linjc16/ctgov huggingface dataset:
Diagnostic Interest of Leukocyte Immunophenotyping Using Multiparameter 8-color Flow Cytometry in Heart Surgery

Study Overview
=================
Brief Summary
-----------------
In septic patients, Septiflux1 study identified immature granulocytes which may have a diagnostic and prognostic interest. However, with these preliminary results it is not possible to make a difference between what is linked to the infection and what is a consequence of the inflammation which goes along with the septic process. Using flow cytometry, the study of leukocytes in a pure inflammatory model such as cardiopulmonary bypass in heart surgery could make possible to test the diagnostic interest of the immature granulocytes but also to attribute a prognostic value for the occurrence of post-operative infections.

Detailed Description
-----------------
Expression of CD10, CD16, CD24, CD64 on granulocytes, of CD14 and CD16 on monocytes and of CD3 on T lymphocytes. Flow cytometers will all be calibrated the same way using common reagents (known fluorescent calibration beads). Moreover, CD45 and CD3 level of expression on lymphocytes will help to check that the collection of data is standardized between the different centers.

Official Title
-----------------
Diagnostic Interest of Leukocyte Immunophenotyping Using Multiparameter 8-color Flow Cytometry in Heart Surgery

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Other: Whole blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient older than 18 years old Patient undergoing planned heart surgery with cardiopulmonary bypass Exclusion Criteria: Pregnancy, progressive solid cancer, HIV infection, history of blood or inflammatory disease, long-term immunosuppressive treatment, urgent surgical intervention, documented preoperative infection

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 |
| --- | --- |
| study cohort<br>Patient undergoing planned heart surgery with cardiopulmonary bypass | Other: Whole blood<br>* preoparatoire whole blood and postoperative whole blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of the marker CD64, CD10 and CD16 | Evolution rate of CD64, CD10 and CD16 in the immediate postoperative cardiac surgery | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early onset of infectious complications | Early onset of infectious complications in the 7 days post-operative | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery, infectious complication
SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of risedronate sodium (Actonel®) after a wrist fracture in postmenopausal women.

Official Title
-----------------
Local (Brazil) Study, Multicenter, Opened, Comparative, Randomized, With Parallel Groups, Phase IV, in Post Menopausal Woman With Colles' Fracture of the Risedronate Sodium Usage in the Consolidation and in the Callus of the Colles'Fracture.

Conditions
-----------------
Colles' Fracture

Intervention / Treatment
-----------------
* Drug: Risedronate sodium
* Drug: Calcium & Vitamine D3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with description of 2 or more years of Menopause; T-score <= -2.0 sd; Confirmed colles'fracture; Independent for the march (preserved ambulatorial ability); Exclusion Criteria: Co-morbidities; Regular use of corticosteroids or other anti-resorptive drug in the last year; Use of drugs that can affect the calcium metabolism; Hypersensitivity to risedronate; Previous wrist or forearm fracture; Hypocalcemia; Renal insufficiency; Rheumatic disease; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sexes Eligible for Study
-----------------
Female

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: 1<br> | Drug: Risedronate sodium<br>* Actonel® 35 mg (risedronate sodium) and 1000 mg of calcium and 400 UI of Vitamine D3<br>|
| Active Comparator: 2<br> | Drug: Calcium & Vitamine D3<br>* 1000 mg of calcium and 400 UI of Vitamine D3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mineral density of the 33% radius region and of the UD radius region |  | after 90 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mineral density of the 33% radius region and of the UD radius region |  | after 180 days of treatment | 
| Size of callus obtained through Rx of the fracture site. |  | from the beginning up to the end of the study | 
| Safety: Adverse events occurrence. |  | from the inform consent signature up to the end of the study |
Feminizing Treatment in Transgender Women and Non-binary Persons

Study Overview
=================
Brief Summary
-----------------
Cohort study in 100 transgender women treated with gender affirming hormone treatment. Follow up affter 1year, 3 years, 5 years and 10 years, Outcomes regarding cardiovascular effects of hormone treatment.

