linjc16/ctgov huggingface dataset:
A Study to Evaluate Endoflip Normal Ranges Data in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to establish the normal range of diameter and distensibility of pylorus and the fasting and postprandial antro-pyloric motility in healthy adults.

Detailed Description
-----------------
An Endoflip catheter will be placed through the mouth into the stomach in order to measure distal antral contractile activity and pyloric diameter and distensibility during fasting and after the ingestion of a standard meal

Official Title
-----------------
Normative EndoFlip Data on the Diameter and Distensibility of the Pylorus During Fasting and Postprandially in Healthy Females and Male Adults

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Diagnostic Test: Endoflip measurement of gastric and pyloric function


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females and males. Between the ages of 18 and 65 years. Body mass index between 18 and 35 kg/m^2. Exclusion Criteria: Heartburn, regurgitation, or symptoms suggestive of gastroparesis such as nausea, early satiety, postprandial bloating, and upper abdominal pain. Pregnant

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observational study of gastric and pyloric motor function measured with Endoflip<br>observational study of gastric and pyloric motor function measured with Endoflip during fasting and postprandial periods There is NO intervention | Diagnostic Test: Endoflip measurement of gastric and pyloric function<br>* Endoflip device to measure gastric and pyloric functions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting and postprandial pyloric diameter | Change in Pyloric diameter will be measured during fasting and postprandial using Endoflip | 1 hour prior to meal and 1 hour following standardized meal | 
| fasting and postprandial pyloric distensibility index | Change in Pyloric distensibility index will be measured during fasting and postprandial using Endoflip | 1 hour prior to meal and 1 hour following standardized meal | 
| fasting and postprandial distal antral motility index | Change in distal antral motility index will be measured during fasting and postprandial using Endoflip | 1 hour prior to meal and 1 hour following standardized meal |
Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effect of nutritional supplementation on the nutritional and clinical course of patients admitted to the hospital for hip fracture surgery.

Official Title
-----------------
Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Hip Fracture Surgery

Conditions
-----------------
Hip Fracture

Intervention / Treatment
-----------------
* Other: Medical Food Supplement
* Other: standard hospital food


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is > 45 years of age. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. Subject plans to undergo hip fracture surgery. Subject has anticipated length of hospital stay of at least 4 weeks. Subject is able to consume foods and beverages orally. Subject has admission total protein ≤ 70 g/L. Subject has screening serum albumin ≤ 38 g/L. Exclusion Criteria: Subject is known to be allergic or intolerant to any ingredient found in the study product. Subject has pre-planned surgery other than hip fracture surgery during the study period. Subject has alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances. Subject has active malignancy Subject has chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. Subject has diagnosis of IDDM. Subject has uncontrolled NIDDM determined by HbA1c > 8%.

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Medical Food Supplement<br>Medical food supplement to be given in divided portions in morning, afternoon and evening | Other: Medical Food Supplement<br>* Medical Food Supplement to be given in divided portions in morning, afternoon and evening<br>|
| Active Comparator: standard hospital food<br>standard hospital diet | Other: standard hospital food<br>* standard hospital diet ad. lib.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood chemistry |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product intake |  | 28 days | 
| Functionality (pain, mobility, strength) |  | 28 days | 
| Surgical site status |  | 28 days |
Correlation Between the Analysis of the Rapid Cortical Oscillations, the General Movements of the Preterm's and the Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
The general movement and the electroencephalogram analysis of the preterm have a high predictive value of the neuro-developmental outcome of the infants.

Detailed Description
-----------------
Compare the technical and the predictive characteristics of the qualitative analysis of the spontaneous motility with those of actual exams of reference diagnosis : magnetic resonance imaging, electroencephalogram and transfontanellar imaging.

