linjc16/ctgov huggingface dataset:
Efficacy Trial of Raices Nuevas

Study Overview
=================
Brief Summary
-----------------
This trial will test the impact of a culturally tailored and theory driven primary intimate partner violence prevention intervention with Spanish speaking Latino men.

Detailed Description
-----------------
In this randomized controlled trial, Spanish speaking Latino men will be recruited from community church settings in Southwest Detroit and randomly assigned to: (a) an intimate partner violence prevention intervention or (b) a wait-list control condition. Latino men assigned to the intervention will receive, in a small group setting, an 8-session, primary intimate partner violence prevention intervention based on the Duluth model and culturally and linguistically tailored for Spanish speaking Latino men. Measures will be administered at pre-test, and at three and six months post-intervention.

Official Title
-----------------
Efficacy Trial of Raices Nuevas

Conditions
-----------------
Intimate Partner Violence

Intervention / Treatment
-----------------
* Behavioral: Raices nuevas


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spanish speaking Latino men between the ages of 18 and 55 in a stable relationship for at least the past three months Exclusion Criteria: severely mentally impaired hearing impaired

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: A<br> | Behavioral: Raices nuevas<br>* 8 90-minute sessions (once a week) of problem-posing and facilitated discussion on respect, anger, support, trust, negotiating, partnership with your intimate partner.<br>|
| No Intervention: 2 B<br>wait-listed for intervention to begin in 6 months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perpetration of violence towards intimate partner |  | 3 and 6 months after completion of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intentions to abuse intimate partner |  | 3 and 6 months after completion of intervention | 
| Beliefs, norms, and perceived self-efficacy |  | 3 and 6 months after completion of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
partner violence, spouse abuse
Epicutaneous Testing of Cosmetics for Skin Compatibility

Study Overview
=================
Brief Summary
-----------------
The dermatological testing of cosmetic products which are new on the market, or existing products with novel formulations is common and a useful procedure, yet necessary to alleviate common irritants and contact allergic reactions. Cosmetic products contain a range of substances that may be considered as potential irritants or contact allergens. In order to estimate that risk, cosmetics are tested by applying patch tests.

Detailed Description
-----------------
The dermatological testing of cosmetic products which are new on the market, or existing products with novel formulations is common and a useful procedure, yet necessary to alleviate common irritants and contact allergic reactions. Cosmetic products contain a range of substances that may be considered as potential irritants or contact allergens. In order to estimate that risk, cosmetics are tested by applying patch tests, as with allergic reactions.

Official Title
-----------------
Epicutaneous Testing of Cosmetic Products to Determine Skin Compatibility

Conditions
-----------------
Dermatitis

Intervention / Treatment
-----------------
* Other: Patch test application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women older than 18 years old Persons undergoing a diagnostic patch test for reason of a skin disease Signed written informed consent Exclusion Criteria: Acute skin inflammation and eczema on the back Systemic corticosteroid and immunosuppressive therapy as well as UV exposure of the back within the last 4 weeks Topical corticosteroids used on the back within the last two weeks

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patch test<br>Patients with patch test of cosmetics | Other: Patch test application<br>* test patch with cosmetic product will be applied to the back<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with positive patch test reactions to cosmetics | Inflammation of Skin at test patch location | 4 weeks |
Platelet Function in Patients With an Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
The aims of the study are to: explore whether platelet reactivity in patients treated wih novel platelet inhibitors is associated with clinical outcome investigate whether a therapeutic window exist for novel platelet inhibitors investigate the incidence of adverse events under treatment with novel platelet inhibitors in the real life clinical scenario investigate the association between genetic polymorphisms, inflammation, platelet reactivity and clinical outcome investigate synergistic effects between aspirin and novel platelet inhibitors

Official Title
-----------------
Association Between the Antiplatelet Drug Efficacy/Safety and Platelet Function in Patients Treated With Novel Platelet Inhibitors Due to an Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome (ACS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Acute coronary syndrome at admission Planned treatment with novel platelet inhibitors Age >18 Exclusion Criteria: * Participation in interventional trials

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 |
| --- | --- | --- |
| Net clinical benefit. | A composite of MACE and BARC=>2 bleedings. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE and Major bleeding | MACE: the composite of stent thrombosis, cardiac death and myocardial infarction. Major Bleeding: BARC =>2, TIMI major, GUSTO moderate-severe-life threatening. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelets, Acute coronary Syndrome (ACS), prasugrel, ticagrelor, aspirin
Treatment of Naevus Flammeus Using Intense Pulsed Light and Pulsed Dye Laser

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to compare efficacy and adverse effects of pulsed dye laser and intense pulsed light in patients with port wine stains.

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

Intervention / Treatment
-----------------
* Device: Pulsed dye laser (Candela), Intense pulsed light (Palomar)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with previously untreated and previously laser-treated naevus flammeus. Naevus flammeus measuring at least 5 x 7 cm within a single anatomical area. For example, the face corresponding to dermatomes V1, V2 and V3, back, abdomen, arms and legs.Patients aged two or above.Patients with skin types I-III. Exclusion Criteria: Patients below two years of age. Pregnant or breastfeeding patients. Patients with known increased sensitivity to visible light. Patients with a tendency to produce hypertrophic scars or celoids. Patients with skin types IV, V and VI. Patients who are clearly pigmented following recent exposure to the sun or a solarium. Patients treated with Roaccutane during the last six months. Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic patients, dementia patients, mentally ill patients, etc.).

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pulsed dye laser (Candela), Intense pulsed light (Palomar)|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
-----------------
Port wine stains, naevus flammeus
Amevive Wisdom Acquired From Real-Time Evidence (A.W.A.R.E™) Program

Study Overview
=================
Brief Summary
-----------------
Purpose: To develop a real time national clinical database to support and share best practices, To generate hypotheses for future clinical research To understand how AMEVIVE is used in routine clinical practice/real world setting. Each patient visit will include the following observational endpoints: AMEVIVE dosing Number of courses Concomitant treatment Response to treatment (patient and physician global assessments) Status of other psoriasis-related medical conditions Time to re-treatment.

Official Title
-----------------
Amevive Wisdom Acquired From Real-Time Evidence (A.W.A.R.E™) Program

Conditions
-----------------
Plaque Psoriasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Amevive is clinically indicated for the patient Exclusion Criteria: Amevive is contraindicated for the patient

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| 1<br>Dermatologic patients in Canada for which Amevive is clinically indicated | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Understand how AMEVIVE is used in routine clinical practice/real world setting |  | End of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis, Plaque Psoriasis, Amevive®, alefacept
Controlling and Lowering Blood Pressure With the MobiusHD™

Study Overview
=================
Brief Summary
-----------------
To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.

Detailed Description
-----------------
The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.

Official Title
-----------------
Controlling and Lowering Blood Pressure With the MobiusHD™ - Defining Efficacy Markers

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: MobiusHD™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mean 24-hour systolic ABPM is ≥130 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medication or dose), and no more than 28 days prior to implantation. Exclusion Criteria: Known or clinically suspected baroreflex failure or autonomic neuropathy Substudy Eligibility Criteria: A maximum of 16 patients will be enrolled in the sub-study at one site (Universitair Medisch Centrum Utrecht) Inclusion Criteria: - Patients must be eligible for the main study and must have passed all CALM-DIEM study inclusion and exclusion criteria at time of screening Exclusion Criteria: Use of anti-hypertensive drugs directly acting on the sympathetic nervous system that cannot be discontinued safely Underlying conditions that prohibit microneurography, performance of a Valsalva maneuver and/or magnetic resonance imaging

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MobiusHD™<br>The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter. | Device: MobiusHD™<br>* The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM) | Change in the mean 24-hours systolic Ambulatory Blood Pressure | Baseline to ninety (90) days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | Incidence of SAEs and UADEs reported from implantation through three years post treatment | Baseline to three (3) years post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension
Efficacy of Telepsychiatry in the Treatment of Depression

Study Overview
=================
Brief Summary
-----------------
Telepsychiatry is a novel means of providing expert psychiatric treatment to patients who live far from a source of care. If it can be demonstrated that treatment via telepsychiatry is as effective as in-person treatment, then many individuals with psychiatric illness will have easy access to psychiatric care, even if they live in geographically remote areas.

Detailed Description
-----------------
Background: Telepsychiatry is a novel means of providing expert psychiatric treatment to patients who live far from a source of care. If it can be demonstrated that treatment via telepsychiatry is as effective as in-person treatment, then many individuals with psychiatric illness will have easy access to psychiatric care, even if they live in geographically remote areas. Objectives: The major goal of this study was to determine whether treatment of depressive disorders via telepsychiatry is as effective as in-person treatment. In addition, this study was designed to determine if depressed patients are as compliant and as satisfied with telepsychiatry as with in-person treatment. Another goal was to compare the cost and cost-effectiveness of remote treatment via telepsychiatry to in-person treatment. Methods: In this randomized controlled trial, veterans who presented with depression to any of three VA Maryland Health Care facilities with a SCID-IV depression diagnosis and a Hamilton Rating Scale for Depression (Ham-D) score of 16 or above were eligible for participation. