linjc16/ctgov huggingface dataset:
Simplifying Menstrual Regulation (MR): Post Abortion Care in Pakistan

Study Overview
=================
Brief Summary
-----------------
This study is an additional component of protocol 6005, titled Simplifying Menstrual Regulation (MR): Exploring the role of at-home semi-quantitative pregnancy tests for follow-up to menstrual regulation service provision in Pakistan. The study seeks to pilot a self-assessment checklist that will help women, who receive medical services for incomplete abortion, correctly identify warning signs and symptoms and determine whether to return to the clinic. The checklist can serve as a useful resource to help with the timely identification of women who need additional care and can help streamline service delivery. In addition, this study will provide important data on the role of misoprostol at varying levels of health services offering an array of treatments for incomplete abortion.

Official Title
-----------------
Simplifying Menstrual Regulation (MR): Exploring the Role of At-home Semi-quantitative Pregnancy Tests for Follow-up to Menstrual Regulation Service Provision in Pakistan: Post Abortion Care (PAC)

Conditions
-----------------
Medical Abortion

Intervention / Treatment
-----------------
* Device: PAC checklist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vaginal bleeding during pregnancy Open cervical os. No signs of severe infection, defined as at least one of the following of: 1) foul smelling discharge, 2) fever > 38 degrees C , 3) uterine tenderness No hemodynamic disturbances (pulse >110/min and systolic bp <100) Exclusion Criteria: Suspected to have an ectopic pregnancy Unable to provide informed consent
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAC checklist<br>Pictorial checklist which illustrates these signs and symptoms | Device: PAC checklist<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify symptoms | Proportion of women able to use a checklist to correctly identify any signs and symptoms that warrant immediate return to the clinic and additional care | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of treatment | Proportion of women who find the treatment of 400 sublingual misoprostol for incomplete abortion acceptable and satisfactory. | 1 week | 
| Uptake of contraceptive use | Proportion of women who receive a contraceptive method after receipt of 400 sublingual misoprostol | 1 week |
Real World Data Analysis of PARP Inhibitors Use in Patients With Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
Real-world clinical outcomes and toxicity data will be evaluated in patients with advanced high grade ovarian cancer who will receive PARP inhibitors.

Detailed Description
-----------------
A prospective-retrospective analysis of patients with histologically confirmed high grade ovarian cancer who will receive or received olaparib or niraparib will be conducted at any line of treatment.

Official Title
-----------------
Real World Data Analysis of PARP Inhibitors Use in Patients With Ovarian Cancer

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: PARP inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - women >18 years old with advanced high grade ovarian cancer Exclusion Criteria: -

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| One cohort<br>women with advanced epithelial ovarian cancer who received PARP inhibitors at any line of treatment | Drug: PARP inhibitor<br>* use at any line of treatment in patients with advanced ovarian cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Progression Free Survival |  | 12/2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the safety profile of olaparib in women with advanced high grade ovarian cancer |  | 12/2021 | 
| Assessment of the safety profile of niraparib in women with advanced high grade ovarian cancer |  | 12/2021 |
ARC in Hemorrhagic Stroke

Study Overview
=================
Brief Summary
-----------------
To determine the incidence and predictors of augmented renal clearance (ARC) in patients with hemorrhagic stroke.

Official Title
-----------------
Augmented Renal Clearance in Hemorrhagic Stroke Patients Admitted to the Neurosciences Intensive Care Unit

Conditions
-----------------
Hemorrhagic Stroke, Augmented Renal Clearance

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥ 18 years Patients with hemorrhagic stroke Anticipated length of stay in the neuroscience intensive care unit > 48 hours Informed consent provided by the patient or by the patient's designated medical proxy Exclusion Criteria: Pregnancy Patients with pre-existing renal dysfunction (chronic kidney disease stages 3 - 5) Patients receiving renal replacement therapy Patients with an admission serum creatinine > 1.4 mg/dL Patients with non-aneurysmal subarachnoid hemorrhage Patients with history of nephrectomy or body mass index < 18 kg/m2

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 |
| --- | --- |
| Patients with hemorrhagic stroke<br>All patients with hemorrhagic stroke admitted to the neurosciences ICU are eligible for study enrollment. | Other: No intervention<br>* No interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the onset, magnitude, and change over time of ARC in patients with hemorrhagic stroke | Daily 8-hour urine collections will be performed to directly measure creatinine clearance up to ICU discharge | Over neurosciences intensive care unit stay |
Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

Study Overview
=================
Brief Summary
-----------------
This clinical investigation examined the influence of cytostatic chemotherapy with 5-fluorouracil, modulated by biologically active leucovorin, on patients' survival time following surgery for colon carcinoma Stage II.

