linjc16/ctgov huggingface dataset:
Sano V First In Human Study to Treat ED

Study Overview
=================
Brief Summary
-----------------
A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System

Official Title
-----------------
A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System

Conditions
-----------------
Erectile Dysfunction (ED)

Intervention / Treatment
-----------------
* Device: ED surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient understands and has signed the study informed consent form. Documented history of erectile dysfunction Sexually active Exclusion Criteria: - 1. Current participation in any clinical study with any investigational drug or device. 2. Patient is known or suspected not to tolerate the procedure, including exposure to contrast 3. Active infection or fever that may be due to infection 4. Life expectancy < 2 years due to other illnesses

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treating Patients with ED<br>Treatment of patients with ED | Device: ED surgery<br>* The surgical implant for ED treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The surgical implant for ED treatment | Primary Safety Endpoint • 30-day Freedom from Major Adverse Events | 12 months |
Higher Intensity Interval Training in Cardiac Rehabilitation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect higher intensity interval exercise (HIIT) with standard intensity non-interval exercise on fitness in cardiac rehabilitation patients with CAD. Also to assess practical implementation of HIIT in cardiac rehabilitation.

Official Title
-----------------
Practical Use of Higher Intensity Interval Exercise in Cardiac Rehabilitation to Improve Aerobic Fitness

Conditions
-----------------
CAD

Intervention / Treatment
-----------------
* Behavioral: HIIT
* Behavioral: Standard intensity non-interval training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 years Male or female Angiographic documentation of CAD Exclusion Criteria: Unstable angina pectoris MI / PCI < 3 weeks CABG < 4weeks Exercise induced ischemia > 1mm ST depression LVEF < 40% complex ventricular arrhythmias or atrial fibrillation orthopedic limitations to treadmill exercise

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIIT<br>Higher intensity interval training. | Behavioral: HIIT<br>* Higher intensity interval training.<br>|
| Active Comparator: Standard intensity non-interval training<br>Standard intensity non-interval training | Behavioral: Standard intensity non-interval training<br>* Standard intensity non-interval training.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular fitness |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAD, cardiac rehabilitation, fitness
Effect of Vildagliptin on Fat and Muscle Metabolism in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Please note this study is not being conducted in the United States. The purpose of this study is to test the hypothesis that acute DPP-4 inhibition with vildagliptin improves fat and muscle metabolism in patients with type 2 diabetes mellitus.

Official Title
-----------------
Effect of Vildagliptin on Adipose Tissue and Skeletal Muscle Metabolism in Obese Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: Vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be able to complete a 3-week wash-out of current anti-diabetic medication Cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose Must discontinue beta-blockers and lipid lowering drugs Blood glucose criteria must be met BMI in the range 30-35 Exclusion Criteria: History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes Need for insulin within 3 months or patients on thiazolidinediones Patients taking a sulfonylurea or metformin who cannot safely discontinue medication for the duration of the study Significant concomitant disease or complications of diabetes Patients with any history of gastrointestinal surgery or positive gastrointestinal symptons High tryglycerides as defined by the protocol Smokers who cannot abstain from smoking during the treatment periods

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vildagliptin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore whether vildagliptin augments insulin mediated inhibition of adipose tissue lipid mobilization following a mixed meal in patients with type 2 diabetes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the effects of vildagliptin on tissue carbohydrate metabolism (skeletal muscle) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vildagliptin, Type 2 diabetes
Project Bidof - Monovision by Pairing Bifocal and EDOF Lens

Study Overview
=================
Brief Summary
-----------------
Modern day cataract surgery isn't just a rehabilitative procedure anymore but rather aims at improving a patient's quality of life by reducing the need for spectacles in everyday life to a minimum. One way of achieving this goal is by using different lens technologies, such as a mono- or bifocal lens paired a lens with EDOF technology, as EDOF lenses provide an enhanced depth of focus by creating a single elongated focal point. As this method is well established, the aim of this study is to compare the monofocal/EDOF cohort to the bifocal/EDOF cohort and evaluate visual acuity and patient satisfaction for both combinations.

