linjc16/ctgov huggingface dataset:
Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

Official Title
-----------------
MK-0431/ONO-5435 Phase III Clinical Study - Long-term Treatment Study for Patients With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: Sitagliptin phosphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes mellitus on diet and exercise therapy Exclusion Criteria: Patients with type 1 diabetes mellitus

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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E<br> | Drug: Sitagliptin phosphate<br>* 50 mg QD or 100 mg QD for 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  | 52 weeks | 
| tolerability |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 52 weeks | 
| Plasma glucose |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MK-0431, ONO-5435, Type 2 diabetes mellitus
Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Disturbances of acquired immunity are considered to be responsible, at least partly, for the high infection rate and inadequate response to vaccinations observed in hemodialysis (HD) patients and renal transplant recipient (RTR). The present prospective trial aims at (a) evaluating the immunogenicity of a standard influenza vaccine in HD and RTR patients and (b) at identifying determinants of the immune response.

Official Title
-----------------
Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients

Conditions
-----------------
Hemodialysis, Renal Transplantation

Intervention / Treatment
-----------------
* Biological: trivalent split influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: maintenance hemodialysis patients or renal transplant recipients (beyond month 3 after transplantation) Exclusion Criteria: patients with known allergy to chicken proteins

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: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: influenza vaccination<br>All participants received a standard dose of 0.5 ml commercially available trivalent split influenza vaccine (Vaxigrip®, Aventis Pasteur MSD) by intramuscular injection. The vaccine contained 15 μg hemagglutinin of each of the following influenza strains: A/ New Caledonia/20/99 (H1N1), A/ Panama/2007/99 (H3N2), and B/Shangdong/7/97, recommended by WHO as components of the influenza vaccine for the epidemic season 2003/2004. | Biological: trivalent split influenza vaccine<br>* standard dose of 0.5 ml commercially available trivalent split influenza vaccine (Vaxigrip®, Aventis Pasteur MSD) by intramuscular injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection rate, defined as the percentage of patients with an HI antibody titer ≥ 40, |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroresponse rate, defined as the percentage of patients with a fourfold rise in HI titer after vaccination; impact of booster vaccination on the immune response, and safety of influenza vaccination. |  |  |
Pharmacological Predictors of Successful Cyclosporine Acute GVHD Prophylaxis in Children Undergoing HSCT

Study Overview
=================
Brief Summary
-----------------
The specific objectives of this study are: Primary: 1)To determine the relationship between cyclosporine AUC achieved prior to engraftment and severe aGVHD (grade III and IV) Secondary: To determine the relationship between individual concentration-time points achieved prior to engraftment and severe aGVHD (grade III and IV) To validate the previously developed LSS to determine cyclosporine AUC after IV administration at steady state and To describe the relationship between cyclosporine AUC and individual concentration-time points achieved prior to engraftment and other HSCT outcomes (clinically significant aGVHD (grade II to IV), hypertension, engraftment failure, relapse

Official Title
-----------------
PHARMACOLOGICAL PREDICTORS OF SUCCESSFUL CYCLOSPORINE ACUTE GRAFT VERSUS HOST DISEASE PROPHYLAXIS IN CHILDREN UNDERGOING HAEMATOPOIETIC STEM CELL TRANSPLANT

Conditions
-----------------
Acute-graft-versus-host Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: less than 18 years of age undergoing allogeneic myeloablative HSCT at one of the participating centres and scheduled to receive cyclosporine for aGVHD prophylaxis minimum patient weight: 6.4kg if < 6 months old or 7.2kg if > 6 months old All patients or guardians will provide informed consent or assent as appropriate. Initial contact will be made by a member of the patient's current care team. Consent will be obtained by a co-investigator or the CTSU personnel. Exclusion Criteria: -receipt of voriconazole or posaconazole within 14 days of the first cyclosporine dose or at any time until engraftment

