linjc16/ctgov huggingface dataset:
Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation

Study Overview
=================
Brief Summary
-----------------
Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with optimized pacemaker programming. Hypothesis: Dynamic atrial Overdrive (AF Suppression) reduces AT/AF Burden by 30% as compared to programming DDDR-(60) without AF Suppression when all other parameters are optimized.

Detailed Description
-----------------
Atrial Fibrillation is the most common Heart Rhythm Disorder requiring therapy.

Official Title
-----------------
Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation

Conditions
-----------------
Bradycardia, Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Pacemaker Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for dual chamber pacemaker documented paroxysmal or persistent Atrial Fibrillation P-wave >1.0 mV in Sinus Rhythm or sufficient detection of AFib stable antyarrhythmic therapy age >= 19 years written informed consent implantation of a Identity DR 5370/5376 or later bipolar atrial lead Exclusion Criteria: permanent AFib reversible etiology of AFib HYHA II or IV Coronary Artery disease with stable angina pectoris implanted ICD or planned implantation of a ICD cardiac surgery within the last 6 months or planned within 12 months live expectancy < 12 months pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 19 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AF Suppression On<br>AF Suppression Algorithm On, optimized AF Pacemaker Programming | Device: Pacemaker Implantation<br>* Implantation of a dual chamber pacemaker<br>* Other names: Pacemaker St. Jude Medical Identity DR Model 5370 or 5376;|
| Active Comparator: AF Suppression Off<br>AF Suppression programmed Off, Optimized Pacemaker Programming | Device: Pacemaker Implantation<br>* Implantation of a dual chamber pacemaker<br>* Other names: Pacemaker St. Jude Medical Identity DR Model 5370 or 5376;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of AT/AF Burden in the pacemaker diagnostics |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pacemaker, atrial fibrillation
The Link Between Periodontitis, Smoking and Oral Cancer

Study Overview
=================
Brief Summary
-----------------
Periodontitis is a widely prevalent disease worldwide that has serious public health consequences. Its prognosis includes tooth loss and edentulism, a condition that negatively affects chewing causing functional disability; and esthetics causing social impairment. Consequently, periodontitis may end up causing marked impairment of the quality of life of the affected patients, impairment of general health and increasing the dental care costs significantly. Changes in the oral mucosa arise by primary products resulting from tissue breakdown due to gingivitis. It then triggers the host cells to produce proteinases that mediate loss of marginal periodontal ligaments, apical migration of the junctional epithelium and apical spread of bacterial biofilm. Therefore, this research aims to identify the risk of smoking to both periodontitis and oral cancer, and the risk of periodontitis to oral cancer.

Official Title
-----------------
Analysis of the Link Between Periodontitis, Smoking and Oral Cancer: Cohort Study

Conditions
-----------------
Chronic Periodontitis, Oral Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: biopsy for oral cancer
* Diagnostic Test: periodontal examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years or older. Exclusion Criteria: Patients with any systemic diseases. Pregnant females. Handicapped and mentally retarded patients. Patients undergoing radiotherapy. Patients having oral cancer

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 |
| --- | --- |
| Smokers<br> | Diagnostic Test: biopsy for oral cancer<br>* surgical biopsy is to be taken for diagnosis of oral cancer or premalignant lesions<br>Diagnostic Test: periodontal examination<br>* Periodontal clinical examination to all by periodontal charting<br>|
| non-Smokers<br> | Diagnostic Test: biopsy for oral cancer<br>* surgical biopsy is to be taken for diagnosis of oral cancer or premalignant lesions<br>Diagnostic Test: periodontal examination<br>* Periodontal clinical examination to all by periodontal charting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontitis | arising of periodontitis or increase in the grade of an already existing case of periodontitis | the 10 years of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral cancer | Arising of a lesion of oral cancer or a premalignant lesion | the 10 years of the study |
Development and Validation of a Prognostic Score for Early Death in Head Injury Patients.

Study Overview
=================
Brief Summary
-----------------
Traumatic brain injury (TBI) is a serious condition with high morbidity and mortality. The Glasgow score alone, assessed at the initial phase, is not enough to determine the prognosis. The aim of this study is to define and to evaluate a prognostic score for early death based on clinical and CT-scan findings in an observational retrospective derivation cohort of patients hospitalized for traumatic brain injury. This cohort will allow us to carry out a uni- and then multi-variate analysis so as to create a prognostic score for early death. We will subsequently test this score in a prospective validation cohort.

Official Title
-----------------
Development and Validation of a Prognostic Score for Early Death in Head Injury Patients in the Traumatic Brain Injury Intensive Care Unit of Dijon CHU

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Other: death


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Traumatic brain injury (PMSI code (Programme Médicalisation des Systèmes d'Information) S 06.70 and S 06.71) Age>14 years Surviving more than 6h after the trauma Hospitalized in the traumatic brain injury intensive care unit and managed in accordance with international guidelines Who underwent a cerebral CT-scan Exclusion Criteria: Ongoing treatment with anticoagulants or antiplatelets Pregnant women Persons without national health insurance cover Children less than 15 years old Under guardianship.

