linjc16/ctgov huggingface dataset:
Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of Prostaglandin I2 analogue use on the development of chronic allograft nephropathy and changes in allograft function in prevalent renal transplant recipients

Official Title
-----------------
Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy

Conditions
-----------------
Chronic Allograft Nephropathy

Intervention / Treatment
-----------------
* Drug: prostaglandin I2 analogue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prevalent renal transplant recipients 2 years after transplantation no history of acute rejection stable renal function Exclusion Criteria: history of biopsy-proven chronic allograft nephropathy history of biopsy-proven CNI nephrotoxicity history of biopsy-proven or clinical acute rejection unstable trough level of CNI or extremely low level of CNI bleeding tendency(+) pregnancy or pregnant-willing anticoagulation(+) antiplatelet agent (+) significant comorbidity(+): Acute coronary syndrome, pneumonia

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br> | Drug: prostaglandin I2 analogue<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| graft pathology, serum creatinine, creatinine clearance, eGFR |  | 1 year after drug administration |
Blood Glucose Homeostasis in Type 2 Diabetes: the Effects of Saccharose

Study Overview
=================
Brief Summary
-----------------
Hyperglycemia forms a direct and independent risk factor for the development of cardiovascular co-morbidities in type 2 diabetes. Consumption of sucrose-sweetened soft drinks might further increase the prevalence of hyperglycemic episodes. The objective of the study was to assess glycemic control in type 2 diabetes patients and healthy lean and obese controls under strict dietary standardization but otherwise free living conditions, with and without the consumption of soft drinks.

Official Title
-----------------
Blood Glucose Homeostasis in Type 2 Diabetes: the Effects of Saccharose

Conditions
-----------------
Type 2 Diabetes, Glycemic Control

Intervention / Treatment
-----------------
* Dietary Supplement: Sucrose consumption
* Dietary Supplement: water consumption


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lean NGT Group Normoglycemic (according to 2006 ADA guidelines) BMI < 27 kg/m2 Obese NGT Group Normoglycemic BMI 30- 35 kg/m2 Obese type 2 diabetes Group BMI 30- 35 kg/m2 Oral blood glucose lowering medication Exclusion Criteria: Exogenous insulin use Cardiac disease (any cardiac event in the last 5 years) HbA1c >10% Microalbuminuria: albumin:creatinine ratio >2,5

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sucrose<br>Sucrose | Dietary Supplement: Sucrose consumption<br>* Sucrose<br>|
| Placebo Comparator: Water<br>Water | Dietary Supplement: water consumption<br>* water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperglycemia |  | 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperglycemia |  | Postprandially | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, Glycemic control, (postprandial) Hyperglycemia, Sucrose
Phase 1 Study of SK3530 to Investigate of the Effect of Food

Study Overview
=================
Brief Summary
-----------------
This study was designed to investigate the food effect of SK3530 on the pharmacokinetics (PKs).

Detailed Description
-----------------
The PDE5 inhibitor, SK3530, is expected to be taken concomitantly with food. The food interaction studies of other PDE5 inhibitors (Viagra, Levitra and cialis) have already accomplished and the results have provided useful information to the patients. The objective of this study is to compare the pharmacokinetics (PKs) of SK3530 and its metabolite (SK3541) under the fasted and fed (low-fat meal and high-fat meal) conditions.

Official Title
-----------------
Clinical Trials to Investigate the Influence of Food on Pharmacokinetics of SK3530 in Healthy Male Volunteers.

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

Intervention / Treatment
-----------------
* Drug: SK3530


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 19 to 50 body weight of (IBM) ± 20% Exclusion Criteria: cardiovascular disease color-blindness or weakness

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SK3530|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters - AUC, Cmax, Tmax |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters-t1/2 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SK3530, Food effect, Pharmacokinetics
Effective Implementation of Interpersonal Psychotherapy

Study Overview
=================
Brief Summary
-----------------
The study is designed to observe the impact of improved measures of the fidelity on the community delivery of Interpersonal Psychotherapy. Pairs of therapist-patient dyads will be observed, first to develop and test brief measures of fidelity, and then to correlate those measures with symptomatic outcomes.

Detailed Description
-----------------
The study is designed to observe the impact of improved measures of the fidelity on the community delivery of Interpersonal Psychotherapy. In Phase I, 250 pairs of therapist-patient dyads will be observed as IPT Fidelity measures are developed and validated. In Phase II, 175 pairs of therapist-patient dyads will be observed to prospectively validate the IPT Fidelity measures with longitudinal outcomes on the PHQ-9.

