linjc16/ctgov huggingface dataset:
Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50 mg tablet and Casodex following a 50 mg dose in healthy subjects under fasting conditions.

Official Title
-----------------
Randomized, Open-Label, 1-Way Parallel, Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex (Reference) Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions.

Conditions
-----------------
Prostate Cancer, Hirsutism

Intervention / Treatment
-----------------
* Drug: Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)
* Drug: Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 63 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA) | Drug: Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)<br> <br> |
| Experimental: 1<br>Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA) | Drug: Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 11 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
treatment
Montreal Toulouse Test With Eye Tracking in Intensive Care Unit to Evaluate Comprehension

Study Overview
=================
Brief Summary
-----------------
Assessment of the level of oral comprehension of the intensive care patient is essential to improve their care because they have often troubles like delirium.

Detailed Description
-----------------
Assessment of the level of oral comprehension of the intensive care patient is essential to improve their care because they have often troubles like delirium.

Official Title
-----------------
Montreal Toulouse 86 Test Modified to be Used With Eye Tracking: Test Automation and Eye Course in Healthy Volunteers and Intensive Care Patients

Conditions
-----------------
Critical Care

Intervention / Treatment
-----------------
* Other: Montreal-Toulouse Test adapted in eye tracking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: French speaker, RASS (Richmond Agitation-sedation scale) between -1 and +1, agree for participation Exclusion Criteria: neurovisual disorders

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 |
| --- | --- |
| Healthy volunteers<br>healthy volunteers | Other: Montreal-Toulouse Test adapted in eye tracking<br>* participant pass an eye tracking test to evaluate comprehension<br>|
| intensive care patient<br>patient hospitalized in intensive care unit | Other: Montreal-Toulouse Test adapted in eye tracking<br>* participant pass an eye tracking test to evaluate comprehension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish eye tracking standards for the test | fixation time measurement in the defined area of interest | during hospitalization in intensive care | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eye tracking, critical care, comprehension
Acute Bronchitis in Korea:Associated Microorganisms and Clnincal Findings.

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that acute bronchitis will be associated with various bacteria and viruses.

Detailed Description
-----------------
The investigators will investigate various bacteria and viruses from colleced specimens from patients with acute bronchitis, and also investigate an assoication of the miroorganims with clinical findings

Official Title
-----------------
Acute Bronchitis in Korea:Associated Microorganisms and Clnincal Findings.

Conditions
-----------------
Acute Bronchitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults patients aged over 18 years. Patients who complain of recent sputum and cough. Exclusion Criteria: Patinets who took antibiotics within 7 days. Patinets whose symptoms last for < 5 days. Patients who have definite cause of acute cough such as pneumonia, allergic rhinnits, sinusitis, GERD and drug. Immunocompromised patients.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Microorganisms (bacteria and/or viruses) related to acute bronchitis |  | Outcome measure is just type of microoganisms from collected specimens at hospital visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute bronchitis, bacteria, virus, clinical symoptoms
Evaluation of Graft Material in Coronary Artery Bypass Grafting (CABG)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the patency in different kinds of vessels used as graft material in coronary artery bypass grafting. The hypothesis is that vein grafts harvested with a pedicle of surrounding tissue have the same, or better, patency compared to radial grafts and that skeletonisation of the left internal mammary artery does not effect the patency for this graft.

Detailed Description
-----------------
Patients undergoing coronary artery bypass grafting are included in the study. Each patient receive a radial artery graft and a vein graft harvested with a pedicle of surrounding tissue to the right and left side of the heart respectively. The left internal mammary artery is used for the left anterior descending artery in a skeletonised or non-skeletonised fashion. The evaluation is made with angiography up to 5 years after surgery.

Official Title
-----------------
Mid-term Patency of Radial Artery and No Touch Saphenous Vein as Grafts in CABG; A Randomised Controlled Trial.

