linjc16/ctgov huggingface dataset:
Effects of Heating Transfusion on Brain Function

Study Overview
=================
Brief Summary
-----------------
To inversitage whether routine warming of blood is harmful to brain fuction of sugical patients receiving massive transfusion.

Detailed Description
-----------------
Hypothermia is an effective therapeutic intervention to reduce hypoxic ischemia brain injury in animal experiments and in clinics.In a recent study, it has been shown that perioperative warming was associated with a higher incidence of cognitive dysfunction in elderly patients.Therefore, we hypothesised that perioperative heating transfusion have a side effect on brain function of surgical patients.

Official Title
-----------------
Effects of Heating Transfusion on Brain Function of Surgical Patients

Conditions
-----------------
Blood Transfusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients scheduled for major surgery under general anesthesia and they probably need a blood transfusion during the procedure. Exclusion Criteria:•Patients with a history of stroke, central nervous system disease , metabolic disturbance, psychiatric illness, hearing impairment, drug abuse or unwilling to participate in assessment -

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain fuction during perioperative period | Brain function includes cerebral blood flow and cerebral oxygen saturation | Change from baseline at post-transfusion 15min, 30min, 1hour, 2hour, 3 hour, 6hour, 12hour, 24hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the cognitive performance and the score of postoperative quality recovery scales ( PQRS) |  | Chang from baseline at 15min,40min,1day,3day and 7day postoperative lay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heating transfusion
Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study

Study Overview
=================
Brief Summary
-----------------
(1) to compare the differences of neural activation of pathological worry between pre-treatment GAD patients and normal subjects; (2) to measure the differences of brain activation on worry in GAD patients before and after duloxetine treatment

Detailed Description
-----------------
The study will recruit 20 GAD patients and 20 healthy controls. Both patients and controls receive a medical and psychiatric screening procedure at visit 1 and are asked to complete three self-rating questionnaires and one health questionnaire at visit 1. All qualified participants will receive functional magnetic resonance imaging (fMRI) at baseline. The patients will begin treatment with duloxetine 30 mg/day at visit 2 and will be titrated to 60 mg/day at visit 3 (2 week since drug dispensed). The dosage will be maintained on 60 mg/day for 6 more weeks. During the period, the patients will receive periodic evaluations at visit 2 (0 week drug dispensed), 3 (2 week since drug dispensed), 4 (4 weeks since drug dispensed), and 5 (8 weeks since drug dispensed). The patients will receive fMRI examination at baseline and at the end of the 8-week treatment.

Official Title
-----------------
Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study

Conditions
-----------------
Worry, Anxiety

Intervention / Treatment
-----------------
* Drug: duloxetine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV criteria of generalized anxiety disorders with moderate degree Participants above 18 years old Exclusion Criteria: Major depression Panic disorder Obsessive-compulsive disorder Post-traumatic disorder Eating disorders Psychotic disorders; and Alcohol or other substance use disorders Neurological disease Cardio-vascular disease Respiratory disease Head trauma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: duloxetine hydrochloride|duloxetine 30 mg QD, may titrate to 30 mg BID, and maintain the dosage for 6 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference of brain activation on worry |  | two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Generalized anxiety disorder, fMRI, Worry
Retinal Thickness and Volume Estimates Given by Time Domain and Spectral Optical Coherence Tomography

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to determine if the retinal thickness estimates of the Stratus OCT, the 3D OCT-1000, and the CirrusHD OCT are comparable in diabetic and in healthy individuals (OCT=Optical Coherence Tomography).

Official Title
-----------------
Retinal Thickness and Volume Estimates Given by Time Domain and Spectral Optical Coherence Tomography

Conditions
-----------------
Healthy, Diabetic Maculopathy

Intervention / Treatment
-----------------
* Device: Optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic retinopathy in the diabetic group healthy retinas in the healthy group Exclusion Criteria: not able to cooperate retinal disease other than macular oedema severe media opacities (e.g. cataract) prior macular laser photocoagulation except for large oedemas

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Optical coherence tomography|Stratus OCT: fast radial lines 3D OCT-1000: radial 2048 and 3D OCT Cirrus HD OCT: 3D OCT|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal thickness and retinal volume from each OCT scan |  | within 24 hours |
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on pioglitazone or rosiglitazone alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

Official Title
-----------------
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: vildagliptin
* Drug: pioglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only patients successfully completing study CLAF237A2304 are eligible Written informed consent Ability to comply with all study requirements Exclusion Criteria: Premature discontinuation from study CLAF237A2304 Other protocol-defined exclusion criteria may apply

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vildagliptin 50 mg qd + pioglitazone 45 mg qd<br>vildagliptin 50 mg qd + pioglitazone 45 mg qd for 28 weeks | Drug: vildagliptin<br> <br> Drug: pioglitazone<br>* pioglitazone 45 mg qd<br>|
| Experimental: vildagliptin 50 mg bd+ pioglitazone 45 mg qd<br>vildagliptin 50 mg bd + pioglitazone 45 mg qd for 28 weeks | Drug: vildagliptin<br> <br> Drug: pioglitazone<br>* pioglitazone 45 mg qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of vildagliptin in combination with pioglitazone during 52 weeks of treatment |  |  | 
| Change from baseline in HbA1c at 52 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c between 24 weeks and 52 weeks |  |  | 
| Change from baseline in fasting plasma glucose at 52 weeks |  |  | 
| Change in fasting plasma glucose between 24 weeks and 52 weeks |  |  | 
| Change from baseline in HOMA B at 52 weeks |  |  | 
| Change from baseline in HOMA IR at 52 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin
Evaluation of the Condition of Rheumatoid Arthritis After Treatment

Study Overview
=================
Brief Summary
-----------------
To examine the safety and effectiveness after Xeljanz treatment in rheumatoid arthritis patients

Official Title
-----------------
Evaluation of the Condition After Xeljanz Treatment in Rheumatoid Arthritis Patients

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

Intervention / Treatment
-----------------
* Drug: The effectiveness of Xeljanz in rheumatoid arthritis patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid arthritis Exclusion Criteria: Other connective tissue disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The condition of rheumatoid arthritis<br> | Drug: The effectiveness of Xeljanz in rheumatoid arthritis patients<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of clinical evaluation in rheumatoid arthritis | DAS28, SDAI, Blood testing, Plain radiograph, and Ultrasound will be performed. | Every month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Every month |
Gut Microbiota and Stool Frequency

Study Overview
=================
Brief Summary
-----------------
We hypothesized that some difference in the composition and distribution of gut microbiota in people with a large number of defecation (two or three times a day or more), people with normal defecation (one time a day or two days), and people with a small number of defecation (two times a week or less). And we investigate the association between gut microbiota and stool frequency.

Detailed Description
-----------------
We divided three groups. (total number = 60 subjects) a large number of defecation group (≥ 2-3 times/day) - 20 subjects normal defecation group (1 time/day or 1 time/2 days) - 20 subjects a small number of defecation group (≤ 2 times/week) - 20 subjects After collection of stools, we will analyze the composition and distribution of gut microbiota, and compared the results of three groups.

Official Title
-----------------
The Association Between Gut Microbiota and Stool Frequency

Conditions
-----------------
Gut Microbiota

Intervention / Treatment
-----------------
* Other: Stool frequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults between the age of 20 and 50 Exclusion Criteria: subjects with cancer or IBD (inflammatory bowel disease) subjects with history of abdominal surgery subjects who take medication related to gastrointestinal motility within 3 months subjects who take antibiotics within 3 months

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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 |
| --- | --- |
| group 1<br>a large number of defecation group (≥ 2-3 times/day) - 20 subjects | Other: Stool frequency<br>* This study is just observational study.<br>|
| group 2<br>normal defecation group (1 time/day or 1 time/2 days) - 20 subjects | Other: Stool frequency<br>* This study is just observational study.<br>|
| group 3<br>a small number of defecation group (≤ 2 times/week) - 20 subjects | Other: Stool frequency<br>* This study is just observational study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stool frequency and gut microbiota | Analysis of correlation between stool frequency and gut microbiota | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stool consistency and gut microbiota | Analysis of correlation between stool consistency and gut microbiota | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gut microbiota, stool frequency
Gene-Environment Interactions in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
This study will create Alzheimer 's disease risk profiles for defined combinations of genotypes and environmental exposures. This study will carry out a molecular epidemiologic study to identify genetic and environmental risks factors using state of the art techniques. The following will be done during the course of this study 1) Recruit both Alzheimer's patients and cognitively normal aged veterans. 2) Evaluate gene interaction in Alzheimer's disease. 3) Evaluate gene-environment interactions on the risk of Alzheimer's disease. These procedures should initially address the question as to whether certain genes either independently or synergistically modify the risk of Alzheimer's disease. This study will also determine whether certain environmental factors (smoking, alcohol consumption etc.) can modify the risk of AD and whether this effect is dependent on certain genetic backgrounds. This study will provide information that will be useful in designing therapies, develop risk factor profiles to be further tested in future studies, designating patients for specific therapies based on genetic factors and providing data and genetic material for future studies. This study will also provide a cohort of older and well characterized cognitively normal veterans for prospective genetic epidemiological studies on aging.

