linjc16/ctgov huggingface dataset:
A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Solution And A Varenicline Patch Applied To The Skin

Study Overview
=================
Brief Summary
-----------------
To evaluate the absorption, safety, and tolerability of a varenicline solution and a varenicline patch applied to the skin.

Detailed Description
-----------------
Additional Study Purpose Details: Evaluation of the pharmacokinetic profile of a varenicline solution and a varenicline patch applied to the skin

Official Title
-----------------
A Phase 1, Open-Label, Nonrandomized, Single Dose Study To Characterize The Pharmacokinetics Of A Varenicline (CP-526,555) Transdermal Solution And A Varenicline Transdermal Delivery System Applied To The Skin Of Adult Smokers

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: Varenicline free base solution
* Drug: Varenicline free base patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, adult, male smokers Exclusion Criteria: significant medical illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Varenicline free base solution<br> | Drug: Varenicline free base solution<br>* A single application of a 4.8 mg varenicline solution will be applied to the upper back over a 24 hour period<br>|
| Experimental: Varenicline transdermal delivery system<br> | Drug: Varenicline free base patch<br>* A single application of a nominal 1.2 mg dose of a varenicline transdermal delivery system (5 cm2 patch, 4.8 mg drug payload) will be applied to the upper back over a 24 hour period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Varenicline area under the curve from 0 to the last quantifiable concentration (AUClast) and varenicline area under the curve from 0 to infinity (AUCinf) |  | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of adverse events (including skin irritation) |  | 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
percutaneous, transcutaneous, topical, varenicline, transdermal, transdermal delivery system, patch
Short Term Group Therapy for OCD

Study Overview
=================
Brief Summary
-----------------
Assessing OCD before and after group therapy

Conditions
-----------------
Obsessive Compulsive Disorder

Intervention / Treatment
-----------------
* Behavioral: Group therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OCD Eligibility to participate in group therapy Exclusion Criteria: PTSD Suicidal thoughts Psychotic state Severe hostile personality disorder

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Group therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the postprandial (anytime after a meal) effect of different dietary fats on endothelial function in HIV-infected and HIV-uninfected men.

Detailed Description
-----------------
This study requires two visits. Once determined eligible by the study criteria, during the first visit the participant will be randomly placed to receive one of two high-fat meals. The participant will receive the other study meal during the second visit. At each visit, brachial artery ultrasounds will be performed before and 3 hours after the meal is eaten. The sample size is 50 subjects. This study will be conducted at the Clinical Research Center at Tufts Medical Center.

Official Title
-----------------
Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men

Conditions
-----------------
HIV Infection, Cardiovascular Risk, HIV Infections

Intervention / Treatment
-----------------
* Other: Omega-3 study meal
* Other: Saturated fat study meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-positive white male aged >18 years Under one of the following treatment categories: Treatment naive or have never taken any HIV medications Taking Kaletra Taking Sustiva Taking Atripla Exclusion Criteria: Smoker Pre-existing diagnosis or treatment for the following: Lipid disorder Cardiovascular disease High blood pressure Diabetes Acute opportunistic infection or malignancy within last 3 months or current therapy for either Active IV drug use

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| 1<br>High omega-3 | Other: Omega-3 study meal<br>* Participant will eat a study meal high in omega-3 fatty acids.<br>|
| 2<br>High saturated fat | Other: Saturated fat study meal<br>* Participant will eat a study meal high in saturated fat.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure flow-mediated dilation before and after eating the two study meals. |  | Study visit 1 and 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effect of different dietary fats on endothelial function. |  | Study visit 1 and 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brachial artery ultrasound, brachial artery reactivity, HIV, human immunodeficiency virus, cardiovascular risk, omega three, saturated fat, sustiva, atripla, kaletra, treatment naive
An Evaluation of Etanercept in the Treatment of Subjects With Psoriasis

Study Overview
=================
Brief Summary
-----------------
The purpose of this multicenter, open-label, prospective study is to evaluate the effectiveness and safety of etanercept in the treatment of subjects with psoriasis.

