linjc16/ctgov huggingface dataset:
Saint Luc Valve Registry

Study Overview
=================
Brief Summary
-----------------
The Cliniques Universitaires Saint Luc are one of the high specialized center in valvular heart diseases and valvular heart surgery. Aortic stenosis, mitral and aortic regurgitation are the three valve pathology that are mainly frequent and studied. International guidelines in the management of valvular heart diseases are based on few limited old studies, mainly retrospective. And, a matter of concern is staying, about the timing of surgery for asymptomatic patients. A prospective registry will help us to better understand the pathologies and try to better define guidelines criteria for surgery.

Detailed Description
-----------------
With this prospective registry, all patients with aortic stenosis, mitral and aortic regurgitation will be followed. The investigators will find followed patients not yet operated or until surgery, but also patient after surgery according to the presence or abscence of guidelines criteria. It will permit to compare different kind of management of patients with valvular heart disease and to better define guidelines criteria for surgery.

Official Title
-----------------
Saint Luc Valve Registry

Conditions
-----------------
Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of aortic stenosis, mitral or aortic regurgitation at the time of an echocardiography at the Cliniques Universitaires Saint Luc. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Overall survival | From the date of the first echocardiography until the date of death from any cause, documented progression and surgery will be regularly assessed up to 10 years. | every two years up to 10 years |
Laser Therapy for Patients With Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease that has detrimental effects on connective tissue and other organs. The musculoskeletal system is one of the most affected systems in this group of patients including the temporomandibular joint. The most common symptoms when muscle involvement in SLE are muscle atrophy decreased muscle strength and myopathy. SLE activity and long-term corticosteroid use are thought to be responsible for these symptoms, thus, SLE patients are accepted to be at higher risk for temporomandibular joint disorders (TMD). Low-level laser therapy(LLLT) is frequently used in the treatment of TMD due to its pain relief and anti-inflammatory effect. Thus, in this study, LLLT has been used to evaluate this treatment modality on the chewing function and pain values of SLE patients with myogenic TMD.

Official Title
-----------------
The Effect of Dental Laser Therapy for Patients With Systemic Lupus Erythematosus

Conditions
-----------------
Systemic Lupus Erythematosus, Muscle Pain, Chewing Function

Intervention / Treatment
-----------------
* Device: GaAlAs semiconductor diode laser device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having myogenic temporomandibular joint disorder, Following a stable medical regime, Showing minimum pain intensity of 50 mm on the visual analog scale. Exclusion Criteria: Having concurrent systemic diseases, Using antimalarial drugs, Wearing removable prosthesis, History of facial 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test group<br>SLE patients treated with infrared laser irradiation | Device: GaAlAs semiconductor diode laser device<br>* low-level laser therapy<br>|
| Placebo Comparator: placebo group<br>SLE patients treated with red laser irradiation | Device: GaAlAs semiconductor diode laser device<br>* low-level laser therapy<br>|
| No Intervention: control group<br>no therapy group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain value | Pain intensity was evaluated by using Visual Analog Scale(VAS). | 2 months | 
| chewing function | The chewing function was evaluated by measuring the geometric mean diameter of crushed test food. | 2 months |
Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Grafting (CABG) Involving Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to identify a dose or doses of INS50589 intravenous infusion that are well-tolerated and which reduce postoperative bleeding and blood product transfusion.

Official Title
-----------------
Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel Group Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Graft Surgery Involving Cardiopulmonary Bypass

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Drug: INS50589 Intravenous Infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are scheduled for primary CABG by median sternotomy involving cardiopulmonary bypass Willing to receive allogeneic blood product transfusions during and after surgery Exclusion Criteria: Have had previous cardiac surgery Have had previous median sternotomy Have tendency for bleeding or family history of bleeding Have an abnormally low platelet count Have received certain anticoagulant or antiplatelet medications within a specified time period prior to the scheduled CABG surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: INS50589 Intravenous Infusion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative chest drainage volume |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Requirement for perioperative blood product transfusion |  |  | 
| Incidence of complications after surgery |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Bypass Graft Surgery involving Cardiopulmonary Bypass
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation

Study Overview
=================
Brief Summary
-----------------
This trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.

