linjc16/ctgov huggingface dataset:
Effect of Glucose-insulin-potassium Solution on Myocardial Protection During Off-pump Coronary Bypass Surgery in Patients With Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
Patients undergoing multivessel off-pump coronary bypass surgery (OPCAB) inevitably experience cumulative ischemia-reperfusion injury at myocardium. Glucose-insulin-potassium (GIK) is a potentially useful adjunct to myocardial protection. This study was designed to evaluate the effects of GIK infusion on myocardium in patients undergoing OPCAB. Patients undergoing OPCAB with acute coronary syndrome are randomly assigned to GIK or Control group. The trial is double-blind and conducted at a single center.

Official Title
-----------------
Effect of Glucose-insulin-potassium Solution on Myocardial Protection During Off-pump Coronary Bypass Surgery in Patients With Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Drug: GIK solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing isolated OPCAB. Age: 20 75. Exclusion Criteria: Emergency operation. Patients with MR ≥ 2. Patients with IDDM. Patients with random sugar ≥ 250 mg/dL. Patients with serum creatinine ≥ 2.0 mg/dL. Patients with acute myocardial infarction within 1 week of surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: GIK group<br> | Drug: GIK solution<br>* Patients receive 0.3 ml/kg/hr GIK solution or the same volume of normal saline depending on the group during off-pump coronary bypass surgery. GIK solution consist of 50% glucose, potassium 80 mEq, and regular insulin 325 IU/500ml.<br>* Other names: glucose-insulin-potassium(GIK) solution;|
| Placebo Comparator: Control group<br> | Drug: GIK solution<br>* Patients receive 0.3 ml/kg/hr GIK solution or the same volume of normal saline depending on the group during off-pump coronary bypass surgery. GIK solution consist of 50% glucose, potassium 80 mEq, and regular insulin 325 IU/500ml.<br>* Other names: glucose-insulin-potassium(GIK) solution;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CK-MB(creatinine kinase-MB) mass | Comparison of cardiac enzyme elevation after surgery between GIK and Control group. | 12 hours after the surgery |
Docetaxel, Vinorelbine and Trastuzumab in the Treatment of Patients With Metastatic Her-2 Positive Breast Cancer

Study Overview
=================
Brief Summary
-----------------
In this phase II trial we attempt to improve upon the efficacy of the trastuzumab/vinorelbine combination by adding weekly docetaxel. When administered on a weekly schedule, docetaxel is well tolerated with minimal myelosuppression, so that it is likely that fully efficacious doses of all three drugs can be administered

Detailed Description
-----------------
Upon determination of eligibility, all patients will be receive: Trastuzumab + Vinorelbine + Docetaxel

Official Title
-----------------
Phase II Trial of Weekly Docetaxel, Vinorelbine, and Herceptin in the First-Line Treatment of Patients With Metastatic Breast Cancer and Overexpression of Her-2

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Docetaxel
* Drug: Vinorelbine
* Drug: Trastuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be included in this study, you must meet the following criteria: Metastatic breast cancer confirmed by biopsy Overexpression of the Her-2 oncogene Age > 18 years Measurable disease Able to perform activities of daily living with minimal assistance No previous chemotherapy for metastatic disease One or more previous hormonal therapies for metastatic disease. Adequate bone marrow, liver and kidney function Patients with < grade 1 peripheral neuropathy are eligible. Must give written informed consent prior to entering this study. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Abnormal heart function Previous treatment with trastuzumab Brain metastases untreated Pre-existing symptomatic peripheral neuropathy Serious underlying medical conditions Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Docetaxel|Docetaxel|
|Drug: Vinorelbine|Vinorelbine|
|Drug: Trastuzumab|Trastuzumab|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility and toxicity of the combination of weekly docetaxel, vinorelbine, and trastuzumab in patients with metastatic breast cancer who overexpress Her-2. |  | 18 Months |
Interest of the HEART Score for the Management of Patients With Chest Pain in Emergency Department

Study Overview
=================
Brief Summary
-----------------
Chest pain is a frequent reason of consultation in emergency department. Emergency physician have to identify patients at high risk of Acute Coronary Syndrome from those presenting a lower risk.

Detailed Description
-----------------
The aim of the study is to study the interest of the HEART score for the management of patients with chest pain in emergency department

Official Title
-----------------
Interest of the HEART Score for the Management of Patients With Chest Pain in Emergency Department

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Other: data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women Aged more than 18 Chest pain Consulting in emergency department Agreeing to participate to the study Exclusion Criteria: aged less than 18 not agreeing to participate to the study

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patient with chest pain<br> | Other: data collection<br>* HEART score calculation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HEART score | Cardiovascular risk evaluated using HEART score. HEART score includes 5 items on history of chest pain, electrocardiogram, patient's age, cardiovascular risk factors and initial troponin. Each item is coded from 0 to 2 points, the overall score ranges from 0 to 10 points. Score between 0 and 3 indicated low risk of major adverse cardiovascular event, Score between 4 and 6 indicated moderate risk of major adverse cardiovascular event, Score between 7 and 10 indicated high risk of major adverse cardiovascular event | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Coronary Syndrome, chest pain, emergency department, HEART score
Safety and Efficacy of Switching to Quetiapine in Outpatients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This is a single-arm, phase IV, open-label, prospective, non interventional study in approximately 600 patients that will be followed for 6 months in order to evaluate the safety and efficacy of quetiapine. Patients will be switched over a 4 to 7 day cross-titration period from their previous antipsychotic medication to quetiapine according to the approved SPC.

Official Title
-----------------
A Non-interventional, Open Label, Phase IV Observational Study for the Safety and Efficacy of Switching to Quetiapine (Seroquel) in Outpatients With Schizophrenia Who Have Been Unsuccessfully Treated With Other Antipsychotics

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of schizophrenia at least 1 year prior to screening Inadequate response or poor safety /tolerability or non-compliance to previous antipsychotic medication Provision of Informed Consent prior to enrolment Exclusion Criteria: Known hypersensitivity to active substance of excipients Patients receiving P450 3A4 inhibitors Pregnancy or lactation Substance abuse or dependence

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Safety of quetiapine assessed through analysis of AE/SAE data (rate of patients presenting SAEs, rate of patients who discontinue treatment due to any AE, time to treatment discontinuation due to any AEs) |  | 5 visits (Day 0, Week 1, Week 4, Week 12, Week 24); SAEs will be reported during all study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Clinical Global Impression of Severity and Improvement (CGI-S, CGI-I) and in Brief psychiatric Rating Scale (BPRS) from baseline to end of study treatment |  | 5 visits (Day 0, Week 1, Week 4, Week 12, Week 24) | 
| Percentage of extra-pyramidal side effects assessed using the Simpson-Angus Scale (SAS) |  | Changes from baseline to end of study treatment or (6 months) or early withdrawal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Switching, Quetiapine, schizophrenia, unsuccessfully treated, antipsychotics
Back Pain and Arthroplasty in Orthopedists

Study Overview
=================
Brief Summary
-----------------
The relationship between arthroplasty and low back pain in orthopedists will be evaluated.

Official Title
-----------------
Investigation of the Relationship Between Back Pain and Arthroplasty in Orthopedists

Conditions
-----------------
Pain, Chronic, Back Pain

Intervention / Treatment
-----------------
* Procedure: arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who have received specialization of orthopaedics and work as a orthopaedics surgery. Those who want to participate in the study Exclusion Criteria: Patients with discomfort and operation due to the low back pain Physicians in other branches
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: orthopedists<br>orthopedists working actively and performing arthroplasty every day | Procedure: arthroplasty<br>* back pain in orthopedists due to working actively and performing arthroplasty every day<br>* Other names: back pain;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| back pain in orthopedists | The relationship between arthroplasty performing and back pain in orthopaedics. Some orthopaedics perform arthroplasty every day, some perform 2 or 3 times a day. This can cause some pain in the low back due to the position during the operation. In our study, the investigators will have a survey of orthopaedics and answer some questions: How long have they been doing this job, how many arthroplasty operation they made during a day, do they have any complaints of low back pain. The investigators will try to relate back pain with their answers. | 2 month |
Thromboxane A2 and Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
TXA2 inhibits the expression of the primary marker of thermogenesis (UCP1) while prostacyclin (PGI2), another metabolite derived from arachidonic acid, enhances its expression. Given the close relationship between the adipocyte and the chondrocyte, the study team hypothesises that thromboxane A2 controls chondrocyte formation and function and thus cartilage homeostasis. The study objectives are: i) to analyse the role of TXA2 on chondrocyte differentiation in vitro, ii) to determine the association between circulating and tissue TXA2 levels in a rat model of osteoarthritis, and iii) to correlate circulating and synovial fluid levels of TXA2 with the development of osteoarthritis in a small human cohort. The proposed research aims to better understand the mechanisms underlying the role of lipid metabolites in chondrocyte formation and function, paving the way for the development of nutritional and pharmacological therapies to combat OA and associated metabolic disorders.

Official Title
-----------------
Throboxane Effect on Chondrocytes; Role in Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Other: biological samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of knee osteoarthritis with effusion, , no inflammatory disease Exclusion Criteria: anticoagulant treatment inflammatory disease

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| ThroboxaneOA<br>Patient with osteoarthritis and knee effusion | Other: biological samples<br>* blood and synovial liquid will be sampled<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to look for correlation between the rate of throboxane and the grade of osteoarthritis | kellgren and lawrence classification | 6 months |
Withdrawal or Reduction TKIs in CML-CP

Study Overview
=================
Brief Summary
-----------------
Compare MMR on 12 month treated with half TKIs(including imatinib, dasatinib, and nilotinib) or TKIs withdrawal.

Detailed Description
-----------------
Chronic myeloid leukemia-Chronic phase(CML-CP) patients treated with receive effective Tyrosine kinase inhibitor -TKI(including imatinib, dasatinib and nilotinib) for more than 5 years, and patients with BCR/ABLIS continuous negative in the last 18 months were randomly admitted to maintain the original effective TKI by half or stop taking . Q-pcr detected BCR/ABLIS in peripheral blood once every month, once every two months after half a year, and continuously monitored for 12 months. If the patients detected molecular recurrence (loss of MMR, BCR/ABLIS > 0.1%), the original dose of TKI should be administered again.