Conditions
-----------------
Angina Pectoris

Intervention / Treatment
-----------------
* Procedure: Coronary artery bypass grafting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Isolated coronary artery disease embracing all three main branches of the coronary artery tree. Exclusion Criteria: Kidney insufficiency (Creatinine > 120 µmol/L) War-farin anticoagulation therapy Ejection fraction < 40% Repeat operation Other concurrent sur-gery Signs of reduced circulation in non-dominant hand Other severe illness, or if the patient declines to participate.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Coronary artery bypass grafting|Bypass of stenoses in coronary arteries using different types os vessels as conduit.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional grafts defined as opened or closed. |  | Up to 5 years after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of stenosis in implanted grafts. |  | Up to 5 years after surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CABG, LIMA, saphenous vein, radial artery
Predictive Factors of Morbidity and Mortality and Overall Survival of Patients With Gastric Cancer : a Case Series

Study Overview
=================
Brief Summary
-----------------
This is a retrospective study extending over a period of three years concerning patients with gastric adenocarcinoma hospitalized in the digestive cancer surgery and liver transplant service of the IBN ROCHD University Hospital Center in Casablanca. Evaluation from a series of 80 cases of gastric adenocarcinomas, follow-up to determine the prognostic factors influencing mortality, morbidity and survival.

Official Title
-----------------
Predictive Factors of Morbidity and Mortality and Overall Survival of Patients With Gastric Cancer : a Case Series

Conditions
-----------------
Gastric Cancer, Mortality of Gastric Cancer, Overall Survival of Patients With Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: Total or subtotal gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with gastric cancer Exclusion Criteria: patients with benign tumors or other pathologies requiring gastric resection

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Total or subtotal gastrectomy|Gastric resection with digestive continuity according Roux or Bilroth|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | An overall survival of patients treated for gastric cancer | 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric cancer mortality, gastric cancer treatment
The Effect of Atorvastatin on Endothelial Cell Dysfunction in Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if patients with chronic kidney disease have endothelial cells that don't function properly, which is thought to be a marker for cardiovascular risk. Endothelial cells line the heart and blood vessels. The investigators will treat your high cholesterol with a cholesterol-lowering drug (atorvastatin, or Lipitor). They will determine if this cholesterol lowering drug improves subjects' cholesterol as well as the function of endothelial cells.

Official Title
-----------------
The Effect of Atorvastatin on Endothelial Cell Dysfunction in Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Disease, High Cholesterol

Intervention / Treatment
-----------------
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage 3, 4 and 5 chronic kidney disease (not on dialysis) Hyperlipidemia requiring cholesterol lowering therapy Aged 18 to 80 years old Ability to provide informed consent Exclusion Criteria: Patients requiring multiple cholesterol reducing agents Patients with neovascularization present, such as neoplasm, active wounds, or significant retinopathy Patients with contraindications or allergy to statins

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin<br>Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging. | Drug: Atorvastatin<br> <br> * Other names: Lipitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Counts of Endothelial Progenitor Cells | Improvement of endothelial cell (EC) dysfunction will be assessed by improved counts of endothelial progenitor cells. | baseline, 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic kidney disease, High cholesterol
Northwest Adult Congenital Heart Disease Observatory

Study Overview
=================
Brief Summary
-----------------
The incidence of congenital heart disease is about 8 per thousand live births. Thanks to advances in cardiac surgery, 90% of children born with heart defects reach adolescence and adulthood. Congenital heart defects are the leading cause of heart disease in young adults and expectant mothers in Western countries. The number of patients increases continuously as life expectancy increases. An increasing number of patients with complex heart defects survive to adulthood. The medico-surgical management of this highly specialized growing number of patients is difficult and requires a multidisciplinary collaboration. In France, an estimated 200,000 patients the number of carrier patients with congenital heart disease. Half of them will require monitoring, medical procedures, catheterizations and/or surgical re-intervention. No objective demographic data are currently available on the French patients. So, the investigators decided to set up an epidemiological project to better understand this cohort of patients. The main objective of this project is to obtain accurate epidemiological data needed to adapt the supply of care.

