linjc16/ctgov huggingface dataset:
Randomized Population-Based Study on Chlamydia Trachomatis Screening

Study Overview
=================
Brief Summary
-----------------
30,000 individuals living in Aarhus County, Denmark by Oct 1997 were randomized into two groups. The intervention group received an invitation to be tested for urogenital Chlamydia trachomatis by use of home-obtained and mailed sample (9,000 individuals). The control group received no intervention (21,000 individuals). Outcome measures: Number of tested individuals, number of detected infections, number of women developing PID, ectopic pregnancy or infertility, number of women giving birth to a child, number of women receiving IVF treatment and number of men developing epididymitis. The hypothesis was that more individuals would be tested and treated for infections and that number of long term fertility complications would decline in the intervention group compared to control group.

Official Title
-----------------
Populationbased Screening for Urogenital Chlamydia Trachomatis Infections by Use of Home-Obtained and Mailed Samples: A Randomized Study

Conditions
-----------------
Chlamydia Trachomatis, Infertility, Ectopic Pregnancy

Intervention / Treatment
-----------------
* Behavioral: Screening for urogenital Chlamydia trachomatis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: born in 1974, 1974 or 1976 AND living in Aarhus County October 1007 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 24 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Screening<br>Individuals receiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample. | Behavioral: Screening for urogenital Chlamydia trachomatis<br>* Receeiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample.<br>|
| No Intervention: 2 Control<br>Control group receiving usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term infertility complications |  | 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mass screening
Effect of Adding Renin-Angiotensin System Inhibitors to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Ellitus

Study Overview
=================
Brief Summary
-----------------
Type 2 diabetes mellitus (T2DM) is a progressive metabolic disorder in which a substantial number of patients cannot attain treatment target despite antidiabetic drugs. The renin-angiotensin system (RAS) has recently been implicated in the development of insulin resistance and impaired glucose metabolism. This study investigates the effect of adding RAS inhibitors to standard antidiabetic therapy in patients with T2DM. The primary outcome measure is the change in serum glycosylated hemoglobin A1c after 24 weeks of treatment. Secondary outcomes measures include changes in plasma lipid profile and blood pressure after treatment.

Official Title
-----------------
Investigating the Effect of Renin-Angiotensin System Inhibitors in Addition to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Mellitus: A Prospective Open-label Study

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Valsartan 80 mg and metformin
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults over 21 years of age clinically diagnosed type 2 diabetes mellitus recipients of metformin monotherapy compliance with prescriptions and dietary intervention Exclusion Criteria: recipients of any second-line antidiabetic drug in addition to metformin recipients of any antihypertensive medication before study enrollment hemoglobin disorders chronic kidney disease thyroid dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valsartan and metformin<br> | Drug: Valsartan 80 mg and metformin<br>* Valsartan 80 mg once daily in addition to metformin monotherapy<br>|
| Active Comparator: Metformin only<br> | Drug: Metformin<br>* Metformin monotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum glycosylated hemoglobin A1c | Change in serum glycosylated hemoglobin A1c of the participants | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lipid fractions | Change in plasma triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol | 24 weeks | 
| Blood pressure | Change in systolic blood pressure and diastolic blood pressure | 24 weeks |
The Use of Abdominal Binders in Patients Undergoing Cesarean Sections

Study Overview
=================
Brief Summary
-----------------
To see if the use of Abdominal Binders improves patients out comes after cesarean delivery

Detailed Description
-----------------
Inclusion: All patients admitted to labor and delivery Consented patients who had a cesarean delivery will be randomized using a number table to receive or not receive an abdominal binder. Outcomes: On postoperative days 1 and 2, patients were asked to complete a pain visual analog scale and the validated Symptom Distress Scale. Postoperative hemoglobin and hematocrit were also recorded.

