linjc16/ctgov huggingface dataset:
Non-interventional Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction

Study Overview
=================
Brief Summary
-----------------
This is local prospective, non-interventional multi-center comparative study. Primary study objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year after insertion ( patient assessment questionnaire) in daily practice. For each patient, the treating gynecologist documents demographics, medical data, safety parameters and treatment signs and symptoms at an initial visit and one or two follow-up visit(s).

Official Title
-----------------
Prospective Multicentre Non-interventional Comparative Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Levonorgestrel (Mirena, BAY86-5028)
* Device: Copper IUD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 20-40 years old Parity ≥ 1 child Requesting long-term contraception Written informed consent. Exclusion Criteria: in accordance with the current leaflet

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Group 1<br> | Drug: Levonorgestrel (Mirena, BAY86-5028)<br>* intrauterine system containing 52 mg levonorgestrel, with daily release of 20 mcg levonorgestrel<br>|
| Group 2<br> | Device: Copper IUD<br>* Copper device, inserted intrauterine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User satisfaction of the contraception method with Mirena or Copper IUD |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUD |  | up to 12 months | 
| Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies) |  | up to 12 months | 
| Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations) |  | up to 12 months | 
| Relationship between different parameters and women preferences in choosing Mirena or Cooper IUD as their contraceptive method ( demographic parameters, age group, residence, reproductive history and plans, etc.) using patients questionnaire |  | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-interventional, Mirena, Contraception, Russian Federation
Maternal and Neonatal Outcome in Pregnant Women Before and After 1 Year Since Bariatric Operation

Study Overview
=================
Brief Summary
-----------------
Ultrasound follow up for 9 months pregnancy in women underwent baraitric surgery before and after 1 year of surgery.

Detailed Description
-----------------
Ultrasound follow up for 9 months pregnancy in women who had laparoscopic adjustable gastric banding done within last 1 year or earlier.

Official Title
-----------------
Comparison of Maternal and Neonatal Outcome Before and After 1 Year of Bariatric Surgery

Conditions
-----------------
Pregnancy, Complications

Intervention / Treatment
-----------------
* Other: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Pregnant women in third trimester 2.after laparoscopic adjustable gastric banding done within last 1 year or earlier Exclusion Criteria: medical disorders affecting pregnancy as diabetes, hypertension, SLE

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 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 |
| --- | --- |
| surgery done less than 1 year<br>Pregnant women who had bariatric surgery done within the last year before pregnancy. Ultrasound fetal monitoring,biophysical profile assessment and maternal follow up investigations and blood pressure monitoring through all pregnancy | Other: Ultrasound<br>* Ultrasound assessment of fetal growth, anomalies , liqour and placenta<br>|
| surgery done more than 1 year<br>Pregnant women who had bariatric surgery done more than 1 year before pregnancy. Ultrasound fetal monitoring,biophysical profile assessment and maternal follow up investigations and blood pressure monitoring through all pregnancy | Other: Ultrasound<br>* Ultrasound assessment of fetal growth, anomalies , liqour and placenta<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal outcome | development of pregnancy complications as preeclampsia or gestational diabetes or postpartum complications as postpartum hemorrhage or puerperal sepsis | though 9 months of pregnancy and 6 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal outcome | Apgar score, neonatal ICU admission | 2 weeks after birth | 
| Route of delivery | vaginal delivery or cesarean section and if cesarean its indications | time of delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maternal outcome, Fetal outcome, bariatric surgery, Third Trimester
Aortic Calcium: Epidemiology and Progression -- Ancillary to MESA

Study Overview
=================
Brief Summary
-----------------
To study the epidemiology of aortic calcium.

