linjc16/ctgov huggingface dataset:
Prevention of Parastomal Hernia by Primary Mesh Insertion

Study Overview
=================
Brief Summary
-----------------
Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. Preliminary investigations suggest a role for primary mesh placement to prevent parastomal hernia. The use of a mesh as a preventive measure is a safe procedure. This study will focus on the effect of primary mesh placement (two different operative procedures are used) compared to patients without mesh placement.

Official Title
-----------------
Prevention of Parastomal Hernia by Primary Mesh Insertion: a Randomized Double-blinded Controlled Multi-centre Study.

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

Intervention / Treatment
-----------------
* Device: onlay mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Permanent end-colostomy after surgery for rectosigmoid cancer with extirpation or Hartmann's procedure. Exclusion Criteria: ASA > 3 Acute surgery Known immune deficiency Surgery with insertion of foreign body (orthopaedic prosthesis, mechanical or bio-logical heart valve etc.) within the last 3 months. Pregnancy Known inflammatory bowel disease Lack of written 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?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: onlay mesh<br> | Device: onlay mesh<br>* StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)<br>|
| Active Comparator: sublay mesh<br> | Device: onlay mesh<br>* StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)<br>|
| No Intervention: no mesh<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parastomal hernia verified by CT-scan |  | one year after surgery, reassessed after 2, 3 and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically detected parastomal hernia |  | one year after surgery, reassessed after 2, 3 and 5 years | 
| Pain |  | one year after surgery, reassessed after 2, 3 and 5 years | 
| Disease specific and general health questionnaire |  | one year after surgery, reassessed after 2, 3 and 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parastomal hernia, Onlay mesh, Sublay mesh, Pain, Health questionnaire
Covid-19 Patients Management During Home Isolation

Study Overview
=================
Brief Summary
-----------------
The study will investigate management of Covid-19 patients in home isolation.

Detailed Description
-----------------
A clinical trial concerned with the treatment of home isolated COVID-19 patients

Official Title
-----------------
Covid-19 Patients Management During Home Isolation

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Procedure: Oxygen therapy and physical therapy
* Device: Oxygen therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Covid-19 patients American Society of Anesthesiologists (ASA) class I >= 21 years old <= 40 years old Exclusion Criteria: Not being consistent with home-isolation regimen

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 42 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxygen therapy and physical therapy<br> | Procedure: Oxygen therapy and physical therapy<br>* Patients receive oxygen therapy and physical therapy<br>|
| Active Comparator: Oxygen therapy<br> | Device: Oxygen therapy<br>* Patients receive oxygen therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for recovery of pH | Acidity Potential Hydrogen | 24 hours | 
| Time for recovery of PaO2 | Partial Pressure of Oxygen | 24 hours | 
| Time for recovery of PaCO2 | Partial Pressure of Carbon Dioxide | 24 hours | 
| Chest CT scan | Chest computed tomography scan | Baseline | 
| Chest CT scan | Chest computed tomography scan | 1 day post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for recovery of Temperature | vital sign | 24 hours | 
| Time for recovery of Respiratory Rate | vital sign | 24 hours | 
| Time for recovery of Oxygen Saturation | vital sign | 24 hours | 
| Time for recovery of Heart Rate | vital sign | 24 hours | 
| Time for recovery of Blood Pressure | vital sign | 24 hours |
Topiramate for the Treatment of Methamphetamine Dependence - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence.

Official Title
-----------------
Phase 2, Double-Blind, Placebo-Controlled Trial of Topiramate for the Treatment of Methamphetamine Dependence

Conditions
-----------------
Methamphetamine

Intervention / Treatment
-----------------
* Drug: Topiramate
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment seeking individuals as the time of the study Must be able to proved written informed consent Must have a body mass index greater than 18 kg/m(2) Must meet DSM-IV criteria for methamphetamine dependence Must currently be using methamphetamine as confirmed by a positive urine test over the past 14 days If female of child bearing potential, must agree to use birth control Exclusion Criteria: Please contact the site for more information

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topiramate<br>Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks. | Drug: Topiramate<br> <br> * Other names: Topamax;|
| Placebo Comparator: Placebo Oral Tablet<br>After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks. | Drug: Placebo Oral Tablet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence (Weeks 6 - 12) | The number of participants who abstained from methamphetamine from weeks 6 through 12 | weeks 6 through 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence (Weeks 1 - 12) | Number of participants who abstained from methamphetamine from weeks 1 through 12 | Weeks 1 through 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methamphetamine addiction
The Paired Donation Consortium Paired Donation Program

Study Overview
=================
Brief Summary
-----------------
The purpose of the protocol is to increase the number of living donor transplants by eliminating immune incompatibilities between donors and recipients through paired donation.