Detailed Description
-----------------
Cohort study in 100 transgender women treated with gender affirming hormone treatment. Follow up affter 1year, 3 years, 5 years and 10 years, Outcomes: Non-calcified and calcified plaque formation by contras coronary CT angiograms Heartfunction by ekko Cardiovaskular risk markers, f. eks. bp Markers of cardiovascular risk in blood and urine

Official Title
-----------------
Feminizing Treatment in Transgender Women and Non-binary Persons BODY IDENTITY CLINIC - ESTROGEN

Conditions
-----------------
Transgenderism

Intervention / Treatment
-----------------
* Other: standard treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: assigned male at birth and eligeble for gender affirming feminizing treatment Exclusion Criteria: none -

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| transgender women<br>transgender women eligeble to start gender affirming hormone treatment | Other: standard treatment<br>* starndard treatment for transgender women<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coronary plaque formation | mm3 | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gender affirming hormone treatment, estrogen, cardiovascular risk
Efficacy and Safety of Repaglinide Combined With Insulin NPH in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia and South Africa. The aim of this trial is to compare the efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn) with insulin NPH alone in subjects with type 2 diabetes inadequately controlled on repaglinide.

Official Title
-----------------
Multi-centre, Multinational, Open-labelled, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled on Repaglinide, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime NPH Insulin Versus Twice Daily NPH Insulin

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

Intervention / Treatment
-----------------
* Drug: repaglinide
* Drug: insulin NPH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes HbA1c (glycosylated haemoglobin): 7-13% (both inclusive) BMI (body mass index) maximum 35 kg/m^2

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rep + NPH<br> | Drug: repaglinide<br>* 2 mg at each main meal<br>Drug: insulin NPH<br>* Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.<br>|
| Active Comparator: NPH<br> | Drug: insulin NPH<br>* Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycosylated haemoglobin) |  | Week 0 (visit 5); week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FPG (fasting plasma glucose) |  | Week 0 (visit 5); week 26 | 
| 7-point blood glucose profile |  | Week 0 (visit 5); week 26 | 
| Hypoglycaemic episodes |  | Week 0 (visit 5); week 26 | 
| Adverse events |  | Week 0 (Visit 5); week 26 |
Radiofrequency Ablation (RFA) in Breast Tumors

Study Overview
=================
Brief Summary
-----------------
To validate the efficacy and safety of the cool-tip ablation method for breast tumors smaller than 2 cm.

Detailed Description
-----------------
A prospective, phase II-III study, which will include a series of cases of 30 patients. The hospitals involved will be Bellvitge University Hospital and Hospital del Mar. Efficacy was evaluated according magnetic resonance image and biopsy of the breast 1 month after the procedure. Patients will be followed up over a 2-year period to assess cosmetic results, short and long-term complications and possible recurrences.

Official Title
-----------------
Radiofrequency Ablation in Breast Tumors in Early Stages

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

Intervention / Treatment
-----------------
* Device: Cool-tip electrode for Radiofrequency Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infiltrating ductal carcinoma according the biopsy of the breast, Tumor visible by ultrasound, smaller than 2 cm, Located > 1 cm from the chest wall and the skin. Exclusion Criteria: Personal antecedents of breast cancer Multifocality or intraductal carcinoma Lobular infiltrating carcinoma Neoadjuvant therapy

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Radiofrequency ablation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency<br>Radiofrequency Ablation of breast cancer tumour by Cool-tip electrode. | Device: Cool-tip electrode for Radiofrequency Ablation<br>* Radiofrequency ablation of the tumour in the surgery group, associated whith axillary surgery when applicable<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI post-RFA | Magnetic Resonance Image after Radiofrequency ablation to confirmate complete disappearance of tumor contrast enhancement. | 1 month after procedure | 
| BAG post-RFA | Breast biopsy after Radiofrequency to confirmate absence of viable tumor tissue using NADH, CK18 and CK19 stainings. | 1 month after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Effects | Adverse effects related to radiofrequency | Through study completion, an average of 1 year | 
| Quality | Breast-Q | 1 month after procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiofrequency, early stage
Laparoscopic Adjustable Gastric Banding in Adolescents

Study Overview
=================
Brief Summary
-----------------
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.

