linjc16/ctgov huggingface dataset:
Risk Factors for Morbidity After Parastomal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DVHD to uncover risk factors for readmission, reoperation (any indication), death and reoperation for recurrence after parastomal hernia repair.

Detailed Description
-----------------
All principal parastomal hernias registered in the Danish Ventral Hernia Database are included in the study. The included patients will be followed in up to 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.

Official Title
-----------------
Nationwide Prospective Study of Surgical Risk Factors for Poor Outcome After Parastomal Hernia Repair

Conditions
-----------------
Parastomal Hernia

Intervention / Treatment
-----------------
* Procedure: differences in surgical techniques


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All parastomal hernia repairs registered in the Danish National Ventral Hernia Database

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 |
| --- | --- |
| Patients with parastomal hernia repair<br>Patients registered in the Danish Ventral Hernia database | Procedure: differences in surgical techniques<br>* follow the risk for morbidity after incisional hernia repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence repair | Surgical risk factors for recurrence repair after parastomal hernia repair. | up to 4 years after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrence, readmission, reoperation, mortality, morbidity
Effects of Concord Grape Juice Alone on Glycemia, Appetite and Cognitive Function in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
Assess the impact of 100% grape juice on postprandial glycemic response and subsequent appetite, food intake and cognitive function.

Detailed Description
-----------------
Investigators earlier clinical work and published literature suggest that the phenolic content and strong flavor intensity of 100% Concord grape juice hold potential beneficial effects on appetite and glycemia. Investigators aim to better understand the use of 100% grape juice modifies appetite and glycemia acutely and over the day using a 24 hour glucose monitor.

Official Title
-----------------
Effects of Concord Grape Juice Alone on Glycemia, Appetite and Cognitive Function in Healthy Adults

Conditions
-----------------
Glycemic Response, Appetitive Behavior

Intervention / Treatment
-----------------
* Other: Concord Grape Juice
* Other: Low flavoniod low essence beverage
* Other: Low flavonoid beverage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 25.0-34.9 kg/m2 Willingness to eat all test foods Low consumer of tea and coffee, willingness to refrain from both during the 48 hours prior to test days and on the test day. Fasting blood glucose below 6.1mmol/l via capillary finger-stick blood sample using a SureStep glucometer (Lifescan, Milpitas, CA) Exclusion Criteria: Taking medications known to affect glycemia, lipid metabolism or appetite Body weight fluctuation of >5kg in the past 3 months Taking vitamin or other supplements Smokers Acute or Chronic disease

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Concord Grape Juice<br>100% Concord Grape Juice | Other: Concord Grape Juice<br>* Concord Grape Juice<br>|
| Sham Comparator: Low flavonoid low essence beverage<br>Low flavonoid low essence beverage | Other: Low flavoniod low essence beverage<br>* Low flavoniod low essence beverage<br>|
| Sham Comparator: Low flavonoid beverage<br>Low flavonoid beverage | Other: Low flavonoid beverage<br>* Low flavonoid beverage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood glucose over 24 hours | samples taken every 5 minutes for 24 hours by a continuous glucose monitor | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite | Questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly on same day as grape juice intervention | 24 hours |
Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI

Study Overview
=================
Brief Summary
-----------------
Tigecycline's activity against resistant organisms, as well as significant coverage of both gram-positive and gram-negative bacteria, may provide a valuable therapeutic alternative in treating patients with complicated skin and/or skin structure infections.

Detailed Description
-----------------
To evaluate the safety and the efficacy of tigecycline in treating hospitalized patients with complicated skin and/or skin structure infections.

Official Title
-----------------
A Multicenter, Open Label Study to Evaluate the Safety and Efficacy of Tigecycline to Treat Complicated Skin and Skin Structure Infections (cSSSI) in Hospitalized Patients

Conditions
-----------------
Skin Diseases, Infectious

Intervention / Treatment
-----------------
* Drug: Tigecycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized male and female patients, 18 years of age or older. Anticipated need for intravenous antibiotic therapy of 5 days or longer. Patients known or suspected to have a complicated skin and skin structure infection. Exclusion Criteria: Patients with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed. Patients with severely impaired arterial blood supply and insufficiency such that the likelihood of amputation of the infected anatomical site within one month is likely. Infected diabetic foot ulcers or decubitus ulcers where the infection is present for greater than one week's duration or chronically infected decubitus ulcers in patients who can not be compliant with measures necessary for chronic wound healing.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy endpoint will be the clinical response for all clinically evaluable patients (primary population) at the test-of-cure visit |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiological response at the patient level microbiological response at the pathogen level clinical cure rates by baseline pathogen response rates for patients with polymicrobial and monomicrobial infections |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tigecycline, cSSSI, complicated skin and skin structure infections
SGO Society of Gynecologic Oncologists Data Outcomes Project

Study Overview
=================
Brief Summary
-----------------
SGO Society of Gynecologic Oncologists Data Outcomes Project.