Official Title
-----------------
A Multicenter, Open-Label, Prospective Study to Evaluate the Effectiveness and Safety of Etanercept in the Treatment of Subjects With Psoriasis

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

Intervention / Treatment
-----------------
* Drug: Etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Stable, active plaque psoriasis involving greater than or equal to 10% of body surface area (BSA) at screening and baseline Exclusion Criteria: - Any grade 3 or 4 adverse event or infection within 28 days before screening, or between the screening visit and study drug initiation - Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis - Psoralen plus ultraviolet A radiation (PUVA), oral retinoids, cyclosporine, alefacept (Amevive®), efalizumab (Raptiva®), or any other systemic anti-psoriasis therapy within 28 days of study drug initiation - Ultraviolet light B (UVB) therapy, topical steroids, topical vitamin A or D analog preparations, or anthralin within 14 days of study drug initiation (exception: topical steroids, at no higher than moderate strength, are permitted on scalp, axillae, and groin but dose and formulation must remain stable throughout trial) - Prior exposure to any tumor necrosis factor (TNF)-inhibitor, including etanercept - Severe comorbidities - Known history of tuberculosis (TB), or previous positive purified protein derivative (PPD) test

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Physician's Global Assessment of Psoriasis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported outcomes including Dermatology Life Quality Index, SF-36, Euro-QoL 5D, and Beck Depression Index |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis
Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether hepatitis B immunoglobin can be discontinued early after hepatitis B virus (HBV) induced liver transplantation and be replaced by the nucleoside analogue entecavir to prevent hepatitis B reinfection.

Official Title
-----------------
Prevention of HBV Reinfection After Liver Transplantation Using Entecavir Monotherapy After Short-term HBIg Administration: A Pilot Study

Conditions
-----------------
Liver Transplantation, Hepatitis B, Liver Disease

Intervention / Treatment
-----------------
* Drug: Entecavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver transplantation for hepatitis B induced endstage liver disease absence of coinfection with HIV and HCV female and male patients >= 18 years of age Exclusion Criteria: any evidence of other causes for endstage liver disease patients that do not fulfill the criteria for liver transplantation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Entecavir<br> | Drug: Entecavir<br>* Entecavir monotherapy after short-term HBIg therapy for patients transplanted for hepatitis B induced end-stage liver disease; in case of prior lamivudine treatment, tenofovir will be added to the reinfection prophylaxis<br>* Other names: Baraclude;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hepatitis Bs antigen negativity can be maintained by entecavir in the second year after HBV induced liver transplantation |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis B, liver transplantation, shortterm HBIg, lamivudine resistance
PEComas: Natural History and Prognostic Factors

Study Overview
=================
Brief Summary
-----------------
Perivascular epithelioid cell tumors are rare and characterized by the expression of myomelanocytic markers. They belong to a complex tumor family that includes angiomyolipomas, lymphangioleiomyomatosis and other soft-tissue tumors. Given their rarity, the natural history of pecomas is not yet understood, and a comprehensive classification that integrates clinical, pathological and molecular features has not been achieved as of today. This study is a national multicenter retrospective study to better understand the natural history of PEComas, excluding lymphangioleiomyomatosis and classic triphasic angiomyolipomas. The primary purpose is the identification of prognostic markers impacting the relapse. Secondaries purposes are to identify prognostic markers impacting the overall survival and to have a better understanding of natural history

Official Title
-----------------
National Multicenter Retrospective Study: PEComas: Natural History and Prognostic

Conditions
-----------------
PEComas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patient (≥18 years old) Minor patient (1 to 17 years old) PEComas diagnosed in France between 1990 and 2018 and read back by a pathologist referent of sarcomas Patient having agreed to the use of his medical data for the purpose of this research. Parental authorities having given their agreement for the reuse of their child's medical data for the purpose of this research. Exclusion Criteria: Opposition of the patient (or his legal representative) to the reuse of his data for the purposes of this research Impossibility of giving the subject clear information Patient under safeguard of justice Patient under guardianship Lymphangioleiomyomatosis Classic triphasic angiomyolipoma

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
| Study of the prognostic factors associated with the risk of relapse |  | The period from January 1st, 1990 to December 31, 2018 will be examined |
Pediatric Ovarian Tissue Banking - Operative Specimens From Females 0-18 Years of Age

Study Overview
=================
Brief Summary
-----------------
A child is eligible to participate in this study because she is having surgery on her ovary. The investigators may obtain a sample of any discarded tissue from the surgery for an ovarian tissue library. This study is being conducted to understand how common ovarian conditions effect the number and quality of ovarian follicles and the reproductive potential of the ovary.

Detailed Description
-----------------
The investigators intend to enroll 100 girls and women in this study who are undergoing surgery involving the ovary. This may include patients with different conditions for comparison, such as ovarian cysts or masses and ovarian torsion. For each patient, the investigators will obtain the discarded tissue from the operating room after the affected ovarian tissue is resected. The tissue sample will only be taken for the tissue library from ovarian tissue that would otherwise be discarded. No additional tissue will be collected other than that which is already removed as part of the ovarian procedure. No additional surgery or other procedures will be performed for the purposes of this study. The tissue will be assigned a study ID number and the age, gender and diagnosis of the child will be entered on the tissue library log and maintained for the duration of the study.