Official Title
-----------------
The Use of Abdominal Binders in Patients Undergoing Cesarean Sections: A Randomized Controlled Trial

Conditions
-----------------
Cesarean Section Post Operative Management

Intervention / Treatment
-----------------
* Device: abdominal Binder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing cesarean section for any indication Exclusion Criteria: unable to give consent

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: abdominal binder<br>Post cesarean section patients will get a abdominal binder placed | Device: abdominal Binder<br>* placement of abdominal binder<br>|
| No Intervention: No Abdominal Binder<br>Post cesarean section patients will not have abdominal binder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measurement | Pain will be measured using a visual analog scale | up to post operateive day 2 | 
| Patient Distress score | A validated patient distress score will be used | up to post operateive day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin and hematocrit |  | post operative day 1 and 2 | 
| Pain medication usage |  | post operative day 1 and 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, cesarean section, postoperative pain, abdominal binder
S9346A Blood Samples From Patients With Metastatic Prostate Cancer Previously Treated With Bicalutamide and Goserelin

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study is studying blood samples from patients with metastatic prostate cancer previously treated with bicalutamide and goserelin.

Detailed Description
-----------------
OBJECTIVES: To test the association between serum PSA response (< 4 ng/mL) at 7 months with inherited variability of germline single nucleotide polymorphisms, in a set of candidate genes, in patients with metastatic prostate cancer treated with combination induction androgen-deprivation therapy comprising bicalutamide and goserelin. OUTLINE: DNA extracted from whole blood or serum samples is analyzed for inherited variability of germline single nucleotide polymorphisms.

Official Title
-----------------
Germline Polymorphisms Associated With the PSA Response in Men With Metastatic Prostate Cancer Treated With Androgen Deprivation Therapy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Genetic: gene expression analysis
* Genetic: polymorphism analysis
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosed with metastatic prostate cancer Accrued to SWOG-9346 and received androgen-deprivation therapy (ADT) Must have serum PSA values from the beginning to the end of 8 courses of ADT Must have whole blood or serum samples available PATIENT CHARACTERISTICS: Caucasian and African-American participants PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Genetic: polymorphism analysis|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum PSA values at 7 months |  | 7 months | 
| Role of genetic variation in response to therapy |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent prostate cancer, stage IV prostate cancer
A Study of Ibandronate (Bondronat) in Participants With Metastatic Bone Disease

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy, safety, and effect on quality of life of oral ibandronate (Bondronat) in participants with breast cancer and metastatic bone disease. The anticipated time on study treatment is 25 weeks, and the target sample size is 50 individuals.

Official Title
-----------------
An Open Label Study of the Efficacy, Safety, and Pharmacoeconomics of Oral Ibandronate (Bondronat 50 mg) in Treatment of Metastatic Bone Disease

Conditions
-----------------
Pain; Bone Neoplasms; Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: Ibandronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females at least 18 years of age Breast cancer Bone metastases Exclusion Criteria: Use of bisphosphonates within the last 3 months Prior use of gallium nitrate or metastron Severely impaired renal function Hypocalcemia or primary hyperparathyroidism Central nervous system (CNS) metastases

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibandronate<br>Female participants with metastatic bone disease secondary to breast cancer will receive ibandronate for a period of 25 weeks. | Drug: Ibandronate<br>* Participants will receive ibandronate, 50 milligrams (mg) by mouth every morning, for a period of 25 weeks.<br>* Other names: Bondronat;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR) |  | Up to 25 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bone pain according to participant questionnaire |  | Up to 25 weeks | 
| Analgesic consumption according to participant questionnaire |  | Up to 25 weeks | 
| Change in serum pyridinoline cross-linked carboxyterminal telopeptide of collagen type I (ICTP) |  | Up to 25 weeks | 
| Short Form 36 (SF-36) score |  | Up to 25 weeks | 
| Incidence of adverse events (AEs) |  | Up to approximately 7 months |
Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to assess the effect of spironolactone on interstitial fibrosis in kidney transplant recipients receiving calcineurin inhibitors

Official Title
-----------------
The Role of Spironolactone in Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

