linjc16/ctgov huggingface dataset:
Docetaxel in Treating Patients With Advanced Cancer of the Cervix

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 docetaxel in treating patients with advanced cancer of the cervix.

Detailed Description
-----------------
OBJECTIVES: I. Assess the antitumor activity of docetaxel as neoadjuvant chemotherapy in patients with locally advanced squamous cell carcinoma of the cervix. II. Assess the tumor response, toxic effect, and survival rate of this regimen in these patients. OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Treatment is repeated every 3 weeks for 3 courses. Patients are followed every 3 months posttreatment. PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study.

Official Title
-----------------
Neoadjuvant Chemotherapy With Docetaxel in Advanced Cervical Carcinoma

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Drug: docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically proven stage IIB, IIIA, IIIB, and IVA squamous cell carcinoma of the cervix Bidimensionally measurable disease No bilateral hydronefrosis PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 10 g/dL Leukocytes at least 4,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin less than 1.25 times upper limit of normal (ULN) AST less than 1.25 times ULN Renal: BUN less than 30 mg/dL AND Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No prior or other concurrent malignancies, other than properly treated basal cell skin cancer PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|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
-----------------
stage III cervical cancer, stage IIB cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma
Efficacy, Safety, Tolerability of Pegaptanib Sodium (Macugen) in Filipino Patients With Neovascular Age Related Macular Degeneration.

Study Overview
=================
Brief Summary
-----------------
An open label, non-comparative, multicenter, non-interventional, post marketing surveillance study to evaluate the overall safety and tolerability of pegaptanib sodium(Macugen) in the treatment of Filipino patients with neovascular age-related macular degeneration based on incidence of adverse events and to evaluate the efficacy based on visual acuity, and the patient's and physician's overall satisfaction with tolerability and efficacy.

Detailed Description
-----------------
Open-label, non-comparative, non-interventional study

Official Title
-----------------
The Efficacy, Safety, and Tolerability of Pegaptanib Sodium in Filipino Patients With Neovascular Age-related Macular Degeneration: A Post Marketing Surveillance Study.

Conditions
-----------------
Neovascular Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Macugen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have at least one eye which was diagnosed with neovascular degeneration Exclusion Criteria: Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, multifocal choroiditis

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Phase IV Post Marketing Surveillance Study<br>Open-label, observational study | Drug: Macugen<br>* Intravitreous injection of Pegaptanib Sodium 3.47 mg/mL solution every 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events and serious adverse events |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in visual acuity in the study eye at 6 months from baseline |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
A5751025
Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A

Study Overview
=================
Brief Summary
-----------------
The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A.

Official Title
-----------------
A Randomized Two-Way Blinded Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII,Refacto AF) With a Full Length Recombinant Factor VIII Preparation (FLrFVIII,Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients With Hemophilia A.

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Genetic: ReFacto AF
* Genetic: B-Domain deleted Recombinant Factor VIII
* Genetic: BDDrFVIII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subjects with severe or moderately severe hemophilia A A negative past medical history of a Factor VIII inhibitor Age greater than or equal to 12 years Exclusion Criteria: A history of Factor VIII inhibitors Presence of a bleeding disorder in addition to hemophilia Known hypersensitivity to hamster protein

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: ReFacto AF|nan|
|Genetic: B-Domain deleted Recombinant Factor VIII|nan|
|Genetic: BDDrFVIII|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the incidence rate of Factor VIII inhibitors in the study patient population.To establish bioequivalence of ReFacto AF as compared to Advate using the one stage Factor VIII activity assay. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the efficacy of ReFActo AF in preventing and treating bleeding episodes during prophylaxis.To characterize PK of ReFacto AF as compared to Advate over time. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemophilia A
Antihemostatic Therapy and Endoscopic Biliary Sphincterotomy Induced Bleeding

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to observe the effects of antihemostatic therapy including nonsteroidal antiinflammatory, anticoagulant and antiaggregant therapy and other patient and procedure related factors on the risk of endoscopic biliary sphincterotomy induced bleeding.