Official Title
-----------------
A Prospectively Randomized Study on Adjuvant Chemotherapy in Patients With Operated Colon Carcinoma Dukes B (Stage II; T3-4, N0, M0).

Conditions
-----------------
Colon Cancer Stage II

Intervention / Treatment
-----------------
* Drug: Fluorouracil
* Drug: Leucovorin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically verified, operable colon carcinoma Stage II (RO, T3-4, N0, M0) Age: less than 80 years WHO Performance > 2 Adequate bone marrow reserve, renal and hepatic functions Informed consent Exclusion Criteria: Rectal cancer R1or R2 resection; carcinosis peritonei Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic or metabolic disease, malignant second carcinoma

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluorouracil|nan|
|Drug: Leucovorin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluorouracil, Leucovorin, Colon cancer
Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to assess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females. The secondary purpose is to provide the initial pharmacokinetic and pharmacodynamic profiles of PRA-027 in healthy Japanese female subjects.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Japanese Females

Conditions
-----------------
Uterine Leiomyomata (Fibroids)

Intervention / Treatment
-----------------
* Drug: PRA-027


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA Women of nonchildbearing potential aged 20 to 64 years. Must have a negative pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight must be at least 45 kg. Healthy as determined by the investigator on the basis of screening evaluation. EXCLUSION CRITERIA Any significant cardiovascular, hepatic, renal, respiratory, gynecologic gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Any history of drug abuse or admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements. Use of any investigational drug within 90 days before study day 1, use of any prescription drug within 30 days before study day 1, consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages within 48 hours before study day 1, consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1, use of any over-the-counter drugs, including herbal supplements (except for the occasional use of vitamins ≤100% of the recommended daily allowance), within 14 days before study day 1, or the donation of blood within 90 days before study day 1.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PRA-027|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females. |  |  |
Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the hormone dynamics in women with anorexia nervosa and hypothalamic amenorrhea is related to bone loss in those populations.

Official Title
-----------------
Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea

Conditions
-----------------
Anorexia Nervosa, Hypothalamic Amenorrhea, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Amenorrhea for at least three months (unless participating as healthy control) Normal TSH or free thyroxine (free T4). Exclusion Criteria: A condition known to affect bone metabolism, including Cushing's syndrome or renal failure, with the exception of bone fracture. Any medication known to affect bone metabolism within 3 months of the study, including estrogen and progestins. Patients receiving depot medroxyprogesterone (Depo-Provera) will be excluded from participating for 6 months after their last injection. Pregnant and/or breastfeeding. Diabetes mellitus. Active substance abuse, including alcohol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| 1<br>lean healthy women, age 18-45 | |
| 2<br>overweight healthy women, age 18-45 | |
| 3<br>women with hypothalamic amenorrhea (have not had a period in three months), age 18-45 | |
| 4<br>women with anorexia nervosa, age 18-45 | |

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
-----------------
healthy, overweight, obese, anorexia nervosa, weight, cortisol, hormone, bone density, bone, osteopenia, osteoporosis, amenorrhea, menses, irregular, stress, depression, exercise, diet
Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that chemotherapy of irinotecan and gemcitabine will improve local control of cancer and prolong survival in patients with inoperable biliary tract cancer.

Conditions
-----------------
Biliary Tract Cancer

Intervention / Treatment
-----------------
* Drug: Irinotecan and Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed inoperable biliary tract cancer Age: 18  75 years old Performance status: ECOG 0-2 Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin No greater than 2 fold the upper normal limit AST/ALT : No greater than 3 fold the upper normal limit Renal: Creatinine - no greater than 1.5 mg/dL Not pregnant No other serious medical or psychiatric illness that would preclude giving informed consent or limit No prior chemotherapy within 6 months No other concurrent anticancer radiotherapy within 6 months

Ages Eligible for Study
-----------------
Minimum Age: 17 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: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Irinotecan and Gemcitabine<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
-----------------
toxicity
Lung Transplantation in Respiratory Failure Patients

Study Overview
=================
Brief Summary
-----------------
Survival after cadaveric lung transplantation in recipients depended on ventilation support prior to transplantation has been reported to have relative high surgical mortality and morbidity rate. The objectives of this study were to describe the short-term outcomes of bilateral sequential lung transplantation under extracorporeal membrane oxygenation (ECMO) support in a consecutive series of patients who depended on noninvasive and invasive ventilation support preoperatively .

