linjc16/ctgov huggingface dataset:
Genetic- and Biological-Markers of Predisposition to Atherosclerosis: Leipzig-Heart Study

Study Overview
=================
Brief Summary
-----------------
Atherosclerotic cardiovascular disease is the major cause of morbidity and mortality in Western societies. It is a complex genetic disorder with many genes involved and significant gene-environment interactions. The aim of the study is to identify novel genetic- and biological-markers of atherosclerosis. Atherosclerosis is assessed in the coronary arteries using coronary angiography as well as in the carotid artery (intima-media-thickness) and peripheral vessels (ankle brachial index). Association analysis of genetic and metabolic markers with atherosclerotic burden will be performed to identify novel factors of disposition to atherosclerotic vascular disease.

Official Title
-----------------
Observational Study for Identification of Genetic- and Biological-Markers of Predisposition to Atherosclerosis: Leipzig-Heart Study (LE-Heart)

Conditions
-----------------
Atherosclerosis, Coronary Arteriosclerosis, Carotid Artery Diseases, Genetic Predisposition to Disease, Biological Markers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients assigned to coronary angiography Exclusion Criteria: Cancer Acute myocardial infarction Inability to give informed consent

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pudendal Block Versus Penian Block For Circumcision In Children

Study Overview
=================
Brief Summary
-----------------
The authors study the efficacy of the pudendal versus penile block for the relief of postoperative pain in children receiving ambulatory circumcision. In this prospective, double-blind, randomized, parallel-arm trial, 60 children recruited during the anesthesia consultation will be allocated a general anesthesia with a pudendal block (PUD group) or a penile block (PEN group). Each block will be made with equal parts lidocaine 1% and ropivacaine 0.75% (0.3 ml/kg).

Official Title
-----------------
Pudendal Block Versus Penian Block For Circumcision In Children: A Double Blind Randomised Controlled Trial

Conditions
-----------------
Regional Anesthesia, Postoperative Pain, Circumcision

Intervention / Treatment
-----------------
* Procedure: circumcision
* Drug: Lidocaine
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: circumcision in day surgery hospital Exclusion Criteria: allergy to amino-amide local anesthetics parental consent not received infection at injection site

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 Years

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

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 |
| --- | --- |
| Active Comparator: Pudendal Block<br>The anesthesia is produced by blocking the pudendal nerves near the ischial spine of the pelvis.Local anesthetic (mixed of ropivacaine and lidocaine) is injected into the pudendal canal where the pudendal nerve is located. | Procedure: circumcision<br> <br> Drug: Lidocaine<br> <br> Drug: Ropivacaine<br> <br> |
| Active Comparator: Penian Block<br>The anesthesia is produced by blocking the dorsal penile nerves. Local anesthetic (mixed of ropivacaine and lidocaine)is injected under the pubis symphysis just below the Buck fascia where the nerve is located. | Procedure: circumcision<br> <br> Drug: Lidocaine<br> <br> Drug: Ropivacaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain score | using the FLACC (Face Leg Activity Cry Consolability) Scale | pain score at 0 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of satisfaction of the patient or his/her parents and the surgeon assessed by telephone interview | telephone interview | Day 5 after the procedure |
Factors Associated With Complications of Cervical Necrotizing Fasciitis

Study Overview
=================
Brief Summary
-----------------
Cervical necrotizing fasciitis (CNF) is a rare but severe complication of pharyngeal or dental infections. The infection can rapidly descend into the mediastinum and lead to a life-threatening prognosis. Treatment consists of a multidisciplinary approach in intensive care with radiologist and with early and repeated surgical debridement. Anti-inflammatory drugs have been incriminated by authors in the development of necrotizing fasciitis. Recently, a single-center study demonstrated that pharyngeal source of CNF and oral glucocorticoid intake before admission was associated with the occurrence of mediastinitis. The aim of the study is to assess the incidence and factors associated with CNF complications, in particular mediastinitis. Secondary outcome is to describe patient characteristics, medical and surgical management. Methods: A retrospective, observational, non-interventional multicentre study is conducted in nine intensive care units in France from January 2005 to December 2016.