Conditions
-----------------
Kidney Transplant

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney Failure Age > 18 Kidney transplant recipients Exclusion Criteria: Patients taking angiotensin receptor blockers or inhibitors of the angiotensin reconverting enzyme Kidney transplant performed more than one month from enrollment in the study Hyperkalemia (K> 5.5 meqL)

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Half of the subjects will be assigned to receive either spironolactone or placebo for 6 months | Drug: Placebo<br>* Half of the subjects will be assigned to receive placebo for 6 months<br>|
| Active Comparator: spironolactone<br>Half of the subjects will be randomized to receive spironolactone for 6 months | Drug: spironolactone<br>* Half of the subjects will be assigned to receive 25 mg of spironolactone for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| allograft function and proteinuria |  | 2 years | 
| Fibrosis markers in kidney biopsies such as TGF-B |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
calcineurin inhibitors, fibrosis, spironolactone, Focus of the study is to assess if aldosterone blockade has an effect on interstitial fibrosis amongst kidney transplant recipients
A Diagnostic Study of the Advanced Endoscopy to Detect Early Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
This descriptive cross sectional study aims to directly compare the diagnostic capability of the probed-based confocal laser endomicroscopy (pCLE) and the magnifying narrow band imaging (M-NBI) in the Lugol's voiding lesions.

Official Title
-----------------
Diagnostic Values of Probe-based Confocal Laser Endomicroscopy (pCLE) and Magnifying Narrow Band Imaging (M-NBI) for Early Neoplasms Detection in Esophageal Lugol'S-voiding Lesions.

Conditions
-----------------
Esophageal Neoplasms

Intervention / Treatment
-----------------
* Device: Olympus
* Device: Cellvizio


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 20 years Having histological-confirmed diagnosis of head and neck cancer Having no esophageal symptoms Exclusion Criteria: Having index cancer of nasopharynx History of esophageal surgery Having esophageal stricture or obstruction Having esophageal varices Known case of esophageal cancer Uncorrectable coagulopathy and thrombocytopenia Pregnancy Thyrotoxicosis Creatinine clearance less than 30 ml/min Allergy to iodine or fluorescein.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study<br>probe-based confocal laser endomicroscopy narrow band imaging with magnification | Device: Olympus<br>* narrow band imaging with magnification<br>Device: Cellvizio<br>* probe-based confocal laser endomicroscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy | Diagnostic performance of the pCLE and M-NBI in Lugol's voiding lesions size larger than 5 millimeters. | an expected average of 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Confocal Laser Endomicroscopy, Narrow Band Imaging, Lugol Chromoendoscopy, Esophageal Neoplasm, Head and Neck Cancer
A Study of ABT-384 Levels and Pharmacodynamic Activity Measured in Cerebrospinal Fluid

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to assess the cerebral spinal fluid (CSF) pharmacokinetics and the plasma/CSF pharmacokinetic/pharmacodynamic relationship of ABT-384 in healthy male volunteers.

Official Title
-----------------
A Study to Evaluate the Cerebrospinal Fluid Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-384 in Healthy Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ABT-384


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age is between 18 and 55 years Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG Exclusion Criteria: Use of protocol-prohibited medications within 2 weeks prior to study drug administration. Positive urine drug screen for non-prescribed drugs of abuse including alcohol. Receipt of any drug depot by injection within 30 days prior to study drug administration. Receipt of any investigational product within 6 weeks prior to study drug administration. History of significant sensitivity or allergy to any drug. History of drug or alcohol abuse. Positive test result for HAV, HBsAg, HCV or HIV. Donation or loss of 550 mL or more blood volume or receipt of any blood product within 3 months prior to study drug administration. Contraindication for lumbar puncture (e.g., lumbar scoliosis, coagulopathy, infected skin at puncture site) Current enrollment in another clinical study.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-384<br> | Drug: ABT-384<br>* Doses will be administered daily for 5 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations) |  | Days -1 through 9 | 
| Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect) |  | Days 1, 4 through 9 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Pharmacology, Drug Safety, Phase 1 Clinical Trials