linjc16/ctgov huggingface dataset:
A Prospective Multicenter Study to Evaluate Usefulness of Cardio-Ankle Vascular Index in Japan

Study Overview
=================
Brief Summary
-----------------
The objective of this five-year prospective observational follow-up study is to examine the additional benefits of using cardio-ankle vascular index (CAVI) as a predictive indicator of cardiovascular events in high-risk patients.

Official Title
-----------------
A Prospective Multicenter Study to Evaluate Usefulness of Cardio-Ankle Vascular Index in Japan

Conditions
-----------------
Stroke, Cardiovascular Death, Nonfatal Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 40 and 74 years of age who have either of the following: Type 2 diabetes mellitus Metabolic syndrome Grade I to III hypertension with the third layer of risk factors according to the guidelines for the management of hypertension japanese society of hypertension(JSH)2009 Chronic kidney disease(stage G3a or G3b) according ot the clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease 2012 in Japan History of coronary artery disease or noncardiogenic cerebral infarction Exclusion Criteria: Under 40 years of age or over 74 years of age An ankle-brachial index less than 0.9 Chronic atrial fibrillation Current symptoms of heart failure(NYHA class III or IV) or left ventricular dysfunction (EF below 40%) Malignancy Chronic kidney disease(G4 or G5)according ot the clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease 2012 in Japan chronic dialysis due to renal failure Taking steroids/immunosuppressants Hepatocirrhosis

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 74 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 |
| --- | --- |
| Optimal therapy<br>All subjects will be treated by optimal medical therapy and lifestyle modification. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major cardiac events | cardiac death, nonfatal myocardial infarction, stroke | five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality, cardiovascular events, and renaly dysfunction | all cause death, angina pectoris (with revascularization), New incidence of lower limb peripheral arterial disease(including lower limb arteriosclerosis obliterans), Aortic aneurysm, Aortic dissection, Heart failure that requires hospitalization, Deterioration in renal function (dialysis or renal transplantation) | five years |
Protocol to Obtain Blood Samples for Leukemia Research

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect a blood sample in patients with Chronic Lymphocytic Leukemia (CLL).

Detailed Description
-----------------
The blood sample will be used in the laboratory to perform studies focusing on Chronic Lymphocytic Leukemia (CLL).

Official Title
-----------------
Protocol to Obtain Blood Samples for Leukemia Research

Conditions
-----------------
Chronic Lymphocytic Leukemia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing routine blood draws as part of their ongoing follow-up for Chronic Lymphocytic Leukemia (CLL) at the Norris Cotton Cancer Center of DHMC. Exclusion Criteria: Patients who have received cytotoxic drug, oral or intravenous steroid or targeted antibody therapy for CLL or other disease process within the past 6 months are excluded. Use of intravenous immunoglobulin (IVIg) is not a reason for exclusion.

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 |
| --- | --- |
| No Treatment<br> | Other: No Intervention<br>* Patients with Chronic Lymphocytic Leukemia (CLL)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the frequency with which CLL cells incubated ex vivo with vincristine undergo rapid interphase apoptosis. |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether suppression or inhibition of BCL2 family members can acutely sensitize CLL cells to vincristine. |  | 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLL
An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Open-label exloratory pharmacodynamic and pharmacogenomic study to evaluate teh biologic effects of 3 dose levels (1mg, 5 mg, and 15 mg) of temsirolimus administered orally once daily for approximately 4 weeks (+/- 2 weeks) before prostatectomy

Official Title
-----------------
An Open Label Study of Exploratory Pharmacogenomics and Pharmacologic Effects of Neoadjuvant Oral Temsirolimus in Newly Diagnosed Prostate Cancer Patients Undergoing Radical Prostatectomy Who Have a High Risk of Relapse

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Drug: temsirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Histologically confirmed diagnosis of adenocarcinoma of the prostate gland via a minimum of 6 core biopsy samples. Subjects must be a candidate for radical prostatectomy No evidence of metastatic disease as determined by CT scans and bone scans More criteria apply Exclusion Criteria: Subjects from whom sufficient diagnostic biopsy material is not available for full characterization of the tumor Active Infection requiring antibiotic therapy, or serious intercurrent illness, active bleeding, or ongoing urinary tract infection necessitating rapid or emergent surgical resection Subjects who have had hormonal injection or implants which will last longer than 6 months More criteria apply

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: temsirolimus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effects of oral temsirolimus on changes in phosphorylation state of proteins in the mTOR signaling pathway in tumor tissue and on phosphorylation state of mTOR pathway proteins and on global and targeted gene expression pattern PBMCs |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine effects of oral temsirolimus on global and targeted gene expression; compare effects in the tumor and PBMCs; obtain preliminary information on potential antitumor effects; evaluate PK using whole blood and tumor tissue. |  |  | 
| To evaluate the relationship between PTEN status and the pharmacodynamic/pharmacogenomic effects of temsirolimus and to determine the effects of temsirolimus on changes in protein expression patterns in the plasma |  |  |
Adding Specialist Palliative Care to Transplantation Pilot Trial

Study Overview
=================
Brief Summary
-----------------
Specialist palliative care has been shown to be beneficial for patients experiencing serious illness, but has not been studied for patients being evaluated for liver transplantation. The investigators hope in the future to design a multi-center trial of a specialist palliative care intervention to measure the effects of specialist palliative care for patients undergoing liver transplant evaluation. This project represents a pilot to gather needed information to design such a future study.

Official Title
-----------------
Adding Specialist Palliative Care to Transplantation Pilot Trial

Conditions
-----------------
End Stage Liver DIsease

Intervention / Treatment
-----------------
* Behavioral: Palliative Care Consultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients (age 18 years or greater) undergoing evaluation for liver transplantation at Vanderbilt University Medical Center Exclusion Criteria: Patient does not speak English fluently Patient lacks a telephone Patient is a prisoner Patient is deaf Patient currently receives specialist palliative care Patient is not a resident of Tennessee

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Specialist Palliative Care<br>All patients will be assigned to receive the intervention, consisting of two outpatient palliative care visits at Vanderbilt University Medical Center (VUMC). | Behavioral: Palliative Care Consultation<br>* In person or telehealth clinic visit with palliative care physician or nurse practitioner<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of Intervention | Score on the Acceptability of Intervention Measure (AIM) which measures how acceptable participants find the intervention with 4 questions, each scored 1-5 with higher scores indicating greater acceptability. | 2 months | 
| Appropriateness of Intervention | Score on the Intervention Appropriateness Measure (IAM), which measures how appropriate the palliative care intervention seems to the study participants with 4 questions, each scored 1-5 with higher scores indicating higher appropriateness. | 2 months |
Levosimendan in Congenital Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Many pediatric patients undergoing cardiac surgery under cardiopulmonary bypass for repair of complex congenital malformations, require inotropic support for low cardiac output syndrome. Milrinone through its positive inotropic and vasodilatory effects is widely used for this purpose. The aim of the study is to compare Milrinone with Levosimendan, a novel inotope with calcium-sensitizing properties. We hypothesized that using Levosimendan would result in reduced serum lactate through a higher cardiac index.

Conditions
-----------------
Congenital Cardiovascular Defects, Low Cardiac Output Syndrome

Intervention / Treatment
-----------------
* Drug: Levosimendan
* Drug: Milrinone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients undergoing complex cardiac surgery under cardiopulmonary bypass and requiring inotropic support Exclusion Criteria: Patients with renal and/or hepatic dysfunction Patients requiring inotropic support before their surgery Septic patients

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 5 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: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levosimendan|Intravenous injection|
|Drug: Milrinone|Intravenous injection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum lactate |  | 12 h postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery with cardiopulmonary bypass
Active Management for Low Back Pain for 6 to 8 Year Old Schoolchildren

Study Overview
=================
Brief Summary
-----------------
The objective is to assess the effectiveness of a prevention campaign promoting active management in shifting beliefs in 6 to 8 year old schoolchildren. Subjects will be taken from a random sample of schools in Majorca, Spain: private, public and concerted. A 10 item questionnaire will be given to all children in that age group, to be answered in class on days 1, 14 and 97. Schools will be randomly assigned to the study and control groups. In the study group the students will get a Back Comic-Book (promotes active management) after the first assessment. The control group will have no other intervention than the questionnaire.

Official Title
-----------------
Active Management for Low Back Pain Taught to 6 to 8 Year Old Schoolchildren

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: Education (Back Comic-Book)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Students in randomly selected private, public and concerted Majorca schools Must be present in class on day of intervention and assessments Exclusion Criteria: Absent from class on day of intervention and assessments

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>The intervention group will receive prevention of low back pain education through a Back Comic-Book, and their beliefs/knowledge will be tested twice after intervention. | Behavioral: Education (Back Comic-Book)<br>* Through the Back Comic-Book the schoolchildren are taught prevention methods for low back pain.<br>|
| No Intervention: 2<br>The control group will receive no intervention, and their beliefs/knowledge on low back pain will be tested twice after the first assessment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the effectiveness of a prevention campaign promoting active management of low back pain in shifting beliefs in 6 to 8 year old schoolchildren. |  | 4 months | 
| Assessment of the effectiveness of a prevention campaign promoting active management on low back pain in 6 to 8 year old schoolchildren. |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, prevention, schoolchildren, education campaign
A Case of Sesamoid Displacement Causing the First Metacarpophalangeal Joint Locking

Study Overview
=================
Brief Summary
-----------------
Traumatic sesamoid displacement of the first metacarpophalangeal joint can affect thumb function.

