linjc16/ctgov huggingface dataset:
Safety of Mesh Used Repairs in Emergency Abdominal Wall Hernias. Prospective Randomized Multicenter Trial

Study Overview
=================
Brief Summary
-----------------
Repairing of emergency (strangulated) abdominal wall hernias with mesh may cause infective complications.

Detailed Description
-----------------
Repairing of emergency (strangulated) abdominal wall hernias with mesh is controversary. Strangulated abdominal hernias are not clean surgical wounds so applying prostetic materials such as meshes are problematic. Using of prostetic materials in un-clean wounds (clean contaminated, contaminated and dirty) is not proposed. But in surgical practice meshed surgical repair techniques are using largeley. In this multicenter study we try to find the answer for emergency hernia repairs meshed or not.

Official Title
-----------------
Mesh Used Repairs in Emergency Abdominal Wall Hernias

Conditions
-----------------
Hernia

Intervention / Treatment
-----------------
* Procedure: inguinal hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 16 years old, Strangulated abdominal wall hernia No any contrindications to operation Exclusion Criteria: Younger than 16 years old, Non-strangulated abdominal wall hernis Any causes of contrindications to operation

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Active Comparator: mesh used repair<br>mesh used hernia repair will be perform | Procedure: inguinal hernia repair<br>* strangulated hernias will be repaired surgically<br>|
| Active Comparator: nonmesh<br>nonmesh hernia repair techniques will be used | Procedure: inguinal hernia repair<br>* strangulated hernias will be repaired surgically<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound infection | surgical wound infection is the primary outcome measure of this trial | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hernia, abdominal, strangulation, emergency, wall
Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fasted conditions.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Quetiapine Fumarate 25 mg Tablets Under Fasting Conditions

Conditions
-----------------
Treatment for Bipolar I Disorder

Intervention / Treatment
-----------------
* Drug: Quetiapine Fumarate


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 quetiapine 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: Quetiapine Fumarate|25 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 15 days |
Retrospective Observational Study of Patients With a Sutureless Aortic Valve Implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU

Study Overview
=================
Brief Summary
-----------------
The incidence of aortic valve disease is increasing steadily because of the ageing of the population. At a certain stage, replacement of the aortic valve improves symptoms and thus the quality of life of patients. Surgical aortic valve replacement is the  gold standard . The procedure involves stopping the heart and setting up cardiopulmonary bypass (CPB) to ensure the oxygenation of tissues. The reference technique consists in suturing a prosthetic valve to the aortic annulus so as to restore normal function. This technique has very good results in the long term. The elective approach is sternotomy, which has certain drawbacks: post-operative pain, risk of infection, psychological trauma of a major incision. In recent years an alternative approach, right minithoracotomy, has been proposed. The drawback to this approach is that it increases aortic cross-clamp time and CPB time. More recently, new prosthetic valves, so-called sutureless or rapid deployment valves have become available. The main advantage of these valves is that they are easy to implant, as they do not require or need just a few sutures. As a result heart-arrest time is shorter, post-operative inflammatory syndrome is less frequent and transfusion needs are reduced. However, these valves have a metallic stent to fix the valve in place by pressing against the aortic annulus, which may give rise to intra-cardiac conduction disorders. Yet, very few studies have been conducted on this subject. The investigators wish to evaluate these conduction disorders in a cohort of patients operated on in this Department with this sutureless or rapid deployment valve technique.

Official Title
-----------------
Retrospective Observational Study of Patients With a Sutureless Aortic Valve Implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU

Conditions
-----------------
Patients With a Sutureless Aortic Valve

Intervention / Treatment
-----------------
* Other: Data collection
* Other: Review of ECGs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who underwent implantation of a Suturless valve since 2015 (Intuity Elite Edwards or Perceval S Liva Nova) Exclusion Criteria: patients with a pacemaker patients who underwent double valve replacement
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Data collection|demographic and clinical data|
|Other: Review of ECGs|nature and frequency of proven conduction disorders|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of conduction disorders on postoperative ECGs |  | through study completion, an average of 2 years |
A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohn's Disease.