Detailed Description
-----------------
Examines data over period of time

Official Title
-----------------
SGO Society of Gynecologic Oncologists Data Outcomes Project

Conditions
-----------------
Pelvic Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Must have a pelvic mass with surgery taking place.
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
-----------------
Pelvic mass
Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0

Study Overview
=================
Brief Summary
-----------------
To validate the Respiration Rate Version 2.0 algorithm, housed in the Nellcor Bedside Respiratory Patient Monitoring System, for performance during motion conditions.

Official Title
-----------------
Evaluation of Respiration Rate Parameters During Motion in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0

Conditions
-----------------
Monitoring Arterial Oxygen Saturation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female subjects 18 years or older (inclusive) Subject is able to participate for the duration of the study Subject is willing to sign an informed consent Exclusion Criteria: Subject with abnormalities that may prevent proper application of the devices Physiologic abnormalities that prevent proper application of pulse oximetry sensor Severe contact allergies that cause a reaction to standard adhesive materials such as those fund in medical sensors and electrodes Subjects with significant arrhythmia, as determined by subject self-report during screening and I/E criteria assessment at study start. (Three events of irregularities in radial pulse with thirty seconds).

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the respiration rate performance in healthy adult volunteers during motion when compared to established technologies for measuring parameters related to respiration. |  | up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Portable pulse oximeter
Enhanced Triage for COVID-19

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate of the accuracy of biomarkers (i.e. circulating endothelial and immune activation markers) that indicate progression to severe disease in patients with suspected COVID-19 in the Emergency Department. It is a prospective observational study of patients presenting to emergency departments with a clinical suspicion of COVID19. All participants will have plasma samples collected for biomarker analysis, and will be tested for SARS-CoV-2 infection with a nasopharyngeal swab. Participants will be managed according to the best local practices.

Official Title
-----------------
Enhanced Triage for COVID-19 to Validate the Rapid Acute Lung Injury Diagnostic (RALI-Dx) Test

Conditions
-----------------
COVID-19, SARS-CoV 2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting with clinical suspicion of COVID-19 infection, as per UHN case definition at the time of presentation Age >18 years Ability to provide verbal informed consent Exclusion Criteria: Patients who are not suspected of COVID-19 infection, as per UHN definition at the time of presentation

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 |
| --- | --- | --- |
| Predictive Accuracy of Biomarkers for Risk Stratification | Given the expected clinical utility, we will use likelihood ratios (LRs) as our target milestone. +LR = (test sensitivity)/(1-test specificity); -LR= (1- sensitivity)/specificity. We will conservatively target benchmarks of +LR>5 for a disposition towards and a -LR<0.1 for a disposition away from mortality risk. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of Biomarkers as Indicators of Clinical Severity: Disposition post-ED visit (admitted vs discharged home vs discharged home and readmitted) |  | 28 days | 
| Performance of Biomarkers as Indicators of Clinical Severity: Hospital and ICU length of stay |  | 28 days | 
| Performance of Biomarkers as Indicators of Clinical Severity: Need for artificial respiratory support or hemodynamic support (mechanical ventilation, ECLS) |  | 28 days |
PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)

Study Overview
=================
Brief Summary
-----------------
To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction

Detailed Description
-----------------
To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction

Official Title
-----------------
Clinical Evaluation of Pacing During the Onset of Revascularization / Feasibility Study

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Device: Temporary RV VVI pacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of acute myocardial infarction, requiring PCI within 2 to 6 hours following symptoms Total occlusion of a coronary artery with reference vessel diameter >or= 3mm Exclusion Criteria: Thrombolitics Severe bradycardia requiring cardiac pacing Previous PCI or CABG Recent stroke or CV surgery Recent major surgery or trauma Clinical and hemodynamic unstability Implanted CRM device Evidence of previous MI Diabetes using rosiglitazone or other fibrates Permanent AF Mechanical tricuspid valve Pregnancy Exclusion for MRI Incapability of participating in exercise test

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: 1<br>Standard PCI procedure + pacing post conditioning | Device: Temporary RV VVI pacing<br>* temporary pacing at the onset of revascularisation<br>|
| No Intervention: 2<br>Standard PCI procedure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months |  | 4 & 12 months |
Clinical Characteristics of Aquagenic Pruritus in Patients With Myeloproliferative Neoplasms

Study Overview
=================
Brief Summary
-----------------
Description of the characteristics of aquagenic pruritus expressed by patients suffering from myeloproliferative neoplasms. Prospective work based on the distribution of a dedicated questionnaire.