Official Title
-----------------
A Multicenter, Open-access Study of CML-CP Patients Treated With Effective TKIs at Least 5 Years and MR4.5(BCR/ABLIS<0.0032%) Maintenance More Than 18 Months Who Treatment With Half TKIs or Discontinue

Conditions
-----------------
MMR on 12 Month

Intervention / Treatment
-----------------
* Drug: withdrawal TKIs or halve TKIs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 years old, gender is not limited; Diagnosed CML chronic phase and effective TKI(including imatinib, dasatinib, and nilotinib) was continued for more than 5 years Q-PCR monitored BCR/ABLIS duration < 0.0032% in the last 18 months Informed consent of the patient or his legal representative Exclusion Criteria: Patients had history of CML-AP or CML-BC CML patients with previous or current ABL kinase mutations CML Patients who have received allogeneic hematopoietic stem cell transplantation CML Patients who have received immunotherapy (except interferon, including car-t and other cellular immunotherapy) Woman who is pregnant or nursing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Withdrawal TKIs<br> | Drug: withdrawal TKIs or halve TKIs<br>* Stop TKIs or treated by half TKIs<br>|
| halve TKIs<br> | Drug: withdrawal TKIs or halve TKIs<br>* Stop TKIs or treated by half TKIs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMR(BCR/ABL IS<0.01) on 12 moth | Half dose TKIs or discontinue TKIs treatment | 12 moth |
Clinical and Radiographical Analysis of the Distal Radioulnar Joint Following Implantation of a Scheker Total Distal Radioulnar Joint Prosthesis

Study Overview
=================
Brief Summary
-----------------
This project is set to describe by objective measures as the range of motion and weight-bearing ability of the distal radioulnar joint one to five years after primary implantation of a Scheker total distal radioulnar joint prosthesis.The range of motion and stability of the distal radioulnar joint (DRUJ) are important outcomes to preserve function, especially the pronation and supination. Unlike other ulnar endoprostheses that replace only the ulnar head, the Scheker prosthesis replaces the ulnar head, resurfaces the lesser sigmoid notch, and is semi-constrained in design.

Official Title
-----------------
Clinical and Radiographical Analysis of the Distal Radioulnar Joint Following Implantation of a Scheker Total Distal Radioulnar Joint Prosthesis

Conditions
-----------------
Scheker Total Distal Radioulnar Joint Prosthesis

Intervention / Treatment
-----------------
* Procedure: Implantation of a Scheker total distal radioulnar joint prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient treated with a Scheker total distal radioulnar joint prosthesis and with a follow-up time between 12 and 60 months after primary implantation Patient willing and able to give written informed consent to participate in the study Exclusion criteria: Inflammatory disease (e.g. rheumatoid arthritis) Pregnant women German language barrier to complete the questionnaires Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder) Legal incompetence Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Implantation of a Scheker total distal radioulnar joint prosthesis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcomes of this study are active DRUJ range of motion (pronation and supination) and weight-bearing ability in neutral and pronated position. |  | Follow-up time between 12-60 months after primary implantation of the Scheker prothesis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes of this study are radiological parameters, pain level by Visual Analog Scale, objective functional parameters (passive stability, grip strength), subjective functional parameters, and complications affecting the examined wrist. |  | Follow- up time between 12-60 months after primary implantation of the Scheker prothesis |
Cocoa Flavanols and Painfree Walking Distance

Study Overview
=================
Brief Summary
-----------------
To characterize potential vascular long-term effects of flavanols in patients with peripheral artery occlusive disease (PAOD), a placebo-controlled double-blinded randomized control study will be performed in 62 patients randomized in two groups. Patients will twice daily receive either a flavanol-poor cocoa drink or a flavanol-rich cocoa drink over a period of 60 days months.

Detailed Description
-----------------
62 Type 2 diabetics according to the criteria of the American Diabetes Association suffering from PAOD with a pain free walking distance less than 250m will be enrolled. Patients will twice daily receive either a flavanol-poor cocoa drink (13mg/dl)or a flavanol-rich cocoa drink (596mg/dl) over a period of 60 days. The general condition, the pain free walking distance and the vascular function measured by Doppler Ultrasound will be determined before and two month after cocoa ingestion

Official Title
-----------------
Long-term Effect of Dietary Intervention With Flavanol-containing Cocoa on Vascular Function of Diabetic Patients

Conditions
-----------------
Peripheral Artery Disease, Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: cocoa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: peripheral artery disease (Fontaine IIb) diabetes mellitus > 18 years Exclusion Criteria: acute and terminal renal failure acute infection heart failure (NYHA III-IV) arrhythmias

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: flavanol rich cocoa drink (596mg)<br>dissolved in water, twice daily intervention | Other: cocoa<br>* dissolved in water twice-daily intervention<br>|
| Experimental: flavanol poor cocoa drink ( 13mg)<br>dissolved in water, twice daily intervention | Other: cocoa<br>* dissolved in water twice-daily intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| painfree walking distance |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial function |  | 60 days |