Official Title
-----------------
Project Bidof - Achieving Hybrid Monovision by Pairing Bifocal and EDOF Lens Technology

Conditions
-----------------
Cataract Senile

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 21 and 99 years signed informed consent form condition after cataract surgery Exclusion Criteria: no signed informed consent form laser treatment of the Cornea macular pathologies corneal pathologies irregular astigmatism pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 99 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 |
| --- | --- |
| Monodof<br>monofocal and EDOF lens | |
| Bidof<br>Bifocal and EDOF lens | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity | percentage of patients with binocular distance corrected visual acuity of logMAR > 0.2 | 6 months | 
| Intermediate Visual Acuity | percentage of patients with binocular intermediate distance corrected visual acuity of logMAR > 0.2 | 6 months | 
| Near Visual Acuity | percentage of patients with binocular near visual acuity logmar < 0.2 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| contrast vision | contrast sensitivity vision | 3 months | 
| Halo and Glare | Halo and Glare Simulator | 3 months | 
| Defocus curve | Defocus curve | 3 and 6 months |
Ambulation as a Factor on Oscillating Thermometry

Study Overview
=================
Brief Summary
-----------------
This research study aims to better understand how the plantar temperature data collected by the Podimetrics RTM System corresponds to physical activity level in subjects.

Detailed Description
-----------------
Subjects with prescription for monitoring with Podimetrics RTM System will be assigned activity monitors to track physical activity. Data from the Podimetrics RTM System and the activity monitor will be assessed after one month of use to determine any correlation between the two data sets and adherence to the use of activity monitor.

Official Title
-----------------
Ambulation as a Factor on Oscillating Thermometry

Conditions
-----------------
Diabetic Neuropathy Peripheral

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study subjects must Be at least 18 years old Not be pregnant Provide informed consent Have a prescription for monitoring with Podimetrics Remote Temperature Monitoring System Exclusion Criteria: Be younger than 18 years old Unable to understand English Unable to provide consent At the discretion of the investigator

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 |
| --- | --- |
| Emergent Inflammation<br>Subjects with emergent inflammation detected by Podimetrics RTM Mat within the last week. | |
| No Inflammation<br>Subjects with no emergent inflammation detected by Podimetrics RTM Mat within the last week. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of foot temperature data and daily activity in patients with emergent inflammation. | The primary objective of the study is to examine whether temperature data from subjects with inflammation to the plantar foot as determined by the Podimetrics RTM System is correlated with activity as measured by the activity monitor. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of foot temperature data and daily activity in patients without inflammation to the plantar foot. | The secondary objective of the study is to examine whether temperature data from patients without inflammation to the plantar foot as determined by the Podimetrics RTM System is correlated with subject activity as measure by the activity monitor. | 1 month |
PREPARE - Primary Prevention Parameters Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test specific device programming in patients without a previous history of a life-threatening, abnormally fast heartbeat who are implanted with a Medtronic ICD (Implantable Cardioconverter Defibrillator) or ICD with CRT (Cardiac Resynchronozation Therapy) device. The information learned from this study could be used to guide physicians in future ICD or CRT device programming.

Official Title
-----------------
PREPARE - Primary Prevention Parameters Evaluation

Conditions
-----------------
Tachycardia, Ventricular, Implantable Cardioverter Defibrillator (ICD), Fibrillation, Ventricular, Syncope

Intervention / Treatment
-----------------
* Device: Implanted Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is a candidate for a non-replacement Medtronic ICD device from the Marquis family or has had a non-replacement Medtronic Marquis based ICD system implanted within the previous 6 months and has not had any appropriately treated spontaneous VT/VF episodes during that time. Exclusion Criteria: Patient has history of spontaneous sustained symptomatic ventricular arrhythmias. If patient has had an electrophysiology test in the past, and has sustained inducible VT <180 bpm.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Implanted Device|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate that patients programmed using a prescribed set of parameters have a lower rate of cardiac syncope, symptoms of fast heart rate, VT/VF events and cardioversion or defibrillation shocks compared to patients programmed per physician discretion |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the percentage of inappropriate VT/VF detections |  |  | 
| characterize the true incidence of VT/VF detections |  |  | 
| therapy efficacy |  |  | 
| time to first inappropriate VT/VF detection |  |  | 
| incidence of untreated but monitored VT |  |  | 
| programming changes |  |  | 
| deaths and cardiovascular adverse event |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Implantable cardioverter defibrillator (ICD), Sudden Cardiac Death, Primary Prevention
A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if reduced port totally laparoscopic distal gastrectomy with complete D2 lymph node dissection for gastric cancer is safe and oncological feasible. 67 patients with gastric cancer with preoperative staging from T1 to T3 will undergo reduced port totally laparoscopic distal gastrectomy. The primary end point of this study is to measure compliance rate with pathology report and compare with previous compliance rate data.

