linjc16/ctgov huggingface dataset:
Evaluation of Vitrase as an Adjuvant to Increase Absorption and Dispersion of Other Injected Anesthetics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate Vitrase as an adjuvant to increase absorption and dispersion of other injected anesthetics

Official Title
-----------------
Phase IV Post-Approval Evaluation of Vitrase as an Adjuvant to Increase the Absorption and Dispersion of Other Injected Anesthetics for Ophthalmic Surgical Procedures

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

Intervention / Treatment
-----------------
* Drug: Vitrase (ovine hyaluronidase) Lyophilized


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for an ophthalmic surgical procedure Exclusion Criteria: Known allergy to bee venom

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vitrase (ovine hyaluronidase) Lyophilized|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate physician acceptance of efficacy of Vitrase as an adjuvant to increase absorption and dispersion of anesthetics used for ophthalmic surgical procedures |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine physician usage of and satisfaction with Vitrase in the 6200 USP unit vial |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adjuvants, Anesthesia, hyaluronate lyase
Comparison Study of Using Ultrasound Guidance for Hematoma Blocks vs. Traditional Approach

Study Overview
=================
Brief Summary
-----------------
Will use visual analog scales to compare effectiveness of traditional hematoma block vs ultrasound guided hematoma block with regards to pain. This will be done for closed forearm fractures.

Official Title
-----------------
Are Ultrasound-guided Hematoma Blocks for Distal Forearm Fractures Superior to the Landmark-guided Method for Hematoma Blocks?

Conditions
-----------------
Forearm Fracture

Intervention / Treatment
-----------------
* Other: ultrasound guided hematoma block
* Other: ultrasound guided hematoma block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Closed forearm fracture Exclusion Criteria: Mentally impaired, visually impaired or deaf Age < 18 Alcohol on board

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 |
| --- | --- |
| Other: traditional hematoma block<br>people will receive traditional hematoma block for closed forearm fractures | Other: ultrasound guided hematoma block<br>* pt. will receive ultrasound guided hematoma block<br>* Other names: ultrasound;|
| Other: ultrasound guided hematoma block<br>pts. will receive a hematoma block using bedside ultrasound to guide the placement | Other: ultrasound guided hematoma block<br>* ultrasound will be used to guide hematoma blocks<br>* Other names: ultrasound;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale movement |  |  |
Xanthine Oxidase Inhibition in Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Cardiovascular disease is the leading cause of mortality in kidney transplantation. The enzyme xanthine oxidase may play an important role in the cardiovascular disease of kidney transplant recipients. Inhibiting this enzyme with allopurinol may improve vascular health and protects against cardiovascular complications.

Detailed Description
-----------------
This is a prospective, double-blind, placebo controlled, clinical trial examining vascular effects of allopurinol in patients who received a kidney transplant that are maintaining stable renal function for at least 1 year. End-points include pulse-wave velocity, systemic blood pressure and kidney function among others.

Official Title
-----------------
Xanthine Oxidase Inhibition in Renal Transplant Recipients

Conditions
-----------------
Complications of Renal Transplant

Intervention / Treatment
-----------------
* Drug: allopurinol or placebo
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years or older both genders recipients of living donor or deceased-donor kidney transplant with stable renal function Exclusion Criteria: history of gout allergy to allopurinol use of azathioprine

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allopurinol<br> | Drug: allopurinol or placebo<br>* Daily active drug (allopurinol administered orally) administered orally for 3 years.<br>|
| Placebo Comparator: Placebo (sugar pill)<br> | Other: Placebo<br>* Sugar pill administered orally for 3 years.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Events | Number of major cardiovascular events | 3 years | 
| Endothelial Function | Changes in flow-mediated dilatation of braquial artery. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Stiffness | Changes in pulse wave velocity. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiovascular disease, kidney transplantation
Natural History Study in Huntington Disease Gene Expansion Carriers (HDGECs) - SHIELD HD

Study Overview
=================
Brief Summary
-----------------
SHIELD HD is an international, multisite, prospective, longitudinal cohort natural history study to assess the natural history of HD and its biomarkers that are associated with modulation of the number of cytosine-adenine-guanine (CAG) repeats in the mutant Huntingtin (HTT) gene. Approximately 60 patients will be enrolled into the study and followed for up to 24 months at clinical sites in North America and Europe. The results of this study will inform assessments for a future interventional treatment trial.

Detailed Description
-----------------
The rationale for this study is to obtain longitudinal information related to Somatic Instability and DNA damage response genes in HDGECs at various stages of the disease. Established assessments of disease progression will also be recorded.

