linjc16/ctgov huggingface dataset:
Behavior and Driving Safety Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether brief motivational interviews reduce the likelihood of driving under the influence of alcohol (DUI).

Detailed Description
-----------------
Despite extensive legislative, law enforcement, and public awareness efforts, driving under the influence of alcohol (DUI) remains a major cause of mortality and loss of years of productive life. A brief motivational interview (BI) is a non-confrontational, patient-centered discussion during which the individual's motivation and confidence to change health-related behaviors are explored. Previous studies of BIs in health care settings suggest that BIs administered after hospitalization for alcohol-related injury reduce the likelihood of repeat injury hospitalization and arrest for DUI.

Official Title
-----------------
Behavior and Driving Safety Study

Conditions
-----------------
Alcoholic Intoxication

Intervention / Treatment
-----------------
* Behavioral: Brief motivational interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Second or greater arrest for driving under the influence of alcohol Arrest involved operation of a motor vehicle At least 18 years of age English-speaking Exclusion Criteria: Arrest involved injury to another person Previous participation in this study

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Brief motivational interview | Behavioral: Brief motivational interview<br>* The brief motivational interview is a non-confrontational, patient-centered discussion between a counselor (e.g., social worker, nurse, physician, or psychologist) and an at-risk individual during which the individual's motivation and confidence to change health-related behaviors are explored.<br>|
| No Intervention: 2<br>No discussion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to repeat arrest for driving under the influence of alcohol |  | Up until one year after the conclusion of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol Use Disorders Identification Test score |  | 6 and 12 months | 
| Time to alcohol-related injury hospitalization |  | Up until one year after the conclusion of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Automobile driving, Driving under the influence, Interview, psychological, Brief intervention, Brief motivational interview
Clinical Investigation of the Vision-R800 Device.

Study Overview
=================
Brief Summary
-----------------
Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and associated spectacle lenses.

Official Title
-----------------
Clinical Investigation of the Vision-R800 Device. Understanding the Value of High Precision Refractions and Lenses to Optometrists and Patients. Phase 2

Conditions
-----------------
Myopia, Hyperopia, Astigmatism, Presbyopia

Intervention / Treatment
-----------------
* Device: Vision R-800 Phoropter
* Device: Standard Phoropter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: current adaptated progressive addition lens wearer, if bifocal lens required wearable pair of glasses < 2 years old wear glasses at least 6 hours per day Exclusion Criteria: Eye Disease with an impact on visual acuity or binocular vision abnormalities (by self-report) Formal training in optometry, vision science or in the eyecare field

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R-Refraction<br> | Device: Vision R-800 Phoropter<br>* Refraction utilizing the Vision R-800 Phoropter with resulting glasses<br>Device: Standard Phoropter<br>* Refraction utilizing the standard phoropter with resulting glasses<br>|
| Active Comparator: S-Refraction<br> | Device: Vision R-800 Phoropter<br>* Refraction utilizing the Vision R-800 Phoropter with resulting glasses<br>Device: Standard Phoropter<br>* Refraction utilizing the standard phoropter with resulting glasses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Questionnaire Response | Patient questions of refraction preference for quickness, efficiency, comfort, and stress | at Visit 5 (final visit), up to 5 weeks |
Neonatal Outcome of Children With Antenatal Colic Hyperechogenicity

Study Overview
=================
Brief Summary
-----------------
Fetal colic hyper-echogenicity is a presenting symptoms for cystinuria lysinuria. A few cases of fetuses with dibasic protein intolerance (more complex prognosis) presented with colic hyper-echogenicity antenatal. The aim of this retrospective study is to assess the outcome of fetuses with colic hyperechogenicity in order to increase prenatal counseling

Detailed Description
-----------------
Observational multicenter retrospective study from january 2011 to january 2021. No supplementary visit, directly related to the research, will be necessary. This study does not change the usual management of the patient. Patients will be included after their usual medical check-up.

Official Title
-----------------
Neonatal Outcome of Children With Antenatal Colic Hyperechogenicity

Conditions
-----------------
Colic, Nephropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Fetuses with prenatal colic hyperechogenicity Between January 2011 and January 2021 Born without term limitation. Exclusion criteria: Intestinal hyperechogenicity polymalformative syndrome Patients Age<15 years

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Postnatal outcome of fetuses | Postnatal outcome of fetuses with hyperechogenic colon. | day 1 (End of follow up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of lysinuria/cystinuria | Rate of lysinuria/cystinuria | day 1 (End of follow up) | 
| Rate of dibasic protein intolerance | Rate of dibasic protein intolerance | day 1 (End of follow up) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound, Gynecology-Obstetrics, Medical genetics, Pediatrics, Nephropathy, Colic hyperechogenicity, Antenatal, Lysinuria-cystinuria, lysinuric protein intolerance
Fludrocortisone for Sudden Hearing Loss

Study Overview
=================
Brief Summary
-----------------
The standard of care treatment of sudden hearing loss uses a type of steroid called glucocorticoid. Examples of glucocorticoids are prednisone, methylprednisolone and dexamethasone. Not everybody recovers hearing with glucocorticoid treatment. Fludrocortisone is a different type of steroid called mineralocorticoid. Unlike glucocorticoids, which work by reducing inflammation, mineralocorticoids work by changing salt and fluid balance. In animal studies, fludrocortisone is at least as effective as glucocorticoid in preserving hearing. Fludrocortisone is not approved for the treatment of sudden hearing loss. The purpose of this study is to test whether fludrocortisone can treat sudden hearing loss.

Official Title
-----------------
Mineralocorticoid Treatment for Sudden Sensorineural Hearing Loss

Conditions
-----------------
Hearing Loss, Sensorineural

Intervention / Treatment
-----------------
* Drug: Fludrocortisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older Idiopathic sudden sensorineural hearing loss within 3 months Failure to recover hearing with glucocorticoid treatment or inability to tolerate glucocorticoid Exclusion Criteria: Other diagnosis for the sudden hearing loss Concurrent systemic use of another steroid Hypersensitivity to fludrocortisone Systemic fungal infection Hypertension requiring two or more medications Pitting edema Cardiomegaly Congestive heart failure Electrolyte abnormality Concurrent use of barbiturates, phenytoin, fosphenytoin, rifampin, or rifapentine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fludrocortisone<br> | Drug: Fludrocortisone<br>* Fludrocortisone 0.2 mg by mouth daily for 30 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing | Hearing outcome will be determine by pure-tone and speech audiometry measured at the completion of a one-month course of treatment and compared with pre-treatment test results. | At one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sudden, sensorineural, hearing loss, fludrocortisone, mineralocorticoid, steroid
Timing of Smoking Intervention in Alcohol Treatment (Nicotine Patch)

Study Overview
=================
Brief Summary
-----------------
This study will attempt to determine the best time to begin a smoking cessation program in individuals who undergo intensive treatment for alcohol dependence. The goal of this trial is to determine whether a smoking cessation program is more effective if it occurs at the same time as or after treatment for alcohol dependence. The study also will attempt to determine the effect of smoking cessation programs on the outcome of treatment for alcohol dependence.

Official Title
-----------------
Timing of Smoking Intervention in Alcohol Treatment

Conditions
-----------------
Alcoholism, Smoking

Intervention / Treatment
-----------------
* Drug: nicotine replacement patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets criteria for alcohol use disorder and other drug dependence. Complete first week of alcohol treatment program. Current cigarette smoker (more than 5 cigarettes/day, smoking more than 1 year). Exclusion Criteria: Lifetime diagnosis of an excluding psychiatric disorder: bipolar disorder, schizophrenia or other psychotic disorder, panic disorder with or without agoraphobia, obsessive-compulsive disorder, generalized anxiety disorder, eating disorder, post- traumatic stress disorder, antisocial personality disorder, or borderline personality disorder. Unable to participate in protocol due to functional deficits or severe depression. Suicidal or homicidal ideation. Current use of disulfiram (Antabuse) or naltrexone (Revia). Current use of pipes, cigars, or smokeless tobacco and unwillingness to stop. Lives more than 100 miles from alcohol treatment facility. No telephone.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nicotine replacement patch|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety, tolerability and antibody response of Lu AF20513 in patients with Alzheimer's disease who have completed the 16026A study.

Official Title
-----------------
Interventional, Open-label, Multiple-immunization Extension Study on the Safety, Tolerability and Immunogenicity of Lu AF20513/Adjuvant in Patients With Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Lu AF20513


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion criteria: The patient has completed the 16026A study and has received the last study treatment within 12 months of the screening visit for the present study. The patient has an MRI scan done in relation to study 16026A performed within 9 months before first study visit in the extension study. The patient has a knowledgeable and reliable caregiver/ study partner who will be available and able to accompany the patient to clinical visits, monitor Immunisation-Related Events after each immunisation, and participate with the patient at phone visits during the study Main exclusion criteria: The patient uses or has recently used (pre-trial time limits specified in Appendix II) disallowed concomitant medication or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications (Appendix II) during the study. The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety and tolerability More inclusion and exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lu AF20513 high dose<br> | Drug: Lu AF20513<br>* Injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Based on the safety assessments (clinical safety laboratory tests, vital signs, ECGs, physical examinations (including neurological), Immunisation-Related Events (IRE) (selected from Brighton Collaboration guidelines) and magnetic resonance imaging (MRI) safety scans) | Baseline to week 96 | 
| Aβ-specific antibody titre in plasma |  | Baseline to week 96 |
Infusion Laboratory: Protocol 1 - Selegeline - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of selegiline on the subjective and physiological effects of cocaine challenge in chronic crack abusers, and to evaluate clinical safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack dependent population.