Detailed Description
-----------------
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents

Official Title
-----------------
Laparoscopic Adjustable Gastric Banding for Treatment of Morbid Obesity in Adolescents

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Device: Adjustable Gastric Band


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 14-19 BMI > 35 history of obesity for at least 5 years with failed attempts at diet and medical management for at least 6 months. confirmation by a pediatric psychologist that the subject is sufficiently mature emotionally and has adequate family support to comply with the study protocol. Exclusion Criteria: history of congenital or acquired anomalies of the GI tract. history of esophageal motility disorders uncontrolled psychiatric problems previous esophageal, gastric or bariatric surgery; intestinal obstruction or peritonitis. uncontrolled eating disorders

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 19 Years

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

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

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: Gastric Banding<br>Surgical placement of an adjustable gastric band around the upper portion of the stomach. Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction. | Device: Adjustable Gastric Band<br>* Surgical placement of an adjustable gastric band around the upper portion of the stomach. Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.<br>* Other names: Lap-Band;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Weight Loss | Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial | Up to five years post surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Resistance | Fasting insulin level | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lap-Band, morbid obesity, adolescents
Clinical Evaluation on the Use of the X-pander Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to clinically evaluate the use of the x-pander device.

Detailed Description
-----------------
Clinical evaluation on the use of the x-pander device during THA-surgery

Official Title
-----------------
Clinical Evaluation on the Use of the X-pander Device

Conditions
-----------------
Osteoarthrosis, Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Procedure: x-pander


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis for hip osteoarthrosis Exclusion Criteria: Previous surgery of the actual hip

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 |
| --- | --- |
| All patients<br>Measurement with x-pander in acetabulum prior to inserting the artificial hip socket. | Procedure: x-pander<br>* Measurement of the size and quality of the bony acetabulum before mounting the artificial hip socket.<br>|

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
-----------------
Total Hip Arthroplasty, Osteoarthritis
Registry of Cardiovascular Disease Patients

Study Overview
=================
Brief Summary
-----------------
A computerized registry of cardiovascular disease patients in a large health maintenance organization in Israel. The registry is aimed to be used by health professionals to identify cardiovascular disease patients and to follow the courses of their illnesses and risk factors.

Detailed Description
-----------------
The registry was initiated in 1998 by Maccabi Healthcare services, which is the second largest publicly funded HMO in Israel,serving 24% of the total population with a nationwide distribution. The registry uses advanced information technology that integrates personal computerized community and hospital records, data from laboratory tests, dispensed medications, physiological signals, radiological images, and reports from investigations and procedures.

Official Title
-----------------
Computerized Registry of Cardiovascular Disease Patients

Conditions
-----------------
Ischemic Heart Disease, Congestive Heart Failure, Peripheral Vascular Disease, Cerebrovascular Disease, Atrial Fibrillation, Cerebrovascular Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical Diagnosis of the following: Ischemic Heart Disease,MI,non-MI,congestive heart failure,peripheral vascular disease, cerebrovascular disease CVA,TIA,patients with first AMI diagnosis from community physicians if they were hospitalized for lasting at least 3 days during a 30-day period prior to diagnosis. Patients with prior coronary artery bypass grafting(CABG) or percutaneous coronary intervention (PCI), using relevant Current Procedural Terminology (CPT) codes Exclusion Criteria: patients who were diagnosed as suffering from CHD by primary physician or general hospitals prior to 2000 with no further indication Patients whose primary physician reported that the patient is CHD-free providing adequate medical records
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiovascular Disease Patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Cardiovascular disease |  | Up to 100 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence rates of CVD |  | up to 100 years | 
| Major Adverse Cardiac Events |  | up to 100 years | 
| Number of LDL Tests performed reaching target LDL |  | up to 100 years | 
| Proportion of dyslipidemia patients treated with Statins |  | up to 100 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Registry, Cardiovascular, CVD, Health Maintenance Organization
Multicenter Cohort Prospective Study on Multidisciplinary Treatment of Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the diagnostic and treatment procedures employed for patients with rectal cancer in each participating center. Outcomes to treatment, costs of treatment will be described. Exploratory analyses will be done to identify factor that influence patient prognosis, as well as factors that predict patient response to treatment.

Official Title
-----------------
Multicentered Observational Prospective Cohort Study on Multidisciplinary Treatment of Rectal Cancer

Conditions
-----------------
Metastatic Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic diagnosis rectal carcinoma Signed informed consent Exclusion Criteria: Refusal or incapability of providing informed consent

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 |
| --- | --- |
| rectal cancer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| list of diagnostic procedures used in clinical practice, according to participating Institute |  | 5 years |