linjc16/ctgov huggingface dataset:
Hygiene and Bucco-dental Status of Patients With Oral Streptococcal Endocarditis

Study Overview
=================
Brief Summary
-----------------
Infective endocarditis (IE) is a rare (30 cases / million / year in France) and serious disease (20 % of deaths during hospitalization and 40 % after 5 years). The development of an IE results from the meeting between a bacteremia and a pre-existent heart disorder, most of the time valvular, allowing the transplant of the circulating bacteria and their multiplication in the endocardium. Recommendations of prophylactic antibiotic treatment have been established since 1954 for some medical, particularly dental procedures, at the origin of bacteremia. But this policy has recently been questioned because its efficacy has not been demonstrated. The purpose of this study is identify the situations with risk, by comparing the oral health status and the hygiene of patients having an IE with oral streptococci to those in patients having an IE with microorganisms not of oral origin.

Detailed Description
-----------------
It is a case-control observational study. The IE cases are recruited in hospitals participating to the french prospective observational EI2008 cohort. Cases are IE with oral streptococci whereas controls are IE with microorganisms not of oral origin.

Conditions
-----------------
Infective Endocarditis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patient Definite IE caused by oral streptococci (case) or by non-oral pathogens (control) 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health status | Dental and periodontal evaluation by a dental surgeon or a stomatologist, according to a protocol of standardized examination | During the IE event |
Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Enhancin in Prevention of Postadenotonsillectomy Morbidity.

Study Overview
=================
Brief Summary
-----------------
Null hypothesis; The efficacy of Enhancin]Co-Amoxiclav given as a single intravenous dose at induction is not better than a five days oral course of the same given postoperatively in reducing postoperative morbidity after adenotonsillectomy.

Detailed Description
-----------------
Adenotonsillectomy results in morbidity that is reduced by the use of antibiotics.This study had the sole objective of comparing two route of administration to see which has superior results.

Official Title
-----------------
Single Intraoperative Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Full Oral Course in Prevention of Post Adenotonsillectomy Morbidity:A Randomised Clinical Trial.

Conditions
-----------------
Adenotonsillar Hypertrophy,Under 12 Years.

Intervention / Treatment
-----------------
* Drug: Enhancin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients below 12year scheduled to undergo adenotonsillectomy whose parents or guardians give consent for recruitment into the study. Exclusion Criteria: Non consenting parents or guardians. Antibiotic use in the week preceding surgery. Patients with co mordities. Known allergies to Co-amoxiclav. Patients who develop complication that warrant change of antibiotic.

Ages Eligible for Study
-----------------
Maximum Age: 12 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous intraoperative Enhancin<br>Patients received a dose of intravenous Enhancin at induction and only oral Paracetamol in the postoperative period. | Drug: Enhancin<br>* Intravenous Enhancin at induction at a dose of 25 mg/kg amoxycillin equivalent. Oral dose of the same at the same dosage for the active comparator arm.<br>* Other names: Co- amoxiclav;|
| Active Comparator: Postoperative oral Enhancin.<br>Patients received postoperative oral Enhancin for five days in addition to oral Paracetamol for the same duration. They did not receive an antibiotic during the operation. | Drug: Enhancin<br>* Intravenous Enhancin at induction at a dose of 25 mg/kg amoxycillin equivalent. Oral dose of the same at the same dosage for the active comparator arm.<br>* Other names: Co- amoxiclav;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POSTOPERATIVE FEVER | Temperature monitored at 1st ,4th and 7th postoperative days. | OPERATION DAY TO 7 DAYS POSTOPERATIVELY | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenotonsillectomy.
Proof of Concept (Bone Resorption/Bone Mineral Density) Study (0429-005)

Study Overview
=================
Brief Summary
-----------------
A study to asses the safety and efficacy of MK0429 in postmenopausal women with osteoporosis.

Conditions
-----------------
Post-Menopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: MK0429


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person is a women with osteoporosis who is unwilling or unable to take other treatments for osteoporosis Exclusion Criteria: Person has had a previous fracture Person has rheumatoid arthritis. Person has has certain types of cancer Person has donated blood or has been in another investigational study within the last 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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: MK0429|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
EXTENSION OF THE EUROPEAN E-BUG PROJECT

Study Overview
=================
Brief Summary
-----------------
Bacterial resistance to antibiotics is a growing concern in Europe, vaccination coverage is inadequate, and young adults, who are the highest antibiotic consumers, have the lowest level of knowledge. Extension of the e-Bug project, a European educational school programme concerning microbes, antibiotics and vaccination, to 15-18-year-olds implies the development of educational resources based on social marketing to promote sustainable behavioural changes. The objectives of the present study, which is part of the needs assessment in France, are to explore the attitudes, knowledge and behaviour of 15-18-year-olds concerning antibiotics and vaccination and their health education needs. Individual semi-structured interviews were conducted using purposeful sampling of 15- to 18-year-olds, until data saturation, and were transcribed and analysed.

