linjc16/ctgov huggingface dataset:
Long-term of 10 Years Results of a Prospective Longitudinal Study

Study Overview
=================
Brief Summary
-----------------
Previous cross-sectional studies have demonstrated that blood pressure (BP) measurements at home (HBP) in the morning offer stronger predictive power for micro- and macrovascular complications in patients with type 1 and 2 diabetes than casual/clinic blood pressure measurements (CBP) (Kamoi K et al, 2002-2003). Further, a prospective, longitudinal study for 6 years in patients with type 2 diabetes also demonstrated that control of wakening-up HBP provides the stronger predictive power for the outcomes than that of CBP did (Kamoi et al, 2010). However, it is not clear to show which of BP measurement provides the stronger predictive power for outcomes by comparing cumulative events over a longer time than 6 years. Therefore, the investigators examined which of HBP or CBP provides the stronger predictive power for outcomes in addition of renal anemia reported previously over 10 years in the patients with type 2 diabetes.

Official Title
-----------------
Usefulness of Home Blood Pressure Measurement in the Morning in Type 2 Diabetic Patients : Long-term (10 Years) Results of a Prospective Longitudinal Study

Conditions
-----------------
Type 2 Diabetes Mellitus, Blood Pressure

Intervention / Treatment
-----------------
* Procedure: Blood pressure measurement based on HBP or CBP
* Procedure: Blood pressure measurement based on HBP or CBP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: After a detailed baseline examination, 400 Japanese subjects with type 2 diabetes reported previously are followed up for all-cause mortality and morbidity. Exclusion Criteria: Other than the above, patients judged inappropriate as the subjects of this study by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 95 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 |
| --- | --- |
| 1. Morning HP and NT<br>Subjects based on HBP were divided into MH and MN patients | Procedure: Blood pressure measurement based on HBP or CBP<br>* To clarify which of HBP or CBP provides the stronger prediction power for the outcomes.<br>|
| 2. Clinic HP and NT<br>Subjects based on CBP were divided into CH and CN patients | Procedure: Blood pressure measurement based on HBP or CBP<br>* To clarify which of HBP or CBP provides the stronger predictive power for the outcomes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Number of participats not alive | Average time is 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvascular complications including renal anemia |  | Average time is 10 years | 
| Macrovascular complications |  | Average time is 10 years |
Mirena Efficiency and Tolerability During the First Year of Use

Study Overview
=================
Brief Summary
-----------------
In this trial the efficacy and safety of Mirena was investigated during the first year of use

Official Title
-----------------
A Multicentre, Open Label, Uncontrolled Study of the Tolerance, Acceptability and Contraceptive Efficacy of Mirena 52 mg®, an Intra-uterine Levonorgestrel Device, During the First Year After Insertion Post-partum

Conditions
-----------------
Medicated Intrauterine Devices, Contraception

Intervention / Treatment
-----------------
* Drug: Mirena (BAY86-5028)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 25 to 39 years who sought effective contraception during the post-partum period (i.e. insertion of the device between 6 and 12 weeks after parturition). Exclusion Criteria: Standard exclusion criteria for use of intrauterine hormone devices

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 39 Years

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

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

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: Arm 1<br> | Drug: Mirena (BAY86-5028)<br>* Intrauterine levonorgestrel containing device (market product)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena |  | within 12 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General safety assessment |  | within 12 months after randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mirena, Levonorgestrel, Intrauterine device, Efficacy, Tolerability, First year of use
Does Undercorrection of Myopia Retard Myopia Progression Among Kindergarten Children?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if undercorrection of myopia slow down the progression of myopia in kindergarten children.

Official Title
-----------------
Does Undercorrection of Myopia Retard Myopia Progression Among Kindergarten

Conditions
-----------------
Refractive Error - Myopia

Intervention / Treatment
-----------------
* Drug: cyclopentolate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children of chinese descent aged 5 - 6yrs Refractive error of -1.00 to -3.00Ds Less than 1.50 astigmatism in each eye. (No oblique axis) Visual acuity is 6/6 or better in both eyes. No binocular problems, no anisometropia >1.50D Will be staying in S'pore for at least 2 years. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 6 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: Factorial Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Test of Different Degrees of Cost Sharing on Program Uptake and Attendance

Study Overview
=================
Brief Summary
-----------------
To test the uptake of four different cost sharing discounts for enrolling in the Weight Watchers weight loss program as well as outcomes (program attendance and weight loss) over 12 months.

Official Title
-----------------
A Test of Different Degrees of Cost Sharing on Program Uptake and Attendance

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

Intervention / Treatment
-----------------
* Behavioral: Different levels of cost sharing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be employee of Vanguard Health Systems over the age of 18 Must have a BMI of 21 or greater Exclusion Criteria: Must not be under the age of 18 Must not have a BMI lower than 21

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Participant has 50% subsidy, i.e. gets a 50% discount off regular price of the program | Behavioral: Different levels of cost sharing<br> <br> |
| Experimental: B<br>Participant has 100% subsidy, i.e. program attendance is free | Behavioral: Different levels of cost sharing<br> <br> |
| Experimental: C<br>Participant has 80% subsidy; i.e. gets 80% discount off regular price of the program | Behavioral: Different levels of cost sharing<br> <br> |
| Experimental: D<br>Participant has 50% subsidy up front (i.e. pays 50%), with possibility for 100% subsidy based on attaining monthly participation goals | Behavioral: Different levels of cost sharing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake | the percent of patients who sign up for the program, by arm | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Program attendance and weight loss among participants who sign up for the program | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight loss program, incentives, Obesity
Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)

Study Overview
=================
Brief Summary
-----------------
A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

Official Title
-----------------
Phase II Study on Sitagliptin -Assessment of Glucose-lowering Effects

Conditions
-----------------
Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
-----------------
* Drug: sitagliptin phosphate
* Drug: Comparator: Placebo
* Drug: Comparator: Sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Have Type 2 Diabetes Mellitus On Diet/Exercise Therapy Exclusion Criteria: Patients Have Type 1 Diabetes Mellitus

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 69 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 |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Comparator: Placebo<br>* Placebo tablet, QD, taken orally for 4 weeks<br>|
| Experimental: 2<br>Sitagliptin 100 mg | Drug: sitagliptin phosphate<br>* 100 mg once daily (QD), taken orally for 4 weeks<br>* Other names: MK0431;|
| Experimental: 3<br>Sitagliptin 50 mg | Drug: Comparator: Sitagliptin<br>* 50 mg twice daily (BID), taken orally for 4 weeks<br>* Other names: MK0431;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 24-hour Weighted Mean Plasma Glucose | Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0. | Baseline and Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Plasma Glucose | Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0. | Baseline and Week 4 |
Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)

Study Overview
=================
Brief Summary
-----------------
Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder.

Conditions
-----------------
Refractory Overactive Bladder

Intervention / Treatment
-----------------
* Device: PINS SNS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 16 years OAB and/or OAB symptoms Refractory to standard medical therapy 100ml bladder capacity with normal upper urinary tract Good surgical candidate Able to complete study documentation and return for followup evaluation Exclusion Criteria: Neurological conditions Stress urinary incontinence OAB symptoms caused by urinary tract infections

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sacral Neuromodulation is on<br>Sacral Neuromodulation is on as soon as implantation | Device: PINS SNS<br> <br> |
| Placebo Comparator: Sacral Neuromodulation is off<br>Sacral Neuromodulation is off after implantation | Device: PINS SNS<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month |  | 6 month of stimulation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PINS SNS OAB
Study to Evaluate Safety and Immunologic Biomarker of Rapamune in Patients With Stable Renal Transplant Recipient

Study Overview
=================
Brief Summary
-----------------
For patients who meet the inclusion criteria and who agree to participate in this study, the investigators sampled peripheral blood 10cc and performed the analysis for immunologic profile just before the conversion of immune suppressant. At 1 month, 6 month, and 1 year from the conversion of Immune suppressant (CNI to rapamune), the investigators performed tha analysis fo immune profile again. During the study period, the interval of the visit of subclinic and the kinds of laboratory test (Blood and urine test) would not change compared to before the start of this study.

