linjc16/ctgov huggingface dataset:
Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar manic symptoms, when given once daily in the evening vs. twice daily.

Official Title
-----------------
A Phase IIIb, Randomized, Double-Blind, Parallel Group Study in Bipolar I Patients to Assess the Efficacy and Safety of SPD417 Administered Once Daily vs Twice Daily in the Treatment of Manic Symptoms

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Extended-release carbamazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV criteria for bipolar I disorder Screen YMRS score => 16 Women of childbearing potential agree to take adequate precautions against contraception Exclusion Criteria: Hospitalization required for treatment of psychiatric symptoms Patients who meet DSM-IV for ultra-rapid cycling History of serious suicide attempt requiring medical intervention

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Extended-release carbamazepine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Young Mania Rating Scale (YMRS) at 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to remission |  |  | 
| Clinical Global Impressions Scale - Bipolar Version |  |  | 
| HAM-D and MADRS scales for depression |  |  |
Cost of Long Term Disability in Patients With Chronic Non-Specific Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to determine the cost-effectiveness of a function-centred treatment (FCT) compared with a pain-centred treatment (PCT) in patients with chronic low back pain (LBP) in an in-patient setting. Follow-up lasted three years. Direct and indirect costs were recorded by questionnaires sent to health insurances, employers and Swiss Disability Insurance Company.

Official Title
-----------------
Cost of Long Term Disability in Patients With Chronic Non-Specific Low Back Pain. Three-Year Follow up of a Randomized Trial

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

Intervention / Treatment
-----------------
* Other: Physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic low back pain, sick leave of 6 weeks during the last 6 months Exclusion Criteria: not able to perform a training program

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 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 |
| --- | --- |
| FCT<br>Patients passing a function- centred rehabilitation | Other: Physiotherapy<br>* The two groups passed an in-patient rehabilitation and a physiotherapy: FCT function-centred vs. PCT pain-centred<br>|
| PCT<br>Patients passing a pain-centred rehabilitation | Other: Physiotherapy<br>* The two groups passed an in-patient rehabilitation and a physiotherapy: FCT function-centred vs. PCT pain-centred<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost- effectiveness |  | 3 year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low back pain, Economics, Cost-effectiveness
Microcirculation in Continuous Venovenous Hemofiltration Patients on the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
In patients where fluid is withdrawn from the bloodstream by Continuous Venovenous Hemofiltration (CVVH), the ultrafiltration rate will be calculated for a zero balance. From there, the ultrafiltration steps are performed, after increasing the ultrafiltration rate, the sublingual microcirculation is assessed by sidestream dark field (SDF). The images are subsequently randomly analyzed, and the sublingual microcirculation is expressed as a number, the microvascular flow index (MFI).

Detailed Description
-----------------
Before deciding to threat a patient actively with CVVH, a target balance will be agreed for the next 12 hours. Then the ultrafiltration rate for the zero balance is calculated. From there, the ultrafiltration rate progressively increased to 50 ml per hour, up to a maximum ultrafiltration rate of 300 ml per hour. After each increase of the ultrafiltration rate, the sublingual microcirculation is assessed by SDF. After obtaining the desired ultrafiltration rate, the microcirculation will again be assessed before and after the patient is temporarily placed in Trendelenburg position. This could possibly show that underfill has the greatest influence on the microcirculation, and not other factors like a rising hematocrit.

Official Title
-----------------
Evaluation of Sublingual Microcirculation by Means of SDF Imaging by Stepwise Ultrafiltration in CVVH Patients on the ICU

Conditions
-----------------
Continuous Venovenous Hemofiltration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 jaar informed consent Exclusion Criteria: age < 18 jaar oral surgery

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 |
| --- | --- |
| CVVH patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in MFI between zero balance and maximal ultrafiltrationrate (300 ml/hr) |  | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microcirculation, intensive care, ultrafiltration, CVVH
In Vivo Evaluation of Image Registration Techniques During Endovascular Repair

Study Overview
=================
Brief Summary
-----------------
Fluoroscopy is traditionally used for guidance of endovascular aortic repair (EVAR). In order to minimize exposure to radiation and nephrotoxic contrast medium, it is possible to generate a navigation road map by registering the intraoperative images with preoperative computed tomography angiograph (CTA). In modern hybrid operating rooms, several commercial solutions for this exists today (e.g. Siemens Syngo iPilot, Phillips Vesselnavigator). In order to register (fuse) the preoperative and intraoperative imaging to each other, a registration algorithm has to be applied. Sufficient accuracy of this algorithm is crucial, for if it fails the road map cannot be used for intraoperative navigation. The purpose of this study is therefore to evaluate two different 3D registration algorithms with regard to registration accuracy.

