linjc16/ctgov huggingface dataset:
Effect of Garlic Tablet Some Indicators Related to Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether garlic in adjunct to conventional medical treatment is effective in improving carotid intima media thickness (CIMT), Flow mediated dilation (FMD) and plasma lipid profile or c-reactive protein of coronary artery disease (CAD) patients.

Official Title
-----------------
Effect of Garlic Tablet on Carotid Intima Media Thickness and Flow-mediated Dilation in Patients Undergoing Angioplasty

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Garlic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: angiography confirmed coronary artery disease lack of consistent use of the garlic in the last month Exclusion Criteria: Change in type of medication during study

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Garlic<br>daily consumption of two odor controlled garlic tablets | Dietary Supplement: Garlic<br>* Garlic tablet in adjunct to medical treatment<br>|
| Placebo Comparator: Placebo<br>daily consumption of placebo | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid Intima Media Thickness | Change from baseline and compared to placebo group in Carotid Intima Media Thickness at 12 weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated dilatation | Change from baseline and compared to placebo group in Flow-mediated dilatation at 12 weeks | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CIMT, FMD, CAD
Vitamin D Levels in Residents in Medicine

Study Overview
=================
Brief Summary
-----------------
the study aims to messure the vitamin D levels in medical staff in the hospital. The physicians in the course of their internship who work indoors and work many night shifts have limited sun exposure in all seasons. Nursing staff who work shifts and work indoors are at the same risk of liltle sun exposure. The study addresses the amount of sun exposure, assessed by a sun exposure questioner, age, gender,work load related to number of shifts in the physicien group and in nursing group the job percentile we also adress religion (clothing cover)as a factor.

Detailed Description
-----------------
The population in Israel is heterogeneous in the aspect of skin exposure to the sun. Women in the Moslem community with traditional long sleeve dress code whose sun exposure to the sun even in the summer months is limited. The physicians in the course of their internship who work indoors and work many night shifts and nurses with their shift work have limited sun exposure in all seasons. The study addresses the amount of sun exposure, assessed by a sun exposure questioner, age, gender,number of shifts in the physicien group and in nursing group the job percentile religion (clothing cover). The standard for measuring vitamin D status is 25(OH) D levels in the serum. The staff members from which blood will be drawn will be have an explanation about the aim of the study and will sign an informed consent.

Official Title
-----------------
Vitamin D Deficiency in Medical Residence in Israel

Conditions
-----------------
Vitamin D Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:medical staff Exclusion Criteria:pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| medical residents, vit d<br>vitamin | |
| levels of vitamin d<br>resident | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low vitamin D levels in direct relation to nomber of shifts/ job percentile |  | 1 year | 
| low leves of vitamin D in direct relationship to nomber of shifts job percentile |  | 1 year |
Gonadal Steroid Manipulation and Personality Characteristics: Association With Mood Fluctuations and in Vitro Fertilization (IVF) Outcomes

Study Overview
=================
Brief Summary
-----------------
The current study's primary aim is to investigate the association between neuroendocrine fluctuations and mood disorders by monitoring mood states over distinct hormonal phases during in-vitro-fertilization (IVF) treatment. The secondary goal of this study is to explore psychological profiles and coping mechanisms of women undergoing IVF, and to identify the ones that are associated with successful psychological adaptation to the process and a successful biological outcome.

Official Title
-----------------
Gonadal Steroid Manipulation and Personality Characteristics: Association With Mood Fluctuations & IVF Outcomes

Conditions
-----------------
Mood Disorders

Intervention / Treatment
-----------------
* Procedure: IVF procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted for their first or second IVF cycle; Demonstrated sufficient communication skills and level of understanding in the Hebrew language; signed an informed consent; Were under the age of 42; Were not suffering from endometriosis or male factor in patients who underwent testicular sperm extraction (TESE); Were not under psychotherapeutic or psychopharmacological treatment. The accepted indications for the IVF included a female factor, male factor or unexplained infertility. Exclusion Criteria: 1. All others.