Official Title
-----------------
Pediatric Ovarian Tissue Banking - Operative Specimens From Females 0-18 Years of Age

Conditions
-----------------
Benign Cysts Ovarian, Cystectomy, Torsion, Malignant Cysts Ovarian

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre and Post Pubertal females Ages 0-18 years old Undergoing scheduled or emergent operative procedures involving the ovary oophorectomy (torsion, benign mass/cyst, malignant mass/cyst) ovarian cystectomy Exclusion Criteria: Pregnant females

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian Tissue Banking | The primary purpose of this study is analyzing the histologically ovarian tissue obtained surgically due to different ovarian pathologies. The tissue will be stained and follicles of varying stages will be counted and compared for different patient ages and ovarian pathologies. The extra-cellular matrix will also be stained and compared between different patient ages and ovarian pathologies. | October 2016- January 2023 |
Carbohydrates and Children

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the impact of test carbohydrate blends on fat and carbohydrate oxidation, glucose, insulin and hunger scores in pre-adolescent boys and girls.

Official Title
-----------------
An Evaluation of Carbohydrates and Children

Conditions
-----------------
Carbohydrate Metabolism

Intervention / Treatment
-----------------
* Other: Control
* Other: Experimental


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 9 -13 years of age, or female 9- 10 years of age Tanner stage 1 Subject was born full term Subject was born normal weight Subject passes the Physical Activity Readiness Questionnaire Body mass index >5th percentile and <95th percentile for age and gender Subject has voluntarily signed and dated a youth assent document Exclusion Criteria: History of metabolic. endocrine, or hyperactivity disorders Allergy or intolerance to any ingredient found in the study products Participation in a concomitant trial of a non-registered drug or that otherwise conflicts with this study

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>- 237 ml beverage; consumed once per test visit | Other: Control<br>* control carbohydrate blend<br>|
| Experimental: Experimental<br>- 237 ml beverage; consumed once per test visit | Other: Experimental<br>* experimental carbohydrate blend<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy Utilization | Calculated by Indirect Calorimetry using volume of oxygen consumed (liters/minute) and the volume of carbon dioxide expired (liters/minute). | Study Visits 1 to 2 (1- 14 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hunger Assessment | Visual analog scale (units on a scale) | Study Visits 1 to 2 (1- 14 days) | 
| Blood Measurements - Glucose | mg/dl | Study Visits 1 to 2 (1- 14 days) | 
| Blood Measurements - Insulin | IU | Study Visits 1 to 2 (1- 14 days) |
CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the relationship between the side effects(especially arthralgia and arthritis) which appear in the patients who are prescribed aromatase inhibitor(AI) and the CYP19 genetic polymorphisms.

Official Title
-----------------
Significance of CYP19 Genetic Polymorphism on Musculoskeletal Symptom & Complication of Aromatase Inhibitor(AI)

Conditions
-----------------
Breast Neoplasms, Arthralgia, Arthritis, Genetic Polymorphism

Intervention / Treatment
-----------------
* Drug: Aromatase Inhibitor(Femara or Arimidex)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must sign the informed consent. The patient must sign the informed consent of genetic screening test. The patient must be between 18 years old and 80 years old who can make a decision independently. The patient must be post-menopause status. The patient should be the stage 1,2 or 3 of the breast cancer. The test result of the estrogen receptor or progesterone receptor is positive, so the patient should be taking the medication of AI (Aromatase Inhibitor). Exclusion Criteria: The patient is pre-menopause status. The test result of serum FSH level is below 30mU/ml. The test result of the hormone receptor(ER & PR) is negative or unknown. Patient's breast cancer stage is 4 which has systemic metastatics.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CYP19<br>CYP19 genetic polymorphism | Drug: Aromatase Inhibitor(Femara or Arimidex)<br>* Femara(Letrozole) 2.5mg 1tab qd, Arimidex(Anastrozole) 1mg 1tab qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level |  | 6, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC (European Organization for Research and Treatment of Cancer)- QOL(Quality of Life)- C30, BR23 & Skeletal pain information, BMI |  | 3,6,12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast neoplasms, Aromatase inhibitors, Genetic polymorphisms, Arthralgia, Arthritis