Ages Eligible for Study
-----------------
Maximum Age: 18 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 |
| --- | --- | --- |
| Relationship between CSA area-under-the-curve (AUC) prior to ENGRAFTMENT and severe aGVHD | 1)To determine the relationship between cyclosporine AUC achieved prior to engraftment and severe aGVHD (grade III and IV) | Weekly for 7 weeks or until engraftment and for 100 days after HSCT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CYCLOSPORINE, ACUTE GRAFT VERSUS HOST DISEASE, PROPHYLAXIS, CHILDREN, HAEMATOPOIETIC STEM CELL TRANSPLANT
Clinical and Structural Outcome After Early Repair of the Traumatic Rotator Cuff Tear

Study Overview
=================
Brief Summary
-----------------
The optimal timing for surgical repair of traumatic rotator cuff tears is controversial. Today there are no prospective studies investigating the short to mid-term outcome after early arthroscopic repair of traumatic rotator cuff tears and the Swedish National Musculoskeletal Competence Centre requests more research to this subject. The investigators will follow 60 patients with acute rotator cuff tear undergoing early rotator cuff repair during the first year after surgery. The investigators hypothesise that the outcome after rotator cuff repair is good.

Detailed Description
-----------------
There exists controversy in the current literature regarding timing for surgical repair of traumatic rotator cuff tears. We have seen no prospective studies describing the progression of shoulder function improvement the first year after arthroscopic rotator cuff repair. We hypothesize that early arthroscopic repair of traumatic rotator cuff tears yields successful functional and structural outcomes but there will be a progression of shoulder function improvement during the hole first postoperative year.

Official Title
-----------------
Arthroscopic Repair of Traumatic Rotator Cuff Tears. A Prospective Trial

Conditions
-----------------
Full Thickness Rotator Cuff Tear

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: trauma to the shoulder with sudden onset of symptoms asymptomatic shoulder before trauma mr positive for full thickness rotator cuff tear Exclusion Criteria: fracture severe comorbidity more than 6 weeks after trauma glenohumeral degeneration signs or osteoarthritis on x-ray

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Western Ontario Rotator Cuff Index (WORC) |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Shoulder Score (CS) |  | One year | 
| standardised measure of health status with EQ-5D |  | Two years | 
| cuff integrity |  | One year | 
| Complications |  | within one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
traumatic rotator cuff tear, arthroscopic rotator cuff repair, age, early rotator cuff repair
the Effects of Air Pollution on Respiratory Diseases in Children

Study Overview
=================
Brief Summary
-----------------
The investigators expect to reveal the association between air pollution and childhood respiratory diseases through a multi-center observational study, and summarize the relationship between air pollution and childhood respiratory diseases.

Detailed Description
-----------------
The investigators will collect the data of outpatient and emergency children in Beijing Children's hospital and other participating hospitals due to respiratory diseases from 2010 to 2021, , collect clinical data and basic information, obtain air pollution data and meteorological monitoring data and perform data processing and statistical analysis,，then analyzes the impact of air pollution on children's respiratory diseases.

Official Title
-----------------
A Multicenter Observational Study of the Effects of Air Pollution on Respiratory Diseases in Children

Conditions
-----------------
Respiratory Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children participating in this clinical study must meet all of the following criteria: Age: 0-18 years old, male and female Consultation for respiratory diseases Visit time is between 2010-2021 Provide complete personally identifiable information and medical information Exclusion Criteria: All children with any of the following conditions must be excluded from this study: children who visit hospital don't for respiratory diseases children participating in this clinical study don't provide complete personally identifiable information and medical information Visit time is not between 2010-2021.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 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 |
| --- | --- | --- |
| Major air pollutant concentrations | The air pollutant data comes from the daily air quality data published by the National Environmental Monitoring Center. Calculate the arithmetic average of the daily average concentrations of air pollutants (PM10, PM2.5, SO, NO, CO, etc.) Converted from air pollution index (API). | 12 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of daily visits for respiratory diseases in outpatient and emergency departments | The number of daily outpatient visits for respiratory diseases( rhinitis, allergic rhinitis, upper respiratory tract infection, bronchitis and bronchiolitis, bronchiolitis obliterans, pneumonia, asthma , allergic cough, chronic cough, upper airway cough syndrome,etc.) in each hospital participating in this study during the study period. | 12 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory Diseases, children, air pollution
Hepatitis B Seroepidemiology Among Young Adults