Ages Eligible for Study
-----------------
Maximum Age: 42 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GNRH<br>Observational (IVF is not done as part of the study) | Procedure: IVF procedure<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
-----------------
women admitted to the In Vitro Fertilization unit
Study to Evaluate Methods That Assess the Effect of AZD4017 in Adipose Tissue

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to investigate different methods to evaluate the effect of AZD4017 in adipose tissue after single and multiple doses of AZD4017 in abdominally obese but otherwise healthy subjects.

Official Title
-----------------
A Randomised, Single-blind, Placebo-controlled, Single-centre, Phase I Study in Abdominally Obese Healthy Volunteers to Evaluate Methods to Assess 11-βHSD1 Activity in Adipose Tissue and Related Downstream Biomarkers After Single and Repeated Oral Doses of AZD4017 for 10 Days

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: AZD4017
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed written and dated informed consent Have a body mass index (BMI) between 27 and 35 kg/m2 Waist circumference of >102 cm Exclusion Criteria: History of any clinical significant disease Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD4017<br>* oral suspension, 1200mg, once daily, for 10 days<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the effect of single and repeated doses of AZD4017 and placebo on mechanisms in adipose tissue involved in metabolic regulation |  | A adipose tissue biospy is taken at baseline, on first day of dosing day, on 4th dosing day and on 9th dosing day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables |  | The variables will be measure predose and the repeatedly during the following 10 days after dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacodynamic method evaluation
Liver Function Assessment - Feasibility and Dosing Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to 1) determine the feasibility of using Cardiox Liver Function Assessment System (LFA) to measure indocyanine green (ICG) clearance; 2) determine an adequate dose based on LFA technology and 3) determine an adequate time period for LFA determination.

Detailed Description
-----------------
Four cohorts of subjects will be enrolled. The fist two cohorts will receive fixed doses of ICG dye (2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg) followed by 20 minutes of LFT monitoring. The final two cohorts will receive weight based doses of ICG dye (0.1 mg/kg, 0.5 mg/kg) followed by 20 minutes of LFT monitoring. Additionally the final two cohorts will have serial blood draws before the ICG dose and at 5, 10, 15 and 20 minutes post ICG dose.

Official Title
-----------------
A Feasibility Study to Determine an Adequate Dose of ICG for the Liver Function Assessment System in Healthy Volunteers

Conditions
-----------------
Hepatic Failure

Intervention / Treatment
-----------------
* Drug: ICG Dye


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects, aged 18 to 75 years, inclusive Informed consent documentation understood and signed. Exclusion Criteria: Known allergy or sensitivity to the ICG or to iodide contrast dye Pregnant women or those nursing babies

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Serial Blood Draws<br>Cohorts 3 and 4 - weight based doses of ICG dye followed by serial blood draws at 5, 10, 15 and 20 minutes post ICG injection. | Drug: ICG Dye<br> <br> |
| Experimental: Liver Funtion Test Dye Detection Monitor<br>All cohorts receive continuous LFT monitoring post ICG injection. | Drug: ICG Dye<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICG dye detection using the LFT system compared to serial blood sampling ethods. | Determination of an adequate dose for the Cardiox Liver Functioning Assessment LFA system to produce liver function assessments consistent with serial blood sampling methods. | 20 minutes post ICG dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICG fluorescence detection at the scaphoid fossa of the ears |  | 20 minutes post ICG dose | 
| Repeatability of the Cardiox LFA system to detect the ICG fluorescence in the same subjects over time. |  | 20 minutes post ICG dose |
Propolis Effects in Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the impact of Propolis on proteinuria reduction and protection of the glomerular filtration rate in chronic renal failure patients.

Official Title
-----------------
Propolis Effects on Proteinuria and Kidney Function in Patients With Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Drug: Propolis
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years; less than 90 years; glomerular filtration rate between 25 and 70 ml / min; proteinuria in the urine 24 hours more than 300 mg or protein / creatinina in isolated urine greater than 0.3g / g or microalbuminuria (albumin / creatinine ratio) between 30-300 mg / g. Exclusion Criteria: Pregnants; Neoplasia carrier; Renal transplant patients; Patients who refuse to participate in the study. Glomerulopathy on Immunosuppression