Detailed Description
-----------------
BACKGROUND: Aortic calcium measured by computed tomography occurs earlier in life than other subclinical (that is, asymptomatic) markers of cardiovascular disease (CVD), shows a wide range, and is common in women. The large size of the aorta and relative lack of image artifact from motion make it ideal for radiographic quantitative imaging. This study is ancillary to and coordinated with the Multi-Ethnic Study of Atherosclerosis (MESA), a large prospective epidemiologic study investigating multiple subclinical CVD measures and CVD risk factors. Subclinical measures in MESA include coronary calcium, carotid ultrasound, cardiac magnetic resonance imaging, and the ankle/brachial blood pressure index. The extensive CVD risk factor measurements include both traditional risk factors and newer measures such as inflammatory and genetic markers. DESIGN NARRATIVE: This ancillary study will determine the epidemiology of aortic calcium in 2000 randomly selected (from 6500 total) MESA participants. Questions to be addressed include predictors of aortic calcium progression; associations of aortic calcium and aortic calcium progression with other subclinical CVD measures, CVD risk factors, and demographics; and the prognostic significance of aortic calcium. The project has three primary specific aims: 1) to predict the cross-sectional aortic calcium burden as a function of other subclinical CVD measures and CVD risk factors; 2) to predict aortic calcium progression as a function of other subclinical CVD measures and CVD risk factors, and 3) to predict aortic calcium progression as a function of progression of selected subclinical CVD measures and CVD risk factors. The two secondary specific aims are 1) to contrast the results of the three primary specific aims for men vs. women, and for four major ethnic groups (White, Hispanic, Black, and Asian); and 2) to provide a database for future evaluation of whether aortic calcium and/or aortic calcium progression independently predict subsequent myocardial infarction, stroke, and other CVD events.

Official Title
-----------------
Aortic Calcium: Epidemiology and Progression

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Atherosclerosis, Coronary Arteriosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Participation in the original MESA Study

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 84 Years

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

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 |
| --- | --- | --- |
| Abdominal Aortic Calcium |  | During the Exam 2 and Exam 3 MESA visits |
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single-dose of UB-921 in healthy male volunteers.

Detailed Description
-----------------
This is an open-label, two-part, dose-escalation and comparative pharmacokinetics study of UB-921 in healthy male volunteers. There will be two parts: dose escalation study (Main Study) and comparative pharmacokinetics study (Sub-study).

Official Title
-----------------
Open-label, Two-part, Dose-escalation and Comparative Pharmacokinetics Study of UB-921 in Healthy Male Volunteers

Conditions
-----------------
Breast Neoplasm

Intervention / Treatment
-----------------
* Biological: UB-921
* Biological: Herceptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total body weight ≧50 kg (110 lbs) No clinically relevant abnormalities To agree on using birth control barrier (eg. male condom) during the entire study period. Signing the written informed consent form Exclusion Criteria: Previous exposure to chimeric, humanized or human monoclonal antibody, whether licensed or investigational A history of drug abuse or heavy drinking. Blood donation over 250 mL within 90 days prior to the screening Not in the condition to participate in this study considered by investigator(s)

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UB-921 2 mg/kg (Main-study)<br>Intravenous infusion | Biological: UB-921<br>* 150 mg/vial<br>|
| Experimental: UB-921 6 mg/kg (Main-study)<br>Intravenous infusion | Biological: UB-921<br>* 150 mg/vial<br>|
| Experimental: UB-921 8 mg/kg (Main-study)<br>Intravenous infusion | Biological: UB-921<br>* 150 mg/vial<br>|
| Experimental: UB-921 6 mg/kg (Sub-study)<br>Intravenous infusion | Biological: UB-921<br>* 150 mg/vial<br>|
| Active Comparator: Herceptin 6 mg/kg (Sub-study)<br>Intravenous infusion | Biological: Herceptin<br>* 440 mg/vial<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event incidence | from the baseline to the end of study visit | 63 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
UB-921, anti-HER2 monoclonal antibody, breast neoplasm, breast cancer, Herceptin, Trastuzumab, HER2
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate the safety and tolerability of PTH134 in healthy subjects and to assess the exposure from PTH134.

Official Title
-----------------
A Partially-Blinded, Randomized, Placebo and Active Controlled, Ascending Single-Dose Crossover Phase I Study to Explore the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of PTH134 Formulated With Different Concentrations of 5-CNAC in Healthy Postmenopausal Women

Conditions
-----------------
Postmenopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: PTH134


