linjc16/ctgov huggingface dataset:
Azilsartan Tablets Special Drug Use Surveillance: Long-term Use

Study Overview
=================
Brief Summary
-----------------
The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical setting.

Detailed Description
-----------------
This surveillance was designed to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in hypertensive patients in daily medical practice. The usual dosage for adult is 20 mg of azilsartan administered orally once daily. The dose can be adjusted according to the patient's age and condition. The maximum daily dose is 40 mg.

Official Title
-----------------
Azilsartan Tablets Special Drug Use Surveillance: Long-term Use

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Azilsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertensive patients Exclusion Criteria: Patients with a history of hypersensitivity to any of the ingredients of Azilsartan Patients who are pregnant or having possibilities of being pregnant
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Azilsartan<br>Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care. | Drug: Azilsartan<br>* Azilsartan tablets<br>* Other names: Azilva Tablets;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. | Up to 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Reported data are changes in SBP from baseline at Month 1 and final assessment (up to 12 months). | Baseline, Month 1 and final assessment (up to 12 Months) | 
| Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point | Reported data are changes in DBP from baseline at Month 1 and final assessment (up to 12 months). | Baseline, Month 1 and Final assessment (up to 12 Months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacological therapy
WINROP Algorithm Validation for Retinopathy Screening in a Cohort of Premature Infants

Study Overview
=================
Brief Summary
-----------------
When a child was born too early, it is more likely to develop an alteration of its visual function than in the case of term birth. Significant visual disturbances are found in 3% of children born prematurely, but visual impairment can be very severe, up to the loss of vision in case of retinopathy of prematurity (ROP) in the most immature infants. The introduction of screening surveillance systems, such as WINROP software, might reduce the need for stressful eye examination in low risk neonates. This retrospective study aimed at validating the WINROP algorithm in a cohort of premature infants, born below 32 weeks of gestation, who had systematic eye examination for ROP screening over 4 year period.

Official Title
-----------------
WINROP Algorithm Validation for Retinopathy Screening in Premature Infants: a Retrospective Cohort Analysis Over 4 Years

Conditions
-----------------
Retinopathy of Prematurity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All infants born below 32 weeks gestation within the study period At least one eye examination recorded by Retcam Exclusion Criteria: Any ophthalmic abnormality Any genetic abnormality

Ages Eligible for Study
-----------------
Minimum Age: 24 Weeks
Maximum Age: 40 Weeks

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 |
| --- | --- | --- |
| algorithm validation | risk of retinopathy occurence | from birth up to 40 weeks post menstrual age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk factor for retinopathy | standardized perinatal data collection | from birth up to 40 weeks post menstrual age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
screening, very premature infants, retinopathy
A Comparison of Two Multi-Drug Therapies in HIV-Infected Patients Who Have Never Received Anti-HIV Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare 2 combination drug therapies in HIV-infected patients who have never received anti-HIV treatment.

Detailed Description
-----------------
In this open-label study antiretroviral-naive patients are randomized to one of two drug regimens: Arm I: 141W94 (amprenavir), 1592U89 (abacavir), and Combivir (3TC/AZT tablet). Arm II: Nelfinavir and Combivir.

Official Title
-----------------
A Comparison of a Four-Drug Regimen Comprised of 141W94, 1592U89, and Combivir With a Three-Drug Regimen Comprised of Nelfinavir and Combivir in Antiretroviral-Naive HIV-Infected Patients.

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

Intervention / Treatment
-----------------
* Drug: Lamivudine/Zidovudine
* Drug: Abacavir sulfate
* Drug: Amprenavir
* Drug: Nelfinavir mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: CD4 count > 50. HIV RNA > 5,000. No active AIDS (excluding CD4 count < 200). Ability to comply with dosing schedule and protocol evaluations. Prior Medication: Allowed: 3TC or any protease inhibitor, if < 1 week of therapy. Other nucleoside analogs, if < 4 weeks of therapy. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Active AIDS (not including CD4 count < 200). Malabsorption syndrome affecting drug absorption. Concurrent Medication: Excluded: Enrollment in any other investigational drug protocol. Prior Medication: Excluded: Non-nucleoside reverse transcriptase inhibitors.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lamivudine/Zidovudine|nan|
|Drug: Abacavir sulfate|nan|
|Drug: Amprenavir|nan|
|Drug: Nelfinavir mesylate|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
-----------------
Drug Therapy, Combination, HIV Protease Inhibitors, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, abacavir
Cerebral Resonance Magnetic Imaging During Rectal Distention

Study Overview
=================
Brief Summary
-----------------
Irritable bowel syndrome is responsible for chronic abdominal pain, diarrhea and/or constipation. It is a very frequent problem. However, the exact cause of irritable bowel syndrome remains unknown. The purpose of this study is to look for a different cerebral response by magnetic resonance imaging after rectal stimulation in patients with irritable bowel syndrome compared to healthy subjects and to patients with digestive organic disease. Our hypothesis is that irritable bowel syndrome could be a problem of cerebral integration of visceral stimulation.

