linjc16/ctgov huggingface dataset:
Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The study examines whether DPP-4 inhibition by vildagliptin affects the glucagon counterregulatory response to hypoglycemia in type 1 diabetes.

Detailed Description
-----------------
Vildagliptin (50 mg BID) or placebo is given as add-on to insulin treatment for four weeks in patients with type 1 diabetes. Then, a hypoglycemic clamp (2.5 mmol/l glucose) is undertaken with the determination of glucagon.

Official Title
-----------------
Study of the Effect of Vildagliptin on Glucagon Counterregulation Response During Hypoglycemia in Patients With Type 1 Diabetes

Conditions
-----------------
Diabetes, Hypoglycemia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes Age >18 years HbA1c 6.5-8,5% Exclusion Criteria: Pregnancy Lactation Acute infection Liver disease Treatment with cortisol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br>Vildagliptin (50 mg BID) given for four weeks | Drug: Vildagliptin<br>* Vildagliptin (50 mg BID) in four weeks<br>* Other names: Galvus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucagon response to hypoglycemia | Change in glucagon from before hypoglycemic clamp until after 45 min | 45 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catecholamine response to hypoglycemic | Change in catecholamines from before hypolycemic clamp to 45 min | 45 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DPP-4, GLP-1, Glucagon, Catecholamines, Counterregulation, Type 1 diabetes
Meropenem-FL058 Phase 2 Study in the Treatment of Complicated Urinary Tract Infections

Study Overview
=================
Brief Summary
-----------------
Phase 2, randomised, double-blind,double-dummy study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis.Treatment duration for each cohort was 7 to 14 days. Patients were not permitted to switch to oral therapy.

Official Title
-----------------
Phase Ⅱ, Randomized, Double-Blind,Double-Dummy Study Evaluating Safety,Tolerability,Efficacy of Meropenem-FL058 in Adult Patients With Complicated Urinary Tract Infections, Including Acute Pyelonephritis

Conditions
-----------------
Complicated Urinary Tract Infection, Acute Pyelonephritis

Intervention / Treatment
-----------------
* Drug: Meropenem- FL058
* Drug: Piperacillin -tazobactam
* Drug: Saline
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients, aged 18   75 years (inclusive);； Acute pyelonephritis or other complicated urinary tract infection. Exclusion Criteria: Patients needing concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups; Fungal urinary tract infection; History of allergic to any carbapenem, cephalosporin, penicillin, other β -lactam drugs or other β -lactamase inhibitors; Pregnant or breastfeeding women; Inability to tolerate intravenous fluids, due to medical reasons, of 1050 mL per day required for study drug administration; Unable or unwilling, in the judgment of the Investigator, to comply with the protocol.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meropenem-FL058 (180min infusion)<br> | Drug: Meropenem- FL058<br>* Meropenem-FL058(Meropenem 1000mg plus FL058 1000mg)q8h Meropenem-FL058(Meropenem 2000mg plus FL058 1000mg)q8h<br>Drug: Saline<br>* 30min<br>|
| Active Comparator: Piperacillin-Tazobactan (30min infusion)<br> | Drug: Piperacillin -tazobactam<br>* Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g)q8h<br>Drug: Saline<br>* 180min<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC). | Treatment success is defined as the composite of clinical outcome of Cure and the microbiological outcome of Eradication. | 5 to 9 days post-End of Treatment |
Video/Audio Distraction Analgesia for Simulated Oncology Procedure Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the analgesic efficacy of three different types of video/audio distraction in normal volunteers subjected to carefully controlled and non-injurious thermal pain delivered to the skin of the lower back, simulating discomfort of a lumbar puncture. Two of the distraction techniques include immersive virtual reality (VR). The most efficacious distraction technique will be used in a subsequent clinical study in cancer patients.

Official Title
-----------------
Video/Audio Distraction Analgesia for Simulated Oncology Procedure Pain

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Procedure: Virtual Reality distraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men and women 18-21y, 40-60y, or older than 60y Exclusion Criteria: a predisposition to motion sickness unusual sensitivity or lack of sensitivity to pain chronic pain peripheral neuropathy sensitive skin

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>3 cohorts: 18-21 years, 40-60 years, and older than 60 years | Procedure: Virtual Reality distraction<br>* Virtual Reality involves the participant wearing a helmet with sight and sound. the visual provided is a type of immersive video game, the game used is Snow World. In some cases the participant will be exposed to 3D representation of the game, and in other cases a lower tech version with less immersive qualities.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare positional techniques and differing types of VR presentation (immersive vs. low tech). We will also compare age cohorts (18-21, 40-60, and older than 60 years). |  | upon completion of data collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual Reality, Oncology, Lumbar puncture
ECG AI-Guided Screening for Low Ejection Fraction

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction.