Detailed Description
-----------------
Patients with myeloproliferative neoplasms identified and followed in our Institution (Brest University Hospital). Patients could be followed for polycythemia vera or essential thrombocythemia or myelofibrosis. Distribution of the questionnaire to each patients with myeloproliferative neoplasms (treated or not) suffering from aquagenic pruritus. Analyse of each characteristic of the aquagenic pruritus by a statistician and publication at the end.

Official Title
-----------------
Aquagenic Pruritus Among Patients With Myeloproliferative Syndromes (in English) Prurit Aquagénique Dans Les SYndromes MyéloProLifEratifs (in French)

Conditions
-----------------
Myeloproliferative Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients followed with myeloproliferative neoplasms suffering from aquagenic pruritus Exclusion Criteria: Unable to fulfil the questionnaire No written informed consent
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 |
| --- | --- | --- |
| Intensity of the pruritus | Analogic Visual Scale, from 0 to 10, Worse if >6 | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the pruritus | Timing expresses in minutes | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aquagenic pruritus
Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children

Study Overview
=================
Brief Summary
-----------------
To study the improvement in airway inflammation in children with asthma non-invasively with exhaled breath NO, a marker of inflammation, after therapy with nebulized budesonide as 0.5mg daily.

Detailed Description
-----------------
Comparisons will be made before and after 2 week therapy of nebulized budesonide in children not on prior anti-inflammatory medications.

Official Title
-----------------
Phase IV Study of the Effect of Nebulized Budesonide on Exhaled Nitric Oxide in Children, Four to Six Years of Age, With Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Nebulized Budesonide
* Device: Nitric Oxide Analyzer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthma diagnosis previously for 6 months Past asthma medication without change for previous 6 months Increased NO levels and ability to perform maneuver ICF signed by parents Exclusion Criteria: Systemic steroids in past 60 days,inhaled/nebulized steroids in past 4 weeks Hospitalization within 3 months Upper or lower airways active infection or cigarette smoke direct exposure Use of other asthma medications other than bronchodilators one month prior and during the trial Noncompliance

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 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 |
| --- | --- |
| Active Comparator: A<br>Nebulized budesonide | Drug: Nebulized Budesonide<br>* Pulmicort Respules 0.5mg/2cc<br>* Other names: Pulmicort Respules 0.5mg/2ml nebulized;Device: Nitric Oxide Analyzer<br>* Niox NO analyzer<br>* Other names: Niox NO analyzer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled breath nitric oxide pre- to post treatment |  | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry with peak flow measurements and daily diary scores |  | two weeks |
A Post Market Study on DRG Stimulation in FBSS (SYMPATHY)

Study Overview
=================
Brief Summary
-----------------
The purpose of this Post Market Observational Study is to monitor the effect of the Axium® SCS System in the management of chronic pain following surgical lumbar discectomy in subjects whom are routinely scheduled for treatment with the Axium® SCS System.

Official Title
-----------------
A Post Market ObServational StudY on the Effect of DRG StiMulation in PATients witH Chronic Pain Following Surgical Lumbar DiscectomY (Failed Back Surgery Syndrome): SYMPATHY

Conditions
-----------------
Failed Back Surgery Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 years old Subject is able and willing to comply with the follow-up schedule and protocol Chronic pain following surgical lumbar discectomy for at least 6 months Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain Minimum baseline pain rating of 60 mm on the VAS in the subjects' primary area of pain Subject is able to provide written informed consent Exclusion Criteria: Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study Escalating or changing pain condition within the past month as evidenced by investigator examination Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days Subject has had radiofrequency treatment of an intended target DRG within the past 3 months Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump Subject is unable to operate the device Subjects with indwelling devices that may pose an increased risk of infection Subjects currently has an active infection Subject has participated in another clinical investigation within 30 days Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation Subject has been diagnosed with cancer in the past 2 years. Subject has an anatomical spinal abnormality which is anticipated to require further surgery

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 |
| --- | --- |
| Treated subjects<br>All subjects recruited and treated wiht the Axium neurostimulator | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief | Assessed by change in pain intensity on a Visual Analogue Scale (VAS) from pre-treatment baseline | Post implantation at; 1 week and 1, 3, 6 and 12 months |