Official Title
-----------------
Cerebral Activity During Rectal Pain in Patients With Irritable Bowel Syndrome or Inflammatory Bowel Disease:Resonance Magnetic Imaging Study.

Conditions
-----------------
Ulcerative Colitis, Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Procedure: rectal distension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects irritable bowel syndrome (Rome II criteria) colitis ulcerative Exclusion Criteria: pregnant or breast feeding metallic material implanted good tolerance of rectal distension acute phase of ulcerative colitis

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: rectal distension|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
-----------------
cerebral activity, rectal distension, colitis ulcerative, irritable bowel syndrome, magnetic resonance imaging
Prospective Database for Chronic Myelogenous Leukemia

Study Overview
=================
Brief Summary
-----------------
Prospective Database for Chronic Myelogenous Leukemia

Conditions
-----------------
Leukemia, Myeloid, Chronic

Intervention / Treatment
-----------------
* Other: Database


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with CML
Sexes Eligible for Study
-----------------
All

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

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

| Intervention/Treatment |
| --- |
|Other: Database|data base for CML|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and efficacy |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CML
Pregnancies Complicated by Fetal Anomalies

Study Overview
=================
Brief Summary
-----------------
The focus of this research is to create a repository of ultrasonographic images and their corresponding medical data from pregnant women (the mothers of the fetuses that are imaged), focusing on fetal anomalies. These women will visit the obstetrical clinics at Regional One Health and the Le Bonheur Fetal Center.

Detailed Description
-----------------
Repository data will be collected from the medical record and entered into the data base after the patient has completed the appointment. Data collection will continue into the postpartum period for each participant. Data collection will continue for the child during the treatment of the medical condition, up to approximately 6 months of age if required by the condition.

Official Title
-----------------
Characteristics of Pregnancies Complicated by Fetal Anomalies

Conditions
-----------------
Pregnancy, Congenital Abnormalities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant females age 8 years to 50 years who have referred to the clinic for high risks pregnancies Infants (male and female) born with anomalies Exclusion Criteria: Non-pregnant females.

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 50 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 |
| --- | --- |
| Pregnant Women & their fetuses/infants<br>Information about pregnant women and their fetuses/infants, including the medical history, prenatal, perinatal, and postpartum periods (6 weeks after delivery) and throughout the treatment (e.g.surgery) for the child's medical condition (up to approx. child is @ 6 months of age), will be collected in this repository. The analysis of this information may help in understanding of the causes of fetal anomalies. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data Collection | Data collection from participant's medical records will be entered into a data base | From the initial visit @ the High Risk Clinic through the infants approx. age of 6 months |
Thai Traditional Massage Increases Biochemical Marker of Bone Formation in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
To investigate the skeletal effect of Thai traditional massage by examining the changes in biochemical markers of bone turnover.

Official Title
-----------------
Thai Traditional Massage Increases Biochemical Marker of Bone Formation in Postmenopausal Women: a Randomized Crossover Trial

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

Intervention / Treatment
-----------------
* Procedure: Thai traditional massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women EXclusion Criteria: History of hyperthyroidism, thyrotoxicosis, diabetes, rheumatoid arthritis and cancer glucocorticoid or medication for osteoporosis Swelling joints
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Thai traditional massage|two hours of Thai traditional massage twice a week for 4 weeks|

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
-----------------
Thai traditional massage, Bone formation, Bone resorption
Out-of-Hospital Resuscitation in Winterthur - an Outcome Study

Study Overview
=================
Brief Summary
-----------------
The investigators will retrospectively examine all patients with out-of-hospital resuscitation by the emergency medical Team (EMT) from the Kantonsspital Winterthur in the year 2013 with a two year follow-up and a structured interview about Quality of life. Furthermore, the costs generated by the local health system are analysed.

Detailed Description
-----------------
The Primary objective of this study is to evaluate the Quality of out-of-Hospital resuscitation by the ambulance Service from the Kantonsspital Winterthur including a 2-year follow-up of the survivors. In this follow-up we evaluate the Quality of life by a validated questionnaire. The following endpoints will be retrospectively analysed: time-to-Response Interval; Initial cardiac rhythm; medications given; number of Defibrillations; return of spontaneous circulation, Overall costs for the local health System Furthermore length of hospital-stay, survival until Hospital discharge, one-year survival, Quality of life two years after resuscitation and total costs will be analysed.

Official Title
-----------------
Out-of-Hospital Resuscitation in an Urban Setting in Switzerland - an Outcome Study and Cost Effectiveness Analysis

Conditions
-----------------
Resuscitation

Intervention / Treatment
-----------------
* Other: Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with out-of-hospital resuscitation in Winterthur in the year 2013 and treatment by the emergency medical team from the Kantonsspital Winterthur Written informed consent of patients for structured interview Exclusion Criteria: Patients with resuscitation but death on Scene no written informed consent from patients for structured interview

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Survivors<br>Patients with out-of-Hospital resuscitation and return of spontaneous circulation. Structured interview for quality of life (questionnaire) one year after resuscitation. | Other: Interview<br>* Interview by validated Quality-of-life-questionnaire<br>* Other names: patient interviews;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival after prehospital cardiac Arrest until discharge of Hospital and a one-year follow-up |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of direct costs of local health care system |  | 1 year | 
| Quality of life one year after resuscitation |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resuscitation, quality of life
Preoperatively Walking's Effect of Postoperative Bowel Functions in Patient With Gynecologic Cancer.

Study Overview
=================
Brief Summary
-----------------
Preoperative walking's effect of postoperative bowel functions ASA 1 or 2 in patient with gynecologic cancers.

Official Title
-----------------
Jinekolojik Kanserler Nedeni Ile Opere Edilen Hastalarda Preoperatif yürümenin Postoperatif Barsak fonksiyonlarına Etkisi

Conditions
-----------------
Postoperative Bowel Functions

Intervention / Treatment
-----------------
* Other: walking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with gynecological cancer ASA score 1 or 2 via laparascopy or laparatomy Exclusion Criteria: ASA score >2 orthopedic problems ileostomy or colostomy >24 hours stay in intensive care unit early postoperative complications (relaparotomy, massive blood transfusion)

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: walking preoperatively not walking preoperatively
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Walk preoperativelying<br>Patients will be operated gynecologic cancers and have American Society of Anesthesia score 1 or 2. Subjects will walk during one hour with average speed 3 km/hour 12 hour before surgery. | Other: walking<br>* walking and not walking<br>|
| Active Comparator: not walking preoperatively<br>Patients will be operated gynecologic cancers and have American Society of Anesthesia score 1 or 2. Subjects will not walk preoperatively. | Other: walking<br>* walking and not walking<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time to the first passage of flatus after surgery | Doctor will detect the time with auscultation | 6 hours- 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time to first defecation | Doctor will detect the time with auscultation | 6 hours- 7 day | 
| time to first bowel movement | Doctor will detect the time with auscultation | 6 hours- 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gynecologic cancer, postoperative bowel function, walking, debulking
Vitamin D and HIV-Cardiovascular Disease in Children and Young Adults

Study Overview
=================
Brief Summary
-----------------
The relationship of Vitamin D levels in children and young adults to atherosclerosis.

Official Title
-----------------
Vitamin D Metabolism Inflammation, and Cardiovascular Risk in HIV-infected Children and Young Adults

Conditions
-----------------
Vitamin D Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - Documentation of HIV Infection Between ages of 8 and 25 On stable ART for at least 12 weeks for the HIV+ patients Cumulative duration of ART for at least 48 weeks for HIV + patients Healthy child/young adult with age and race matched to HIV+ patient for the HIV- controls Absence of HIV based on medical and medication history Exclusion Criteria: Taking > 800 IU of Vitamin D per day Parathyroid or Calcium disorders Acute illness and active inflammatory condition Chronic illnesses that include malignancy, diabetes, CAD Pregnancy and lactation Creatinine Clearance <50 ml/min Hgb < 9.0 g/dL AST and ALT > 2.5 upper limits of normal

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 25 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV+<br>HIV Positive children or young people between the ages of 8 and 25 | |
| HIV Negative<br>HIV Negative matched controls by age and race | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D levels | To perform a cross-sectional analysis of blood vitamin D status among the HIV-infected children and young adults to evaluated the point prevalence fo plasma 25(OH)D levels indicating vitamin D insufficiency, deficiency and severe deficiency, and to compare the prevalence to a matched uninfected healthy control group. | One time point at entry | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D Deficiency, HIV+ Children, HIV+ Young Adults