Official Title
-----------------
Electrocardiogram Artificial Intelligence-Guided Screening for Low Ejection Fraction (EAGLE)

Conditions
-----------------
Asymptomatic Left Ventricular Systolic Dysfunction (Disorder), Heart Failure

Intervention / Treatment
-----------------
* Other: AI-enabled ECG-based Screening Tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary care clinicians who are part of a participating care team that care for adult patients and have the ability to order ECG and TTE (this includes physicians, nurse practitioners, and physician assistants). Exclusion Criteria: Primary care clinicians working in pediatrics, acute care, nursing homes, and resident care teams.

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Care teams randomized to intervention will have access to the screening tool. | Other: AI-enabled ECG-based Screening Tool<br>* A novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction.<br>|
| No Intervention: Control<br>Care teams randomized to control will continue routine practice. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New Diagnosis of Low Ejection Fraction (defined as ejection fraction ≤50%) | Ejection fraction obtained by echocardiography. | Within 90 days |
Hirschsprung Disease Trends

Study Overview
=================
Brief Summary
-----------------
Hirschsprung disease (HD) is associated with significant morbidities including long-term bowel dysfunction. The aim of this study was to update national and regional trends in the epidemiology and inpatient care utilization of HD in the United States between 2009 and 2014 using the National Inpatient Sample (NIS).

Official Title
-----------------
Inpatient Care Utilization and Epidemiology of Hirschsprung Disease in the United States: Analysis of the National Inpatient Sample

Conditions
-----------------
Hirschsprung Disease

Intervention / Treatment
-----------------
* Procedure: Pull through surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We included all patients who were 18 years or younger with an ICD-9-CM code of 751.3 for HD among the first 10 diagnosis. Exclusion Criteria: Data from 2015 to 2018 were not included since diagnoses and procedures were reported using the ICD-10-CM coding system.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pull through surgery|The principal purpose of pull through surgery for Hirschsprung disease is to remove aganglionic bowel and reconstruct the intestinal tract by connecting the normally innervated bowel just above the anus so that normal sphincter function is preserved.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study was to analyze cost of HD-related admissions in the United States between 2009 and 2014 using the National Inpatient Sample (NIS) database. |  | 2009 to 2014. |
Two or Six cm From Pylorus at Laparoscopic Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
Randomized controlled trial comparing between two technique of laparoscopic sleeve gastrectomy for treatment of morbid obesity. In the first technique the investigators started dissection of gastrocolic ligament 6 cm from pylorus and in the second one the distance was only 2 cm. The main primary outcome measure was weight loss.

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

Intervention / Treatment
-----------------
* Procedure: distance of dissection of gastrocolic ligament from pylorus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: morbid obesity with body mass index more than 40 or 35 with at least one comorbidity Exclusion Criteria: extreme of age less than 18 or over 65 years contraindications to laparoscopy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2 cm<br> | Procedure: distance of dissection of gastrocolic ligament from pylorus<br> <br> |
| Experimental: 6 cm<br> | Procedure: distance of dissection of gastrocolic ligament from pylorus<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | 12 months postoperative |
Influence of Dietary Nitrate on Time Trial Performance in Swiss Paracycling Athletes

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate wether beetroot juice or sodium nitrate enhances time trial performance in Swiss paracycling athletes compared to the ingestion of a placebo supplement. Furthermore, the effects of beetroot juice and sodium nitrate on performance will be investigated in spinal cord injured and non-injured athletes.

Detailed Description
-----------------
The influence of dietary nitrate on performance will be tested performing a time trial on a handbike. The time trial will be the same as in the Paralympics 2016 in Rio. The subjects perform three trials and receive another supplement for each trial: beetroot juice with 6mmol nitrate, 6mmol sodium nitrate or plain water (placebo supplement). The time to complete the time trial will be the main outcome parameter.

Official Title
-----------------
Influence of Dietary Nitrate on Paralympics 2016 Time Trial Performance in Swiss Elite Paracycling Athletes

Conditions
-----------------
Exercise Nutritional Physiology

Intervention / Treatment
-----------------
* Dietary Supplement: beetroot juice
* Dietary Supplement: sodium nitrate
* Dietary Supplement: water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy paracycling athletes healthy, able-bodied, upper-body trained individuals Exclusion Criteria: female smoking any medication affecting performance medical conditions affecting performance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: beetroot juice<br>beetroot juice containing 6mmol nitrate, ingested 3hours before the exercise test | Dietary Supplement: beetroot juice<br>* 6mmol nitrate<br>|
| Active Comparator: sodium nitrate<br>6mmol sodium nitrate dissolved in plain water, ingested 3hours before the exercise test | Dietary Supplement: sodium nitrate<br>* 6mmol sodium nitrate<br>|
| Placebo Comparator: water<br>85ml of plain water, ingested 3 hours before the exercise test | Dietary Supplement: water<br>* plain water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to perform trial |  | 3 hours after supplement ingestion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygen consumption during time trial performance measured by a metabolic cart (Oxycon Pro) in ml/min/kg |  | 3 hours after supplement ingestion |
A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy

Study Overview
=================
Brief Summary
-----------------
This will be a retrospective review of approximately 900 patients who have undergone laparoscopic myomectomy since 1999. patients will be contacted by phone and surveyed. All patients who have had laparoscopic myomectomy will be included. Only those not wishing to take part in the survey will be excluded. The data will then be compiled for statistical analysis , looking at pain, bleeding and subsequent fertility.

Detailed Description
-----------------
Patients will be called and surveyed using a survey tool. They will be asked about what factors lead them to have surgery and then was their issue resolved after surgery.

Official Title
-----------------
A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy

Conditions
-----------------
Laparoscopic Myomectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who are willing to be surveyed Exclusion Criteria: Those patients who are not willing to answer the survey will be excluded Those patients who are unable to be contacted( ie; moved) will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| I<br>Patients of Dr C Miller who have undergone laparoscopic myomectomy from 1999- to present | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| That patients who had pain prior to laparoscopic myomectomy will have less pain in 75% of the cases |  | since 1999 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| That patients who had menorrhagia prior to laparoscopic myomectomy would see a reduction after surgery 75% of the time |  | since 1999 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic, myomectomy, menorrhagia, pelvic pain
Post-Market Observational Study of Intra-Renal Drug Delivery

Study Overview
=================
Brief Summary
-----------------
This is a prospective, observational, multi-center study with consecutive enrollment. Up to 1,000 patients will be enrolled. The objective of this post-marketing surveillance study is to collect clinical usage patterns of the Benephit Infusion Systems. As a result, FlowMedica will be able to: Better understand and quantify usage patterns including patient characteristics, adjunctive procedures, and infusion agents. Collect user-interface information and overall customer satisfaction. Monitor post-marketing device performance.

Official Title
-----------------
Post-Market Observational Study of Intra-Renal Drug Delivery

Conditions
-----------------
Targeted Renal Therapy

Intervention / Treatment
-----------------
* Device: Targeted Renal Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exposure to one or more components of the Benephit Infusion System Ability to give written informed consent Exclusion Criteria: Inclusion in another clinical study that may affect usage of the Benephit system

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 |
| --- | --- |
| 1<br>All (consecutive) patients in whom one or more components of the Benephit Infusion System are planned to be used are eligible for enrollment in the study and should be offered informed consent. | Device: Targeted Renal Therapy<br>* Patient diagnosis, treatment, and follow-up are left to the discretion of the participating investigator. There are no requisites as to how patients should be managed as this is intended to be an observational study. No procedures other than usage of the Benephit Infusion System per its Instructions for Use are specifically required for participation in this study.<br>* Other names: Benephit XT Infusion System;|

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
-----------------
TRT, FlowMedica, Benephit, Patients, Components, Benephit Infusion System, Planned, To be used
Safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration : A Prospective Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find all kinds of complications and it's frequency related to the Endobronchial Ultrasound- Transbronchial Needle Aspiration (EBUS-TBNA) and to evaluate associated risk factors in patients who developed complications. The investigators performs EBUS-TBNA examination on all subjects that need mediastinal evaluation. All complications during or after the procedure will be recorded prospectively.

Official Title
-----------------
Safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration : A Prospective Study

Conditions
-----------------
Ultrasound, Complication

Intervention / Treatment
-----------------
* Device: Endobronchial ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mediastinal lymph node enlargement on chest CT or PET-CT Exclusion Criteria: Inadequate oxygenation during procedure uncontrolled cardiac arrythmia Bleeding diathesis Severe thrombocytopenia Recent use of clopidogrel Uncooperative 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Endobronchial ultrasound|EBUS-TBNA is a bronchoscopic diagnostic method that enables real time aspiration of paratracheal and peribronchial lesions.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications related with EBUS-TBNA | Complications during procedure Bleeding pneumothorax shock cardiac arrythmia change of oxygen saturation Complication after procedure fever bleeding pneumothorax all other comlications after 24hr | 1 month interval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors related with the development of complications | Midazolam/Lidocaine dosage Procedure time Total aspiration number Location of sampled lymph node Sampling number of lymph nodes Underlying disease Pulmonary function test | 1 month interval |