linjc16/ctgov huggingface dataset:
Study to Assess Safety & Immunogenicity of GSK Biologicals' Boostrix (dTpa) Vaccine vs. Chinese DT Vaccine

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals' reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in comparison with Chinese DT vaccine, in children 6-8 years of age.

Official Title
-----------------
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix (dTpa) Vaccine and the Chinese DT Vaccine, When Administered as Booster Vaccination in Healthy Children Aged 6-8 Years

Conditions
-----------------
Diphtheria, Acellular Pertussis, Tetanus

Intervention / Treatment
-----------------
* Biological: Boostrix
* Biological: Chinese DT vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female between, and including, 6-8 years of age at the time of vaccination, Written informed consent obtained from the parent or guardian of the subject, Exclusion Criteria: Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate. Subjects with history of diphtheria, pertussis or tetanus diseases can not participate.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 8 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Boostrix|nan|
|Biological: Chinese DT vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited symptoms (Day 0-3), unsolicited AEs (Day 0-30) & SAEs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chinese DT vaccin
Computer Aided Diagnosis of Colorectal Neoplasms During Colonoscopic Examination

Study Overview
=================
Brief Summary
-----------------
An NBI-based diagnosis requires training and experience. We are developing a system of computerized image recognition, which can detect possible NBI features of polyps, and provide a more objective diagnosis, which allows nonexpert endoscopists to achieve a high diagnostic accuracy.

Official Title
-----------------
Computer Aided Diagnosis of Colorectal Neoplasms During Colonoscopic Examination

Conditions
-----------------
Colon Polyp

Intervention / Treatment
-----------------
* Diagnostic Test: Computer-aided diagnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the same as colonoscopy Exclusion Criteria: the same as colonoscopy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer-aided diagnosis<br> | Diagnostic Test: Computer-aided diagnosis<br>* computer-aided diagnosis to assist colonoscopists<br>|
| No Intervention: traditional diagnosis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, Specificity, False Positive, False Negative | Diagnostic accuracy | Duration between endoscopic diagnosis and pathologic diagnosis is about one week |
Effect of Formula on Growth of Infants From Overweight or Obese Mothers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth

Official Title
-----------------
Effect of Protein Levels and Caloric Density on the Growth of Formula Fed Infants From Overweight or Obese Mothers

Conditions
-----------------
Infant Nutrition

Intervention / Treatment
-----------------
* Other: standard infant formula
* Other: Test formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy newborn infant birth weight between 2500g and 4800g singleton birth mother's BMI before pregnancy was between 26 and 25 for the breastfeeding group: mother has elected to exclusively breastfeed her baby from birth to at least 6 months of age for the formula groups: mother has elected to exclusively formula feed her baby from 3 to 6 months of age having obtained signed informed consent of legal representative Exclusion Criteria: body weight smaller than 5th percentile for that gestational age newborn whose mother has diabetes newborn whose mother has a drug dependence during pregnancy newborn currently participating in another trial

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 12 Months

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Standard infant formula | Other: standard infant formula<br>* standard infant formula given from 3 to 12 months of age, as per standard requirement<br>|
| Experimental: 2<br>Test formula | Other: Test formula<br>* Test formula with different protein and calorie content than standard formula, given from 3 to 12 months of age. As per standard requirement.<br>|
| No Intervention: 3<br>Breastfeeding reference group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean weight gain |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood test assessments; body composition, bone density |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infant formula, obesity, growth
The Effect of Phosphorus on Diet Induced Thermogenesis

Study Overview
=================
Brief Summary
-----------------
The aim of the trial is to investigate the effect of ingestion of 75g of glucose (with or without phosphorus) on diet induced thermogenesis (using indirect calorimetry) and appetite (using visual analogue scales) in lean and obese healthy subjects

Conditions
-----------------
Imbalance of Constituents of Food Intake, Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Phosphorus
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Sedentary lifestyle Stable weight for the past 3 months On a balanced diet Exclusion Criteria: Underweight (BMI<18.5) or overweight/obese (BMI≥25) age <18 or > 30 years Inability to give valid consent Presence of a chronic or acute illness. Elevated physical activity level (assesses by the physical activity questionnaire) Heavy smokers (≥1 pack per day). Weight gain or loss of > 3% in the past 3 months History of kidney stones

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phosphorus<br>Intervention (500 mg of potassium phosphate) will be administered with 75 g glucose solution and diet induced thermogenesis will be measured afterwards | Dietary Supplement: Phosphorus<br> <br> |
| Placebo Comparator: Placebo<br>Placebo (cellulose) will be administered with 75 g glucose solution and diet induced thermogenesis will be measured afterwards | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet Induced Thermogenesis | Diet Induced Thermogenesis will be measured using indirect calorimetry (VO2 consumption) | 180 minutes (measured every 30 min) |
The Effect of 5-FU and LMW Heparin on the Rate of Retinal Redetachment After Silicone Oil Removal in Cases of PVR

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of combined 5-FU and low molecular weight heparin in infusion on the rate of retinal redetachment after silicone oil removal in cases of proliferative vitreoretinopathy (PVR).

Conditions
-----------------
Proliferative Vitreoretinopathy

Intervention / Treatment
-----------------
* Drug: low molecular weight heparin, 5-FU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases with history of vitrectomy and silicone oil injection for management of PVR who undergo silicone oil removal Exclusion Criteria: any sign of retinal redetachment before silicone oil removal any sign of diabetic retinopathy

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

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

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

| Intervention/Treatment |
| --- |
|Drug: low molecular weight heparin, 5-FU|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal redetachment rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity |  |  | 
| intraocular pressure |  |  | 
| reoperation |  |  | 
| relative afferent pupillary defect |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
silicone oil, PVR, retinal redetachment, low molecular weight heparin, 5-FU
Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)

Study Overview
=================
Brief Summary
-----------------
Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver. Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

Official Title
-----------------
Satavaptan Cirrhotic Ascites Treatment Study: a Double-blind, Randomised, Parallel-group Comparison of Treatment With Satavaptan at 5 to 10 mg Daily Versus Placebo on Top of Conventional Treatment in Patients With Ascites Due to Cirrhosis of the Liver

Conditions
-----------------
Ascites, Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: Satavaptan
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with cirrhosis of the liver Participants with clinically evident ascites primarily managed by diet and/or diuretics Stable treatment of ascites for at least the previous 2 weeks without paracentesis Participants having undergone no more than one therapeutic paracentesis in the previous 6 months. Exclusion Criteria: Participants with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt Known hepatocellular carcinoma Participants with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma Participants previously exposed to satavaptan in the past 12 months

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Satavaptan<br> | Drug: Satavaptan<br>* oral administration once daily<br>* Other names: SR121463B;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* oral administration once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of ascites worsening |  | at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of ascites worsening |  | at week 24 | 
| Increase in ascites |  | at week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ascites, Liver Cirrhosis
Trial of a Home Based Strength and Balance Retraining Program in Reducing Falls Risk Factors

Study Overview
=================
Brief Summary
-----------------
Action Seniors!: A 12-Month Randomized Controlled Trial of a Home Based Strength and Balance Retraining Program in Reducing Falls Risk Factors

Official Title
-----------------
Action Seniors!: A 12-month Randomized Controlled Trial of a Home Based Strength and Balance Retraining Program in Reducing Falls Risk Factors

Conditions
-----------------
Falls

Intervention / Treatment
-----------------
* Behavioral: physical activity program of strength and balance retraining


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 70 years and older, present to a health care provider with a fall, mini mental state exam of at least 24 Exclusion Criteria: Progressive neurological condition, medical condition precluding participation in physical activity, residing in a nursing home/extended care facility

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: physical activity program of strength and balance retraining|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls Risk Factors as measured by the Physiological Profile Assessment (PPA) and its five components (vision, reaction time, knee extension strength, proprioception, sway) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of falling, cost, injurious falls, Physiologic Profile Assessment (overall score and subcomponents), cognitive performance based on standard neuropsychological tests, and everyday function. All measured at 6 and 12 months |  | 12 months |
Rituximab in Combination With Fludarabine and Cyclophosphamide in Patients With Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
Evaluation of safety profile and tolerability of MabThera (rituximab) in combination with chemotherapy (fludarabine and cyclophosphamide) in the treatment of Chronic Lymphocytic Leukemia (CLL).