Detailed Description
-----------------
The purpose of the protocol is to increase the number of living donor transplants by eliminating immune incompatibilities between donors and recipients through paired donation. To increase the number of patients transplanted by paired donation by establishment of regional paired donation programs. To develop educational programs for potential living donors and their recipient, as well as the opportunity for transplant professionals to increase acceptance of the PDC to maximize the opportunity for organ donation. To identify and evaluate ethical and psychological factors that may influence the effects of paired donation on living kidney donation.

Official Title
-----------------
The Paired Donation Consortium Paired Donation Program

Conditions
-----------------
Kidney Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons capable of providing written informed consent. Each recipient must have one or more medically suitable donors who are either ABO-incompatible or HLA-incompatible. Exclusion Criteria: Persons with eligible, compatible donor.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney, Transplant, Paired donation, Living donor
Immunology of Failing Metal-on-Metal Hip Replacement

Study Overview
=================
Brief Summary
-----------------
Metal-on-metal total hip replacement (MoM THR) has been targeted at younger patients with anticipated long-term survival since the bearing surfaces wear less than the traditional metal-on-plastic (MoP) replacements. However, the production of metal ions as a result of the wear is a concern because of the possible toxicity to cells. In Norwich England a number of different metal-on-metal implants have been trialed of which one, the Ultima TPS, has had very poor results. A total of 545 patients have had 652 MoM THRs with the Ultima TPS of whom more than 20% have now been revised. There is an ongoing MHRA program to screen for problems using MRI scans with a technique developed in Norwich. Investigations so far show massive corrosion in the implants with a catastrophic immune response causing death of cells. This may include death of bone leading to fracture. In a third of patients revised there has been pain but normal plain X-rays. In some patients without pain who have been screened there are abnormal changes on an MRI scan. We wish to investigate the immune cells in patients to find out why this has happened. The study will include patients coming for a new hip to act as a comparator, as well as those with a MoM THR and patients being revised with MoM THRs, and MoP THRs. We shall also investigate patients with other MoM THRs opportunistically.

Detailed Description
-----------------
To characterize dendritic cell (DC) populations in MoM THR patients. Dendritic cells are cells that migrate from the circulating blood into tissues and mop up foreign material such as viruses with their abnormal surface makers (antigens)and metal debris, activating specialist white blood cells (such as T cells) that kill viruses and remove abnormal material.

Official Title
-----------------
Immune Cell Involvement in the Tissue Response to Metallosis in Patients With Failed Metal-on-metal Hip Replacements

Conditions
-----------------
Infection of Total Hip Joint Prosthesis, Implants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undergone Ultima TPS THRs in Norwich Patients with a MoP THR under going revision. Patients undergoing primary hip replacement with osteoarthritis Patients with other MoM THRs undergoing revision Exclusion Criteria: Patients undergoing primary THR with rheumatoid arthritis or other inflammatory arthritides, or secondary to infection
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 |
| --- | --- | --- |
Evaluation of Repeat Administration of Purified Poloxamer 188

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of repeat administration of MST-188 during vaso-occlusive crisis of sickle cell disease. Additionally, this study will evaluate the development of acute chest syndrome during VOC and re-hospitalization for recurrence of VOC.

Official Title
-----------------
Evaluation of Repeat Administration of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC-E): An Open-Label Safety Extension Trial Assessing Repeat Administration of MST-188 (Purified Poloxamer 188) Injection in Subjects With Sickle Cell Disease Experiencing Vaso Occlusive Crisis

Conditions
-----------------
Sickle Cell Disease

Intervention / Treatment
-----------------
* Drug: MST-188


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed participation in study MST-188-01 (EPIC study) Subject age 4 through 65 years Subject is experiencing acute pain typical of VOC and requires treatment with parenteral opioid analgesia Subject requires hospitalization Exclusion Criteria: Subject has acute chest syndrome Subject's laboratory results indicate inadequate organ function Subject is pregnant or nursing an infant Subject had a painful crisis requiring hospitalization within the preceding 14 days Subject has been transfused within the past 14 days Subject has complications related to SCD