Official Title
-----------------
Investigation of the Safety and Immunologic Biomarker After Conversion From Calcineurin Inhibitor to Rapamune in Stable Renal Transplant Recipient

Conditions
-----------------
Acute Rejection of Renal Transplant

Intervention / Treatment
-----------------
* Drug: Sirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal transplant recipient who has passed at least 10 years No acute rejection episode during the previous 6 months No change of prescription of immune suppressants Normal allograft function (MDRD eGFR > 80 mL/min/1.73 m2) Change of allograft function less than 10 % of baseline value durant the previous 1 year No proteinuria and hematuria Exclusion Criteria: Patients who donut want to participate in this study Patients who should continue immune suppressant due to another cause (e/g combined autoimmune disease)
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sirolimus|Beginning on day, an initial maintenance dose of 2mg/day should be given. A trough level should be obtained between days 3 and 8, and the daily dose of sirolimus should be adjusted thereafter.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biopsy proven acute rejection | Number of episode of biopsy proven acute rejection | Study duration is 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Creatinine, MDRD eGFR | Mean diurnal Serum Creatinine, MDRD eGFR change of greater than or equal to 20% at month 12 vs baseline | Study duration is 12 months |
Surgiscreen Registration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the consistency of the results of irregular antibody screening with Surgiscreen （investigational reagent) and Serascan Diana 3 (control reagent), and the consistency of the results of irregular antibody screening with investigational reagent on serum and plasma from same patients.

Official Title
-----------------
A Multi-center Clinical Study for Assessment of the Consistency of the Results of Human Irregular Antibody Screening With Surgiscreen and Serascan Diana 3

Conditions
-----------------
Irregular Antibody Screening

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum or plasma samples left after routine clinical testing; Blood sample of the same day, or blood samples stored at 2-8°C for 3 days after collection, or serum or plasma samples stored at -20°C for those separated 3 days after collection. Exclusion Criteria: Samples with severe hemolysis, jaundice or chyle-like samples; Small sample size insufficient for completing the testing; Samples not collected and processed upon the requirements of the instructions.
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 |
| --- | --- | --- |
| The consistency of the results of irregular antibody screening of investigational reagent and control reagent. | The positive coincidence rate, the negative coincidence rate and the overall coincidence rate, as well as their respective 95% confidence interval of the irregular antibody screening results of two reagents. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The consistency of the results of irregular antibody screening with investigational reagent on different types of samples (serum and plasma). | The positive coincidence rate, the negative coincidence rate and the overall coincidence rate, as well as their respective 95% confidence interval of the irregular antibody screening results of investigational reagent on serum and plasma from same patient. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irregular antibody screening
Cerebral Oximetry and Anesthetic Technique

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the effects of spinal and general anesthesia on transcranial regional cerebral oxygen saturation in geriatric patients undergoing total hip arthroplasty.

Detailed Description
-----------------
Geriatric patients who received anesthesia undergoing total hip arthroplasty were randomized by means of a computer-generated randomization order into two groups; general anesthesia group (Group 1) and spinal anesthesia group (Group 2). Before and after induction of the general or spinal anesthesia, patients were monitorized with near infrared spectroscopy for regional cerebral oxygen saturation. Findings were compared statistically.

Official Title
-----------------
Evaluation of the Effects of Spinal Versus General Anesthesia on Transcranial Cerebral Oxygen Saturation in Geriatric Patients Undergoing Total Hip Arthroplasty

Conditions
-----------------
Disorder of Hip Joint

Intervention / Treatment
-----------------
* Other: general anesthesia
* Other: spinal anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who undergo elective total hip arthroplasty American Society of Anesthesiologists class 1 to 3 Ability to consent Exclusion Criteria: Pulmonary disease History of allergic reaction to local anaesthetics Peripheral neuropathy Neurologic disease Coagulation disorders

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: general anesthesia<br>Patients in this group were randomized to receive general anesthesia. | Other: general anesthesia<br>* effect of general anesthesia on transcranial regional cerebral oxygen saturation<br>|
| Active Comparator: spinal anesthesia<br>Patients in this group were randomized to receive spinal anesthesia. | Other: spinal anesthesia<br>* effect of spinal anesthesia on transcranial regional cerebral oxygen saturation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in transcranial regional cerebral oxygenation (rSO2) | Assessed every 5 minutes during the procedure | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post anesthetic complications | During stay at the post anesthetic care unit. Any new neurological symptoms etc | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total hip arthroplasty, cerebral oxygen saturation, general anesthesia, spinal anesthesia