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy postmenopausal female subjects, 40 to 70 years of age and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening Body mass index (BMI) within the range of 19 to 32. Exclusion Criteria: Smokers who report cigarette use of >= 5 cigarettes per day. Use of any prescription drugs or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) started within the last month prior to screening. Previous osteoporosis treatment History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cross-over treatment with increasing doses of PTH134, placebo and active comparator. | Drug: PTH134<br> <br> * Other names: teriparatid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| •Safety and tolerability of ascending single doses of PTH134 over 24 hours as compared to baseline. •Pharmacokinetics after ascending single doses of PTH134, including comparison with reference drug Forteo 20 µg sc over 24 hours. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| •Assessment of PK from PTH134 formulations over 24 hours. •Assessment of the pharmacodynamic profile of serum ionized calcium, total serum calcium, bone biomarkers with reference drug Forteo 20 µg and placebo over 24 hours. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, parathyroid hormone, pharmacodynamic, pharmacokinetic
Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania

Study Overview
=================
Brief Summary
-----------------
The objective of this research is to evaluate the effectiveness of couples Voluntary Counseling and Testing for HIV (CVCT) compared to individual VCT (IVCT) in preventing MTCT, and in increasing preventive behaviors and minimizing spousal abuse among HIV positive women. We hypothesize that offering CVCT will not decrease uptake of VCT among women. This research will be carried out in 3 antenatal clinics in Dar es Salaam, Tanzania.

Official Title
-----------------
Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: Couples VCT
* Behavioral: Individual VCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Up to 6 months of pregnancy Currently married or in cohabiting union for 2+ years and co-resident with husband Exclusion Criteria: In polygamous marriage 7 or more months pregnant

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Women to be asked to bring husbands for couple VCT | Behavioral: Couples VCT<br>* Offer women coming to antenatal clinics to have their husbands come with them for couples VCT<br>|
| Active Comparator: 2<br>Women to receive individual VCT | Behavioral: Individual VCT<br>* Women to receive individual VCT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Testing and receiving results |  | within one month of initial visit to ANC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use of nevirapine |  | 3 months after testing | 
| use of protection at time of sexual intercourse |  | 3 months after HIV test | 
| domestic violence |  | 3 months after HIV test | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Voluntary Counseling and Testing, HIV, HIV seronegativity
Nitrocamptothecin in Treating Patients With Recurrent Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have recurrent non-small cell lung cancer.

Detailed Description
-----------------
OBJECTIVES: I. Determine the response rate, time to progression and overall survival of patients with recurrent non-small cell lung cancer when treated with nitrocamptothecin. II. Assess the toxicities and pharmacokinetics of this regimen in these patients. OUTLINE: Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study.

Official Title
-----------------
Phase II Study of RFS 2000 in Relapsed NSCLC

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: rubitecan


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent non-small cell lung cancer No more than one prior chemotherapy treatment Bidimensionally measurable disease No prior radiotherapy to target lesion OR Progression since prior radiotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL ALT/AST no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN in case of liver metastases) Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled serious medical or psychiatric illness PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No prior camptothecin Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered Surgery: At least 2 weeks since prior major surgery

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


Arms and Interventions

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

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
-----------------
recurrent non-small cell lung cancer
A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)

Study Overview
=================
Brief Summary
-----------------
To perform both PET scans and MRIs in the same setting using a simultaneous PET/MRI scanner.

Detailed Description
-----------------
Primary Objective: --To compare the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI and to determine whether 18F- Fluciclovine pelvic PET/MRI is more accurate than a pelvic mpMRI in detecting pelvic RRPC in men with biochemical recurrence with histopathology as reference standard. Secondary Objective: --To study inter-reader reliability of 18F- Fluciclovine pelvic PET/MRI and pelvic mpMRI among the readers. Exploratory Objective: --To study correlation between SUVmax and ADCmean in the pelvic RRPC.

Official Title
-----------------
A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)

Conditions
-----------------
Prostate Cancer, Prostate Nodule

Intervention / Treatment
-----------------
* Radiation: 18F-fluciclovine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients who are 18 years and older Histologically or cytologically proven prostate carcinoma s/p definitive radiation Patients suspected to have BCR based on phoenix criteria (prostate specific antigen value (PSA) of 2 ng/mL above the PSA nadir) Ability to understand and willingness to sign informed consent Exclusion Criteria: Patients with any medical condition or circumstance that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements. Patients with contraindication to undergo MRI Patients with prior allergy to MRI contrast agent. Extreme Claustrophobia

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-ACBC<br> | Radiation: 18F-fluciclovine<br>* IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI |  | through study completion, an average of 1 year |