Official Title
-----------------
Natural History Study in Prodromal and Manifest Huntington Disease Gene Expansion Carriers (HDGECs) - SHIELD HD

Conditions
-----------------
Huntington Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria Patients who meet all of the following criteria will be eligible to participate in the study: Capacity to comprehend the study objectives and procedures Documentation of genetically confirmed disease by direct DNA testing, defined as a CAG repeat length ≥39 in the HTT gene Ability to undergo and tolerate MRI scans Ability to tolerate blood draws and lumbar punctures Key Exclusion Criteria Patients who meet any of the following criteria will be excluded from participation in the study: Any conditions, including severe chorea and dementia, that would prevent either writing or performing pen and paper, tablet, or computer based tasks as determined by the Investigator Treatment with an investigational drug within 30 days prior to screening or within 5 half lives of the investigational drug, whichever is longer History of gene therapy or cell transplantation or any other experimental brain surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 63 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 |
| --- | --- | --- |
| DDR gene expression | To assess deoxyribonucleic acid (DNA) damage repair (DDR) gene expression in accessible biofluids and disease trajectories for established and novel biomarkers and clinical outcomes. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare rates of change in biomarkers for disease progression | To compare the rates of change for different outcomes and cytosine adenine guanine (CAG) age product (CAP) Scores. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HD
Study of Imaginomics Predicting Early Surgical Rates in Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Crohn's disease (CD), a type of inflammatory bowel disease (IBD), is a chronic intestinal recurrent inflammatory disease involving the entire digestive tract. Most CD patients require surgery for complications, including stenosis, perforation, and severe intestinal bleeding. Predicting early-onset surgery risk is of great importance to assist launching of therapeutic strategies. We aim to establish a digital prognostic model and nomogram using radiomics, which will help clinical practice.

Official Title
-----------------
Study of Imaginomics Predicting Early Surgical Rates in Crohn's Disease

Conditions
-----------------
Crohn Disease, Prognostic Model, Radiomics

Intervention / Treatment
-----------------
* Other: CTE examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a confirmed diagnosis of CD; a follow-up more than 1 year; without previous CD-associated intestinal surgeries; complete data of CTE. Exclusion Criteria: patients without a confirmed diagnosis of CD; with incomplete data and a follow-up less than 1 year; patients have previous intestinal surgeries; patients who have never undergone CTE examination.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CD<br> | Other: CTE examination<br>* each patients should have undergone CTE examination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentages of surgery at one-year after diagnosis | percentages of surgery at one-year after diagnosis | 2017-2021 |
COVID-19 Mortality Prediction Model

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to develop and evaluate an algorithm which accurately predicts mortality in COVID-19, pneumonia and mechanically ventilated ICU patients.

Detailed Description
-----------------
Retrospective study of 53,001 total ICU patients, including 9,166 patients with pneumonia and 25,895 mechanically ventilated patients, performed on the MIMIC dataset. The NPH patient dataset includes 114 patients positive for SARS-COV-2 by PCR test.

Official Title
-----------------
Mortality Prediction Model for the Triage of COVID-19, Pneumonia and Mechanically Ventilated ICU Patients

Conditions
-----------------
COVID-19, Pneumonia, Mechanical Ventilation

Intervention / Treatment
-----------------
* Device: COViage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years or older Record of ICU stay Exclusion Criteria: Patients aged less than 18 years Patients for which there were no records of raw data or no discharge or death dates.

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 |
| --- | --- |
| COViage<br>Machine learning intervention | Device: COViage<br>* The COViage machine learning algorithm is designed to predict mortality in COVID-19, pneumonia and mechanically ventilated ICU patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality outcome in COVID-19 ICU patients | Deceased or not deceased | Through study completion, an average of 2 months | 
| Mortality outcome in mechanically ventilated ICU patients | Deceased or not deceased | Through study completion, an average of 2 months | 
| Mortality outcome in pneumonia ICU patients | Deceased or not deceased | Through study completion, an average of 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
machine learning, COVID-19, mortality, prediction, pneumonia, mechanical ventilation
Efficacy of Seprapack Sinus Dressing Versus No Dressing in the Prevention of Intranasal Adhesions Following Sinus Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if the space occupying effect of Seprapack will lead to a reduction in post operative adhesions and more healing of the sinus cavity when compared to the use of no packing material.