Official Title
-----------------
Northwest Inter Hospital Adult Congenital Heart Disease Observatory

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Other: description


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient, male or female, aged 18 years Congenital heart disease operated or non-operated Followed by a cardiologist specializing in congenital heart disease in the inter northwest region of France Exclusion Criteria: Patient refusal

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 |
| --- |
|Other: description|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients characteristics description | Obtain epidemiological data on adult congenital of the population followed in northwest region of France | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart disease complications description |  | baseline | 
| complications during pregnancy description |  | baseline |
Allogeneic Natural Killer (NK) Cell Therapy in Patients With Lymphoma or Solid Tumor

Study Overview
=================
Brief Summary
-----------------
Allogeneic natural killer (NK) cells (MG4101) were manufactured from normal healthy donor who underwent leukapheresis. These cells were processed based on a novel method for ex vivo activation and expansion using an irradiated and activated autologous feeder cell system. MG4101 has anti-tumor activities against various tumors including malignant lymphomas in vitro as well as in vivo tumor model.

Official Title
-----------------
A Phase I Study of Allogeneic NK Cell Therapy in Patients With Refractory/Relapsed Lymphoma or Solid Tumor

Conditions
-----------------
Malignant Lymphomas, Solid Tumors

Intervention / Treatment
-----------------
* Biological: Allogeneic NK cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Histologically or cytologically confirmed malignant lymphoma or solid tumor After the failure of standard treatment KPS >70 or ECOG PS 0-2 Adequate bone marrow, renal, and liver functions Expected survival at least 3 months Informed consent Exclusion Criteria: Pregnancy or lactating woman HIV patients Prior exposure to cell-based therapy Hypersensitivity to interleukin-2 Patients with autoimmune disease

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Singe-dose infusion<br>Cohort 1: 1x10^6 cells/kg Cohort 2: 1x10^7 cells/kg | Biological: Allogeneic NK cells<br> <br> |
| Experimental: Repeated dose infusion<br>Cohort 3: 1x10^6 cells/kg Cohort 4: 3x10^6 cells/kg Cohort 5: 1x10^7 cells/kg Cohort 6: 3x10^7 cells/kg | Biological: Allogeneic NK cells<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the MTD of allogenetic NK cells | DLT is defined as follows: Any toxicity at grade 3 or over for 5 days or more All grade 4 toxicities GVHD at grade 2 or over | 4-5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the overall response rate | RECIST v1.1 for solid tumor or revised response criteria for malignant lymphoma | 4-5 weeks | 
| To evaluate the safety | NCI-CTCAE v3.0 | 4 -5 weeks | 
| To evaluate the pharmacokinetics of allogeneic NK cells | To quantify the persistence of donor NK cells in recipients | 4-5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allogenetic NK cells, Lymphomas, Solid tumors
Strategies for Musculoskeletal Symptoms Relieving and Ergonomy in Operating Room

Study Overview
=================
Brief Summary
-----------------
It is well known that surgery requires not only a mental diligence, but also a real physical stress due to the need to assume particular postures for many hours or to repeat specific maneuvers several times. To this peculiar condition of surgical specialities over the years has been added the development of a series of instruments and technologies ranging from the use of loopes, to laparoscopic and robotic surgery. From the studies reported in the literature, between 74% and 87% of surgeons report symptoms related to their work with consequent effects on the quality of life (sleep loss, inability to carry out their recreational activities, etc.). Similarly, a lack of knowledge of the principles of ergonomics to be applied during the performance of one's surgical activity emerged, which could improve musculoskeletal symptoms with a positive effect on the quality of life of surgeons and consequently hoping for an improvement in professional performance.

Official Title
-----------------
Strategies for Musculoskeletal Symptoms Relieving and Ergonomy in Operating Room: a Prospective Clinical Trial. (MuSEO Study)

Conditions
-----------------
Musculoskeletal Pain, Surgery

Intervention / Treatment
-----------------
* Behavioral: ergonomics surgical workshop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: young surgeons Exclusion Criteria: no consent to partecipate

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>administration of Surgical ergonomics workshop | Behavioral: ergonomics surgical workshop<br>* ergonomics surgical workshop<br>|
| No Intervention: control<br>no intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of musculoskeletal symptoms |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Musculoskeletal Pain; ergonomics; surgery