Detailed Description
-----------------
Two different registration algorithms will be tested: registration algorithm - centerline registration algorithm (Sintef, Trondheim) A catheter equipped with a position sensor records the travelled path of the instrument, which is assumed to be close to the centerline of the aorta. From the preoperative computer tomography scan (CT) the aorta is segmented and vessel centerline is extracted. The centerline from the position sensor recordings is registered to the extracted centerline of the preoperative CT. 3D-3D registration algorithm (Syngo iPilot, Siemens Medical Solutions, Munich). Intraoperative cone-beam-CT (CBCT) is registered to the preoperative CT

Official Title
-----------------
In Vivo Evaluation of Image Registration Techniques During Endovascular Repair

Conditions
-----------------
Aortic Aneurysm, Abdominal

Intervention / Treatment
-----------------
* Procedure: Endovascular aortic repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infrarenal or juxtarenal abdominal aortic aneurysm undergoing EVAR informed consent Exclusion Criteria: under 18 years

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 |
| --- | --- |
| Image registration<br> | Procedure: Endovascular aortic repair<br>* Endovascular aortic repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Registration accuracy of registration algorithms | Measure the 3D spread between defined points (registration plate, bony landmarks at vertebrae, vessels if visable) | Immediately | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aorta, Abdominal/surgery, Endovascular Procedures
Intraoperative Dexamethasone in Pediatric Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Perioperative administration of steroids has been demonstrated to reduce systemic inflammatory response in infants undergoing cardiac surgery with cardiopulmonary bypass. However, data on effects of steroids on clinical outcomes are lacking. Hence the hypothesis of the present study: intraoperative administration of dexamethasone reduces complication rates and improves clinical outcomes in infants undergoing repair of congenital heart defects under cardiopulmonary bypass.

Official Title
-----------------
Intraoperative Dexamethasone in Pediatric Cardiac Surgery: a Prospective Double-blind Randomised Clinical Trial

Conditions
-----------------
Cardiac Surgery, Congenital Heart Defects, Cardiopulmonary Bypass

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective repair of congenital heart defects under cardiopulmonary bypass Exclusion Criteria: absence of written informed consent signed by parent or guardian; hypoplastic left heart syndrome; participation in conflicting randomised studies; emergency surgery; inotropic support prior to surgery; mechanical ventilation prior to surgery; bacterial, viral or fungal infection in the preceding 30 days; gestational age less that 37 weeks; perinatal central nervous system damage.

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Dexamethasone 1 mg per 1 kg of body weight intravenously immediately after induction of anesthesia | Drug: Dexamethasone<br> <br> |
| Placebo Comparator: Control<br>0.9% Sodium Chloride 0.25 ml per 1 kg of body weight intravenously immediately after induction of anesthesia | Drug: Placebo<br>* 0.9% Sodium Chloride<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major complications | Composite of all-cause death, myocardial infarction, need for extracorporeal membrane oxygenation implantation, cardiac arrest, acute renal failure (stage injury or higher according to pRIFLE scale), prolonged mechanical ventilation (> 24 hours), stroke, seizure, coma. | 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric cardiac surgery, Dexamethasone, Steroids, Cardiopulmonary bypass, Congenital heart defects, Infants
Clinical Evaluation, Biomarkers and Metabolomics of Sarcopenia in Frail Older Adults at Ambulatory Clinics

Study Overview
=================
Brief Summary
-----------------
Sarcopenia related mobility dysfunction was a preventable presentation in transitional variation of frailty. However, the definition, associated risk factors, clinical course and outcome of sarcopenia in Taiwanese older adults are still under-clarified and need for further study.

Official Title
-----------------
Clinical Evaluation, Biomarkers and Metabolomics of Sarcopenia in Frail Older Adults at Ambulatory Clinics

Conditions
-----------------
Frailty, Sarcopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: functional decline in recent one year cognitive impairment depressive symptom mobility impairment fall in recent one year eating or feeding problems weight loss co-morbid conditions≧5 tracking by different physician ≧3 in recent half year poly-pharmacy≧8 in recent 3 months hospitalization ≧1 in recent one year emergency visits≧2 in recent one year aged ≧ 80. Exclusion Criteria: non-ambulatory (bed-ridden) patients long-term residents at nursing homes patients with a life expectancy shorter than six months impairment in vision, hearing, or communicative ability, making convenience of clinical evaluation during the study period impossible.

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| health subjects; outpatients aged over 65<br>The research subjects will be culled from outpatients aged over 65 at NTUH; 1000 Taiwanese subjects aged 20-40 equally divided in both genders will be recruited in order to establish the norm of Taiwanese's skeletal muscle index. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Domestic operation tool of sarcopenia for older adults | Young health adults are recruited for measurement of body composition using bio impedance analysis in order to establish the norm of skeletal muscle index | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in body composition during aging | Using anthropometric measurements, and bio impedance analysis, the change in body composition are measured in the recruited older adults | up to 2 years |
Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and efficacy of manual super small incision cataract surgery (MSSICS) and Phacoemulsification.

