linjc16/ctgov huggingface dataset:
Exercise and Acarbose in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the impact of exercise training, Acarbose, and the combination of exercise and Acarbose on glycemic control, body composition, insulin sensitivity and other cardiovascular risk markers in type 2 diabetes. Further, muscle biopsies will be obtain to study gene expression. Our hypothesis is that the combination therapy will be superior to monotherapy with exercise or Acarbose.

Official Title
-----------------
Effect of Exercise Training - Alone or in Combination With Acarbose - on Clinical and Metabolic Factors, and Studies of Cellular and Moleculargenetic Factors, in Type 2 Diabetes.

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

Intervention / Treatment
-----------------
* Drug: Acarbose
* Behavioral: Exercise
* Other: Exercise + Acarbose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, diagnosis of type 2 diabetes established since at least three months, treatment with diet or maximum one oral anti-diabetic drug, GHb < 8.5 %, age 45 - 60 years, BMI 25 - 30 kg/m2, no participation in any regular exercise program. - Exclusion Criteria: Unable to perform exercise, significant GI-disease, severe heart-disease, renal failure -

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 Years

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

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 |
| --- | --- |
| Active Comparator: Acarbose<br> | Drug: Acarbose<br>* 100mg, 3 times daily<br>|
| Active Comparator: Exercise<br> | Behavioral: Exercise<br>* Moderate combined exercise, 50 minutes 3 times per week<br>|
| Experimental: Exercise + Acarbose<br> | Other: Exercise + Acarbose<br>* See respective monotherapy description<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | Glycated A1c | 12 weeks |
Short Segment vs Long Segment Fixation in Traumatic Dorsolumbar Spine Fractures

Study Overview
=================
Brief Summary
-----------------
A prospective study included 91 patients, who had single level thoracolumbar fracture with Cobb's angle ≤ 25⁰, underwent posterior fixation. Forty four patients underwent short segment fixation with screws into the index level, and 47 patients underwent long segment fixation with skipped index level. The angle of correction, pain, and neurological state were regularly assessed

Official Title
-----------------
Short Segment Posterior Fixation With Index Level Screws Versus Long Segment Posterior Fixation for Thoracolumbar Spine Fracture: Angle of Correction and Pain

Conditions
-----------------
SPINAL Fracture

Intervention / Treatment
-----------------
* Procedure: short segment posterior spine fixation
* Procedure: long segment posterior spine fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: wedge fracture or burst fracture with Thoraco-Lumbar Injury Classification and Severity (TLICS) score ≥ 4 Single level fracture Less than 50% of spinal canal compromised Mild kyphosis or scoliosis Cobb's angle ≤ 25˚ with or without neurological deficit Exclusion Criteria: patients with multiple level fractures patients with more than 50% spinal canal compromise patients who needed anterior approach to decompress the canal patients who have fracture dislocation and / or marked kyphosis and scoliosis with Cobb's angle >25⁰ patients who needed 360⁰ fixation with long segment fixation to maintain the angle of correction.
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 |
| --- | --- |
| Active Comparator: Short Segment posterior spine fixation<br>Short segment transpedicular screw fixation with inclusion of the index level | Procedure: short segment posterior spine fixation<br> <br> |
| Active Comparator: Long Segment posterior spine fixation<br>Long segment transpedicular screw fixation with escape of the index level | Procedure: long segment posterior spine fixation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | Visual analogue scale assessment | 3rd, 6th, 9th, 12th months | 
| Change in disability | assessment of Oswestry Disability Scale | 3rd, 6th, 9th, 12th months | 
| Change in angle of correction | Measurement of Cobb's angle | 3rd, 6th, 9th, 12th months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thoracolumbar fracture, short segment fixation, long segment fixation, index level
Markers of Bone Turnover in Saliva and How This Compares to Urine and Blood

Study Overview
=================
Brief Summary
-----------------
Study is being done to determine if it is possible to use saliva to measure bone specific proteins and predict bone turnover which could be used in the treatment of osteoporosis.

Detailed Description
-----------------
Prevention and treatment of osteoporosis require sensitive and specific assays of bone turnover. Presently, serum or urinary assessments are used. However, the development of other procedures that are more patient-convenient, non-invasive and cost-efficient would significantly facilitate a clinician's ability to determine bone turnover. The objective of this application is to determine the feasibility of using saliva for this measurement. We will compare serum, urinary and salivary levels in 50 pre- and 50 post-menopausal women. Markers to be measured are bone alkaline phosphatase, osteocalcin, procollagen type propepties hydroxypyridinium crosslinks of collagen and crosslinked collagen telopeptides. Collection of saliva, serum and urine will be done at a single visit. We expect to observe reasonable good correlation between serum and saliva levels and poorer correlation between urine and saliva levels.