Official Title
-----------------
Pragmatic Strategies for Assessing and Enhancing High Fidelity Delivery of Interpersonal Psychotherapy (IPT) in Community Practice

Conditions
-----------------
Depressive Symptoms

Intervention / Treatment
-----------------
* Behavioral: Interpersonal Psychotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-99 diagnosis of depressive disorder being treated with IPT in community settings Exclusion Criteria: - none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Phase I Patients<br>Patients with depression receiving community-based services will receive Interpersonal Psychotherapy | Behavioral: Interpersonal Psychotherapy<br>* Interpersonal Psychotherapy (IPT) is an empirically-validated time-limited treatment for depression<br>|
| Phase II Patients<br>Patients with depression receiving community-based services will receive Interpersonal Psychotherapy | Behavioral: Interpersonal Psychotherapy<br>* Interpersonal Psychotherapy (IPT) is an empirically-validated time-limited treatment for depression<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHQ-9 | Patient Health Questionnaire-9 | one year |
Obalon Balloon System Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
The Obalon Balloon System - Post-Approval Study is a prospective, observational, and multi-center study.

Detailed Description
-----------------
The Obalon PAS is a 1-year study that includes 6-month of Obalon Balloon therapy in conjunction of a weight loss behavior modification (WLBM) program and 6-month of continued WLBM program after balloon removal

Official Title
-----------------
Obalon Balloon System - Post-Approval Study

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

Intervention / Treatment
-----------------
* Device: Obalon Balloon System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 22 years old BMI of 30-40 kg/m2 Exclusion Criteria: Contraindicated for the device Use of medications or medical devices known to induce weight gain or weight loss within the preceding 6 months. Known history of endocrine disorders affecting weight. Participation in any clinical study which could affect weight loss within the past year Known history or present condition of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract, including, Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, diverticula, or any other disorder of the esophagus Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- |
| Obalon Balloon System<br>Obalon Balloon System with moderate intensity Weight Loss Behavioral Modification Program | Device: Obalon Balloon System<br>* Obalon Balloon System with a moderate intensity Weight Loss Behavioral Modification Program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Event | Device or Procedure related Serious Adverse Event | 6-Month | 
| Percentage of Patients with at least 5% TBWL | Percentage of Patients with at least 5% TBWL | 6-Month | 
| Mean % TBWL | Mean %TBWL | 6-Month |
Phase II Study of Irinotecan and Cisplatin in Extensive-stage Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Patients with untreated extensive-stage small cell lung cancer(SCLC) were randomly assigned to receive either irinotecan/cisplatin (IP) or etoposide/cisplatin(EP), The association of efficacy and toxicity of IP regimen was analyzed.

Detailed Description
-----------------
This is a randomized, multicenter study. Patients are randomized to irinotecan/cisplatin (IP) or etoposide/cisplatin (EP) treatment arms. The IP regimen consisted of at most 6 cycles of irinotecan 65 mg/m2 of body-surface area on days 1, 8 and cisplatin 75mg/m2 of body-surface area on day 1. The EP regimen consisted of at most 6 cycles of etoposide 100 mg/m2 of body-surface area from day 1 to 3 and cisplatin 75mg/m2 of body-surface area on day 1. Cycle length for the two arms was 3 weeks. The dose adjustment was allowed in at most within ±5% per investigator discretion if necessary.

Official Title
-----------------
Cisplatin Combined With Irinotecan or Etoposide for Untreated Extensive-stage Small Cell Lung Cancer: a Multicenter Randomized Control Clinical Trial

Conditions
-----------------
Extensive-stage Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Irinotecan and cisplatin
* Drug: Etoposide and cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) of 0 to 2 A life expectancy of at least 3 months Measurable lesions Adequate hematologic function Exclusion Criteria: Infection Myocardial infarction within the preceding three months Symptomatic brain metastases or receiving radiotherapy less than 4 weeks Pregnancy or breast-feeding

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 |
| --- | --- |
| Active Comparator: Irinotecan and cisplatin<br>The IP regimen consisted of at most 6 cycles of irinotecan 65 mg/m2 of body-surface area on days 1, 8 and cisplatin 75mg/m2 of body-surface area on day 1. | Drug: Irinotecan and cisplatin<br> <br> |
| Active Comparator: Etoposide and Cisplatin<br>The EP regimen consisted of at most 6 cycles of etoposide 100 mg/m2 of body-surface area from day 1 to 3 and cisplatin 75mg/m2 of body-surface area on day 1. | Drug: Etoposide and cisplatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 1 month |
Migraine and Endothelial Dysfunction

Study Overview
=================
Brief Summary
-----------------
Recently, there is evidence that endothelial activation and dysfunction are associated with migraine, especially in female migraineurs with aura. Our objectives were to determine whether novel endothelial function markers are altered in female migraineurs with aura compared to age-matched controls.

