linjc16/ctgov huggingface dataset:
The Advocate Study

Study Overview
=================
Brief Summary
-----------------
Hollister Incorporated is studying stoma related cost of care related to a new ostomy skin barrier that is designed to maintain adhesive properties and good peristomal skin health compared to other currently marketed barriers.

Official Title
-----------------
A Study Determining Variances in Ostomy Skin Conditions And The Economic Impact.

Conditions
-----------------
Ostomy

Intervention / Treatment
-----------------
* Device: Test Ostomy Barrier
* Device: Control Ostomy Barrier


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ostomy patients who: Have healthy peristomal skin Are within 12 weeks post op Exclusion Criteria: Ostomy patients who: Have a fistula, wound, lesion or suspected infection in the peristomal area Are in-patient in healthcare facility

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Test Ostomy Barrier<br>The test product is a new Hollister ostomy barrier. | Device: Test Ostomy Barrier<br> <br> |
| Other: Control Ostomy Barrier<br>The control product is a currently marketed Hollister ostomy barrier. | Device: Control Ostomy Barrier<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stoma Related Cost of Care | 12 week stoma related cost of care. Cost of care includes treatments related to ostomy and/or PSCs (topical medications, clinic visits, and selected accessory use), social impact of ostomy and/or PSCs (missed work/ appointments), ostomy-related hospitalizations, emergency department visits, physician/clinic visits, medication use and therapies, and product utilization. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peristomal Skin Complication Rate | Observed 8 week Peristomal Skin Complication (PSC) rate. The validated Ostomy Skin Tool DET score was used to describe the status of the peristomal skin. Subjects were deemed to have had a PSC if the DET score was above zero due to anything other than normal postoperative healing and/or scar tissue, or the DET score increased above the normal score obtained at a previous visit. | 8 weeks |
Evaluation of Venous Thromboembolism (VTE) Prophylaxis in Medically Ill Patients

Study Overview
=================
Brief Summary
-----------------
VTE prophylaxis is not as routinely employed in medically ill patients as compared to surgical patients. This retrospective chart review project will evaluate the effectiveness of VTE prophylaxis in medically ill patients at the University of Utah Hospitals and Clinics compared to current literature. The study will ultimately serve as a quality improvement project to help improve patient care.

Official Title
-----------------
Evaluation of Venous Thromboembolism (VTE) Prophylaxis in Medically Ill Patients

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized at the University of Utah on one our medical services. Exclusion Criteria: Patients received therapeutic anticoagulation.

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>Patients cared for before our intervention. | |
| 2<br>Patients cared for after our intervention. | Behavioral: Education<br>* (1) a risk-assessment tool completed at the time of a hospital admission, (2) structured educational sessions on VTE prevention, and (3) audit-feedback where institutional data was reviewed during the educational sessions. These sessions were given once to the clinical pharmacists and on three separate occasions to the medicine house officers.<br>|

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
-----------------
Venous Thromboembolism, Prevention, Quality Improvement, Education, Compliance with VTE prophylaxis
Mechanism of Action of Transcranial Magnetic Stimulation

Study Overview
=================
Brief Summary
-----------------
This is an observational neuroimaging study assessing the effects of TMS on the brains of patients with unipolar depression.

Detailed Description
-----------------
This project aims to use functional connectivity magnetic resonance imaging (fcMRI) to study patients with unipolar depression receiving TMS. Patients will be scanned before and after a full course of TMS and clinical measures for depression severity and memory will be obtained at the same times.The project has the following aims and hypothesis: (1) to determine the therapeutic antidepressant mechanism of action of TMS at the circuit level (2) to study the use of fcMRI as a state biomarker for depression (3) to study the use of fcMRI as a predictor of response for depression.

Official Title
-----------------
Mechanism of Action of Transcranial Magnetic Stimulation

Conditions
-----------------
Major Depressive Disorder, Depression

Intervention / Treatment
-----------------
* Device: Transcranial Magnetic Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females between the ages of 18-80 DSM-IV diagnosis of Depressive Episode Patients requiring TMS treatment as part of their psychiatric care Exclusion Criteria: Comorbid DSM-IV primary diagnoses of schizoaffective disorder, schizophrenia or dementia. Substance use disorder (abuse or dependence) with active use within the last 3 months Severe or unstable medical illness. MRI contraindications as determined by MGH department of radiology.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Other: Unipolar Depression<br>Patients diagnosed with unipolar depression. | Device: Transcranial Magnetic Stimulation<br>* Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects.<br>* Other names: TMS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Functional Connectivity of Key Nodes in Depression | Measured by Magnetic Resonance Imaging | Through Treatment Completion, Average of 6 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcranial Magnetic Stimulation
MASTER SL Clinical Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: to generate data to evaluate Orthopaedic Data Evaluation Panel (ODEP) rating to support existing short-term clinical results and CE documentation; to assess the clinical performance of the MASTER SL femoral stem and the DELTA TT acetabular cup under standard conditions of use; to determine any adverse events and assess whether they constitute risks when weighed against the intended performance of the device.