Detailed Description
-----------------
The one-year survival rate and postoperative pulmonary functional results will be reported in this study.

Official Title
-----------------
Extracorporeal Membrane Oxygenation Support for Bilateral Sequential Lung Transplantation in Respiratory Failure Patients.

Conditions
-----------------
Respiratory Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: respiratory patients depended on ventilator supports prior to lung transplant Exclusion Criteria: non-cardaveric lung transplant
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 |
| --- | --- | --- |
| 6 months and one year survival after lung transplatn. |  | 6 months and one year posttransplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function results, at baseline and posttransplant 1, 3, and 6 months. |  | baseline, post-op 1,3, and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung transplantation, respiratory failure, ECMO, Lung transplants in respiratory failure patients
Acute Effects of Glucose Dependent Insulinotropic Polypeptide (GIP) on Subcutaneous Adipose Tissue

Study Overview
=================
Brief Summary
-----------------
This clinical, randomized, cross-over study in obese healthy subjects aimed to analyse the acute effects of the incretin hormon Glucose Dependent Insulinotropic Polypeptide (GIP) on metabolic parameters and gene expression in subcutaneous adipose tissue.

Conditions
-----------------
Metabolic Syndrome, Obesity, Insulin Sensitivity

Intervention / Treatment
-----------------
* Other: Glucose dependent insulinotropic polypeptide (GIP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 28 Healthy subjects Normal glucose tolerance Exclusion Criteria: Diabetes,IFG, IGT Chronical-inflammatory diseases Hb < 12g/dl Elevation in liver enzymes or creatinin concentrations Great weight changes within last 12 months Any cancer diagnosis in last 10 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Glucose dependent insulinotropic polypeptide (GIP)|GIP-Infusions for 4 h in a postprandial concentration|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in gene expression of subcutaneous adipose tissue with microarray analysis |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of inflammatory marker (blood levels and gene expression), Activity of 11beta HSD and 11-beta HSD mRNA in adipose tissue, etc. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Euglycemic-hyperinsulinemic clamp, fat biopsies, microarray analysis, quantitative real time PCR, overnutrition, low grade-inflammation
Lifestyle Modifications and the Progression of Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Aerobic training has been shown to favorably alter several of the known risk factors for coronary artery disease including hypertension, dyslipidemia, obesity, and diabetes (1). It seems logical that if these risk factors were aggressively controlled in patients with chronic kidney disease (CKD) by implementing lifestyle changes (e.g., diet and exercise training) to support the pharmacologic interventions that are necessary for the control of the disease, then the rate of progression of the disease may be altered. However, to date, there is no clear research evidence to support this hypothesis. Therefore the aims of the proposed study are: To test the hypothesis that lifestyle interventions (i.e., dietary modification and regular, long-term aerobic exercise training) will favorably alter the natural progression of CKD in a sample of patients compared to a control group who will receive the current standard care. To explore possible mechanisms that could contribute to the observed changes.

Official Title
-----------------
Effect of Lifestyle Interventions on the Progression of Kidney Disease in Patients With Chronic Kidney Disease

Conditions
-----------------
Patients With Stage 2-4 Chronic Kidney Disease

Intervention / Treatment
-----------------
* Behavioral: Exercise training
* Behavioral: Diet modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stages 2-4 CKD Exclusion Criteria: CAD MI

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle intervention-exercise & diet<br>Subjects trained for 48 weeks with a personal trainer | Behavioral: Exercise training<br>* Subjects exercise trained for 48 weeks with personal trainers at a college wellness center<br>Behavioral: Diet modification<br>* Exercise training using personal trainers 3 times per week. Individuals were trained at a moderate intensity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular filtration rate (GFR) | GFR was estimated using the MDRD equation, creatinine clearance, urea clearance | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour urine protein output | urine protein output is measured before and after 48 weeks of the training program | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD