linjc16/ctgov huggingface dataset:
Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
This is a double-blind study to evaluate the reduction in systolic blood pressure using a therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12.5 mg compared to a more conventional approach (therapy initiated with low-dose valsartan 80 mg).

Official Title
-----------------
A 6-week Treatment Regimen Study to Evaluate the Efficacy of Initial High Dose Valsartan Monotherapy (160 mg) or Combo Therapy (Valsartan + Hydrochlorothiazide, 160/12.5 mg) to Conventional Low-dose Valsartan Monotherapy (80 mg) in Managing Patients With Hypertension

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

Intervention / Treatment
-----------------
* Drug: Valsartan/Hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female age 18 or older Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but < 180 mm Hg and mean seated diastolic blood pressure ≥ 90 mm Hg and <110 mm Hg) Exclusion Criteria: Patients with severe hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg History of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheochromocytoma etc.) History of myocardial infarction, stroke [e.g. cerebrovascular accident (CVA), thrombotic stroke, transient ischemic attack (TIA)], or onset of heart failure within the last 6 months. Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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: Valsartan/Hydrochlorothiazide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline systolic blood pressure after 4 weeks |  |  | 
| Change from baseline systolic blood pressure after 2 and 6 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in weeks to achieve blood pressure less than 140/90 mmHg over 6 week period |  |  | 
| Blood pressure less than 140/90 mmHg after 6 weeks |  |  | 
| Change from baseline diastolic blood pressure after 6 weeks |  |  | 
| Change from baseline in blood and urine markers after 6 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, High blood pressure, Blood pressure control, Blood pressure reduction, Valsartan
Effectiveness of Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients.

Study Overview
=================
Brief Summary
-----------------
Primary objective was to evaluate the efficacy between daily and pulse oral alfacalcidol treatment of SHPT in chronic hemodialysis patients, a 12-week treatment. Secondary objective was to observe the adverse effects between these two treatment regimens.

Detailed Description
-----------------
ESRD patients with secondary hyperparathyroidism in 3 hemodialysis centers were enrolled. They were assigned to either oral daily or pulse (trice a week) alfacalcidol treatments using block-of-4 randomization. Alfacalcidol in both groups were equal at the dose of 6 microgram per week. Clinical and laboratory data were obtained at baseline and were monitored every 4 weeks for 12 weeks. Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test. All possible adverse events were carefully monitored.

Official Title
-----------------
Effectiveness Between Daily Versus Pulse Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients: A Randomized Controlled Trial and Multicenter Study

Conditions
-----------------
Alfacalcidol, Secondary Hyperparathyroidism, Hemodialysis

Intervention / Treatment
-----------------
* Drug: Alfacalcidol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 y ESRD on HD KT/V ≥ 3.6/wk 2˚HPT Stable in P binder for 4 wk Exclusion Criteria: Alfacalcidol allergy Serum Ca ≥ 10.5 mg/dL Serum P ≥ 5.5 mg/dL Pregnancy On phenytoin, phenobarbital

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Daily<br>A: oral daily alfacalcidol treatments total 6 microgram/week | Drug: Alfacalcidol<br>* Alfacalcidol 1 microgram/capsule<br>* Other names: oral daily alfacalcidol treatments total 6 microgram/week;|
| Experimental: B: Pulse<br>B: pulse (trice a week) alfacalcidol treatments total 6 microgram/week | Drug: Alfacalcidol<br>* Alfacalcidol 1 microgram/capsule<br>* Other names: oral daily alfacalcidol treatments total 6 microgram/week;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test. | mean PTH reduction between two groups at the end of the study by unpaired-T test. | 12 week |
An Open-Label Study Examining the Long-Term Safety of Exenatide Given Twice Daily to Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the long-term safety of exenatide in patients with type 2 diabetes who were treated with exenatide in Study H8O-MC-GWAA (6-month study) or Study H8O-MC-GWAD (12-month study). Study H8O-MC-GWAN serves as an open-ended extension to Studies H8O-MC-GWAA and H8O-MC-GWAD.

Official Title
-----------------
An Open-Label Study Examining the Long-Term Safety of Exenatide Given Twice Daily to Patients With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: exenatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients received exenatide therapy in Study H8O-MC-GWAA or Study H8O-MC-GWAD and completed the respective study. Exclusion Criteria: Patients were excluded or discontinued early from Study H8O-MC-GWAA or Study H8O-MC-GWAD. Patients have received treatment within the last 30 days with a drug, not including exenatide, that has not received regulatory approval for any indication at the time of study entry.

Ages Eligible for Study
-----------------
Minimum Age: 30 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Exenatide injection 5mcg or 10 mcg, twice daily | Drug: exenatide<br>* subcutaneous injection, 5mcg or 10 mcg, twice daily<br>* Other names: Byetta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety of twice-daily exenatide treatment, as defined by the occurrence of adverse events. | Visits for this study occur at 6-mo (±2 wk) intervals until exenatide is approved for marketing. | 128 weeks (average treatment period) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, exenatide, Byetta, Amylin, Lilly
Foreign Body Swallows in Pediatrics

Study Overview
=================
Brief Summary
-----------------
Foreign Body Ingestion (FBI) is a common clinical emergency in children. Most FBs smoothly pass through the digestive tract without complications; nevertheless, some FBs can cause severe morbidity and mortality. The current work aimed at evaluating how FBI can cause respiratory distress and stridor as well as their severity according to age, gender, lodgment site, and type of the object. Factors influencing morbidity and mortality among studied patients will be deliberated as well.

Detailed Description
-----------------
Background: Foreign Body Ingestion (FBI) is a common clinical emergency in children. Most FBs smoothly pass through the digestive tract without complications; nevertheless, some FBs can cause severe morbidity and mortality. The current work aimed at evaluating how the FBI can cause respiratory distress and stridor as well as their severity according to age, gender, lodgment site, and type of the object. Factors influencing morbidity and mortality among studied patients will be deliberated as well. Methods: It is a hospital-based descriptive study where all children between birth and 16 years of age who were admitted from January 1 st, 2018 to December, 31th 2021 for FBs removal were analyzed. All cases were subjected to complete history taking, physical, radiological, and bronchoscopic examination.

Official Title
-----------------
Foreign Body Swallows With Airway Affection in Pediatrics

Conditions
-----------------
Foreign Body in Oropharynx

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children between birth and 16 years of age FBs removal history suggestive of foreign body swallow Exclusion criteria: - none

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 16 Years

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 |
| --- | --- | --- |
| Respiratory distress | stridor due to foreign body swallow | 24 hour after presentation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child, Foreign Bodies, Respiratory distress, Hypopharynx, Esophagoscopy
Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.

Official Title
-----------------
Randomized, Open Label, Phase 3 Clinical Study To Evaluate The Effect Of The Addition Of CP-751,871 To Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: CP-751,871
* Drug: Cisplatin
* Drug: Gemcitabine
* Drug: Cisplatin
* Drug: Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-Small Cell Lung Cancer (NSCLC), advanced, chemotherapy-naive Male or female > 18 years Eastern Oncology Cooperative Group (ECOG) Performance Status (PS) 0 or 1 Adequate organ function Exclusion Criteria: Uncontrolled hypertension or diabetes; Pregnant female; Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic corticosteroids.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CP-751,871 + Gemcitabine + Cisplatin<br>investigational arm | Drug: CP-751,871<br>* CP-751,871 20mg/kg every 3 weeks<br>Drug: Cisplatin<br>* Cisplatin 80 mg/m2 every 3 weeks<br>Drug: Gemcitabine<br>* Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle<br>|
| Active Comparator: Gemcitabine + Cisplatin<br>standard of care | Drug: Cisplatin<br>* Cisplatin 80 mg/m2 every 3 weeks<br>Drug: Gemcitabine<br>* Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Dec 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free survival |  | Dec 2011 | 
| Objective Response |  | Dec 2011 | 
| Overall Safety Profile |  | Dec 2012 | 
| Patient Reported Outcome |  | Dec 2012 | 
| Pharmacokinetics |  | Dec 2012 | 
| Anti-drug Antibody |  | Dec 2012 | 
| Biomarker Analysis |  | Dec 2012 |
Pharmaco-economical Study in Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
The prevalence of renal acute rejection in transplantation is reduced thanks to the optimized use of immunosuppressive drugs. However, graft survival at ten years has not improved since then; this may be explained in part by the toxicity of these drugs, viral infections, and other comorbidities (diabetes, cardiovascular diseases …). According to transplant center, strategies for the combination of immunosuppressive drugs are different, and probably involve a difference in the global cost of patient management. There is no recommendation in France to establish similar practices. EPHEGREN is an observational, prospective, multicentric, pharmacoeconomic study for the renal transplant patients.

Official Title
-----------------
Pharmaco-economical Study in Kidney Transplantation

Conditions
-----------------
Renal Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the first month of renal graft, or patients already included in an other epidemiological French study (EPIGREN) in the 0-6 month period Men of women aged more than 18 years Patients able to exercise in writing their informed and free consent to participate to the biological collection Patients not opposing to collect their medical data Patients registered with a social security system Patients able to complete the questionnaires Exclusion Criteria: Patients aged less than 18 years and patients under guardianship Patients with a follow-up at another center other than those part of the study

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 |
| --- | --- |
| Biological and clinical Data collected<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Death |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to examine nature, dose and exposure in immunosuppresseurs. |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cohort, pharmaco-economic, kidney, transplantation, quality of life
Effect of Natural Cesarean Section on Breastfeeding

Study Overview
=================
Brief Summary
-----------------
Effect of natural cesarean section in comparison to traditional cesarean section on maternal and fetal recovery.

Official Title
-----------------
Effect of Natural Cesarean Section in Comparison to Traditional Cesarean Section on Maternal and Fetal Recovery

Conditions
-----------------
Natural Cesarean Section

Intervention / Treatment
-----------------
* Procedure: natural cesarean section
* Procedure: traditional cesarean section


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primigravida or para one section full term cephalic single baby average weight spinal anathesia Exclusion Criteria: High risk pregnancy. Women with known or suspected fetal malformation. Women with uterine malformations. Breech or transverse lie. Emergency caesarean section. Previous two or more caesarean section

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: group A<br>natural cesarean section | Procedure: natural cesarean section<br> <br> |
| Other: group B<br>traditional cesarean section | Procedure: traditional cesarean section<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to start breastfeeding |  | 3 hrs |
Genetic Modifiers of Cystic Fibrosis: Sibling Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify modifier genes in cystic fibrosis (CF).

Detailed Description
-----------------
BACKGROUND: CF is a highly variable but inevitably fatal single gene disorder. Several lines of evidence suggest that genetic background contributes to the variability of cystic fibrosis phenotypes. The study will develop CF as a model for the identification of modifier genes by capitalizing on the availability of a large motivated population of affected twins and siblings. The study is in response to a Request for Applications titled Genetic Modifiers of Single Gene Defect Diseases released in August 2000 and co-sponsored by the National Institute of Diabetes, Digestive, and Kidney Diseases. DESIGN NARRATIVE: The study has four aims: 1. To identify heritable CF phenotypes by twin study. Intrapair and interpair variance will be determined for selected CF phenotypes, and interclass correlations (monozygotic versus dizygotic) will be performed to identify CF phenotypes with a substantial heritable component. 2. To determine the contribution of genetic and other factors to the variability of CF phenotypes by analysis of affected sibs. Variance component methods will be used to evaluate the CF phenotypes that appear to be heritable based upon other studies or the results of aim 1. 3. To identify biologic phenotypes that correlate with heritable CF phenotypes by clinical study of twins and sibs. Multivariate analysis will be used to find biologic phenotypes associated with CF phenotypes. 4. To identify modifier genes and loci responsible for heritable CF phenotypes by linkage approaches. Identity by descent and transmission disequilibrium methods will be used to test linkage between candidate genes/loci and heritable CF phenotypes. To identify novel loci, genome-wide scans will be performed upon sib pairs selected for extreme concordance or discordance for heritable traits.

Official Title
-----------------
Genetic Modifiers of Cystic Fibrosis: Sibling Study

Conditions
-----------------
Lung Diseases, Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of CF

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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 |
| --- | --- | --- |
| Variation among genes in siblings with cystic fibrosis as assessed by DNA |  | Single collection |
Sit Down and Play India

Study Overview
=================
Brief Summary
-----------------
To gather data essential to evaluate the acceptability and feasibility of a brief, health care-based program delivered in routine healthcare visits in low and low-middle income countries to promote positive parenting behaviors with the aim to support early child development.

Official Title
-----------------
Feasibility of Implementing Sit Down and Play in Routine Visits in India

Conditions
-----------------
Development, Child

Intervention / Treatment
-----------------
* Behavioral: Sit Down and Play


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents/legal guardians will be eligible if they: Are over the age of 18 years Have a child between 6 and 10 weeks Are presenting to Deshnur and Murgod Primary Health Centers in Karnataka, India for a heatlh visit and Self-identify as the primary caregiver. Exclusion Criteria: Parents/legal guardians will be ineligible if they: Are less than the age of 18 years Have a child who is not between 6 and 10 weeks or Have a child who is sick at the time of visit

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sit Down and Play<br> | Behavioral: Sit Down and Play<br>* Brief health care-based program that aims to promote key parenting behaviors that promote early childhood development<br>|
| No Intervention: Usual Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parenting Behaviors that Promote Early Childhood developme | Key items from the UNICEF Multiple Indicator Cluster Surveys Early Childhood Development Module | 1 month after second immunization visit |