Detailed Description
-----------------
Although occurrence is rare, the mechanism of the displacement is commonly complex and varied. Understanding the mechanism is critical for treatment of the disorder. We herein present a locked thumb MCPJ caused by sesamoid displacement.

Official Title
-----------------
Study of the Second Hospital of Qinhuangdao

Conditions
-----------------
Primary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Traumatic sesamoid displacement Exclusion Criteria: Pathologic sesamoid disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sesamoid displacement,, metacarpophalangeal joint,, radial condylar ridge of the metacarpal head.
An Observational Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This open-label, retrospective, observational study will evaluate the compliance to RoActemra/Actemra (tocilizumab) therapy in patients with moderate to severe rheumatoid arthritis. Six months data will be collected from patients records.

Official Title
-----------------
Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION Study)

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, over 18 years of age Moderate to severe rheumatoid arthritis RoActemra/Actemra treatment must have been initiated 6 months prior to signing the informed consent form Exclusion Criteria: Patients with rheumatic autoimmune disease other than rheumatoid arthritis Patients who are not willing to sign the informed consent form Patients who participate in interventional trials during the period of this observational 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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who remained under continued RoActemra/Actemra treatment |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reasons for withdrawal |  | 6 months | 
| Frequency of withdrawal |  | 6 months | 
| Frequency of dose modification |  | 6 months | 
| Reasons for dose modification |  | 6 months | 
| Safety: Incidence of adverse events |  | 6 months |
Immunity to Measles Virus in the Thai Population Age 18-30 Years and Predictive Factors

Study Overview
=================
Brief Summary
-----------------
Prevalence of participants who have protective immunity to measles virus is less than ninety percent. Predictor of adequate measles antibody levels include the following : History of measles infection History of complete measles primary immunization( 2 doses with at least 1 month interval after age of 9 months) History of measles exposure Predictor of inadequate measles antibody levels include the following : Born outside Thailand History of staying outside Thailand for long time in childhood Living in the rural area for a long period in childhood Fail to participate school system on time

Official Title
-----------------
Immunity to Measles Virus in the Thai Population Age 18-30 Years and Predictive Factors

Conditions
-----------------
Measles

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-30 years old Exclusion Criteria: Last measles vaccination less than 10 years of age Immunocompromised host including congenital immune defect, splenectomy or splenic dysfunction, history of suspect HIV exposure, taking immunosuppressant Receiving blood or blood product within 3 months Receiving others vaccinations or immunoglobulins or any medication that possibly decrease immune response

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adequate antimeales antibody levels<br>ELISA test OD > 0.1 | |
| Inadequate measles antibody levels<br>ELISA test OD < 0.1 | |

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
-----------------
measles, antibody, prevalence, predictors, Donor of National Blood Centre, The Thai Red Cross Society who age 18-30 years old, Measles antibody levels, Predictors of adequate measles antibody levels and inadequate measles antibody levels
Transoral Incisionless Fundoplication Database Repository (TIF)

Study Overview
=================
Brief Summary
-----------------
Collect data on individuals who have a transoral incisionless fundoplication (TIF) performed by physicians at Indiana University for the treatment of gastroesophageal reflux disease.

Detailed Description
-----------------
Collect patient information related to transoral incisionless fundoplication (TIF) done for gastroesophageal reflux disease. The database information with be used for research to assess trends improve patient care.

Official Title
-----------------
Transoral Incisionless Fundoplication Database Repository (TIF)

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Other: no intervention, database study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having a TIF procedure completed at Indiana University Health, University Hospital Exclusion Criteria: under 13 years of age

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention, database study|data collection from EMR for database|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD-Health Related Quality of Life Questionnaire (GERD_HRQL) | Change in score for questionnaire related to quality of life with GERD | baseline; 6,12,24 and 60 months | 
| RESQ-7 questionnaire | Change in score for questionnaire related to symptoms of GERD | baseline; 6,12,24 & 60 months |