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propolis<br>Patients will continue to receive standard treatment for their comorbidities, determined by the attending physician. Patients will receive 500 mg / day of the propolis extract in the form of tablets split in two daily doses. | Drug: Propolis<br>* Patients will receive 500 mg / day of the propolis extract in the form of tablets split in two daily doses<br>|
| Placebo Comparator: Placebo<br>Patients will continue to receive standard treatment for their comorbidities, determined by the attending physician. Patients will receive 500 mg / day of the propolis-placebo in the form of tablets split in two daily doses. | Drug: Placebo<br>* Patients will receive 500 mg / day of the placebo in the form of tablets split in two daily doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing Proteinuria | Reduction from baseline proteinuria. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protection of the glomerular filtration rate | Maintaining glomerular filtration rate or inferior reduction to 5 ml per minute per 1.73 m2 of body-surface area from baseline. | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proteinuria, Propolis, Chronic Kidney Disease
A Phase 2 Study of E6005 in Patients With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety profiles of E6005 ointment in patients with atopic dermatitis compared to vehicle. The pharmacokinetic profile after topical application of E6005 is also assessed.

Official Title
-----------------
A Phase 2 Study of E6005 in Patients With Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: E6005
* Drug: E6005 ointment (vehicle)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Adults of both genders aged 20 to 64 years at the time when the written informed consent is obtained. Outpatients diagnosed with atopic dermatitis. Exclusion Criteria Patients with a present illness of Kaposi's varicelliform eruption, scabies, molluscum contagiosum, impetigo contagious, psoriasis, connective tissue disorder, collagen disorder or Netherton's syndrome, etc., which could have an effect on the pathological evaluation of the atopic dermatitis. Patients with active infection that requires oral or intravenous administration of antibiotics, antifungal or antivirus agent/s at baseline. Patients with advanced disease or abnormal laboratory tests that would possibly affect the safety of the subject or the implementation of this study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug: 0.2% E6005 ointment<br> | Drug: E6005<br>* 0.0% E6005 ointment applied twice daily for 4 weeks (vehicle-controlled phase), and then, following 8-week is extension phase which all subjects receive 0.2% E6005 ointment twice daily. Subjects are randomized to either 0.2% E6005 ointment group or vehicle group at a ratio of 2:1.<br>|
| Placebo Comparator: Drug: 0.0% E6005 ointment (vehicle)<br> | Drug: E6005 ointment (vehicle)<br>* 0.2% E6005 ointment applied twice daily for 4 weeks (vehicle-controlled phase), and then, following 8-week is extension phase which all subjects receive 0.2% E6005 ointment twice daily. Subjects are randomized to either 0.2% E6005 ointment group or vehicle group at a ratio of 2:1.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of pruritus score from baseline |  | From baseline through 12 weeks | 
| Changes of eczema area and severity from baseline |  | From baseline through 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dermatitis, Atopic
COMFORT Study: A Crossover Study of NeoRecormon (Epoetin Beta) and Darbepoetin Alfa in Patients With Renal Anemia.

Study Overview
=================
Brief Summary
-----------------
This study will assess the comfort of subcutaneous injections of NeoRecormon and darbepoetin alfa (Aranesp) in patients with renal anemia. Eligible patients will be randomized to receive comparable subcutaneous injections of either darbepoetin alfa (30 micrograms) or NeoRecormon (6000IU). They will then be crossed over to the alternative treatment arm for further treatment. After each injection pain will be assessed using the visual analogue scale (VAS) and 6-point verbal rating scale (VRS), and patient preference will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Official Title
-----------------
A Randomised, Cross-Over Study to Investigate the Comfort of Injection of Renal Anaemia Patients Receiving Subcutaneous NeoRecormon® Compared to Darbepoetin Alfa.

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: darbepoetin alfa
* Drug: epoetin beta [NeoRecormon]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >18 years of age; patients with renal anemia or post-transplant anemia. Exclusion Criteria: poorly controlled hypertension; known hypersensitivity to NeoRecormon or darbepoetin alfa.

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: epoetin beta [NeoRecormon]<br>* 6000 IU sc weekly (2 doses)<br>|
| Active Comparator: 2<br> | Drug: darbepoetin alfa<br>* 30 micrograms sc weekly (2 doses)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local pain due to s.c. injection (by VAS). |  | After each injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preference. |  | At end of study | 
| AEs, vital signs. |  | Throughout study |