Official Title
-----------------
Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification

Conditions
-----------------
Cataract, Phacoemulsification

Intervention / Treatment
-----------------
* Procedure: MSSICS
* Procedure: Phacoemulsification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age related cataract patients Cataract density grade II-III according to the Emery-Little system classification system Exclusion Criteria: Legal guardian(s) is/are not present for permission Other eye diseases impairing visual acuity (ie. glaucoma) patients with severe systemic diseases not good for ocular surgery

Ages Eligible for Study
-----------------
Minimum Age: 50 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phacoemulsification, Safety, Efficacy<br> | Procedure: Phacoemulsification<br>* cataract surgery with Phacoemulsification<br>|
| Experimental: MSSICS, Safety, Efficacy<br> | Procedure: MSSICS<br>* Manual super small incision cataract surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal endothelial cell loss |  | 3 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative astigmatism |  | 3 months postoperatively | 
| visual acuity |  | 3 month postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Age related cataract, Phacoemulsification, Manual super small incision cataract surgery
Study for the Recording of Adherence to Treatment With Perindopril/Indapamide/Amlodipine Fixed Dose Combination

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to record, in routine clinical practice, patients' adherence to treatment with Perindopril/Indapamide/Amlodipine fixed dose combination, during 4 months treatment.

Detailed Description
-----------------
This is a non-interventional study aiming to record adherence to treatment with Perindopril/Indapamide/Amlodipine fixed dose combination. In parallel blood pressure levels will be recorded, as well as safety and tolerability of this fixed dose combination.

Official Title
-----------------
Prospective, Non-interventional Study for the Recording of Adherence to Treatment With Perindopril/Indapamide/Amlodipine Fixed Dose Combination, in a Greek Population With Hypertension

Conditions
-----------------
Adherence to Medication Regime, Hypertensive Disease

Intervention / Treatment
-----------------
* Drug: Perindopril/Indapamide/Amlodipine fixed dose combination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, ambulatory patients >18 years old. Clinically diagnosed essential arterial hypertension. Under treatment with Perindoril/Indapamide/Amlodipine fixed dose combination. The patient has given his/her written consent after being informed, before his inclusion in the study. Exclusion Criteria: Secondary arterial hypertension. Serious end stage diseases, severe neuropsychiatric diseases, cerebrovascular event with serious residual lesions, scheduled procedure or surgical operation or hospital admission. Pregnancy, lactation or intention to become pregnant.

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

| Intervention/Treatment |
| --- |
|Drug: Perindopril/Indapamide/Amlodipine fixed dose combination|Dose selection is based on investigators management.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to treatment | Total score of Hill-Bone High Blood Pressure Compliance Scale will be recorded at each study visit | Change of total score of compliance scale between baseline and 1st month and between 1st and 4th month of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure |  | All visits (baseline, 1st and 4th month of treatment) | 
| Diastolic Blood Pressure |  | All visits (baseline, 1st and 4th month of treatment) | 
| Adverse events recording leading to treatment discontinuation |  | 1st and 4th month of treatment |
Efficacy of Treatment for Obsessive Compulsive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of these questionnaires is to give us an overview of how OCD has affected your life and perhaps also to give us some clues about things that may have set you up to experience OCD.

Detailed Description
-----------------
For us to evaluate the efficacy of our treatment programs, we are interested in your responses before and after treatment. We use two methods to evaluate the efficacy of our treatments: questionnaires and interviews with a member of the Anxiety Disorders Clinic. As part of standard clinic procedure, each person in the program completes an in-person interview with a staff member who will determine your suitability for treatment. If you have received this questionnaire packet, it is likely that your concerns will be appropriately addressed in the Anxiety Disorders Clinic. The purpose of the questionnaire packet is to assess the severity of your obsessive-compulsive disorder; its impact on your functioning, and factors that may contribute to the onset or maintenance of your OCD (e.g., depression, personal standards). We will ask you to complete this questionnaire again when you have completed your treatment along with a brief telephone interview with a staff member of the Anxiety Disorders Clinic.

Official Title
-----------------
Efficacy of Treatment for Obsessive Compulsive Disorder

Conditions
-----------------
Obsessive Compulsive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to the Anxiety Disorders Clinic who receive a primary diagnosis of Obsessive Compulsive Disorder, and are accepted for treatment at the clinic. Exclusion Criteria: Individuals who either have not sought treatment for anxiety at the Anxiety Disorders Clinic or patients who did not receive a primary diagnosis of Obsessive Compulsive Disorder.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 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
-----------------
Obsessive Compulsive Disorder, Anxiety, Treatment efficacy