Official Title
-----------------
A Prospective, Observational, Multi-centre, Cohort Study of the MASTER SL Femoral Stem and the DELTA TT Acetabular Cup in Patients With Degenerative Disease of the Hip

Conditions
-----------------
Patients Requiring Hip Replacement

Intervention / Treatment
-----------------
* Device: MASTER SL femoral stem and DELTA TT acetabular cup


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female ≥18 years; Radiologically confirmed diagnosis of primary osteoarthritis (OA) of the hip and suitable for primary total hip replacement; Life expectancy of >10 years; Voluntary written Informed Consent obtained. Exclusion Criteria: Prospect for recovery to independent mobility compromised by known coexistent, medical problems; Requiring revision hip replacement; Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint; Previous organ transplant; Previous hip replacement (resurfacing or THR) on the contra-lateral side within the last 6 months; Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score <18 points; Body mass index (kg/m2) exceeds 40; Active or suspected infection; Known sensitivity to device materials; Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period.

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 |
| --- | --- |
| MASTER SL<br> | Device: MASTER SL femoral stem and DELTA TT acetabular cup<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of failure |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical progression measured with HHS score, OHS score, Non-Arthritic Hip Score, EQ-5D-5L |  | from baseline to all time-points |
The Effects of Angiotensin II Receptor Blockade on Kidney Function and Scarring After Liver Transplant

Study Overview
=================
Brief Summary
-----------------
This research study is being done to study the effects, both good and bad, of calcineurin inhibitors and the drug Cozaar (losartan), on kidney function and kidney scarring following a liver transplant.

Detailed Description
-----------------
This study is a double-blinded, placebo controlled trial to help determine the pathogenesis of chronic renal dysfunction in patients undergoing liver transplantation. It will examine the renal function and renal morphology in patients on calcineurin inhibitors and the effects of Cozaar (losartan) following liver transplantation. Participants will have blood, urine and iothalamate clearance test, to look at kidney function prior to transplant. At the time of transplant, kidney biopsies will be performed in the operating room under anesthesia. Participants will be in the study for one year. At three weeks following liver transplant, participants will be randomly assigned to receive either a placebo (inactive drug) or the study drug (losartan). The participant will need to continue to return to the clinic at the normal scheduled intervals. During these times blood and urine tests will be done. A kidney biopsy will be performed at the yearly exam and study pills will be stopped. The researchers will continue to follow participant's creatine measurements for the next 10 years.

Official Title
-----------------
A Randomized, Double-blinded, Placebo-controlled Study of Angiotensin II Receptor Blockade to Prevent Renal Dysfunction Following Liver Transplantation.

Conditions
-----------------
Liver Transplant Recipients

Intervention / Treatment
-----------------
* Drug: Cozaar


Participation Criteria
=================
Eligibility Criteria
-----------------
Participants who will be undergoing a liver transplant and are between the ages of 18 to 70 years of age.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of renal dysfunction (measured by iothalamate clearance). |  |  |
Clinical Observation Study With the SBG Stem

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, single-center, postmarket clinical observation to observe the clinical and radiographic long-term performance of the SBG hip stem.

Official Title
-----------------
Clinical Observation Study With the SBG Stem

Conditions
-----------------
Arthroplasty, Hip Replacement

Intervention / Treatment
-----------------
* Device: SBG hip stem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients requiring the implantation of the SBG hip stem Exclusion Criteria: general medical contraindications to surgery acute or recent infection of joint atrophy or deformation of upper femur muscular atrophy or neuromuscular disease pathologic fractures per- and subtrochanteric fractures revision of failed hip endoprosthesis hypersensitivity to used materials any conditions preventing stable anchoring of the hip prosthesis