Detailed Description
-----------------
Natalizumab is a humanized monoclonal antibody currently being investigated as a potential treatment for Crohn's disease. It is believed to work by preventing white blood cells from moving from the blood stream into the bowel tissue. These cells are thought to cause damage to the bowel, leading to the symptoms of Crohn's disease. Elan Pharmaceuticals is currently sponsoring an international study evaluating the safety and efficacy of natalizumab in individuals with moderately to severely active Crohn's disease. Individuals with Crohn's disease will be randomly assigned to receive either placebo (an inactive solution) or natalizumab by intravenous infusion (this means putting it directly into a vein in the arm). There will be a one out of two chance of receiving natalizumab and a one out of two chance of receiving placebo. Participants in the study will receive several infusions of natalizumab or placebo at 4-week intervals. Eligible participants will then have the opportunity to enroll into an extension study that will allow all participants to receive natalizumab. For those patients who do not enroll into the extension study, the total participation in this study will last for approximately 22 weeks.

Official Title
-----------------
A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenous Antegren(TM) (Natalizumab) in Subjects With Moderately to Severely Active Crohn's Disease With Elevated C-Reactive Protein

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: natalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Males and females 18 years of age or older Diagnosis of Crohn's disease for at least 6 months Females must not be pregnant or breastfeeding Must not have previously taken natalizumab Use of some other Crohn's disease medications is permitted, but will be closely supervised

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: Double


Arms and Interventions

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

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
-----------------
Crohn's disease, Inflammatory Bowel Disease, IBD, Gastroenterology, Regional Enteritis, Colitis
Awareness of Systemic Diseases and Its Dental Implications

Study Overview
=================
Brief Summary
-----------------
Implications of systemic diseases on Oral health and their manifestation

Detailed Description
-----------------
Systemic Diseases have oral manifestations and these oral manifestation may affects the treatment plan and may affect the drugs given after dental treatment hence the study aims to assess the awareness and knowledge of systemic diseases and its implications in the dental field

Official Title
-----------------
Awareness and Knowledge of Systemic Diseases and Its Relevance to Oral Health Care Among Dentists and Dental Interns: Observational Cross-sectional Study

Conditions
-----------------
Dental Awareness of the Relation Between Systemic Disease and Oral Health Conditions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dentists working for Egyptian ministry of health - Cairo. Dental interns of Cairo University. Exclusion Criteria: Those who refused to share information. Candidates who refused to sign consent.
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 |
| --- | --- |
| Ministry of health - Cairo<br>Dentists working for Egyptian ministry of health - Cairo | |
| Interns<br>Dental interns of Cairo University | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of awareness among dentists and dental students about systemic diseases and its relevance to oral health. | Questionnaire | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess their knowledge about dental management of these cases | Questionnaire | 1 year |
Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.

Official Title
-----------------
Multi-centre, Randomised, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy of Vardenafil and Its Influence on Self-esteem and Self-confidence in Patients With Erectile Dysfunction

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18 years and older Males with erectile dysfunction Stable heterosexual relationship Exclusion Criteria: Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months Nitrate use Other exclusion criteria apply acc. to Summary of Product Characteristics

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* 5 mg, 10 mg and 20 mg one hour prior to sexual intercourse<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Function - Erectile Function Domain |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment Questionnaire |  | 12 weeks | 
| IIEF-EF domain score |  | 12 weeks | 
| Other diary based variables |  | 12 weeks | 
| Safety and tolerability |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile Dysfunction, Vardenafil
Predictors of Perioperative Cardiac Morbidity

Study Overview
=================
Brief Summary
-----------------
To determine the predictors of perioperative cardiac morbidity and mortality in patients at high risk who underwent major noncardiac surgery with general anesthesia.

