linjc16/ctgov huggingface dataset:
Impact of Web-based School Nutrition Intervention to Increase Fruits, Vegetables and Dairy

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate the impact of an innovative web-based school nutrition intervention (Team Nutriathlon) aimed at promoting the consumption of vegetables and fruit and dairy products in high school students and to identify facilitators and/or barriers influencing its success.

Detailed Description
-----------------
Classes of first and second year secondary students (grades 9 and 10) from the Québec City region will be randomized into two groups. Participants in the intervention (Team Nutriathlon) will be asked to increase their consumption of fruits and vegetables and dairy products using an innovative web-based platform, developed for this study, over six weeks. The control group will follow the regular school curriculum. The number of servings of fruits and vegetables and dairy products consumed by students per day and facilitators and barriers influencing the success of the program will be compared between the two groups over the study.

Official Title
-----------------
The Impact of an Innovative Web-based School Nutrition Intervention to Increase Fruits and Vegetables and Dairy Products in Adolescents

Conditions
-----------------
Eating Behavior

Intervention / Treatment
-----------------
* Behavioral: Team Nutriathlon intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schools were recruited on a voluntary basis via email invitation and sent across the region of Québec. The selected schools were of medium to high socioeconomic levels according to the Deprivation Index of the Ministry of Education of Québec. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 14 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Team Nutriathlon intervention<br>Participants were invited to participate in the Team Nutriathlon for an 8-week period | Behavioral: Team Nutriathlon intervention<br>* 8 wk web-based nutrition intervention program aimed at increasing the consumption of fruits, vegetables and dairy products.<br>|
| No Intervention: Control<br>Participants were invited to follow the regular school curricular for an 8-week period | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fruits and vegetables and dairy products | Change in the servings of fruits and vegetables and milk and alternatives assessed with a web-based questionnaire | Before and after the intervention (0 and 6 wk) |
Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism

Study Overview
=================
Brief Summary
-----------------
A cataract is a clouding of the lens that occurs naturally with age. Cataract surgery involves removal of the cloudy lens and replacement with an artificial one. A special laser (femtosecond laser) is now being used to help make cataract surgery safer and more accurate . The femtosecond laser can also be used to correct astigmatism, an irregular curvature of the cornea, at the time of cataract surgery through a procedure called astigmatic keratotomy (AK). This study is gathering information about the specific laser settings that are used to perform astigmatic keratotomies (AK) during cataract surgery. This information will be used to improve the outcomes of patients that receive cataract surgery with astigmatic keratotomies in the future.

Official Title
-----------------
Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism

Conditions
-----------------
Astigmatism, Cataract

Intervention / Treatment
-----------------
* Device: Femto-AK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: ≥18 years of age Sex: male or female Patients who are planned to undergo femtosecond laser-assisted cataract surgery with astigmatic keratotomy at the Schein Ernst Mishra Eye clinic within the next 60 days of their cataract consultation visit. Subjects with planned single or bilateral cataract eye surgeries are eligible. Planned opposite eye surgery must be within 2-4 weeks of first cataract surgery. Fluent in written and spoken English Exclusion Criteria: Patients with corneal dystrophies, including anterior basement membrane dystrophy, keratoconus, and Fuch's endothelial corneal dystrophy. Age < 18 years Pregnant women Cognitive impairment Prisoners

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
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective, single-center, single-arm, interventional clinical trial. Subjects that meet inclusion and exclusion criteria are invited to participate.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Femto-AK Patients<br>Femtosecond laser assisted cataract surgery with creation of astigmatic keratotomies for the correction of corneal astigmatism. | Device: Femto-AK<br>* Astigmatic Keratotomy / Arcuate Incisions for the correction of astigmatism<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratometric Correction Index |  | 1 month | 
| Refractive Correction Index |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Astigmatism, Cataract, Femtosecond laser
Incidence of Perioperative Hypothermia in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
Perioperative hypothermia is associated with many complications, including surgical site infections, delayed wound healing, coagulopathy, prolonged hospital and intensive care unit length of stay. Perioperative close monitoring of the body temperature is important, and this is recommended by many clinical practice guidelines. In this study the investigators aimed to detect the incidence of perioperative hypothermia in pediatric patients in the operating room, and to detect the possible associated risk factors.