Detailed Description
-----------------
Eligible subjects will be randomized in a 1:1 ratio for up to 5 weeks to be treated with AXS-05 or placebo.

Official Title
-----------------
ADVANCE-2: Addressing Dementia Via Agitation-Centered Evaluation 2: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Alzheimer's Disease Agitation

Conditions
-----------------
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation

Intervention / Treatment
-----------------
* Drug: AXS-05
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria. Diagnosis of clinically significant agitation resulting from probable AD according to the International Psychogeriatric Association (IPA) provisional definition of agitation. Exclusion Criteria: Patient has dementia predominantly of non-Alzheimer's type. Unable to comply with study procedures. Medically inappropriate for study participation in the opinion of the investigator.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXS-05<br>Up to 5 weeks | Drug: AXS-05<br>* AXS-05 tablets, taken twice daily<br>|
| Placebo Comparator: Placebo<br>Up to 5 weeks | Drug: Placebo<br>* Placebo tablets, taken twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohen-Mansfield Agitation Inventory (CMAI) |  | Up to 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AD agitation, AXS-05, NMDA receptor antagonist, dextromethorphan, bupropion, Axsome, ADVANCE-2
Clinical Application of Ultrasound in Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
We hypothesize the width air-colum of retropalatal region and tongue voulme by ultrsound through submental area is different between normal control with those with obstructive sleep apnea syndrome who was comfirmed by polysomography.

Detailed Description
-----------------
Patients with obstructive sleep apnea mainly due to upper airway narrowing are evaluated conventionaly by polysomography. Recently, the magnetic resonace imaging has been well established in evaluating upper airway and correlating with the severity by tongue mass and the area of retropalatal airway. However, some drawbacks of MRI includes expensiveness might lead its less use. As for ultrasound which is very popularly applied in medical illness, is more convenient and money saving than MRI. We propose that ultrsound measuring the tongue volume and width of upper airway through submental area may be a alternative image for a upper airway measuring.

Official Title
-----------------
Clinical Application of Ultrasound in Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: group of sleep apnea: patients who have been diagnosed as having obstructive sleep apnea control group: patients who have a negative polysomogrphy or a normal score of Pittsburg sleep questionaire Exclusion Criteria: Less than 18-year-old un-willing not co-operated person

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sleep apnea<br>a patient has been diagnosed as having obstructive sleep apnea | |
| control<br>a case who has a negative polysomography or noraml score of Pittsburg sleep questionaire | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| apnea-hypopnea index |  | less than one month apart from ultrasound |
Trunkstability: a Predisposition for Armfunction

Study Overview
=================
Brief Summary
-----------------
Trunk stability is supposed to be an important predisposition for arm function. To the investors knowledge this is never been demonstrated.

Detailed Description
-----------------
Fifty healthy subjects will execute a reaching movement in sitting. They will reach to a cone at a distance of little more than armlength. Electromyogram (EMG) and kinematics will be the outcome measures. Secondary outcome measures are: sex, dexterity, skillfulness, Fifty first time stroke patients will execute the same movements. Primery outcome is EMG and kinematics; secundary outcome measures are: side of hemiplegia, arm recuperation.

Official Title
-----------------
Trunkstability: a Predisposition for Armfunction

Conditions
-----------------
Trunk Stability

Intervention / Treatment
-----------------
* Other: one time testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI < 30 no orthopedic, neurologic disorder that can influence the reaching age between 18 and 70 yrs Exclusion Criteria: BMI>30 orthopedic, neurologic disorder that can influence the reaching < 18 yrs of age >70 yrs of age

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: healthy subjects<br>healthy subjects | Other: one time testing<br> <br> |
| No Intervention: stroke patients<br>first time stroke patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyography to analyze muscle activation | which muscle is active during a reaching movement | 2 hours | 
| kinematics to analyze trunk involvement | when is the trunk involved in a reaching movement | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADL, stroke, reaching
Efficacy and Safety of Gemigliptin 50mg qd Added in Patients With Type 2 Diabetes Inadequately Controlled on Glimepiride and Metformin

Study Overview
=================
Brief Summary
-----------------
After a screening, a 2-week, single-blind placebo run-in, 174 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily Gemigliptin 50 mg or placebo to ongoing stable doses of glimepiride in combination with metformin for 24 weeks.

