linjc16/ctgov huggingface dataset:
The Early Truancy Prevention Project

Study Overview
=================
Brief Summary
-----------------
The Early Truancy Prevention Project is designed to prevent elementary school truancy through teacher-led interventions that are individualized to meet student needs.

Detailed Description
-----------------
The Early Truancy Prevention Project is an innovative intervention program designed to prevent elementary school truancy and later school dropout. The intervention model emphasizes the important role of teachers as change agents to address early attendance problems and emerging truancy. Specifically, the goals of this pilot project are: 1) to facilitate positive, trusting, and collaborative home-school relations and to promote a positive teacher-child relationship; 2) to provide teachers with timely information about a student's attendance pattern; and 3) to train and supervise teachers in the implementation of individualized attendance interventions to improve student attendance and prevent emerging truancy among elementary school students. As this is a pilot study, another important goal is to obtain teacher and administrator feedback to improve and refine all aspects of the project.

Official Title
-----------------
The Early Truancy Prevention Project

Conditions
-----------------
Excessive Absenteeism by Primary School Students

Intervention / Treatment
-----------------
* Behavioral: Teacher led intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all first and second grade teachers in 6 schools Exclusion Criteria: none
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 |
| --- | --- |
| Experimental: Teacher led intervention<br>Teachers will conduct teacher-led interventions that are individualized for each student to prevent emerging truancy among elementary students. | Behavioral: Teacher led intervention<br> <br> |
| No Intervention: Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of students who are truant | Truancy is defined as 10 days absent during the academic year (approximately 10 months: August, 2013-June, 2014). | June, 2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of absences per classroom | Average number of absences per classroom during the academic year (approximately 10 months: August, 2013-June, 2014). | June, 2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
education, truancy, attendance, primary school, elementary school
Restore Claims Characterization Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.

Official Title
-----------------
Restore Claims Characterization Study

Conditions
-----------------
Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome

Intervention / Treatment
-----------------
* Device: Spinal Cord Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has chronic refractory pain associated with one of the conditions currently approved for spinal cord stimulation as follows: Failed Back Syndrome, Degenerative Disk Disease (DDD), Herniated Disk pain refractory to conservative and surgical interventions, Peripheral Causalgia, Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD). Primary pain in the lower half of the body. Exclusion Criteria: Requires, or will in the future, diathermy treatments. Had implanted spinal cord stimulation system within the last six 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Spinal Cord Stimulation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measures include pain relief, quality of life, function, patient and physician acceptance. |  |  |
Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
Recently, intravitreal bevacizumab (Avastin) injection has gained popularity as a potential treatment of intraocular neovascularization (CNV) associated with age related macular degeneration and diabetic retinopathy. The efficacy of the drug is thought to be related with its pharmacologic blockade of VEGF. The purpose of this study is to determine the effect of the intravitreal bevacizumab on the fibrovascular membrane associated with proliferative diabetic retinopathy by objective histologic evaluation. The patients scheduled for vitrectomy for tractional fibrovascular membrane due to proliferative diabetic retinopathy will be randomized into two treatment groups. The one will receive conventional vitrectomy and the other group will receive intravitreal bevacizumab injection one week before the scheduled vitrectomy. The fibrovascular membrane will be excised during surgery and fixated for histologic examinations. The expression of VEGF and PEDF, a potent inhibitor of angiogenesis, will be evaluated in the fibrovascular membrane by immunohistochemistry. The results will be compared between two treatment groups.

Official Title
-----------------
Histologic Changes of Fibrovascular Membrane Associated With Proliferative Diabetic Retinopathy After Intravitreal Bevacizumab (Avastin®)

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tractional retinal detachment recently involving the macula with fibrovascular membrane due to proliferative diabetic retinopathy Severe fibrovascular proliferation progressing after appropriate panretinal photocoagulation Exclusion Criteria: Uncontrolled systemic hypertension Recent history of myocardiac infarction within 6 months Recent history of cerebrovascular accident within 6 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: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expression level of VEFG |  |  | 
| PEDG |  |  | 
| Factor VIII |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PEDF, intravitreal bevacizumab, proliferative diabetic retinopathy, VEGF
Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence

Study Overview
=================
Brief Summary
-----------------
Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to examine the effects of buprenorphine/naloxone when given through different routes and at different doses.

Detailed Description
-----------------
Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and effective treatment for opioid dependence. However, there is concern that buprenorphine may be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this study is to characterize the effects of buprenorphine/naloxone in opioid-dependent individuals. This study will last 10 weeks. Participants will stay in a residential research unit, and will be maintained on oral hydromorphone (10 mg). During twice-weekly experimental sessions, participants will be randomly assigned to receive either sublingual tablets, intramuscular injections, or a placebo. The 15 conditions studied will include: sublingual or intramuscular buprenorphine/naloxone (1/0.25 mg, 2/0.5 mg, 4/1 mg, 8/2 mg, and 16/4 mg), 0.25 mg of intramuscular naloxone (antagonist control), 10 mg of intramuscular hydromorphone (agonist control), sublingual and intramuscular buprenorphine (8 mg), and placebo.

Official Title
-----------------
Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently opioid dependent In good health, as determined by a pre-participation medical examination Seeking and eligible for methadone maintenance or detoxification treatment Exclusion Criteria: Significant medical or psychiatric illness, other than drug dependence

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine|single doses given by sublingual and parenteral routes|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid agonist rating |  | up to one day | 
| opiate withdrawal |  | up to one day | 
| physiologic measures |  | up to one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opiate dependence
Natriuretic Peptides After Left Atrial Appendage Amputation

Study Overview
=================
Brief Summary
-----------------
Surgical amputation of the left atrial appendage (LAA) is an established intervention during surgical atrial fibrillation (AF) therapy. However, its effects on the endocrine function of the left atrium are unclear. This study aims to quantify the serum levels of natriuretic peptides in patients who undergo concomitant surgical AF ablation with or without LAA amputation.

Official Title
-----------------
Influence of Left Atrial Appendage Amputation on Natriuretic Peptides - a Randomized Controlled Trial

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: LAA amputation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for concomitant AF therapy during cardiac surgery with cardiopulmonary bypass Exclusion Criteria: Lack of informed consent

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 Randomization
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAA amputation group<br> | Procedure: LAA amputation<br>* complete surgical amputation of the left atrial appendage<br>|
| No Intervention: No LAA amputation group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of proANP and BNP until 800days post surgery |  | 800days |
The Prevalence of Urinary Incontinence in Women and Men With Respiratory Diseases: a Questionnaire Survey

Study Overview
=================
Brief Summary
-----------------
Study the prevalence of the urinary incontinence among adults with respiratory diseases.

Official Title
-----------------
The Prevalence of Urinary Incontinence in Women and Men With Respiratory Diseases: a Questionnaire Survey

Conditions
-----------------
Chronic Respiratory Disease

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults Patients with chronic respiratory diseases Age: 18-90 Exclusion Criteria: Minors Patients with cystic fibrosis Cognitive disorders Patients who do not speak French

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Survey|Urinary Incontinence Survey|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Incontinence | Prevalence | five minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Function | VEMS | five minutes |
Amniotic Membrane Associated With Conjunctival Autograft Versus Conjunctival Autograft for Recurrent Pterygia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare amniotic membrane associated with conjunctival autograft versus conjunctival autograft alone in the treatment of recurrent pterygia.

Detailed Description
-----------------
Patients with recurrent pterygia without symblepharon were randomly assigned to undertake pterygium excision followed by amniotic membrane associated with a small conjunctival autograft (2x3mm) or conjunctival autograft (approximately 5x8mm) alone. The patients were examined after 1, 7, 30, 90, 180 and 360 days after the surgery. Recurrence was considered as a fibrovascular ingrowth of 1.5 mm or more beyond the limbus with conjunctival drag.