Official Title
-----------------
Factors Associated With Complications of Cervical Necrotizing Fasciitis

Conditions
-----------------
Cervical Necrotizing Fasciitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patient admitted in ICU for management of cervical necrotizing fasciitis between 2005 and 2016. Exclusion Criteria: Patients admitted in ICU for management of cervical abscess without cervical necrotizing fasciitis Age < 18 years

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 |
| --- | --- | --- |
| incidence of mediastinitis | Computed tomography (CT) is performed at admission. Mediastinitis is described on CT finding. | At the entry in ICU (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| factors associated with mediastinitis | Computed tomography (CT) is performed at admission. Mediastinitis is described on CT finding. | At the entry in ICU (Day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical necrotizing fasciitis, mediastinitis
A Study of Pentasa in Patients With Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Confirmation of safety profile of Pentasa slow release tablets 500 mg in patients with ulcerative colitis (UC).

Official Title
-----------------
Non-interventional Post Marketing Safety Study Confirming Efficacy and Safety of Pentasa Slow Release Tablets in Patients With Ulcerative Colitis in Common Clinical Practice

Conditions
-----------------
Ulcerative Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from ulcerative colitis Exclusion Criteria: Hypersensitivity to mesalazine, salicylates or to any excipient Severe damage to liver or renal functions

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 |
| --- | --- |
| Non-interventional post-authorisation safety study<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verify the safety profile | Number of AEs/SAEs Intensity and seriousness of reported AEs/SAEs | 1 year |
Obesity Guidelines for Outpatient Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators are concerned about anesthetizing obese children in outpatient locations in case they need prolonged stay, increased respiratory interventions, or need for post-operative narcotics. The investigators will be using a screening guideline to help us determine the higher risk child based on BMI and co-morbid conditions. The investigators will also be doing a retrospective chart review of 300 patients with BMI 95% and looking at various factors during the operative and post-operative period.

Official Title
-----------------
Have NCH Obesity Guidelines Made an Impact? Differences in Anesthetizing the Obese Child in Outpatient Sites Versus Main OR at NCH.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: BMI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 95% or over BMI having outpatient surgery.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 95-99% BMI ASC<br>Patients having a BMI between 95-99% who are seen in the ambulatory surgery centers. | Other: BMI<br>* Screening guideline to assess body mass index.<br>|
| 95-99% BMI NCH main OR<br>Patients having a BMI between 95-99% who are seen in the main operating rooms. | Other: BMI<br>* Screening guideline to assess body mass index.<br>|
| >99% BMI NCH main OR<br>Patients having a BMI >99% who are seen in the main operating rooms. | Other: BMI<br>* Screening guideline to assess body mass index.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with respiratory complications |  | 1 week |
Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
This is a Phase I trial to look at safety and how a patient's body will tolerate the treatment at different dosages.

Official Title
-----------------
A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non-Hodgkin's Lymphoma

Conditions
-----------------
Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: hA20-humanized anti-CD20 antibody


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose level 1<br>120 mg/m2 | Drug: hA20-humanized anti-CD20 antibody<br>* once weekly iv dosing for 4 weeks<br>* Other names: hA20;|
| Experimental: Dose level 2<br>200 mg/m2 | Drug: hA20-humanized anti-CD20 antibody<br>* once weekly iv dosing for 4 weeks<br>* Other names: hA20;|
| Experimental: Dose Level 3<br>375 mg/m2 | Drug: hA20-humanized anti-CD20 antibody<br>* once weekly iv dosing for 4 weeks<br>* Other names: hA20;|
| Experimental: Dose level 1B<br>80 mg/m2 | Drug: hA20-humanized anti-CD20 antibody<br>* once weekly iv dosing for 4 weeks<br>* Other names: hA20;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerance of different dose levels |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lack of immunogenicity |  | 8 and 12 weeks | 
| Pharmacodynamics |  | over 12 weeks | 
| Pharmacokinetics |  | over 12 weeks | 
| Efficacy |  | 4, 8 and 12 wks, every 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
treatment, NHL, CD20+ B-cell NHL, Lymphoma
Transcranial Magnetic Stimulation for Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether non-invasive brain stimulation, such as Transcranial Magnetic Stimulation (TMS) may alleviate pain associated with various chronic pain conditions. We will test various methods of TMS to identify a treatment approach that may reduce the symptoms of chronic pain for the patient.

Official Title
-----------------
Clinical Applicaitons of Non-Invasive Brain Stimulation for the Treatment of Chronic Pain

Conditions
-----------------
Chronic Low Back Pain

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older Patient with Chronic Low Back Pain Meets minimum pain level criteria Ability to perform the experimental Task and Procedures Exclusion Criteria: MRI contraindication if an MRI exam is required per protocol TMS Contraindication History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher. Neurologic illness that would interfere with brain integrity Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher. Currently pregnant or planning to become pregnant. On going legal action or disability claim.