Official Title
-----------------
Correlation Between the Analysis of the Rapid Cortical Oscillations, the General Movements of the Preterm's and the Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Other: Electroencephalogram, recording the movements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children been born between 15/01/08 and 15/01/10 children whose term is lower than 28 weeks of amenorrhoea Exclusion Criteria: Born child superior to 28 weeks of amenorrhoea presenting child a genic syndrome, an evolutionary neurological disease, a pathology malformative

Ages Eligible for Study
-----------------
Maximum Age: 23 Months

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

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

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: 1<br>Recording of the movements Recording of the electroencephalogram | Other: Electroencephalogram, recording the movements<br>* Electroencephalogram, recording the movements of the child, RMI, Transfontanel Imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To prove the predictive value of the  Deltas Brushes  triggered by hand or foot stimulation in correlation with the general movement analysis in the cerebral palsy diagnosis. |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To prove that the general movement of the preterm increases the predictive value the actual monitoring of the preterm's in the diagnosis of cerebral palsy. |  | 36 months |
Korean Multicenter Randomized Controlled Trial (RCT) of Pidogul for Patients With Coronary Stenting

Study Overview
=================
Brief Summary
-----------------
The aim of the current study is to compare the antiplatelet efficacy and safety of clopidogrel napadisilate and clopidogrel bisulfate in Coronary Artery Disease (CAD) patients after coronary stent implantation.

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

Intervention / Treatment
-----------------
* Drug: clopidogrel napadisilate + aspirin
* Drug: clopidogrel bisulfate + aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Korean men and women between the age of 20 and 85 Patients who were diagnosed as having CAD Patients who were planned to undergo PCI Exclusion Criteria: Patients who were not treated with PCI or intended to treat with PCI but failed Patients who were were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days Patients who were had a history of alcohol abuse or intoxication; (4) had hypersensitivity to clopidogrel or aspirin Patients who were had hypersensitivity to clopidogrel or aspirin Patients who were had abnormal laboratory results indicative of liver disease Patients who were had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding Patients who were were pregnant, breastfeeding, or not using effective methods of contraception Patients who were had other contraindication to study drug Patients who were had participated in another clinical study within 4 weeks prior to the start of this study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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: clopidogrel napadisilate + aspirin<br> | Drug: clopidogrel napadisilate + aspirin<br>* clopidogrel napadisilate 75mg + aspirin 100mg<br>|
| Active Comparator: clopidogrel bisulfate + aspirin<br> | Drug: clopidogrel bisulfate + aspirin<br>* clopidogrel bisulfate 75mg + aspirin 100mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of P2Y12 receptor inhibition |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events after study medication |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAD, PCI, Percutaneous Coronary Intervention
Gene-Environment Interaction in Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether certain environmental factors, namely occupational exposures and diet, have a greater effect on prostate cancer risk in the presence of selected inherited genetic factors.

Official Title
-----------------
Gene-Environment Interaction in Prostate Cancer

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
men diagnosed with prostate cancer before age 70 and race/age frequency matched healthy controls

Ages Eligible for Study
-----------------
Maximum Age: 69 Years

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

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
-----------------
gene, environment, occupation, diet, interaction
Test of Digital Breast Tomosynthesis vs. Regular Mammography in Detecting Breast Cancer in Women Undergoing Diagnostic Mammography

Study Overview
=================
Brief Summary
-----------------
Comparison of the ability of DBT and FFDM to detect breast cancer.

Official Title
-----------------
A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 2. Women Undergoing Diagnostic Mammography

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women ≥18 years or older and has underwent screening mammography and is now referred for diagnostic mammography Able and willing to comply with study procedures, and have signed and dated the informed consent form Surgically sterile or postmenopausal Exclusion Criteria: Pregnant or trying to become pregnant Has signs or symptoms of breast cancer Has been previously included in this study Has breast implants Has a history of breast cancer and is in active treatment Has breasts too large to be adequately positioned for the DBT examination

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mammography, mammogram, breast, Abnormal and normal breast tissue
Pharmacokinetic Study of ENVARSUS in Adult De-novo Kidney Transplant Patients

Study Overview
=================
Brief Summary
-----------------
Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients.

Official Title
-----------------
OPEN-LABEL, MULTICENTRE, RANDOMIZED CLINICAL TRIAL TO COMPARE THE PHARMACOKINETICS OF ENVARSUS® TABLETS AND ADVAGRAF® CAPSULES ADMINISTERED ONCE DAILY IN ADULT DE-NOVO KIDNEY TRANSPLANT PATIENTS

Conditions
-----------------
Organ or Tissue Transplant; Complications

Intervention / Treatment
-----------------
* Drug: ENVARSUS®
* Drug: ADVAGRAF®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recipients of a kidney transplant from a deceased donor or a living donor Exclusion Criteria: Recipient of any transplanted organ other than a kidney; Recipients of a bone marrow or stem cell transplant; Recipients of a kidney from a cardiac death donor; Recipients of a kidney from an ABO incompatible donor;