Official Title
-----------------
Salivary Markers of Bone Turnover Compared to Urine and Blood

Conditions
-----------------
Bone Turnover Markers, Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: 50 pre-menopausal females (25-40 yo) 50 post-menopausal females (55-70 yo) Good systemic health Good oral health Exclusion: arthritis active periodontitis history or actively smoking diabetes HIV positive anti-coagulant therapy bone fracture within the past year pregnancy known metabolic bone disease

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 Years

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

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 |
| --- | --- | --- |
Evaluation of Treatment Satisfaction in Children With an Allergy and Who Received an Antihistamine

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional retrospective data collection study from children aged from 2 to 12 years old diagnosed with an allergy and who received a treatment consisting of an H1-antihistamine. The period of last taken medication will be observed to evaluate the global satisfaction of the parents and physician for this last treatment.

Official Title
-----------------
Evaluation of the Treatment Satisfaction in Children Suffering From an Allergy and Who Received an Antihistamine Treatment

Conditions
-----------------
Allergies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children from 2-12 included History of allergy Used an Antihistamine within market authorization Exclusion Criteria: Child not yet treated for the presented allergy

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 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 |
| --- | --- | --- |
| Parent satisfaction on a 11-point scale |  | duration of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician satisfaction on an 11-point scale |  | duration of the study | 
| Efficacy, tolerability and global satisfaction |  | duration of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric, Allergies, Antihistamines, Non-interventional
Xeljanz Special Investigation for Long-term Use in UC Patients

Study Overview
=================
Brief Summary
-----------------
Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under Japanese medical practice

Detailed Description
-----------------
This investigation aims to examine the safety and effectiveness of Xeljanz in post-marketing clinical settings when it is administered chronically to patients with ulcerative colitis, based on the approval conditions.

Official Title
-----------------
XELJANZ(REGISTERED) TABLETS 5 MG SPECIAL INVESTIGATION(INVESTIGATION OF LONG-TERM USE IN PATIENTS WITH ULCERATIVE COLITIS)

Conditions
-----------------
Ulcerative Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ulcerative colitis treated with XELJANZ Patients naive to XELJANZ in the treatment of ulcerative colitis Exclusion Criteria: - None

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |
| The incident condition of major adverse drug reactions (adverse events for which the causal relationship with Xeljanz cannot be ruled out) | Primary outcome measure is the incident condition of major adverse drug reactions (adverse events for which the causal relationship with Xeljanz cannot be ruled out) in 60 weeks observation period. | 60 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Xeljanz, Ulcerative colitis, UC, Long-term
Rehabilitation of Conversion Gait Disorder

Study Overview
=================
Brief Summary
-----------------
Evaluating the effects in functional status after three weeks of cognitive - and behavioural rehabilitation on patients with gait disorder. The patients are followed up as after 1 and 12 months to study if any improvement is still present. The patients are being recruited from neurological units. The intervention is explanation of symptoms, positive reinforcement of normal behaviour and absence reinforcement of dysfunctional behaviour. In addition the study aims at describing typical gait patterns at patients with gait disorder by using biomechanical measurements (EKG).

Detailed Description
-----------------
Patients are being recruited from neurological unit/ div and out patients department of SSR and are randomized to treatment or control group. Essential gait disorders do to conversion symptoms and willingness to participate in either of the two groups with informed consent are required.

Official Title
-----------------
Patients With Conversion Gait Disorder - Effect on Treatment and Common Gait Patterns. Randomized Clinical Trial

Conditions
-----------------
Conversion Disorder

Intervention / Treatment
-----------------
* Other: Rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To determine the changes in functional status after three weeks of multidisciplinary rehabilitation in patients with conversion walking disorder. Exclusion Criteria: Essential gait disorders do to conversion symptoms and willingness to participate in either of the two groups with informed consent are required.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Rehabilitation|Three weeks of rehabilitation in Hospital.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gait patterns |  | three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved life quality |  | 12 months |
Lidocaine Infusion in Hystroscopy

Study Overview
=================
Brief Summary
-----------------
Lidocaine infusion in hystroscopic media versus oral diclofenac

Official Title
-----------------
Lidocaine Infusion Versus Oral Diclofenac During Outpatient Hystroscopy: A Randomized Clinical Trial

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Lidocaine Hydrochloride
* Drug: Diclofenac Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-35 years BMI 18.5-30 kg/m2 Diagnostic hystroscope Exclusion Criteria: Previous cervical surgery Cervical stenosis PID allergy to NSAID Gastritis or peptic ulcer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>Lidocaine Hydrochloride | Drug: Lidocaine Hydrochloride<br>* Lidocaine infusion on hystroscopic media during office hystroscopy<br>|
| Experimental: Diclofenac<br>Oral Diclofenac | Drug: Diclofenac Sodium<br>* Oral Diclofenac Sodium<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of pain measured by visual analogue scale | measured by visual analogue scale | 1 hour |
AST Clinical Investigation

Study Overview
=================
Brief Summary
-----------------
Blood glucose monitoring system are tested in the alternative site to validate the accuracy of the blood glucose.