Official Title
-----------------
Gene-Environment Interactions in Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
The GRECC located at this hospital represents the leading edge of clinical care focusing on the needs of the aging veteran. We will recruit all 100 patients currently hospitalized at the Dementia Unit. We will also recruit from the outpatient memory clinic. We will enroll 400 AD patients total. Since, cases and controls will be ascertained from the same population, we also expect the socioeconomic status of individuals in these two groups to be the same. In the past year 9600 patients were treated on an outpatient basis. They were almost entirely white and male (>90%). The age demographics are 23% between 60-69, 23% between 70-79 and 5 % 80 or greater. The outpatients are seen for a wide variety of conditions. We plan to enroll 100 patients a year for 4 years (400 total). They will be seen once and have the same neuropsychological exams as the AD patients. Control subjects will be enrolled if their Mini-Mental score is greater than 24.
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
-----------------
Risk Factors, Genes, Epidemiology, Apolipoproteins E, Alzheimer's Disease
Seasonal Variation of Ambulatory Blood Pressure

Study Overview
=================
Brief Summary
-----------------
This is a prospective study to evaluate the change in 24 hour ambulatory blood pressure during winter and summer in well controlled treated hypertensives.

Detailed Description
-----------------
Two 24hour ambulatory blood pressure monitorings, 4 to 6 months apart, will be performed on hypertensive subjects on a stable antihypertensive drug therapy for at least 4 weeks. The correlation of weather and temperature with the 24hour ambulatory blood pressure monitoring will be explored.

Official Title
-----------------
Seasonal Variation of 24hour Ambulatory Blood Pressure Monitoring in Treated Hypertensives

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 40 yrs Treated hypertension on stable treatment for at least 8 weeks Average home blood pressure (at least 5 days, 20 readings) < 130/80 mmHg Exclusion Criteria: Congestive heart failure Use of loop diuretics

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Mean Difference of Systolic Daytime Ambulatory Blood Pressure Between Summer and Winter. | Mean difference of systolic daytime ambulatory blood pressure measurement during summer and winter period | 1 year | 
| Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Between Summer and Winter | Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Measurement During Summer and Winter Period | 1 year | 
| Mean Difference of Systolic Night-time Ambulatory Blood Pressure Between Summer and Winter | Mean difference of systolic night-time ambulatory blood pressure measurement during summer and winter period | 1 year | 
| Mean Difference of Diastolic Night-time Ambulatory Blood Pressure Between Summer and Winter |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Difference of Systolic Clinic Blood Pressure Between Summer and Winter |  | 1 year | 
| Mean Difference of Diastolic Clinic Blood Pressure Between Summer and Winter |  | 1 year | 
| Mean Difference of Systolic Home Blood Pressure Between Summer and Winter |  | 1 year | 
| Mean Difference of Diastolic Home Blood Pressure Between Summer and Winter |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TREATMENT OF HYPERTENSION
A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination Tablet With Coadministration of Cilnidipine and Valsartan

Study Overview
=================
Brief Summary
-----------------
A randomized, open-label, single dosing, two-way crossover clinical trial to compare the safety/tolerability and pharmacokinetics of the combination of Cilnidipine 10mg and Valsartan 160mg in comparison to each component coadministered in healthy male volunteers.

Official Title
-----------------
A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: cinidipine, valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20 and 40 Signed informed consent Exclusion Criteria: Has a history of hypersensitivity to IP ingredients Hypertension or hyportension

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cilnidipine/valsartan<br>cilnidipine/valsartan tablet | Drug: cinidipine, valsartan<br> <br> |
| Active Comparator: cilnidipine+valsartan<br>coadministration of cilnidipine and valsartan | Drug: cinidipine, valsartan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast |  | 0 24hrs | 
| Cmax |  | 0 24hrs |