linjc16/ctgov huggingface dataset:
A Reduction in C-section Rates Using the Hem-Avert Perianal Stabilizer

Study Overview
=================
Brief Summary
-----------------
A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.

Detailed Description
-----------------
This study is being conducted to evaluate an existing FDA approved device called the HEM-AVERT® Perianal Stabilizer for its efficacy in reducing Cesarean births and/or reducing the second stage of labor.

Official Title
-----------------
A Reduction in C-section Rates Using the Hem-Avert Perianal Stabilizer

Conditions
-----------------
Complications; Cesarean Section

Intervention / Treatment
-----------------
* Device: Hem-Avert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is scheduled for vaginal delivery. Subject is willing and able to comply with the study plan as indicated by understanding and signing the Subject Informed Consent Form. Subjects' pre-natal examination indicates that this is to be a single birth delivery. Exclusion Criteria: Subject's scheduled for vaginal delivery with anticipated complications. Subject is unable to understand and sign the informed consent form. Subject does not deliver at study facility (hospital).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational<br>Subject receives Hem-Avert Device. | Device: Hem-Avert<br>* Application of Hem-Avert<br>* Other names: Hem-Avert Perianal Stabilizer;|
| No Intervention: Control<br>Subject does not receive Hem-Avert Device. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce C-section Rate | The primary objective (purpose) of this study is to evaluate the success rate of the HEM-AVERT® device as a method of reducing C-section rates | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce duration of 2nd stage of labor. | A secondary objective is to evaluate the success rate of the HEM-AVERT® device as a method of reducing the duration of second stage of labor | 24 hours |
Improving Quality of Colonoscopy Using a 3D-imager

Study Overview
=================
Brief Summary
-----------------
Coloscopy may be a painful procedure for the patient. This is due to a loop-formation of the coloscope. A 3D-real time imager produced by Olympus creates a real-time image of the scope while a traditional fluoroscopy device will only show instant pictures. We want to investigate whether the 3D-imager causes the patient less pain and is more time consuming than ordinary fluoroscopy

Detailed Description
-----------------
Results published in Holme et.al. Gastrointestinal Endoscopy 2011;73:1215-1222.

Official Title
-----------------
Magnetic Endoscopic Imaging Versus Standard Colonoscopy in a Routine Colonoscopy Setting: A Randomised Controlled Trial

Conditions
-----------------
Pain During Colonoscopy

Intervention / Treatment
-----------------
* Device: 3D-imager


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients referred for coloscopy on an out-patient basis Exclusion Criteria: Pregnancy Pacemaker Lack of ability to understand information given Prior resection of the colon/rectum Demanding analgetics prior to start of procedure

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 3D-imager|3D-imager vs fluoroscopy during coloscopy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain during coloscopy |  | instant | 
| Time used to reach the coecum |  | instant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coecum-intubation rate |  | instant | 
| level achieved when the coecum can not be reached |  | instant | 
| Need for assistance by a colleague |  | instant | 
| Need for analgetics |  | instant | 
| Pain during the first 24 hours after coloscopy |  | 24 hours | 
| Polyp detection rate |  | instant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Patient satisfaction
Analysis of Inhaled Corticoid Prescriptions in General Medicine

Study Overview
=================
Brief Summary
-----------------
Chronic obstructive pulmonary disease (COPD) and asthma are frequent and disabling pathologies. The general practitioner is often at the front line vis-a-vis screening, diagnosis and treatment of these pathologies. There are currently many treatments available, in particular inhaled corticosteroids, and although the recommendations for management appear to be well codified in theory, the adaptation of drug therapy remains complex in general practice. The prescription of inhaled corticosteroids, often initiated during a general medicine consultation, is not simple. The aim of this study is to analyze the relevance of the prescription of inhaled corticosteroids in primary care and to identify the criteria necessary for the prescription of inhaled corticosteroids available in general practice. The main objective of our study is to evaluate the rate of consultations where all the elements required for guiding the prescription of an inhaled corticoid are available. The secondary objectives are: Identify other factors associated with decision-making Identify the causes of inhaled corticosteroid stopping (de-prescription)

Official Title
-----------------
Analysis of Inhaled Corticoid Prescriptions in General Medicine

Conditions
-----------------
Asthma, Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with short-term inhaled corticosteroid therapy Informed and not opposed to participate in this research Exclusion Criteria: Patient under judicial or legal protection Adults under any kind of guardianship -

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 |
| --- | --- |
| Study population<br>Adults consulting with one of the participating general practitioners and requiring long term inhaled corticoids and monitoring. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of all factors justifying the prescription of inhaled cortcoids | The presence (yes/no) of all factors justifying the prescription of inhaled cortcoids as described in the associated market authorization. | Day 0 (transversal study) |
EEG in In-hospital Patients With Seizure or Altered Mental State

Study Overview
=================
Brief Summary
-----------------
In Kuopio University Department of Clinical Neurophysiology there have been designed a fast EEG electrode, that is suitable for acute emergency use. It is easy to set up, records high quality EEG and can detect the most important EEG abnormalities comparable to conventional EEG. This study will address the clinical use of acute EEG with fast electrode set in in-hospital patients who have been consulted by Medical Emergency Team because of seizure or altered mental state of uncertain etiology. Patients are going to be treated in ICU and EEG monitoring will continue for 24 hours.