Study Overview
=================
Brief Summary
-----------------
Taiwan has launched a successful nationwide neonatal hepatitis B immunization since July 1, 1984. It successfully decreased the incidence of hepatitis B virus infection, the hepatitis B carrier rate as well as liver diseases among children and adolescents. The sexual transmission route is another important way of hepatitis B infection aside from the mother and child vertical infection, especially for youth and adults. Hepatitis B vaccination cohort refers to those who were born after 1986 and received hepatitis B vaccine immunization during newborn period. They are gradually entering into young adults and adolescent age. Among them, there is no empirical evidence to show the actual infection rate and to help implement hepatitis B vaccine booster policy for those who had three seronegative viral markers of hepatitis B. Therefore, the study design is to collect three consecutive years graduate school students school entry health examination data and undergo three hepatitis B viral markers checkup and blood types. The data linkage includes their health checkup data in the freshmen period, Taiwan CDC databank for neonatal hepatitis B immunization records, pregnancy and birth record registry, Taiwan cancer registry and Taiwan death record registry.

Detailed Description
-----------------
This study is aimed to delineate the hepatitis B seroepidemiology among young adults with or without neonatal hepatitis B immunization, among young adults with hepatitis B booster in the university period, among the mothers of hepatitis B vaccination cohort. The results of this study will provide important information to help government implement hepatitis B vaccine booster policy in the adolescents and young adults.

Official Title
-----------------
A Retrospective Cohort Study of Hepatitis B Seroepidemiology Among Young Adults

Conditions
-----------------
Hepatitis B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Young adults 20 to 30 years old. Exclusion Criteria: Refused to undergo blood draw or questionaire.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serostatus of hepatitis B viral markers |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis B, epidemiology, youth, vaccine
Global Impact of COVID-19 on Pulmonology Special Units

Study Overview
=================
Brief Summary
-----------------
The COVID-19 pandemic is having a profound impact on the world. As of May 18, 2020, there were 4,889,287 confirmed cases and 322,683 deaths globally. The healthcare system is wrestling with a virus that threatens to overwhelm hospital capacity, while simultaneously confronting an unprecedented reduction in elective and non-essential care. A survey by the American Cancer Society showed that 50% of cancer patients and survivors reported some impact to their healthcare due to the COVID-19 epidemic. A recent survey was conducted by Forbes et al to evaluate the changes in GI and endoscopy practices in North America. However, the impact of this epidemic on Pulmonology units ( bronchoscopy, thoracoscopy, ultrsonography and sleep lab) globally has not been studied.

Official Title
-----------------
Global Impact of COVID-19 on Pulmonology Special Units (Bronchoscopy, Thoracoscopy, Ultrasonography and Sleep Lab)

Conditions
-----------------
Covid19, Global Impact, Pulmonology

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Working registered invited pulmonology units; governmental, university, private Exclusion Criteria: non pulmonary medicine registered units
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Survey|invited questionnaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global impact of COVID-19 on baseline patients number | number of patients and procedures before and after pandemic | 6 months | 
| measure the changes in practice in each unit | use of PPE | 6 months | 
| frequency of SARS-CoV-2 infection in healthcare workers | SARS-CoC-2 infection | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchoscopy, Thoracoscopy, Thoracic ultrasonography, Sleep Lab, Global impact
Trial of Fresh Start Weight Loss Intervention in WIC Participants

Study Overview
=================
Brief Summary
-----------------
The Fresh Start postpartum weight loss program will test the effectiveness of a group-based weight loss intervention that includes videos featuring peers who have successfully achieved postpartum weight loss. The group-based condition will be compared to a control condition involving print materials related to weight loss.