Official Title
-----------------
A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection for Gastric Cancer Patients

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: reduced port laparoscopic distal gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed adenocarcinoma of the stomach Eastern Cooperative Oncology Group Eastern Cooperative Oncology Group performance status 0-1, signed informed consent location of the primary tumor in the antrum, angle and lower body no evidence of distant metastasis or invasion to adjacent organs or serosal infiltration Exclusion Criteria: metastatic disease previous history of malignancy in any organ any co-morbidity obviating major surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 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: reduced port<br>gastric cancer patients go through reduced port laparoscopic distal gastrectomy with D2 lymph node dissection | Procedure: reduced port laparoscopic distal gastrectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance rate (Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping) | Compliance rate : Cases with no more than one missing lymph node station according to the Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping | 1 month after enrollment of the patients | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric cancer, laparoscope
To Compare Outcomes After Transurethral Enucleation of Prostate Versus Transurethral Resection of Prostate

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess whether transurethral enucleation of prostate gives better or equivalent outcomes compared to the gold standard of transurethral resection of the prostate

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Procedure: TURP, TUERP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All who underwent TURP or TUERP Exclusion Criteria: Those with prostate cancer, neurogenic bladder, previous urethral or prostate surgery
Sexes Eligible for Study
-----------------
Male

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TURP<br> | Procedure: TURP, TUERP<br> <br> |
| TUERP<br> | Procedure: TURP, TUERP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum urinary flow rate |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BPH
Role of Subcutaneous Negative Pressure Suction Drain Placed for Ten Days on Wound Healing in Obese Patients Undergoing Midline Laparotomies

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the role of subcutaneous negative pressure drain placed for 10 days on wound healing in female obese patients undergoing midline exploratory laparotomies for ovarian cancer.

Conditions
-----------------
Postoperative Wound Healing

Intervention / Treatment
-----------------
* Procedure: Subcutaneous negative suction drain for 10 days
* Procedure: No subcutaneous drain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI more than 30kg/m2 midline laparotomies ovarian cancer Exclusion Criteria: associated medical disorders

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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: group a<br>This arm will receive subcutaneous negative suction drain for the midline wound for 10 days. | Procedure: Subcutaneous negative suction drain for 10 days<br> <br> |
| Active Comparator: group b<br>This arm will receive closure of the midline wound without a subcutaneous drain. | Procedure: No subcutaneous drain<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of a break in the skin wound |  | 10 days |
TRANSFORM-HF Ancillary Mechanistic Study

Study Overview
=================
Brief Summary
-----------------
Patients with heart failure are frequently treated with diuretics, including furosemide and torsemide, but it is not known if one is better than the other. The TRANSFORM-HF trial is studying if torsemide is superior than furosemide for reducing the endpoint of death or hospitalization, but is not designed to study why. This ancillary study seeks to measure proteins in the blood and urine to help explain the underlying mechanism for why patients who take one of these diuretics may have better outcomes than patients who take the other.

Detailed Description
-----------------
Patients who are enrolling in the TRANSFORM-HF study or being prescribed Torsemide or Furosemide at hospital discharge will provide blood and urine at the time of study enrollment (within 72 hours of hospital discharge) and at 90 days (+/- one week) after hospital discharge.

Official Title
-----------------
Mechanistic Insights From Longitudinal Changes in Blood and Urine Proteins to Explain Efficacy and Safety of Torsemide vs Furosemide After a Heart Failure Hospitalization

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in the TRANSFORM-HF trial or prescription of Torsemide or Furosemide Willing to provide blood and urine sample at enrollment and follow-up Exclusion Criteria: Inability or unwillingness to comply with the study requirements

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 |
| --- | --- |
| Torsemide<br>Patients enrolled in the TRANSFORM-HF study randomized to Torsemide, or patients prescribed Torsemide at hospital discharge | |
| Furosemide<br>Patients enrolled in the TRANSFORM-HF study randomized to Furosemide, or patients prescribed Furosemide at hospital discharge | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in proteomic protein clusters between treatment groups | How the biomarkers are different between groups | baseline | 
| Differences in trajectories of protein clusters between treatment groups | How the protein clusters change over time from baseline to 90 days | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in single biomarkers and biomarker trajectories between treatment groups | How the biomarkers are different between groups at baseline and how the biomarkers change over time from baseline to 90 days | baseline and 90 days | 
| Differences in urinary protein levels between treatment groups | How the in urinary protein levels are different between patient prescribed Torsemide vs Furosemide | baseline |