Official Title
-----------------
Integrating EEG Into Acute Medicine: EEG in In-hospital Patients With Seizure or Altered Mental State Who Have Been Consulted by Medical Emergency Team

Conditions
-----------------
Status Epilepticus, Seizure, Altered Mental Status

Intervention / Treatment
-----------------
* Other: Acute EEG with fast EEG electrode


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In-hospital patients who have a seizure or altered mental state and are going to be treated in ICU Exclusion Criteria: Patiets that are not going to be treated in ICU Patients with a Do Not Attempt to Resuscitate - decision
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Acute EEG with fast EEG electrode|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of EEG abnormalities detected |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
status epilepticus, Acute EEG, seizure
A Study to Assess the Pharmacokinetics, Immunogenicity and Safety of Escalating Doses of BMS-188667 Given as a Single Intravenous Infusion to Patients With Psoriasis Vulgaris

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to determine the single-dose pharmacokinetics and immunogicity of BMS-188667 administered as a 1 hour intravenous infusion with extended pharmacokinetic sampling. Safety of all subjects will be assessed in a double blind fashion through the inclusion of placebo controls at each dose level.

Official Title
-----------------
A Phase I,Randomized, Double Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Immunogenicity and Safety of Escalating Doses of BMS-188667 Given as a Single Intravenous Infusion to Patients With Psoriasis Vulgaris

Conditions
-----------------
Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Drug: Abatacept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects required to have a know diagnosis of psoriasis vulgaris involving 5-49% of total body surface area (BSA) for at least six months prior to randomization. Subjects clinically insignificant abnormal laboratory or ECG test results who were otherwise healthy and met all remaining eligibility criteria. Exclusion Criteria: Evidence of active bacterial or viral infections at the time of enrollment, including any history of or clinical evidence of infection with Human Immunodeficiency virus (HIV) Hepatitis B or Hepatitis C. Any underlying metabolic, hematologic, pulmonary, cardiac, renal hepatic, infectious, psychiatric or gastrointestional condition, which in the opinion of the investigator, placed the subject at unacceptable risk from participation in a study with potentially immunosuppresive therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics throughout study period |  | Until Day 43 or Day 120 depending on dose level | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Immunogenicity throughout study period. |  | Until Day 43 or Day 120 depending on dose level and duration of adverse events |
Adaptation of Lumbar Spine to a Mattress: a MRI Evaluation.

Study Overview
=================
Brief Summary
-----------------
People spend almost a third of their life sleeping and understanding how the spine can adapt to a mattress is essential for promoting people's health. The general objective of this study is to study and evaluate the adaptation of the spine to a mattress. The primary objective is the assessment of the variation in the lumbar lordosis angle (sagittal plane) in the supine position, on a mattress, compared to the value measured in the supine position on a rigid surface.

Official Title
-----------------
Adaptation of Lumbar Spine to a Mattress: a MRI Evaluation.

Conditions
-----------------
Lumbar Spine Adaptation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 18 and 45 years old Female or Male sex Cognitive integrity Absence of usual contraindications to MRI Exclusion Criteria: Clinical condition diagnosed by a doctor Spinal pathologies Pregnant woman Claustrophobia

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of lumbar section of spine in a supine position on a mattress | Magnetic Risonance is used to assess the spine | 10 minutes | 
| Evaluation of lumbar section of spine in a supine position without mattress | Magnetic Risonance is used to assess the spine | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of lumbar section of spine in a standing position | EOS is used to assess the spine | 2 minutes |
Randomized Phase II Trial of Dose Dense Docetaxel in N+ Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To screen a dose-dense arm to be used in a future large scale phase III trial. Primary endpoint is safety; secondary endpoints are disease free survival and overall survival. A total of 100 patients were included.