Official Title
-----------------
The Effect of Antiaggregant, Anticoagulant and Nonsteroidal Antiinflammatory Therapy on Endoscopic Biliary Sphincterotomy Induced Bleeding

Conditions
-----------------
Endoscopic Biliary Sphincterotomy, Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalization Endoscopic sphincterotomy The patients whose warfarin treatment was stopped and INR was normalized prior to examination Exclusion Criteria: The patients who had undergone endoscopic cholangiography with no sphincterotomy Outpatient procedures

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- |
| hemorrhage<br>The patients who had bleeding induced by endoscopic sphincterotomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding induced by endoscopic biliary sphincterotomy |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopic sphincterotomy, hemorrhage, nonsteroidal antiinflammatory agents, antiaggregants, anticoagulants, Endoscopic biliary sphincterotomy induced bleeding
Longitudinal Study of Cortisol and Pulmonary Function

Study Overview
=================
Brief Summary
-----------------
To conduct a longitudinal study of the relationship between the rate of decline of pulmonary function and measurements of cortisol concentration and excretion in a sample of middle-aged and older men and their wives. The study tested the hypothesis that persons whose plasma cortisol concentrations were relatively low, albeit within the normal range, were predisposed to excessively rapid deterioration of pulmonary function during aging.

Detailed Description
-----------------
BACKGROUND: It was hoped that the study would provide important insights into the pathogenesis of chronic obstructive pulmonary disease with potential implications for prevention and early therapeutic intervention. DESIGN NARRATIVE: All subjects participating in the Normative Aging Study were recruited for the study at the time of their next scheduled examination. Twenty-four hour urinary excretion of free cortisol, morning serum cortisol concentration, and pre- and post-bronchodilator spirometric indices were measured. For the 700 subjects who were recruited during years one and two of the study, these measurements were repeated when subjects returned for their next triennial examination in years four and five of the study. Respiratory illness and smoking questionnaire data, total and differential leukocyte counts, and methacholine inhalation challenge test data were also available at both time points. The specific aims of the study were to examine: (1) the cross-sectional relationship between level of pulmonary function and both morning serum cortisol concentration and 24-hour urinary free cortisol excretion; (2) the relationship between the rate of decline of pulmonary function during the follow-up interval and these measurements of cortisol concentration and excretion; (3) whether these relationships were modified by smoking history, blood total leukocyte count, methacholine airway responsiveness, or other characteristics; and (4) the stability over time of serum cortisol concentration and urinary cortisol excretion in this aging population. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

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 |
| --- | --- | --- |
Malaria Control : Improving Access to Prevention, Diagnostic and Care for Vulnerable Rural Communities

Study Overview
=================
Brief Summary
-----------------
In the REACT 2 project, a consortium proposes to study in Burkina Faso and Côte d'Ivoire, the impact of a public health intervention in rural communities in order to improve access to malaria therapeutic and preventive arsenal for vulnerable populations (i.e. children, adolescents and pregnant women). The intervention relies on the implementation of mobile health workers to support community health workers.

Official Title
-----------------
Malaria Control : Improving Access to Prevention, Diagnostic and Care for Vulnerable Rural Communities

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Other: Public health intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: global population Exclusion Criteria: absence of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

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: Crossover Assignment
Interventional Model Description: Cluster randomized - Step-wedged design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Heath system strengthening with additional trained mobile health care worker to help community health workers | Other: Public health intervention<br>* additional trained mobile health workers are hired to support and supervise the activities of community health workers<br>|
| No Intervention: Standard of care<br>National strategy to control malaria | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of malaria incidence between control and intervention arms | Incidence will be calculated as the number of malaria cases detected during the cross-sectionnal surveys relative to the population size | Day 0 (cross-sectional survey) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of malaria prevalence between control and intervention arms | Prevalence will be calculated as the proportion of participants with malaria infection (i.e. positive blood smears) detected during the cross-sectionnal surveys | Day 0 (cross-sectional survey) |
Bioavailability of Avenanthramide-Enriched Oats in Healthy Older Adults

Study Overview
=================
Brief Summary
-----------------
This is a placebo-controlled, crossover study investigating the pharmacokinetic bioavailability of avenanthramides from avenanthramide-enriched oats and their in vivo metabolites in a cohort of healthy, older adults.