Ages Eligible for Study
-----------------
Minimum Age: 4 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Drug<br>MST-188 | Drug: MST-188<br>* Intravenous administration as 100 mg/kg for 1 hour followed by 30 mg/kg/hour for up to 48 hours.<br>* Other names: vepoloxamer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured as the incidence of adverse events |  | 30 days after administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of re-hospitalization for recurrence of VOC |  | Within 14 days of the date of discharge | 
| Occurrence of acute chest syndrome |  | Within 120 hours of registration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sickle cell, vaso-occlusive crisis
The Fixation Study

Study Overview
=================
Brief Summary
-----------------
To perform a clinical evaluation of safety and performance for the SeaSpine Non- Cervical Pedicle Screw Systems

Detailed Description
-----------------
A multi-center, post-market, clinical evaluation for subjects implanted with the SeaSpine Non-Cervical Pedicle Screw Systems

Official Title
-----------------
Clinical Evaluation of the SeaSpine Non-Cervical Pedicle Screw Systems

Conditions
-----------------
Degenerative Conditions, Neurologic

Intervention / Treatment
-----------------
* Device: SeaSpine Non-Cervical Pedicle Screw Systems


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have undergone surgery Have undergone at least 12-months of postoperative follow-up Exclusion Criteria: Any condition that the Investigator determines is unacceptable
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 with Non-Cervical Pedicle Screw Systems<br>50 patients who have been implanted with SeaSpine Non-Cervical Pedicle Screw Systems | Device: SeaSpine Non-Cervical Pedicle Screw Systems<br>* Any patient treated with a SeaSpine Non-Cervical Pedicle Screw System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome for the study is device performance. | Device performance is defined as lack of component failure involving screw and/or rod fracture and/or screw loosening or disassociation. | 12 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of unanticipated adverse device effects (UADE) | Intra or Post-Procedure UADEs | 12-months |
Clinical Risk Score Predicting the Cardiac Rupture in Patients With ST-elevation Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate a practical risk score to predict the mechanical complication of ST-elevation myocardial infarction (STEMI).

Detailed Description
-----------------
STEMI patients chewed 300 mg aspirin and 600 mg clopidogrel in the emergency department, followed by oral 100 mg aspirin and 75mg clopidogrel daily for at least 12 months. STEMI patients received low molecular weight heparin (LMWH), β-blockers, and angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) according to the STEMI guideline, unless there were contraindications to these drugs. Peripheral blood samples were collected from patients within 2 hours of admission for blood routines and blood biochemistry examinations. White blood cell counts and level of hemoglobin were assessed with automated cell counters via standard techniques. The investigators followed up patients in validation group for three month to observe the cardiac rupture events and other adverse cardiac events .

Official Title
-----------------
Development and Validation of a Clinical Risk Score Predicting the Cardiac Rupture in Patients With ST-elevation Myocardial Infarction

Conditions
-----------------
Cardiac Rupture

Intervention / Treatment
-----------------
* Other: Grouping by different risk stratification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ST-elevation myocardial infarction: concurrence of symptoms (chest pain or symptoms compatible with acute heart failure or unexplained syncope) and electrocardiogram findings (new onset left bundle branch block or ST-segment elevation≥1 mm in ≥2 inferior leads or ≥2 mm in ≥2 precordial leads) Exclusion Criteria: cancer mental illness

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Grouping by different risk stratification|A simple risk score system based on 7 baseline clinical variables divided patients into four groups|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cardiac rupture | Pericardial tamponade or electromechanical dissociation accompanied with massive pericardial effusion is the indicator of cardiac rupture | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ST-elevation myocardial infarction, Cardiac rupture, Risk assessment
Wound Inflammatory Cells After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
One hundred patients, aged from 41 to 78 years, underwent open heart surgery in the years 1998-1999 and were studied by using the Cellstick device for harvesting wound inflammatory cells during the first 24 hours after surgery. The results of the differential count were computerized by using artificial neural network for obtaining wound inflammatory cell node (WICN). The patients were followed up for sixteen years or to the death. WICN values were compared with the patients´ survival.

Official Title
-----------------
Wound Infammatory Cells After Cardiac Surgery and the Patients´Survival. A Sixteen Years Follow-up Study

Conditions
-----------------
Sternotomy Wound

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective operations Exclusion Criteria: Urgency operations

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 |
| --- | --- | --- |
| death |  | 16 years |
Bioequivalency Study of Anastrozole 1 mg Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Anastrozole Tablet under fasted conditions.

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Anastrozole 1 mg Tablets Under Fasting Conditions

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Anastrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to anastrozole or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anastrozole|1 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 31 days |