Detailed Description
-----------------
Subjects will visit the center on Week 6, 12, 18 and 24 during the entire 24-week treatment period. Total study duration will be approximately 26weeks and the subjects will be to practice exercise/diet control together.

Conditions
-----------------
T2DM

Intervention / Treatment
-----------------
* Drug: Gemigliptin
* Drug: Gemigliptin placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Type 2 Diabetes Mellitus Adults aged ≥ 19 years old Patients with HbA1c 7% 11% at Visit 1

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemigliptin<br>Gemigliptin 50mg qd | Drug: Gemigliptin<br>* DPP-4 inhibitor<br>* Other names: Zemiglo;|
| Placebo Comparator: Placebo<br>Gemigliptin placebo | Drug: Gemigliptin placebo<br>* Placebo of Gemigliptin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of HbAlc from baseline at Week 24 |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes Mellitus
Clozapine Use Pattern in the Province of Seville

Study Overview
=================
Brief Summary
-----------------
CLOZAPINE USE PATTERN IN THE PROVINCE OF SEVILLE

Detailed Description
-----------------
Subjects with a diagnosis of schizophrenia (F20 of ICD-10) under treatment with clozapine in the province of Seville. The use of clozapine, variability between centers and treatment modification will be identified.

Official Title
-----------------
Clozapine Use Pattern in the Province of Seville

Conditions
-----------------
Schizophrenia and Related Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been prescribed (initially or regularly) clozapine during 2018, based on the casuistry provided by the Pharmacy service of the different hospitals. Exclusion Criteria: Parkinson's disease Dementia
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who have been prescribed clozapine during 2018<br>Patients who have been prescribed (initially or regularly) clozapine during 2018, based on the casuistry provided by the Pharmacy service of the different hospitals. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the pattern of clozapine use in the province of Seville | Identify the pattern of clozapine use in the province of Seville | year 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyze the variability between centers or professionals | Analyze the variability between centers or professionals | year 2018 | 
| Analyze the changes in the course of the disease since the prescription of clozapine | Analyze the changes in the course of the disease since the prescription of clozapine | year 2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clozapine
The Clinical Study of Assessing HER-2 Expression in Gastric Cancer With Extra Tumor Tissue Paraffin Blocks Using Immunohistochemistry

Study Overview
=================
Brief Summary
-----------------
Background: Gastric cancer (GC) is major global health concern and the second leading cause of cancer deaths worldwide. Amplification of Her2/neu gene and/or overexpression of the Her2/neu protein have been observed in GC. Trastuzumab (Herceptin™) is an anti-Her2/neu antibody, which has been successfully applied in GC. However, the intratumoral heterogeneity of Her2/neu overexpression and amplification in GC should be noticed. The investigators investigated the significance of evaluating Her2/neu expression in different paraffin blocks of tumor tissue in GC. Methods: 2000 GC patients from ten centers, patients were divided into a cohort using one tumor tissue paraffin block (cohort 1, n=1000) and a cohort using dual tumor tissue paraffin blocks (cohort 2, n=1000) when evaluating Her2/neu expression status by immunohistochemistry (IHC). In cohort 2, the investigators combined the results from two different paraffin blocks and used the higher one as the final score.

Conditions
-----------------
Gastric Cancer Surgical Specimens,18-80 Years Old, at Least Two Tumor Tissue Blocks

Intervention / Treatment
-----------------
* Procedure: choose two tumor tissue paraffin blocks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergone curative surgery of gastric cancer, 18-80 years old. Exclusion Criteria: None

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group 1<br>choose one tumor tissue paraffin blocks | |
| group 2<br>choose two tumor tissue paraffin blocks | Procedure: choose two tumor tissue paraffin blocks<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the positive rate |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric cancer, Her2/neu, Dual paraffin blocks, Trastuzumab, Clinical Prospective Multicenter Cohort Study