Detailed Description
-----------------
The goal is to study the effectiveness and implementation of a postpartum weight loss intervention for WIC clients that has potential for sustainability. The investigators will compare outcomes among participants in a group-based weight loss intervention condition (Fresh Start) to outcomes among participants in a self-directed, print materials only, comparison group. The Fresh Start intervention, informed by formative research studies, consists of an 8-session group-based weight loss intervention delivered by WIC nutritionists and peer leaders. The intervention integrates key educational and skill building strategies from the lifestyle arm of the Diabetes Prevention Program with delivery strategies and messages specific for the WIC program and postpartum women. The intervention will be evaluated in a randomized clinical trial that will contribute to generalizable knowledge.

Official Title
-----------------
Fresh Start: A Randomized Clinical Trial

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Group program
* Behavioral: Print Materials


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6 months or less postpartum Speaks English BMI 25 or greater Client of WIC program, Worcester MA Exclusion Criteria: Not able to give informed consent

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

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

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: Group program<br>8-session group weight loss program and 4 follow-up phone counseling sessions | Behavioral: Group program<br> <br> |
| Active Comparator: Print Materials<br>8 weekly mailings of print materials covering weight loss topics through US mail. | Behavioral: Print Materials<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Mass Index from baseline |  | 3 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pregnancy Physical Activity Questionnaire score from baseline |  | 3 months, 12 months | 
| Change in 24-hour dietary recall from baseline | Dietary behavior will be measured using a 24-hour dietary recall. | 3 months, 12 months |
EuroSIDA As An External Comparator To MOTIVATE Trials

Study Overview
=================
Brief Summary
-----------------
Human Immunodeficiency Virus (HIV) infected patients who meet the entry criteria for the maraviroc pivotal trials (Maraviroc versus Optimized Therapy in Viremic Antiretroviral Treatment-Experienced Patients, MOTIVATE) will be identified from the EuroSIDA HIV cohort. The rates of specific clinical adverse events in this identified patient population will be compared with the rates of these events in the participants of the MOTIVATE trials.

Detailed Description
-----------------
All patients in EuroSIDA cohort that meet the entry criteria of MOTIVATE trials are included without any sampling.

Official Title
-----------------
Incidence And Risk Factors For Acquired Immune Deficiency Syndrome (AIDS) Defining And Non-AIDS Defining Malignancies, And Other AIDS Defining Illnesses In The EuroSIDA Study

Conditions
-----------------
HIV, AIDS

Intervention / Treatment
-----------------
* Other: maraviroc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged over 16 at baseline. Viral Load (VL) > 5000 copies/ml at baseline (and measured in 6 months prior to baseline). No changes in antiretroviral (ARV) regimens in the month period prior to baseline, or on no ARVs in the month prior to baseline. > 3 months exposure (sequential or cumulative) to at least 3 of the following; Any nucleoside or nucleotide reverse transcriptase inhibitor (NRTI) Non-nucleoside reverse transcriptase inhibitor (NNNRTI) Protease Inhibitor (PI ) Enfuvirtide Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| EuroSIDA sub-cohort<br>HIV infected patients in the EuroSIDA cohort who meet the entry criteria for maraviroc pivotal clinical trials (MOTIVATE 1 and MOTIVATE 2) | Other: maraviroc<br>* No intervention is distributed during this trial.<br>* Other names: Selzentry, Celsentri;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malignancy |  | Median follow up of 3 years | 
| Opportunistic infection |  | Median follow up of 3 years | 
| Myocardial infarction |  | Median follow up of 3 years | 
| All cause death |  | Median follow up of 3 years | 
| Liver related death |  | Median follow up of 3 years |