Official Title
-----------------
Incidence of Perioperative Hypothermia in Pediatric Patients

Conditions
-----------------
Hypothermia; Anesthesia, Hypothermia Following Anesthesia

Intervention / Treatment
-----------------
* Diagnostic Test: Measurement of body temperature


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any elective operation American Society of Anaesthesiologists (ASA) I-III physical status Age 0-18 years Exclusion Criteria: Emergency operations ASA IV-V physical status Open heart surgeries Age >=18 years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Measurement of body temperature|The patients' body temperature will be measured pre-, intra- and post-operatively via an infrared thermometer.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body temperature | Body temperature of the patients will be measured via infrared thermometer. | Perioperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypothermia, intraoperative, perioperative, postoperative
Efficacy of Arnica D1 Ointment After Upper Blepharoplasty

Study Overview
=================
Brief Summary
-----------------
Arnica ointment is currently used in homeopathic preparations for strains and bruises. In the field of plastic surgery, some surgeons advise patients undergoing blepharoplasty to use Arnica in order to prevent postoperative ecchymosis, swelling and pain. Thus far, no decent study evaluated the efficacy of topical Arnica ointment in reducing ecchymosis or surgical outcome after upper blepharoplasty. We hypothesize that application of Arnica ointment postoperatively will reduce the development of ecchymosis and improve outcome.

Official Title
-----------------
Efficacy of Arnica D1 Ointment After Upper Blepharoplasty: a Randomized, Double-blind Placebo-controlled Study

Conditions
-----------------
Blepharoplasty, Upper Eyelid Blepharoplasty

Intervention / Treatment
-----------------
* Drug: Arnica
* Drug: Placebo ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing primary blepharoplasty Exclusion Criteria: use of anticoagulants

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arnica ointment<br> | Drug: Arnica<br>* Application of Arnica ointment periorbitally<br>|
| Placebo Comparator: Placebo ointment<br> | Drug: Placebo ointment<br>* Application of Arnica ointment, twice a day, for the period of one week.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical outcome | Overall judgment of surgical outcome, based on the combined analysis of the amount of ecchymosis, swelling and redness, by an unrelated, uninvolved and blinded plastic surgeon. | 7 days and 6 weeks postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of tissue swelling; redness; pain; postoperative recovery; patient satisfaction |  | 3, 7 and 42 days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blepharoplasty, arnica, homeopathy
Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks

Study Overview
=================
Brief Summary
-----------------
The researcher want to improve port wine stain (PWS) therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL) therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome.

Detailed Description
-----------------
Both topical agents inhibit nuclear factor of activated T-cells (NFAT) which blocks the calcineurin/NFAT pathway inhibiting endothelial cell proliferation and angiogenesis, which could be very useful in preventing PWS recanalization. The combined use of PDL to induce PWS blood vessel injury, and topical antiangiogenic agents to prevent PWS blood vessel angiogenesis and recanalization after laser therapy, will improve PWS lesion blanching.

Official Title
-----------------
Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks

Conditions
-----------------
Port Wine Stain

Intervention / Treatment
-----------------
* Drug: Topical Antiangiogenic
* Device: Pulsed Dye Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 16 years of age and older Have PWS suitable for comparison testing as determined by the study doctor Exclusion Criteria: Less than 16 years old Are pregnant Have skin cancer Currently taking immunosuppressive or steroids or photosensitizing drugs Current participation in any other investigational drug evaluation Concurrent use of known photosensitizing drugs

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical Antiangiogenic<br>Topical Antiangiogenic Agents | Drug: Topical Antiangiogenic<br>* Topical Antiangiogenic<br>|
| Experimental: Pulsed Dye Laser<br>Pulsed Dye Laser | Device: Pulsed Dye Laser<br>* Pulsed Dye Laser<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve PWS lesion blanching. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome. |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Birthmark, PWS
Study on Abnormal Dopamine Synthesis and Connectivity According to the Antipsychotic Treatment Response in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate abnormal dopamine synthesis and connectivity according to the antipsychotic treatment response in schizophrenia.

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Other: patients treated with antipsychotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of schizophrenia clinically stable state Exclusion Criteria: history of previous head injury, epileptic disorder, other medical comorbidity substance abuse/dependence

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clozapine<br>stable patients treated with clozapine | Other: patients treated with antipsychotics<br> <br> |
| Other antipsychotics<br>stable patients treated with risperidone or paliperidone or olanzapine | Other: patients treated with antipsychotics<br> <br> |
| Healthy volunteer<br>healthy controls | Other: patients treated with antipsychotics<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Striatal [18F]-DOPA uptake measured using positron emission tomographic 18F-dopa imaging. |  | within 2 weeks from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resting state functional magnetic resonance imaging |  | within 2 weeks from enrollment | 
| diffusion tensor imaging |  | within 2 weeks from enrollment | 
| clinical measure including Positive and Negative Syndrome Scale |  | within 2 weeks from enrollment | 
| neurocognitive function test |  | within 2 weeks from enrollment |
QT Interval in Patients With Pacemaker Dependency

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine a correction term for an adapted QT interval during ventricular pacing (right, left and biventricular pacing) to obtain valid formulae correcting for the QT intervals in various pacing conditions.