Official Title
-----------------
EXTENSION OF THE EUROPEAN E-BUG PROJECT TOWARDS 15-18 YEARS - How to Raise Awareness About Antibiotics and Vaccination Among Frenchteenagers -

Conditions
-----------------
Vaccination Failure

Intervention / Treatment
-----------------
* Behavioral: Individual semi-structured interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 15-18 year olds, various origines, studying in various pathways of higher secondary education or working. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

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 |
| --- | --- |
| Frenchteenagers<br> | Behavioral: Individual semi-structured interviews<br>* Individual semi-structured interviews were conducted using purposeful sampling of 15- to 18-year-olds, until data saturation, and were transcribed and analysed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavior concerning antibiotics and vaccination | questionnary (no scale) used to Explore attitudes, behavior and knowledge of the 15-18-year-old young people in France concerning antibiotics and vaccination . Data collection by means of a questionnary during a unique interview with the teenager. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expectation and media | questionnary (no scale) used to Determine the expectations of the 15-18-year-old young people in France and needs concerning the methods and the supports of education. Data collection by means of a questionnary during a unique interview with the teenager | 5 years |
Prognostic Value of Biomarkers Associated With Endothelial Progenitor Cells Mobilization in Acute Coronary Syndromes

Study Overview
=================
Brief Summary
-----------------
This prospective study aimed to validate a new prognostic approach of endothelial progenitor cells associated biomarkers in patients with acute coronary syndromes . Recruitment is made prospectively by two centers of Inter -region South Mediterranean,

Official Title
-----------------
Prognostic Value of Biomarkers Associated With Endothelial Progenitor Cells Mobilization in Acute Coronary Syndromes

Conditions
-----------------
Acute Coronary Syndromes

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute coronary syndrome (ST + < 12 hours and ST- high risk or intermediate risk ),which there is an indication of percutaneous coronary intervention. Exclusion Criteria: Cancer Chronic inflammatory disease Infectious disease Erythrocyte <4 G/l Thrombopénia less than 100 000/mm3 ;

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: study of PEC markers and chemokines/ chemokine recep<br>blood sample for dosage and study of PEC markers and chemokines/ chemokine receptors | Other: blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the value of circulating endothelial progenitor cells quantification in the initial phase of ACS in predicting the occurrence of a major cardiovascular event (ECVM ) at 1 year. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the technical characteristics (sensitivity and specificity) and predictive value of the number of PEC |  | one day , one month , one year |
Safety and Efficacy of Bone Marrow Cell Transplantation in Humans Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
We will study in a prospective randomised fashion 50 patients who will be treated by intracoronary transplantation of autologous, mononuclear bone marrow cells (BMCs) in addition to standard therapy after MI or standard therapy. After standard therapy for acute MI, 10 patients were transplanted with autologous mononuclear BMCs via a balloon catheter placed into the infarct-related artery during balloon dilatation (percutaneous transluminal coronary angioplasty). Another 10 patients with acute MI were treated by standard therapy alone. After

Detailed Description
-----------------
Experimental and clinical data suggest that bone marrow-derived cells may contribute to the healing of myocardial infarction (MI).

Official Title
-----------------
Cardiac Study. Cellular Cardiomyoplasty of Infarcted Failed Myocardium by Autologous Intracoronary Mononuclear Bone Marrow Cell Transplantation in Humans

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: cell therapy, bone marrow derived stem cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent acute transmural anterior myocardial infarction, (in agreement with WHO) single left anterior descending coronary artery disease <72 hour from the origin of symptoms successful primary angioplasty of the culprit lesion Exclusion Criteria: screening >72 hours after infarction, cardiac shock, severe comorbidity, alcohol or drug dependency severe comorbidity (DM,renal or liver insufficiency) potential child bearing woman inability to provide informed consent

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

| Intervention/Treatment |
| --- |
|Procedure: cell therapy, bone marrow derived stem cell|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  |  | 
| Mortality and Morbidity |  |  | 
| Left ventricular function |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular remodeling |  |  | 
| Heart rate variability |  |  | 
| Baroreflex sensitivity |  |  | 
| Stress induced myocardial ischemia |  |  | 
| Cell dose response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone marrow, cell transplantation, stem cells, PTCA
Efficacy and Safety of Vitamin A Treatment for Children With Sepsis

Study Overview
=================
Brief Summary
-----------------
The prevalence of vitamin A deficiency was found high in children with sepsis. Whether those patients will benefit from the vitamin A supplementation is unknown.