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: ENVARSUS tablets<br>Envarsus® (tacrolimus) prolonged-release tablets provided in 0.75 mg, 1.0 mg and 4.0 mg dose strengths. Envarsus® tablets will be administered orally once daily in the morning | Drug: ENVARSUS®<br> <br> |
| Active Comparator: ADVAGRAF capsules<br>Advagraf® (tacrolimus) prolonged-release hard capsules provided in 0.5 mg, 1.0 mg, 3.0 mg and 5.0 mg dose strengths. Advagraf® capsules will be administered orally once daily in the morning | Drug: ADVAGRAF®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tacrolimus Area under the curve (AUC 0-24h)r h*pg/mL |  | pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hr post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tacrolimus concentration 24 hours post-dose (C24hr) pg/mL | Whole blood trough drug concentration 24hour post dose | 24.0 hr post-dose | 
| Serum creatinine (mg/dL) |  | before dosing | 
| estimated glomerular filtration rate (eGFR) mL/min; |  | before dosing | 
| Heart Rate, (beats per minute) |  | before dosing | 
| Qt (milliseconds) |  | before dosing |
A Weight Loss Trial for Emotional Eating

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a new weight loss treatment which incorporates behavioral weight loss skills and skills for learning how to identify, manage, and cope with emotions helps with weight loss and emotional eating in people who are overweight and eat in response to emotions.

Official Title
-----------------
A Randomized Controlled Trial of a Novel Weight Loss Intervention for Obesity

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Behavioral Weight Loss
* Behavioral: Enhanced Behavioral Weight Loss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-smoker, free of diabetes, overweight and interested in losing weight, eat in response to emotions Exclusion Criteria: Diabetes, any major medical or psychiatric condition that would compromise ability to participate, hypertension, current mental health treatment

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: Behavioral Weight Loss<br>State of the art behavioral weight loss treatment | Behavioral: Behavioral Weight Loss<br>* Weekly group meetings addressing behavioral weight loss skills including calorie counting, exercise, behavior modification, environmental changes, and coping with triggers.<br>|
| Experimental: Enhanced Behavioral Weight Loss<br>Combines behavioral weight loss skills with skills specifically targeting emotional eating. | Behavioral: Enhanced Behavioral Weight Loss<br>* Weekly group meetings that combine behavioral weight loss skills (calorie counting, exercise, behavior modification, environmental changes) with skills to decrease emotional eating by learning ways to manage and cope with emotions without eating.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight change |  | 12 weeks and 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in emotional eating |  | 12 weeks and 20 weeks |
Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

Study Overview
=================
Brief Summary
-----------------
Observational Study of Hemoderivative Transfusion Imputable Complications in Initial Uncomplicated Heart Surgery. Inclusion criteria are patients who discontinued the mechanical ventilation up to 6 hours after exiting operation room and who discontinued vasoactive drugs up to the beginning of the second postoperative day. Blood transfusion might be only a marker of the patient severity.

Detailed Description
-----------------
Criteria for blood transfusion during extra corporeal circulation (if used) is volume expansion need leading to a predictable hematocrit lower than 25%. Criteria for blood transfusion after extra corporeal circulation or in the postoperative period is a hematocrit below 30% with signs of low cardiac output due to hypovolemia.

Official Title
-----------------
Observational Study of Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

Conditions
-----------------
Heart Diseases

Intervention / Treatment
-----------------
* Biological: Blood transfusion
* Biological: No blood transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acquired heart disease with indication for surgery and who discontinued the mechanical ventilation up to 6 hours after exiting operation room and who discontinued vasoactive drugs up to the beginning of the second postoperative day. Exclusion Criteria: Patients who received blood transfusion previous to the heart surgery.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transfusion<br>Patient who received blood transfusion in the perioperative period | Biological: Blood transfusion<br>* Blood transfusion in perioperative period.<br>|
| No Intervention: No Transfusion<br>Patients who did not receive blood transfusion in the perioperative period | Biological: No blood transfusion<br>* No transfusion in the perioperative period.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any postoperative complication | Postoperative complication up to 1 month. Comparison between patients who did or did not receive blood transfusion. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Surgery, Blood Transfusion, Postoperative Complications