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: SBG hip stem|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | Change in Harris Hip Score from Baseline to 10 years post surgery. The Harris Hip Score scales from 0-100 with higher values representing a better score. | Baseline and 10 years post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of position of hip stem | Change in hip stem position from Baseline to 10 years post surgery. | Baseline and 10 years post surgery | 
| Radiographic Analysis: classification of osseointegration of hip stem |  | 10 years post surgery | 
| Radiographic Analysis: radiolucent lines around hip stem | Radiographic measurements will be taken of linear radiolucencies. Radiolucent lines will be measured in mm. | 10 years post surgery | 
| Radiographic Analysis: number of participants with femoral osteolysis around hip stem |  | 10 years post surgery | 
| Radiographic Analysis: bone atrophy around hip stem | Radiographic measurements will be taken of bone atrophy. Bone atrophy will be measured in mm. | 10 years post surgery | 
| Radiographic Analysis: bone hypertrophy around hip stem | Radiographic measurements will be taken of bone hypertrophy. Bone hypertrophy will be measured in mm. | 10 years post surgery |
Non-steroidal Anti-inflammatory Drugs (NSAIDs) and Risk of Acute Kidney Injury in Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether non-steroidal anti-inflammatory drugs (NSAIDs) were associated with acute kidney injury (AKI) in patients with heart failure. In addition, the investigators would like to assess the risk of admission for acute decompensated heart failure following exposure to NSAIDs within 30 days.

Official Title
-----------------
Non-steroidal Anti-inflammatory Drugs (NSAIDs) and Risk of Acute Kidney Injury in Patients With Heart Failure

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patient's age was more than 20 years old Diagnosis of heart failure With prescription of NSAIDs (only oral and intravenous form are included) Exclusion criteria With prescription of NSAIDs administered by topical use Patient was pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Change from baseline in serum creatinine at 1 month | We collect not only patient's baseline serum creatinine level (defined as the median value of the previous-six-months serum creatinine), but also serum creatinine level on the detecting day (defined as the most recent day from index date we detecting the serum creatinine). Acute kidney injury is defined as the absolute increase in the serum creatinine concentration of ≥0.3 mg/dL from baseline; or a percentage increase in the serum creatinine concentration of ≥50 percent. | Baseline and 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission for acute decompensated heart failure |  | 1 month after exposure to NSAIDs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSAIDs, Heart failure, Acute kidney injury
Custom Foot Orthoses & Venous Status

Study Overview
=================
Brief Summary
-----------------
The purpose of the research is to compare the influence of customized foot orthoses use on the venous status among healthy female and male subjects. This is a quasi-experimental study which included 20 healthy subjects. Sociodemographic and medical record data are registered. Furthermore,venous function is evaluated by plethysmography, first, without orthoses and, after 20 days, with orthoses.

Official Title
-----------------
Influence of Custom Foot Orthoses on Venous Status

Conditions
-----------------
Foot, Foot Orthoses, Photoplethysmography, Venous Stasis

Intervention / Treatment
-----------------
* Other: Foot orthoses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects. Exclusion Criteria: Prior diagnosed conditions such as neurological, vascular or traumatic disorders.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foot orthoses<br>Customize foot orthoses | Other: Foot orthoses<br>* Customized foot orthoses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous filling time | Seconds | Change from Baseline venous filling time at 1 month |
A Volunteer Study to Collect Imaging Data for the Development of the Medaphor Anatomy Guide.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine if machine learning can be used to automatically highlight key anatomy on the ultrasound image to help anaesthetists perform ultrasound-guided regional anaesthesia.

Detailed Description
-----------------
The study will involve adult volunteers who are willing to be scanned by a trained sonographer to collect ultrasound video data for the following categories: Adductor canal Popliteal fossa Fascia Iliaca Rectus sheath Axillary region Each volunteer will be scanned to collect data for every category in the list. Where applicable, both sides of the body will be scanned. The videos will be segmented by hand to identify the relevant anatomical regions for each category. The primary objective for this study is to provide the range of data required to develop robust models in conjunction with additional data from patients undergoing a Peripheral Nerve Block procedure that are able to produce the desired segmentation on the unseen validation images. The models will be scored using the standard Mean intersection over Union pixel-level metric for semantic segmentation.

Official Title
-----------------
A Volunteer Study to Collect Imaging Data for the Development of the Medaphor Anatomy Guide.

Conditions
-----------------
Ultrasound Imaging of Anatomical Structures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, at least 18 years of age; Willing to undergo ultrasound scanning and provide ultrasound video data for the following categories: Adductor canal Popliteal fossa Fascia Iliaca Rectus sheath Axillary region Able to comprehend and sign the Informed Consent prior to enrolment in the study. Exclusion Criteria: Aged <18 years of age; Unwilling or unable to provide informed consent.

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 |
| --- | --- | --- |
| Model development | models with a Mean intersection over Union score of 0.95 or better for each region in each category. | 6 months |