Detailed Description
-----------------
To develop a medication for the treatment of cocaine addiction using a medical human physio-neuro-psycho-immunology laboratory setting. To characterize this cocaine abusing population on a variety of psychological and physicologically measures over time from withdrawal through pere and post cocaine administration. To determine the effects of selegeline on the subjective and physiological effects of cocaine challenge in chronic crack abusers. To evaluate clinical safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack dependent population.

Official Title
-----------------
Infusion Laboratory: Protocol 1 - Selegeline

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Selegiline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F, ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Ages Eligible for Study
-----------------
Minimum Age: 31 Years
Maximum Age: 47 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of drug craving |  |  | 
| History, incidence and amount of drug use |  |  | 
| Type and severity of stimulant withdrawal symptoms |  |  | 
| Population incidence of symptoms of depression, possible organic brain syndrome deficits |  |  | 
| Frequency and intensity of drug use and sexual behaviors at risk for HIV |  |  | 
| Evidence of change in neurophysiology and brain activity |  |  | 
| Evidence of change in subjective responses to cocaine challenge |  |  | 
| Clinical physiological response to cocaine challenge - especially adverse effects measures |  |  | 
| Degree to which study medication influences changes in #6, 7 & 8 above (possible efficacy measure) |  |  | 
| Characterization of study population |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Prevalence and Clinical Significance of Co-infection of Mycoplasma Pneumoniae in Patients With Pulmonary Tuberculosis

Study Overview
=================
Brief Summary
-----------------
Several case report showed that the co-infection of Mycoplasma pneumoniae in patients with pulmonary tuberculosis. The aim of this study is to elucidate the prevalence and its clinical significance of co-infection of Mycoplasma pneumonia in patients with newly diagnosed pulmonary tuberculosis.

Official Title
-----------------
Prevalence and Clinical Significance of Co-infection of Mycoplasma Pneumoniae in Patients With Pulmonary Tuberculosis

Conditions
-----------------
Mycoplasma Pneumonia, Pulmonary Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bacteriologically or clinically diagnosed pulmonary TB Older than 17years Exclusion Criteria: HIV positive Immune-compromized

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 |
| --- | --- | --- |
Endoscopic Saphenous Vein Harvest for Coronary Artery Bypass Grafting

Study Overview
=================
Brief Summary
-----------------
Although the long saphenous vein remains the most commonly used conduit in coronary revascularization, traditional open vein harvest may lead to significantly impaired wound healing and post-operative pain. To this end, endoscopic saphenous vein harvesting techniques have been shown to reduce post-operative morbidity. Studies have shown that endothelial integrity and luminal nitric oxide synthase (NOS) are better preserved with novel no-touch techniques; however, the effect and the associated mechanism of endoscopic vein harvest on endothelial integrity and function remain unknown. Therefore, in the present proposal, we will collect the saphenous vein segements immediately after harvesting, reperfusion, and grafting, and then use enzyme-linked immunosorbant assay (ELISA), immunohistochemical staining (IHC), and real-time polymerase chain reaction (RT-PCR) to detect the expression and distribution of endothelial NOS (eNOS), endothelin-1 (ET-1), vascular cell adhesion molecule-1 (VCAM-1), intracellular adhesion molecule-1 (ICAM-1), and platelet endothelial cell adhesion molecule-1(PECAM-1) at protein and RNA levels in the endothelium of saphenous veins. The major aim of this study is to elucidate the effect and mechanism of endoscopic saphenous vein harvesting on endothelial properties as compare to conventional open vein harvest technique.

Official Title
-----------------
The Impact on Endothelial Function and Integrity by Endoscopic Saphenous Vein Harvest for Coronary Artery Bypass Grafting

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: coronary artery bypass grafting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with coronary artery disease underwent coronary artery bypass grafting in our hospital Exclusion Criteria: no
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: coronary artery bypass grafting|patient with coroary artery diseases underwent coronary artery bypass grafting surgery|

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
-----------------
coronary artery bypass grafting, endoscopic vein harvest, saphenous vein, endothelial cells, eNOS, ET-1