Official Title
-----------------
Open, Non-Interventional, Multicentre Trial of Rituximab in Combination With FC for the First-Line Therapy of Patients With Chronic Lymphocytic Leukaemia

Conditions
-----------------
Lymphocytic Leukemia, Chronic, Chronic Lymphocytic Leukemia, Cancer

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years with diagnosed Chronic Lymphocytic Leukemia (CLL) CLL stages: Binet stage C (Rai III or IV), Binet stage B (Rai I and II) requiring treatment Exclusion Criteria: - Patients who are not eligible for rituximab treatment according to Summary of Product Characteristics (SmPC)

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 |
| --- | --- |
| Combination Treatment in Chronic Lymphocytic Leukemia (CLL)<br>All participants receiving combination treatment in Chronic Lymphocytic Leukemia (CLL) | Other: No intervention<br>* No intervention administered in this study: Rituximab in combination with fludarabine and cyclophosphamide for 6 months according to registered indication.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Adverse Events (AEs) |  | From baseline to end of study up to 18 months | 
| Percentage of Serious Adverse Events (SAEs) |  | From baseline to end of study up to 18 months |
The Relationship Between Vitamin D and Hepatitis B Virus Replication

Study Overview
=================
Brief Summary
-----------------
149 HBV carriers with inadequate serum vitamin D levels were randomized to two groups: one is supplied with vitamin D and another without as controls. The markers of HBV replication were compared before and after treatment.

Detailed Description
-----------------
This is a randomized case-control trial. A total of 149 HBV carriers with inadequate vitamin D (< 30 ng/mL) level were enrolled. They were randomly divided to two groups: one group receiving vitamin D supplement (1600 IU/day) for 2 months and another group as controls. The serum vitamin D, HBV DNA and qHBsAg levels were measured at baseline and after vitamin D supplement. Whether HBV DNA and qHBsAg have significant change after vitamin D supplement can be determined.

Official Title
-----------------
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Conditions
-----------------
Vitamin D and Hepatitis B Virus

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >20 y/o, HBV carrier serum vitamin D < 30ng/ml Exclusion Criteria: Other known causes of hepatitis

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1: vitamin D supplement Group 2: controls
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D group<br>Patients receiving vitamin D supplement (2000 IU/day) for 2 months | Dietary Supplement: Vitamin D<br> <br> |
| No Intervention: Control group<br>Patients without receiving vitamin D supplement | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Dynamic Change of HBV DNA | the serum HBV DNA levels were measured in CH-B patients before and after 2-month vitamin D supplement | baseline, after 2-month vitamin D supplement | 
| The Change of Serum qHBsAg (IU/mL) | The serum qHBsAg levels were measured before and after 2-month vitamin D supplement | baseline, after 2-month vitamin D supplement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HBV DNA, qHBsAg
Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)

Study Overview
=================
Brief Summary
-----------------
This analytical descriptive study aims to describe the fertility and sexuality male adult subjects carrying classic bladder exstrophy or epispadias and to highlight infertility risk factors. A questionnaire on paternity, urinary status, erections, ejaculations and sexual self-esteem and a semen analysis will be realized at first consultation, semen analysis results wil be explained at second consultation. It is assumed that fertility and sexuality exstrophic men are impaired.

Official Title
-----------------
Male Bladder Exstrophy in Adulthood : What Sexuality and Fertility Prospects ?

Conditions
-----------------
Fertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients followed the Hospices Civils de Lyon Consultant spontaneously in adult or pediatric Urology, or neuroperineal rehabilitation and sexology Aged over 18 years Born with classic bladder exstrophy or epispadias. Exclusion Criteria: Refusal of participation Refusal to sign consent minor Patients or protected major, under guardianship Patients unable to understand the course of the study cloacal exstrophy

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

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

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 |
| --- | --- | --- |
| paternity rate | paternity rate measured by the ratio of the number of subjects with children to the total number of subjects estimated with questionnaire responses | Baseline (at first consultation) | 
| Sperm quality | concentration of mobile live sperm in semen analysis | up to 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fertility, sexuality, male, exstrophy-epispadias complex, bladder exstrophy, epispadias