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: blood glucose monitor
* Device: blood glucose monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: people ( disbetes people)with at least 8 hours of limosis Exclusion Criteria: After meal(when doing the test) take Hypoglycemic Drugs(when doing the test) with insulin(when doing the test) after strenuous exercise(when doing the test) Pregnant women neonates patients in a hyperglycemic-hyperosmolur state, with or without ketosis. patients who are dehydrated, hypertensive, hypotensive or in shock.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 78 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Andon<br>Andon blood glucose test strips with test meter | Device: blood glucose monitor<br>* Blood glucose monitor is used to monitor the blood glucose level of the human-being<br>* Other names: Andon blood glucose monitor;|
| Active Comparator: Lifescan<br> | Device: blood glucose monitor<br>* Blood glucose monitor is used to monitor the blood glucose level of the human-being.<br>* Other names: Lifescan blood glucose monitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose value |  | 5 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood glucose
Evaluation of the Effectiveness of the New Hospital Accreditation

Study Overview
=================
Brief Summary
-----------------
Since the first hospital accreditation was implemented in our country in 1978, we have become the fifth in the world, the first in Asia that applied the system of hospital accreditation. While discussing the development of the hospital accreditation history of Taiwan, different concerns have been raised over time. The main objective of this study is to scrutinize if there have been any quality improvement of healthcare that hospitals delivered since the renewal of hospital accreditation standards. Also, in order to provide suggestions to make the hospital accreditation a better one, this study firstly endeavors to locate the differences which were brought out by both the old and the new hospital accreditation. Second, this study will analyze and survey the impacts of accreditation on hospitals' performance and healthcare. After finishing the first two steps, this study will then state updated improvement suggestions. Documentary analysis and meta analysis will be the two major scientific research methods in this study. Data will be collected from various resources, such as government agencies, private research institution and hospitals around the nation. By collecting raw data broadly and deeply, the accountability, therefore, can be ensured. Throughout the efforts of identifying differences between the new and old accreditation standards, comparing hospitals' scores on performance index and finding evidence of performance improvement, we hope this study would provide the most comprehensive and solid suggestions to improve our hospital accreditation system.

Official Title
-----------------
Evaluation of the Effectiveness of the New Hospital Accreditation

Conditions
-----------------
Hospital Accreditation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above 20 years old Exclusion Criteria: none

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hospital accreditation, patient-centered, healthcare quality index, documentary analysis, meta analysis
Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter Recurrence

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the safety, tolerability and preliminary efficacy of vernakalant (oral) in subjects with sustained atrial fibrillation of greater than 72 hours and less than 6 months duration

Official Title
-----------------
A Pilot Phase II, Randomised, Double-Blind, Placebo-Controlled, Multi-Centred Safety, Tolerability and Preliminary Efficacy Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter (AF/AFL) Recurrence in Subjects Post-Conversion Form AF

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Vernakalant (oral)
* Drug: Placebo comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (partial list): Subjects must have sustained, symptomatic atrial fibrillation for greater than 72 hours and less than 6 months duration Subjects must have adequate anticoagulant therapy Exclusion Criteria (partial list): Subjects may not have Class III or Class IV congestive heart failure Subjects may not have uncorrected electrolyte imbalance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Tier 1: 1 placebo capsule b.i.d Tier 2: 2 placebo capsules b.i.d | Drug: Placebo comparator<br> <br> |
| Experimental: 2<br>Tier 1: Vernakalant (oral) 1 x 300 mg capsule b.i.d | Drug: Vernakalant (oral)<br> <br> * Other names: RSD1235-SR;|
| Experimental: 3<br>Tier 2: Vernakalant (oral) 2 x 300 mg (600 mg) b.i.d | Drug: Vernakalant (oral)<br> <br> * Other names: RSD1235-SR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All subjects who were exposed to the investigational medication were evaluated for safety. |  | Subjects were assessed for safety within Day 58 of dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of AF/AFL or withdrawal |  | Time for recurrence of AF/AFL or withdrawal within Day 28 of dosing | 
| Improvement in AF symptoms |  | Time to improvement in AF symptoms within Day 28 of dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AFib, AF