidney after reperfusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury | An increase in serum creatinine by 0.3mg/dL or more within 48 hours compared with admission creatinine level or an increase in serum creatinine above 1.5 times baseline within 7 days of admission | 7 days post operative and during 6 months post-surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications | Vascular/Bleeding ect. | 7 days post operative |
Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the long term safety and efficacy of orally administered calcitriol in patients with at least 5% of their body covered with psoriasis. II. Evaluate the long term safety and efficacy of topically administered calcitriol in patients with at least 5% of their body covered with psoriasis. III. Compare the topical calcitriol treatment to the oral calcitriol treatment in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a part placebo-controlled (arm I) study. Patients either apply topical petrolatum (Vaseline) with calcitriol (vitamin D3) on a psoriatic lesion daily and petrolatum only on an other similar lesion daily to serve as a control (arm I) or receive oral calcitriol nightly (arm II). Arm I patients continue treatment for at least 2 months. At the end of 2 months of topical treatment, one biopsy is taken of the lesion treated with calcitriol, one biopsy of the lesion treated with petrolatum alone, and one biopsy of skin unaffected by psoriasis. Lesions are also photographed prior to therapy, 2-4 weeks during therapy for the first two months, then once every 1-3 months, and then once at end of treatment. Arm II patients increase dosage of oral calcitriol every 2 weeks up to a maximum dosage daily in the absence of adverse effects (high urinary calcium or serum calcium levels). Patients continue treatment for at least 1 month. Lesions are photographed prior to therapy, 2-4 weeks during therapy, and then once at end of treatment.

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: calcitriol


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Psoriasis covering at least 5% of body --Prior/Concurrent Therapy-- At least 30 days since prior systemic therapy for psoriasis At least 14 days since prior topical therapy for psoriasis No other concurrent treatment for psoriasis for the first 2-4 months of study No calcium supplement greater than 1,000 mg per day --Patient Characteristics-- No hypercalcemia No hypercalciuria Not pregnant Effective contraception required of all fertile patients
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: calcitriol|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
-----------------
dermatologic disorders, psoriasis, rare disease
Vardenafil Treatment Of Erectile Dysfunction In Depressive And Non-Depressive Men

Study Overview
=================
Brief Summary
-----------------
The primary aim of this open, uncontrolled, prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. The secondary aim of this study is to assess the influence of the treatment with Levitra on self-esteem (depressive symptomology) in men with ED.

Official Title
-----------------
A Non-Interventional, Post-Marketing Surveillance Phase IV Study to Obtain Data on Safety and Efficacy of Levitra® in Routine Treatment of Erectile Dysfunction in Depressive and Non-Depressive Men.

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Levitra (Vardenafil, BAY38-9456)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 Erectile dysfunction untreated or ineffectively treated with other than vardenafil PDE5 inhibitors Exclusion Criteria: Treatment with nitrates Allergy to vardenafil or other tablets ingredients Treatment with CYP3A4 inhibitors (e.g. indinavir, ritonavir, ketoconazole, itraconazole, erythromycin) Cardiovascular status excluding any sexual activity

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* Primary care erectile dysfunction patients for whom physician decided to start the treatment with vardenafil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy, safety, tolerance of the treatment with Vardenafil reported by the physician |  | At the patients control visit (approx. 3 months from the initial) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of vardenafil on depressive symptoms and self-esteem measured with CES-D and Rosenberg scale |  | At the patients control visit (approx. 3 months from the initial) |