Official Title
-----------------
Bioavailability of Avenanthramide-Enriched Oats in Healthy Older Adults

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

Intervention / Treatment
-----------------
* Other: Avenanthramide-enriched oats


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and postmenopausal women BMI 18.5-29.9 kg/m2 Exclusion Criteria: Cigarette smoking and/or nicotine replacement use Use of cholesterol-lowering medications Use of blood pressure-lowering medications Use of any stomach acid-lowering medications Cardiovascular (heart) disease Gastrointestinal disease Kidney disease Endocrine disease: including diabetes, untreated thyroid disease Rheumatoid arthritis Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission Systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 95 mm Hg Regular use of oral steroids Regular daily intake of 2 or more alcoholic drinks Illicit drug use No fish oil supplements (including cod liver oil) for one month prior to study admission No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) or homeopathic remedies, for one month prior to study admission

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo muffin made with no oats<br> | Other: Avenanthramide-enriched oats<br>* Single dose, 24 hour pharmacokinetic trial<br>|
| Active Comparator: Test muffin made with AV-enriched oats<br> | Other: Avenanthramide-enriched oats<br>* Single dose, 24 hour pharmacokinetic trial<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of avenanthramides and their in vivo metabolites in blood, urine, and feces following the consumption of avenanthramide-enriched oats delivered in a baked muffin |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
avenanthramide, enriched, oat, phytochemical, bioavailability
The Role of Acupuncture for the Treatment of Obstructive Sleep Apnea in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
Recent evidences from small studies show potential benefit of acupuncture in the treatment of obstructive sleep apnea (OSA). These studies did not evaluate the benefit of the treatment on the cardiovascular system. Primary end-point: To investigate the effects of acupuncture in improving OSA severity among hypertensive patients. Secondary end-point To investigate the effect of acupuncture in improving the quality of life and sleep assessed by the Short Form 36 (SF-36) questionnaire and Pittsburgh Questionaire (PSQI); To investigate the effect of acupuncture in blood pressure and arterial stiffness

Official Title
-----------------
The Role of Acupuncture for the Treatment of Obstructive Sleep Apnea in Patients With Hypertension

Conditions
-----------------
Sleep Apnea, Obstructive

Intervention / Treatment
-----------------
* Other: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 5<apnea-hypopnea index (AHI)<30 e/h Exclusion Criteria: body mass index > 35 kg/m2 Previous OSA treatment

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 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 |
| --- | --- |
| Sham Comparator: sham acupuncture<br>group will be submitted to placebo electroacupuncture for 20 minutes, two times a week for 5 weeks. Each session lasts about 40 min. | Other: acupuncture<br>* electroacupuncture<br>|
| Experimental: acupuncture<br>group will be submitted to electroacupuncture for 20 minutes, two times a week for 5 weeks. Each session lasts about 40 min. | Other: acupuncture<br>* electroacupuncture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-hypopnea index (AHI) | reduction in AHI | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality | Improvement in PSQI scores | 5 weeks | 
| Pulse Wave Velocity (PWV) | reduction in PWV | 5 weeks | 
| Blood pressure | ambulatory blood pressure monitoring (ABPM) 24h reduction | 5 weeks | 
| Quality of life | Short Form 36 Health Survey (SF36) scores | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupuncture
Prophylaxis of Venous Thromboembolism After Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
This study is a prospective evaluation of the relationship between lean body weight and anti-Xa activity and 5700 International Units (IU) nadroparin 4 hours after subcutaneous administration in morbidly obese patients after bariatric surgery.

Detailed Description
-----------------
There is no guideline for postoperative thromboembolic prevention in morbidly obese patients. The investigators goal is to examine which dose of nadroparin is effective.

Official Title
-----------------
Prospective, Pharmacokinetic Study for Determination of the Relationship Between Lean Body Weight and Anti-Xa Activity 4 Hours After Subcutaneous Injection of 5700 IU Nadroparin in Morbidly Obese Patients After Bariatric Surgery.

Conditions
-----------------
Morbid Obesity, Thromboembolism, Bypass Complications

Intervention / Treatment
-----------------
* Drug: Nadroparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Approval for Roux-en-Y gastric bypass Total body weight > 140 kg Exclusion Criteria: Renal impairment (GFR < 30ml/min and/ or serum creatinin > 150 micromol/ml) Coagulation disorders Use of vitamin K antagonists (such as acenocoumarol) pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nadroparin<br>patients above 140 kg will receive a dose of 2850 IU nadroparine pre-operatively, anti-Xa factor will be determined 3 days after nadroparin use. After surgery patients receive 5700 IU nadroparin (our standard treatment). Three days after surgery and 4 weeks after surgery anti-Xa factor will be measured again. | Drug: Nadroparin<br>* Patients receive before surgery 3 days 2850 IU nadroparin. anti-Xa levels will be measured. After surgery they receive 5700 IU for 4 weeks as standard care in our hospital. 3 days and 4 weeks after surgery anti-Xa levels will be measured again.<br>* Other names: Fraxiparin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin |  | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nadroparin, Anti-Xa activity