Conditions
-----------------
Chronic Sinusitis

Intervention / Treatment
-----------------
* Device: Seprapack Sinus Dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years of age requiring bilateral endoscopic ethmoidectomy (anterior or posterior) intact middle turbinates willing to return for all follow-up visits signed written informed consent Exclusion Criteria: patients with craniofacial abnormalities (e.g. cleft palate) patients without intact middle turbinates patients on long-term oral steroids or other chemotherapeutic agents that might delay healing. Short-term pulse steroid therapy and topical steroids are acceptable patients with inflammatory conditions, other than chronic sinusitis or nasal polyposis, including but not limited to sarcoidosis, rhinitis, ozena, Wegner's granulomatosis, nasal malignancy, recreational drug abuse patients with cystic fibrosis women that are pregnant or women of childbearing age potential who are not practicing an acceptable method of birth control patients with bleeding disorders or who are receiving anticoagulants patients that may require a Lothrop procedure

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Seprapack Sinus Dressing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in post-operative scarring when compared to use of no sinus packing |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sinus
Endocrine Dysfunction and Quality of Life After Subarachnoid Hemorrhage

Study Overview
=================
Brief Summary
-----------------
Investigation of the incidence of endocrine dysfunction following subarachnoid hemorrhage (SAH), and to see if this has a relation to CNS lesions as evaluated by MRI and to common symptoms after SAH such as general exhaustion, lack of initiative, increased sleep demand and reduced quality of life.

Official Title
-----------------
Endocrine Dysfunction and Quality of Life After Subarachnoid Hemorrhage

Conditions
-----------------
Endocrine Dysfunction, Cerebral Infarctions, Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute aneurysmal subarachnoid hemorrhage Exclusion Criteria: unable to give informed consent

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 |
| --- | --- |
| Patients with subarachnoid hemorrhage<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Groin Wound Infection Rate Using Prevena Compared to Standard Dressing in Vascular Surgery Patients With High Risk

Study Overview
=================
Brief Summary
-----------------
Evaluate wound healing using Prevena compared to standard dressings in high risk patients after vascular surgery.

Detailed Description
-----------------
Patients submitted to bilateral femoral endarterectomy will have one groin dressed with PrevenaTM and the contralateral one dressed with conventional bandage immediately after suture. Both PrevenaTM and the conventional bandage at the contralateral side will be removed before the patient discharge. Groin wound complications such as deep space infection, cutaneous cellulitis, dehiscence or re-interventions for wound-related complications will be observed in a 30-day evaluation window. This observation will be performed during the patient admission and in the post-operative standard of care visits among the first 30 days.

Official Title
-----------------
Experience With the Negative Pressure Incision Management System (Prevena) in Vascular Surgery Patients With High Risk for Groin Wound Infection

Conditions
-----------------
Endovascular Procedures

Intervention / Treatment
-----------------
* Other: Prevena Dressing
* Other: Conventional Dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with known bilateral vascular peripheral disease who are being evaluated for possible bilateral femoral endarterectomy Patients with one or more risk factor (diabetes mellitus, Obesity, heavy smoker, immunodeficiency disease, groin reoperation, prosthetic) Patients in follow-up at Clinic in the Vascular Surgery Department Sign of informed consent English speaking Exclusion Criteria: Refusal to participate pregnancy unilateral femoral endarterectomy subjects for whom Prevena IMS is contraindicated

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patient will be randomized sequentially to Prevena alternating with standard of care dressing
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevena Dressing<br>Groin dressed with Prevena | Other: Prevena Dressing<br>* Prevena dressing is applied on one groin<br>|
| Active Comparator: Conventional Dressing<br>Groin dressed with conventional bandage | Other: Conventional Dressing<br>* Conventional dressing is applied on the contralateral groin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of infection at 30 days | % of wound occurrence in the Prevena treated groin compared to conventional treated groin | 30 days |
Double-Blind Naltrexone in Kleptomania

Study Overview
=================
Brief Summary
-----------------
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.

Detailed Description
-----------------
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with kleptomania. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to steal in patients with kleptomania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Official Title
-----------------
A Double-Blind, Placebo-Controlled Study of Naltrexone in Kleptomania

Conditions
-----------------
Kleptomania

Intervention / Treatment
-----------------
* Drug: Naltrexone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women age 21-75 current DSM-IV kleptomania. Exclusion Criteria: unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination history of seizures myocardial infarction within 6 months current pregnancy or lactation, or inadequate contraception in women of childbearing potential clinically significant suicidality current or recent (past 3 months) DSM-IV substance abuse or dependence illegal substance within 2 weeks of study initiation initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of kleptomania within 3 months prior to study baseline initiation of a psychotropic medication within 2 months prior to study inclusion previous treatment with naltrexone treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Active Comparator: A<br>Naltrexone | Drug: Naltrexone<br>* daily<br>* Other names: Revia;|
| Placebo Comparator: B<br>Placebo | Drug: Placebo<br>* daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS) | The K-YBOCS measures symptom severity (urges/thoughts and behavior) across the past week. Scores range from 0 (no symptoms) to 40 (highest symptom severity). | K-YBOCS is done at each visit by the investigator. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Compulsive Shoplifting, Kleptomania, Compulsive Stealing