Detailed Description
-----------------
Our objectives were to determine whether novel endothelial function methods and novel markers of endothelial activation are associated with migraine in female migraineurs with aura. Migraine is an independent risk factor for stroke, especially in young women with aura symptoms. Endothelial dysfunction is a risk factor for cardiovascular diseases. Recent studies suggest that there is a link between migraine with aura and endothelial activation, dysfunction and impaired vascular reactivity. In this case-control study the investigators examine several novel biomarkers of endothelial function such as endothelial progenitor cells and endothelial microparticles as well as novel methods such as reactive hyperemic peripheral arterial tonometry in female migraineurs with aura and age-matched controls.

Official Title
-----------------
Migraine and Endothelial Dysfunction

Conditions
-----------------
Migraine With Aura

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: migraine with aura age < 50 female gender Exclusion Criteria: severe infectious disease cardiovascular disease (stroke, coronary heart disease, myocardial infarction) vasculitis peripheral artery disease diabetes mellitus pregnancy drug abuse medication: statin, anticoagulation, aspirin, clopidogrel intake of triptans <24h

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| migraine group<br>female migraineurs with aura | |
| control group<br>healthy women without headache syndrome | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Microparticles | Levels of endothelial microparticlel in the peripheral blood using flow cytometry | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of circulating Endothelial Progenitor Cells | Levels of cEPC (CD34+/CD133+/VGF2R/CD31) in % of mononuclear cells using flow cytometry | baseline | 
| Digital pulse volume change | Digital pulse volume change (with RH PAT as non invasive measurement (PAT-ratio; ENDOPAT, Itamar Medical Ltd.) for non-invasive, peripheral endothelial function | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine with aura
Study of the Osteoprotector Effects of a Milk Product Based on Anthocyans and Enriched in Calcium and Vitamin D

Study Overview
=================
Brief Summary
-----------------
We hypothesize that anthocyans with calcium and vitamin D have a positive effect on bone reshaping in menopausal women.

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Dietary Supplement: Anthocyans, Calcium and Vitamin D
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women Aged between 50 and 65 years Between 1 and 5 years menopause IMC between 19 and 30 kg/m² Exclusion Criteria: Medical Treatment for bone metabolism Vitamin D not including in the range of 20nmoles<25(OH)<100nmoles/l Vegan and vegetarian diet Regular consumption of food supplementary benefits Lactose intolerance While dieting

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 Years

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

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 |
| --- | --- |
| Placebo Comparator: 1<br> | Dietary Supplement: placebo<br> <br> |
| Experimental: 2<br> | Dietary Supplement: Anthocyans, Calcium and Vitamin D<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
-----------------
Osteoporosis prevention
Validation and Evaluation of a Portable Body Scanner for Determination of Obesity

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to validate a portable 3D human body measurement system which will improve approaches in obesity assessment.

Detailed Description
-----------------
Obesity has become an epidemic in the United States. A new technique of three-dimensional (3 D) photonic scanning will be used to create and validate a portable instrument that rapidly assesses obesity in clinical and field settings. This new portable body scanner will be a safe and easy method to help determine the incidence and type of obesity.

Official Title
-----------------
Validation and Evaluation of a Portable Body Scanner for Determination of Obesity

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-60 years old BMI between 18.50 to 39.99 kg/m3 Free of known diseases Hispanic and Not Hispanic or Latino Whites Exclusion Criteria: Women who are pregnant, could be pregnant, or lactating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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:one group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body volume |  | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validating body imaging as an indicator of central obesity |  | 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body Scanning, Body Fat, Body Volume, Obesity, No Conditions
Expectations and Beliefs of Transgender People Regarding Hormonal Treatment

Study Overview
=================
Brief Summary
-----------------
Hormonal treatment of gender dysphoria can have repercussions on metabolism, cardiovascular system and fertility and represents à potential oncological risk. According to the recommendations of the Endocrine society. Therefore, initial assessment and follow-up visits are necessary and must be carried out to avoid the apparition of potentially undesirable effects.

Official Title
-----------------
Expectations and Beliefs of Transgender People Regarding Hormonal Treatment

Conditions
-----------------
Transgenderism

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being a parent of adolescent/child presenting Gender dysphoria adult subject (age > 18 years) presenting Gender dysphoria non-inclusion criteria Severe, uncontrolled psychiatric or somatic illness Chronic alcoholism Substance abuse Refusal or linguistic, physical or psychological incapacity to participate in the study Ongoing pregnancy

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe expectations and beliefs of transgener people about hormonal therapy | qualitative analysis of qualitative data from collective discussions (focus groups) | 12 months |