Official Title
-----------------
A Phase II Randomized Trial of 6 TEC Every 3 Weeks, Versus 4 EC Followed by 4 Taxotere Every 2 Weeks, Versus 4 Taxotere Followed by 4 EC Every 2 Weeks in Node Positive Breast Cancer

Conditions
-----------------
Node Positive Breast Cancer

Intervention / Treatment
-----------------
* Procedure: 6 TEC q 3 weeks
* Procedure: 4 EC q 2 weeks followed by 4 TXT q 2 weeks
* Procedure: 4 TXT q 2 weeks followed by 4 EC q 2 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with histologically proven breast cancer Surgical resection performed with clear margins (R0 resection) At least 1 histologically proven involved axillary node ER + or ER- Interval between surgery (2nd surgical procedure in case of multiple procedures) and randomization inferior to 60 days Aged over 18 years, and more than 10-year life expectancy ECOG performance status 0-1 Signed informed consent form prior to randomization Exclusion Criteria: Bilateral breast cancer Inflammatory breast cancer Personal history of breast cancer Immunohistochemical only node involvement Intraductal breast cancer Distant metastases Contraindication to any drug contained in the chemotherapy regimens Any serious active disease or co-morbid medical condition including recent history of severe sepsis and digestive inflammatory disease Poor renal function (creatinin level > 120 micromol/L), poor hepatic function (total bilirubin level > 1 UNL), transaminases > 2.5 UNL) Poor bone marrow reserve as defined by neutrophils < 1.5 G/L or platelets < 100 G/L; Hemoglobin < 10 G/dL Poor contractile cardiac function (LVEF < 50%) Coronary disease Any history of cancer during the last 5 years, with the exception of basal cell carcinomas or stage 0 (in situ) cervical carcinoma Pregnancy or breast feeding Absence of contraception in non menopausal women Adult patient unable to give informed consent because of intellectual impairment Concomitant participation to another trial

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

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

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

| Intervention/Treatment |
| --- |
|Procedure: 6 TEC q 3 weeks|nan|
|Procedure: 4 EC q 2 weeks followed by 4 TXT q 2 weeks|nan|
|Procedure: 4 TXT q 2 weeks followed by 4 EC q 2 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
K-RAS and EGFR in Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis where patients with histologically confirmed Non-small cell lung cancer (NSCLC) were centrally evaluated for the presence of KRAS and EGFR mutations.

Detailed Description
-----------------
A retrospective analysis, performed by the Hellenic Co-operative Oncology Group (HeCOG), in samples from patients with histologically confirmed NSCLC, who had been treated within HeCOG-affiliated centres from March 2000 through December 2012, were centrally evaluated for the presence of KRAS and EGFR mutations. All patients had available clinicopathological data at diagnosis. Formalin-fixed, paraffin-embedded tissue blocks were retrospectively retrieved from the HeCOG tumor repository. Cytologic material was prospectively submitted for genotyping in more recent years (2010-2012).

Official Title
-----------------
Genotyping K-RAS and EGFR in Greek Non-small-cell Lung Cancer Patients: Incidence, Significance and Treatment Implications

Conditions
-----------------
Non Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed NSCLC Signed and dated written informed consent Age 18 years Available cytological material Exclusion Criteria: -

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 |
| --- | --- |
| K-RAS and EGFR mutated<br> | |
| Wild type<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | from the date of treatment start until verified disease progression, death from any cause or date of last contact whichever occurred first, up to 9 months | 
| Overall survival |  | from the date of treatment start until verified disease progression, death from any cause or date of last contact whichever occurred first, up to 36 months |
Translation of Pritikin Program to the Community

Study Overview
=================
Brief Summary
-----------------
The broad, long-term aims of this scope of work are to investigate the effects of the Pritikin Program to the general population. The study will test the effects on individuals from the community with dysfunctional lipids, blood pressure and glycemic control. To assess the effectiveness of the Pritikin Program in the community, the effects of Pritikin lifestyle intervention on overall health will be investigated.

Official Title
-----------------
Population-Based Lifestyle Intervention: Translation of the Pritikin Program to the Community- Pilot Study Protocol

Conditions
-----------------
Metabolic Syndrome, Obesity, Weight Loss, Hypertension, Hypercholesterolemia, Hypertriglyceridemia

Intervention / Treatment
-----------------
* Other: Healthy Lifestyle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dysfunctional lipids, blood pressure and glycemic control determined at a screening visit: Triglycerides > 150 mg/dL OR HDL <50 in females, <40 mg/dL in males Systolic blood pressure ≥130 mmHg OR diastolic blood pressure ≥80 mmHg (or on hypertension medication) HbA1c ≥5.7% or higher No diagnosis or treatment for cancer in the past year No diagnosis of mild cognitive impairment or dementia in the past year Ability to perform daily exercise, including aerobic activity and resistance exercise Non-smoker in the past year Exclusion Criteria: Positive exercise stress test

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention group participated in a 6-week Pritikin diet, exercise program, and behavioral modification. | Other: Healthy Lifestyle<br>* 6 week Diet, Exercise training, Behavioral modification<br>|
| No Intervention: Control<br>This group did not receive any intervention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight |  | 6 weeks | 
| Blood Pressure |  | 6 weeks | 
| Cholesterol |  | 6 weeks | 
| Triglycerides |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metabolic syndrome, obesity