Conditions
-----------------
Recurrent Pterygia

Intervention / Treatment
-----------------
* Procedure: Conjunctival autograft versus conjunctival autograft treatment for recurrent pterygia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrent pterygium Exclusion Criteria: Less than 15 year of age Symblepharon Glaucoma, Ocular Allergy Ocular surface disorders

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 80 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Conjunctival autograft versus conjunctival autograft treatment for recurrent pterygia|Amniotic membrane Conjunctival autograft Conjunctival autograft Recurrent pterygia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amniotic membrane treatment for recurrent pterygia |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amniotic membrane, Conjunctival autograft, Recurrent pterygia, compare amniotic membrane associated with conjunctival autograft versus conjunctival autograft alone in the treatment of recurrent pterygia
Study of Prognostic Factors in Interventional Rhythmology

Study Overview
=================
Brief Summary
-----------------
Develop a prospective register assessing the short- and long-term complications of patients undergoing interventional rhythm

Detailed Description
-----------------
To assess the fate of patients who have undergone a technical procedure at the Cardiology Plate (implantation / extraction of a pacemaker, a defibrillator, radiofrequency ablation or cryo-ablation, left auricle closure, electro- Physiological exploration), and to determine prognostic factors / markers in this population.

Official Title
-----------------
Study of Prognostic Factors in Interventional Rhythmology

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Other: follow-up of patients after interventional rhythm operation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient to undergo: Implantation of a cardiac pacemaker or cardiac defibrillator or Extraction of pacemaker / defibrillator housing or probes or Realization of a radiofrequency / cryo-ablation: Atrial fibrillation Focus of ventricular tachycardia An accessory or Any electrophysiological exploration or Installation of Holter implantable or Left auricular closure percutaneously Having formulated its non-opposition Exclusion Criteria: Minor Patient's refusal Patients under legal protection

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: follow-up of patients after interventional rhythm operation|The follow-up will take place at 3 months postoperatively, then at 1 year and then annually for 5 years.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of adverse clinical events | The occurrence of the following adverse clinical events: infectious, rhythmic complications, hemodynamic, mortality any causes and cardiovascular post--interventional and in the length-course | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of intervention | The duration of the operation of interventional rhythmology will be measured | Day 1 | 
| dose of X-radiation used | the dose of X-radiation used shall be measured | Day1 | 
| volume of used contrast agent | The volume of used contrast agent will be measured | Day1 | 
| duration of hospitalization | the duration of hospitalization will be measured | 3 months | 
| need for reoperation | the need for reoperation will be assessed | 5 years | 
| evolution of the ECG | The evolution of the ECG will be estimated | 5 years | 
| evolution of the echocardiographic parameters | the evolution of the echocardiographic parameters will be estimated | 5 years |
A Study of the Interaction of Rifampin and Vinflunine in Subjects With Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test how vinflunine interacts with rifampin in the human body

Official Title
-----------------
Effect of Rifampin on the Pharmacokinetics of Intravenous (IV) Vinflunine in Subjects With Advanced Cancer

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: Vinflunine
* Drug: Rifampin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer unresponsive to previous treatment Consent for genetic samples Exclusion Criteria: Cancer of the blood Spread of cancer to the brain Moderate or severe nerve damage Low white blood cell counts and platelet counts Inadequate liver or kidney function Prior treatment with vinflunine Use of certain medications that might interfere with the metabolism of vinflunine

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

| Intervention/Treatment |
| --- |
|Drug: Vinflunine|nan|
|Drug: Rifampin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Outcome Measure of the effect of rifampin on the pharmacokinetics (PK) of intravenous (IV) vinflunine will be determined from the PK measurements |  | taken during Cycle 2 of study treatment, at approximately 4 weeks after the start of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Secondary Outcome Measures of the safety and tolerability of vinflunine when administered alone and with rifampin |  | determined after 2 complete 21-day Cycles of study treatment, at approximately 6 weeks after the start of study treatment |