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Traumatic brain injury<br> | Other: death<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early death |  | Through the study completion up to 2 years |
3D FLAIR Versus Coronal T2-WI MRI in Detecting Optic Neuritis (FLACON)

Study Overview
=================
Brief Summary
-----------------
3D FLAIR, 3D T1 FAT SAT, coronal T2 and coronal T1 dixon sequences were usually used to assess visual deficits in MRI. Optic nerve examination is preferably performed using a coronal T2 sequence in order to detect a hypersignal suggestive of inflammation whereas brain examination is preferably performed using a 3D FLAIR sequence to highlight signs of spatial dissemination and lesions suggestive of multiple slerosis (MS). Recently, a study based on a small number of patients showed the interest of 3D FLAIR in the detection of the hypersignal of the optic nerve.The objective of this retrospective study is to determine whether a single 3D FLAIR sequence allows simultaneous exploration of the optic nerve and the brain for the positive diagnosis of optic neuropathy and/or MS.

Official Title
-----------------
3D FLAIR Versus Coronal T2-WI MRI in Detecting Optic Neuritis in Patients Presenting With Acute Visual Loss and Otherwise Normal Ophthalmological Examination

Conditions
-----------------
Optic Neuritis, Multiple Sclerosis, Encephalopathy

Intervention / Treatment
-----------------
* Diagnostic Test: Magnetic Resonance Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Decrease in visual acuity explored in MRI between january 2018 and january 2020 Exclusion Criteria: Past history of episode of Optic neuritis

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 |
| --- |
|Diagnostic Test: Magnetic Resonance Imaging|Comparing 3D FLAIR versus Coronal T2-WI MRI in detecting Optic Neuritis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of optic neuropathies using MRI | MRI comparison of the diagnostic performance of the 3D FLAIR sequence and the T2 coronal in the detection of optic neuropathies. | 1 hour |
Efficacy of a Nurse-based Intervention on Tobacco Consumption in Hospitalized Patients

Study Overview
=================
Brief Summary
-----------------
Tobacco consumption is a major public health problem, ranking second in the leading cause of morbidity and mortality worldwide, in 2010. The prevalence of tobacco smoking in hospitalized patients is evaluated around 20% and the management of tobacco reduction/cessation is an major issue for the course and outcome of many disorders. Recent recommendations published by the French National Health Authority (Haute Autorité de Santé, HAS) call for the involvement of all health professionals in helping patients to stop smoking and hospitalized patients are identified as a specific target. In addition, the meta-analysis of Rigotti et al. (2012) showed that the most effective programs (tobacco cessation) were those that include all patients, starting during the hospitalization with a specific follow-up of at least one month, and with the addition of nicotine replacement therapy. This combination increased the odds of successful tobacco cessation by 54%. The project aims to evaluate the short-term efficacy (1 month) of a nurse-based program on tobacco smoking consumption in a population of hospitalized patients.

Official Title
-----------------
Efficacy of a Nurse-based Intervention on Tobacco Consumption in Hospitalized Patients

Conditions
-----------------
Smoking Patients

Intervention / Treatment
-----------------
* Other: Tobacco management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient (>= 18 years), tobacco smokers, hospitalized in one of the participating unit during the inclusion period. For the sake of coherence with the literature, only subjects who smoked at least one cigarette a day in the previous 30 days before the hospitalization will be considered as smokers. Affiliated to the national health system Signed informed consent Exclusion Criteria: Patients enrolled in an addiction treatment during their hospitalization stay Cognitive deficit that makes the informed consent and the telephone interview impossible Aphasia Patient who does not speak French Life expectancy below 6 months

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: Tobacco management|Training of healthcare teams for tobacco management by trained nurses. The intervention will consist of 3 minimum interviews, about 30 minutes each.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 month tobacco smoking prevalence |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 month tobacco smoking prevalence |  | 6 months |
Project Healthy Eating in Adults. A Study on the Health Effects of Fish Intake in Overweight Adults (FINS)

Study Overview
=================
Brief Summary
-----------------
It has previously been observed that increased fish intake improves the metabolic health of overweight and obese adults, and animal protein improved metabolic health of obese rats. In this project the investigators will investigate whether increased intake of fish or meat improves metabolic health in overweight/obese adults aged 20-55 years when replacing processed food. The hypothesis is that increased intake of unprocessed fish or meat will improve metabolic health in adults as measured by glucose tolerance, lipid metabolism and inflammatory markers.

Official Title
-----------------
Title in Norwegian: Sunn og Frisk. En Studie av Helseeffekter av Fiskeinntak i Overvektige Voksne (FINS)

Conditions
-----------------
Overweight or Obese Adults, Healthy

Intervention / Treatment
-----------------
* Other: Salmon Group
* Other: Cod Group
* Other: Meat Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 27 20-55 years healthy Exclusion Criteria: diagnosed diseases such as diabetes, CVD, intestinal diseases, arthritis prescription medications affecting the metabolism of glucose, lipids or the immune system use of supplements containing long chain n-3 fatty acids high intake of fish food allergy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salmon Group<br>Participants will eat 150g salmon for dinner, 3 times per week for 12 weeks | Other: Salmon Group<br> <br> |
| Experimental: Cod Group<br>Participants will eat 150g cod for dinner, 3 times per week for 12 weeks | Other: Cod Group<br> <br> |
| Active Comparator: Meat Group<br>Participants will eat 150g mixed meat for dinner, 3 times per week for 12 weeks | Other: Meat Group<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in metabolic status (glucose, lipids, inflammation) | The effects of fish intake on glucose homeostasis, lipid metabolism and inflammation will be assessed. | Baseline and end of intervention (12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasma concentrations of amino acids and their metabolites |  | Baseline and end of intervention (12 weeks) | 
| Changes in plasma concentrations of vitamins |  | Baseline and end of intervention (12 weeks) |
Intravenous Interferon During Liver Transplant

Study Overview
=================
Brief Summary
-----------------
The main goal of this study is to prevent liver allograft infection with Hepatitis C virus in hepatitis C positive patients undergoing liver transplantation. The hypothesis is that patients who receive ribavirin immediately before transplant and intravenous interferon alfa 2b during the anhepatic phase(while the liver is removed)will have sustained virologic response post liver transplant.

Detailed Description
-----------------
The study is evaluating intravenous interferon given during the anhepatic phase of lvier transplant. Ribavirin was given as well. Serial measurements for HCV RNA were determined 12, 24 72, 96 hrs and 4 weeks after liver transplant.

Official Title
-----------------
Intravenous Interferon During the Anhepatic Phase of Liver Transplantation and Prevention of Recurrence of Hepatitis C Virus

Conditions
-----------------
Hepatitis C, Cirrhosis

Intervention / Treatment
-----------------
* Drug: IV interferon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver transplant for hepatitis c Exclusion Criteria: allergy to interferon

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV interferon<br>IV interferon oral ribavirin | Drug: IV interferon<br>* IV interferon 5MU during anhepatic phase<br>|
| No Intervention: Standard of care<br>standard of care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV RNA Result | Will measure mean HCV RNA levels 4 weeks after liver transplant | 4 weeks after liver transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cirrhosis, hepatitis C
A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions

Study Overview
=================
Brief Summary
-----------------
This proof of principle PK study will allow GSKCH to select the most favorable sustained release formulation among 3 prototypes to move to the next stage of drug development.

Official Title
-----------------
A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Paracetamol fast dissolution suspension
* Drug: Paracetamol medium dissolution suspension
* Drug: Paracetamol slow dissolution suspension
* Drug: Paracetamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteer Body Mass Index between 19.0 - 28.0 (kg/m2) inclusive

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fast dissolution suspension<br> | Drug: Paracetamol fast dissolution suspension<br> <br> |
| Experimental: Medium dissolution suspension<br> | Drug: Paracetamol medium dissolution suspension<br> <br> |
| Experimental: Slow dissolution suspension<br> | Drug: Paracetamol slow dissolution suspension<br> <br> |
| Active Comparator: Marketed suspension<br> | Drug: Paracetamol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to plasma level above therapeutic level |  | baseline to 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General PK parameters (e.g. AUC, Tmax, Cmax) |  | baseline to 8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
paracetamol
Group B Streptococcus (GBS) Associated Stillbirths in a High Burden Setting

Study Overview
=================
Brief Summary
-----------------
This is a descriptive study to determine the role of fetal GBS disease as a cause for stillbirths

Detailed Description
-----------------
A prospective, descriptive study will be undertaken involving mothers who have a stillbirth at Chris Hani Baragwanath Academic Hospital (CHBAH), a secondary-tertiary care hospital, from 2014 up until 2016.

Official Title
-----------------
Group B Streptococcus (GBS) Associated Stillbirths in a High Burden Setting

Conditions
-----------------
Stillbirth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women delivering a stillbirth at CHBAH Participants aged ≥18 years Able to understand and comply with planned study procedures Provides written informed consent (either generic ICF or V98_28OBTP) Exclusion Criteria: Refuses to consent to study participation

Ages Eligible for Study
-----------------
Maximum Age: 1 Day

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 |
| --- | --- | --- |
| Determine the number of stillbirths who have GBS isolated from cord blood, gastric aspirates, placenta and/ or skin swabs |  | Birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of stillbirths occurring at CHBAH, and identify potential causes of the stillbirths (maternal and obstetric risk factors) | To determine the epidemiology of stillbirths, including identification of maternal risk-factors | Birth | 
| Number of stillbirths related to a probable Infectious cause | To determine the proportion of stillbirths that are associated with common fetal in-utero infections including; Syphilis (Treponema pallidum), Klebsiella sp, E. Coli | Birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Group B Streptococcus, stillborn