Detailed Description
-----------------
It was reported that the prevalence of vitamin A deficiency was highly as 58% in critically ill children with sepsis. However, whether those patients will benefit from the vitamin A supplementation is unknown. We design an randomized, double-blind, placebo-controlled, multi-center trial to investigate the effect of vitamin A supplementation on the outcome of critically ill children with sepsis.

Official Title
-----------------
Efficacy and Safety of Vitamin A Treatment for Children With Sepsis: a Randomized Placebo-controlled Clinical Trial

Conditions
-----------------
Pediatric, Vitamin A Deficiency, Sepsis

Intervention / Treatment
-----------------
* Drug: Vitamin A
* Drug: Oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age < 18 years, Expected to stay in the ICU for 48 hours or more, Vitamin A deficiency (VA < 0.2 mg/L) Exclusion Criteria: Severely impaired gastrointestinal function Premature infants and low birth weight (LBW) infants Condition of underlying organ dysfunction Having received chemotherapy or radiotherapy Hematological malignancies Primary or acquired immunodeficiency

Ages Eligible for Study
-----------------
Minimum Age: 0 Months
Maximum Age: 192 Months

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Septic children with vitamin A deficiency who will receive vitamin A supplementation. | Drug: Vitamin A<br>* Children in intervention group will receive 50,000 IU vitamin A after being randomized.<br>|
| Placebo Comparator: control group<br>Septic children with vitamin A deficiency who will receive placebo. | Drug: Oil<br>* Children in control group will receive equal volume of oil.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay | The length of hospital stay will be measured by days | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital mortality | Hospital mortality will be record as ratio | 2 years |
Antidepressant Effect of Theta-Burst rTMS

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the safety and efficacy of theta-burst rTMS in patients with major depression. Patients will be randomized to receive ether left-sided intermittent theta-burst rTMS or rigt-sided continuous theta-burst rTMS or sham theta-burst rTMS over two weeks period with an option for an additional two weeks period, depending on treatment response. Clinical assessments will be performed weekly by the Hamilton depression rating scale. In addition, standard neurophysiological assessment of cortical excitability will be done.

Official Title
-----------------
Antidepressant Effect of Theta-Burst rTMS

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Device: theta-burst rTMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major depressive episode (DSM IV criteria). Informed consent. Age: 18-70. Exclusion Criteria: Suicidality Psychosis Pacemaker Cardiac arrythmia seizure disorder implantable metal devices PNS and CNS disorders any other contraindications as specified in safety guidelines for rTMS (Wassermenn, 1998).

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: theta-burst rTMS|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
-----------------
Major depression, Theta-burst rTMS, Cortical excitability, Hamilton depression rating scale
Seated Time for 90% Incidence of Hypotension

Study Overview
=================
Brief Summary
-----------------
The study will determine the 90% effective seated time after intrathecal injection of hyperbaric bupivacaine to avoid hypotension in patients undergoing cesarean delivery.

Detailed Description
-----------------
The study will use a Biased Coin Design (BCD), up-and-down sequential method, to determine the ET90 for absence of hypotension during Cesarean delivery. In this methodology, the first patient will be assigned an a priori initial seated time. Any other patient will be assigned a seated time based on the presence or absence of hypotension in the previous patient. If the previous patient developed hypotension, then the new patient will be seated for a longer time, which will be equal to the seated time of the previous patient plus a pre-determined time increment (up to an also pre-determined maximum allowed time). If no hypotension occurred to the previous patient, the new patient will be assigned one seated time from two choices: The same seated time that has been assigned to the previous patient, or a seated time shorter than that of the previous patient by a pre-determined time decrement (the pre-determined time increment and decrement are the same). The choice will be determined from a biased coin result, with a probability of 0.9 for assigning 'the same as previous' seated time and a probability of 0.1 for assigning a 'shorter seated time'.

Official Title
-----------------
Seated Time for Hypotension in Cesarean Delivery: A Biased Coin Design Trial for 90% Efficacy

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

Intervention / Treatment
-----------------
* Other: seated time


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with singleton pregnancies scheduled for elective cesarean delivery Exclusion Criteria: BMI>35 Unable to communicate in study language ASA greater than 2 Hypertensive disease of pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seated Time<br>Pts will be seated for the allocated time depending on the previous patients hypotensive response | Other: seated time<br>* Pt will be seated for a predetermined time period. All Patients will receive intrathecal bupivacaine and morphine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension | Presence of hypotension before delivery | 30 minutes |