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMS Parameter Condition 1 first<br>Application of Transcranial Magnetic Stimulation | Device: Transcranial Magnetic Stimulation<br> <br> |
| Experimental: TMS Parameter Condition 2 First<br>Application of Transcranial Magnetic Stimulation | Device: Transcranial Magnetic Stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Average Daily Pain | Compared to baseline pain report as provided by Visual Analogue Scale (VAS) | Baseline Compared to each treatmeant series (at 4 weeks, 8 weeks, and 12 weeks) | 
| Change in Worst Daily Pain | As compared to baseline worst daily pain report provided on visual analogue scale (VAS) | Baseline Compared to each treatment series (at 4 weeks, 8 weeks, and 12 weeks) |
Coagulation Factors and Postpartum Hemorrhage

Study Overview
=================
Brief Summary
-----------------
Objective is to analyze a possible association of coagulation factors peripartal with the occurrence of postpartum hemorrhage.

Official Title
-----------------
Peripartal Concentration of Coagulation Factors and Postpartum Hemorrhage

Conditions
-----------------
Postpartum Hemorrhage

Intervention / Treatment
-----------------
* Other: blood exam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women > 22 weeks of gestation Exclusion Criteria: age < 18 years, no informed consent

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PPH<br> | Other: blood exam<br>* laboratory test<br>|
| non-PPH<br> | Other: blood exam<br>* laboratory test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of PPH |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PPH
Vein vs Arterial Grafts for Coronary Artery Bypass Grafting Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators have developed a novel technique for saphenous vein graft harvesting for coronary artery bypass grafting (CABG) where the graft is harvested with a pedicle of surrounding tissue. A randomized trial has shown a significantly higher patency rate for vein grafts harvested with this new methode compared to conventional harvesting technique 8.5 years after surgery (90 vs 76 %). In 2004 the investigators started a prospective randomized trial comparing patency between vein grafts harvested with surrounding tissue and radial artery grafts. The result showed that vein grafts harvested with surrounding tissue had a significantly higher patency rate compared to radial artery grafts 3 years after surgery (98 vs 84 %). The present study is a long-term follow-up (8 years) of the patients included in the second randomized trial. The hypothesis is that vein grafts harvested with surrounding tissue have a significantly higher patency rate compared to radial artery grafts 8 years after surgery.

Official Title
-----------------
No-touch Saphenous Vein Grafts vs Radial Artery Grafts; A Randomized Trial.

Conditions
-----------------
Angina Pectoris

Intervention / Treatment
-----------------
* Procedure: NT SVG grafts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Three vessel coronary artery disease Exclusion Criteria: 65 years or older Elevated creatinine Raynauds disease Vein stripping

Ages Eligible for Study
-----------------
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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NT SVG grafts<br>NT SVG randomized for revascularization of left or right coronary territory | Procedure: NT SVG grafts<br> <br> |
| Active Comparator: RA grafts<br>RA grafts randomized for revascularization of left or right coronary territory | Procedure: NT SVG grafts<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft patency | The grafts will be categorized as either open or closed. A stenosis of the graft exceeding 70 % of the lumen diameter will be considered as closed. | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CABG, Saphenous vein, Radial artery
The Effect of Humidification on Mucus Rheology

Study Overview
=================
Brief Summary
-----------------
In this study the investigators will collect mucus from mechanical ventilated patients and patients with COPD to study the effect of temperature and humidity, on the biophysical properties of the airway mucus. It is hypothesised that changes in inspired gas temperature and humidity (over time) may affect the biophysical properties of the airway mucus and reduce the airway's ability to clear mucus, resulting in deleterious clinical affects.

Detailed Description
-----------------
Expectorated sputum samples are collected and used to measure the biophysical properties of mucus secretions. The samples are later exposed to different temperatures and humidity levels during bench experiments.

Official Title
-----------------
The Effect of Humidification on Mucus Rheology

Conditions
-----------------
Chronic Obstructive Pulmonary Disease(COPD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Mechanically Ventilated Patients Inclusion Criteria: Any Subject Mechanically Ventilated and producing sputum. Exclusion None COPD Group Inclusion Criteria: 40 to 90 years of age suffering from COPD History of mucus production Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- |
| Mechanically Ventilated<br> | |
| Chronic obstructive pulmonary disease (COPD).<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum Collection | Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of sputum. | 10 minutes |