Detailed Description
-----------------
This investigation aims at determining a possibility to assess the usefulness of various formulae that correct for the different effects of various pacing modes on the QT interval. More specifically, the hypothesis will be tested that applying adequate correction will preserve the predictive power of the QT-interval regarding proarrhythmia in various cardiac pathologies and therapies.

Official Title
-----------------
Corrected QT Interval in Patients With Pacemaker Dependency (QT-TENDENCY-Study)

Conditions
-----------------
High Degree AV-block, Left Bundle Branch Block

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: caucasian race implanted cardioverter/defibrillator or pacemaker negative pregnancy test for women of child bearing potential stable function of the implanted device stable medical therapy relating to the underlying disease stable medical therapy of antiarrhythmic drugs and other QT-time changing drugs no instability of rhythm x-ray of thorax during device implantation in two levels (ap and ll axis) written informed consent Exclusion Criteria: coronary heart disease and angina pectoris symptoms patient with acute myocardial infarction or CABG while the last 4 weeks patient with tachycardia and a rest frequency >80 bpm patient with severe pulmonary disease patient with anaemia patient with acute infections patient with severe kidney or liver disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Pacemaker mode programming<br>High grade AV-block | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected QT Interval in Patients With Pacemaker Dependency |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pacemaker, ICD / CRTD, corrected QT-interval
An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext

Study Overview
=================
Brief Summary
-----------------
An open label, extension study for subjects completing the ZPU-003 Ext 1 study.

Detailed Description
-----------------
This is an open label, extension study for subjects completing the ZPU-003 Ext 1 study and an off-drug interval (menses), prior to the start of the first 16-week dosing cycle. Subjects will receive a 50 mg Proellex® daily dose. Total study participation for ZPU-003 Ext 2 (Extension 2) may be up to three 4 month drug cycles separated by off drug intervals.

Official Title
-----------------
An Open-Label Extension Study Evaluating Safety and Efficacy of Proellex® In Women With Leiomyomata Who Have Previously Completed ZPU 003 Ext

Conditions
-----------------
Uterine Fibroids

Intervention / Treatment
-----------------
* Drug: 25 mg Proellex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Four subjects at one site whom have completed ZPU 003 Ext 1 study Exclusion Criteria: All other subjects

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25 mg Proellex<br>25 mg Proellex daily | Drug: 25 mg Proellex<br>* one 25 mg capsules<br>* Other names: Proellex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Further Evaluate Adverse Events of a 25 mg Dose of Proellex® Administered to Women Once Daily for Three 4 Month Cycles Separated by Off-drug Intervals. |  | three 4 month cycles separated by off-drug intervals | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uterine fibroids
Proyecto SOL: A Risk Reduction Intervention for Hispanic Men Who Have Sex With Men (MSM)

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to determine the acceptability, feasibility, and the preliminary efficacy of an HIV prevention behavioral intervention (Proyecto SOL) to reduce behaviors associated with HIV acquisition among Hispanic men who have sex with men (HMSM). The primary goal of the intervention is to motivate and assist participants in forming and carrying out a Safer Options for Life plan, thereby reducing their risk of HIV acquisition or transmission.

Official Title
-----------------
Proyecto SOL: A Risk Reduction Intervention for Hispanic MSM

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: Proyecto SOL
* Behavioral: HCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: self-identify as Hispanic or Latino; be between 18 and 49 years of age; be a resident of South Florida (Miami-Dade, Broward or Palm Beach counties) and not planning to move out of the area for the next 9 months; self-identify as male; have had at least one episode of unprotected anal sex with a man in the preceding 3 months; have had 2 or more male sex partners in the preceding 3 months; be HIV negative or of unknown serostatus; speak English and/or Spanish; provide informed consent. Exclusion Criteria: have previously participated in any Phase of this study; self-identify as transgender; not being a resident of South Florida.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.Group Intervention<br>A group-based intervention consisting of 4 sessions lasting approximately 90 minutes each. Using a variety of pedagogical and interactive approaches, facilitators will introduce new concepts and skills. | Behavioral: Proyecto SOL<br>* Group intervention<br>|
| Active Comparator: 2. HCT<br>Offer of HIV counseling and testing | Behavioral: HCT<br>* Offer of HIV counseling and testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unprotected sex |  | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Seronegativity, HIV risk behavior, Unprotected sex, men who have sex with men, gay, Latino, Unsafe Sex