Detailed Description
-----------------
BACKGROUND: Of the 25 million patients who undergo noncardiac surgery in the United States each year, approximately three million have or are at risk of having coronary artery disease. Despite advances in the diagnosis and therapy of coronary artery disease, approximately 50,000 of these patients have a perioperative myocardial infarction, and more than half of the 40,000 deaths after surgery are caused by cardiac events. For perioperative myocardial infarction alone, health care costs exceeded $500 million per year in the 1980s. Determining the risk factors for adverse postoperative cardiac outcomes allowed the development of preventive strategies and the efficient allocation of health care resources. DESIGN NARRATIVE: Historical, clinical, laboratory, and physiologic data on the subjects were collected during hospitalization for major elective noncardiac surgery with general anesthesia and for six to 24 months after surgery. Myocardial ischemia was assessed by continuous electrocardiographic monitoring, beginning two days before surgery and continuing for two days after. The study published many findings under the title Study of Perioperative Ischemia. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Myocardial Infarction, Ventricular Arrhythmia, Coronary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Fever of Unknown Orgin Registry in Internal Medicine Unit and Infectious Disease Units

Study Overview
=================
Brief Summary
-----------------
This registry has the aim to collect epidemiological and clinical data of classical FUO cases in Italian Internal medicine Dept. and in Italian Infection diseases Dept.

Detailed Description
-----------------
In particular this registry intends to record clinical data observed, diagnostic methods used and the clinical evolution of classical FUO cases

Official Title
-----------------
Fever of Unknown Orgin Registry in Internal Medicine Unit and Infectious Disease Units

Conditions
-----------------
Fever of Unknown Origin

Intervention / Treatment
-----------------
* Other: not aplicable since it is a Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • fever (temperature > 38.3° C) found in several occasions of a duration exceeding 3, unable to make a diagnosis after a period of 3 days of hospitalization or after 3 out-patients visits in Internal Medicine Dept. or Infection Diseases Dept. signed informed consent Exclusion Criteria: • immunocompromised patients patients in treatment with steroidi (prednisone > 0,5 mg/Kg/die per > 4 weeks), anti-TNF, ciclofosfamide, tacrolimus, everolimus, sirolimus, azatioprina, ciclosporina, micofenolato, metotrexate neutropenic patients with less than 500 neutrofili/µL HIV positive patients nocosomial fever.

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 |
| --- |
|Other: not aplicable since it is a Registry|not aplicable since it is a registry|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe FUO cases collected | To describe clinical evolution of classical FUO cases recording clinical data observed, diagnostic methods used. | 6 moths |
Aerobic Interval Training in Cardiac Rehabilitation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare home-based aerobic interval training with supervised interval training performed in groups or on a treadmill at the hospital.

Detailed Description
-----------------
Cardiac rehabilitation is usually first offered in hospitals, but there are several studies that show that home-based rehabilitation is equally efficient. How this comes out when exercise is organized as aerobic interval training is not known.

Official Title
-----------------
Effect of High Intensity Aerobic Interval Training in Cardiac Rehabilitation

Conditions
-----------------
Myocardial Infarction, Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: Exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: coronary artery disease age over 18 referred to cardiac rehabilitation exercise tolerance demonstrated Exclusion Criteria: severe arrhythmia heart failure drug abuse pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treadmill group<br>Interval exercise performed on treadmills, supervised | Other: Exercise training<br>* Interval training at 90% of max heart rate. Warm-up of 10-15 minutes up to 70% of HRmax, then 4 minutes of exercise at 90%. 3 minutes of active pause between the intervals. Total 45 minutes of exercise. Twice a week.<br>|
| Active Comparator: Exercise groups<br>Supervised and organised in groups of ten | Other: Exercise training<br>* Interval training at 90% of max heart rate. Warm-up of 10-15 minutes up to 70% of HRmax, then 4 minutes of exercise at 90%. 3 minutes of active pause between the intervals. Total 45 minutes of exercise. Twice a week.<br>|
| Active Comparator: home-based exercise<br>Interval training at home, free choice of modality | Other: Exercise training<br>* Interval training at 90% of max heart rate. Warm-up of 10-15 minutes up to 70% of HRmax, then 4 minutes of exercise at 90%. 3 minutes of active pause between the intervals. Total 45 minutes of exercise. Twice a week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2peak |  | baseline, after 12 weeks and after 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | baseline, 12 weeks and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rehabilitation outcome, cardiac patients, exercise intensity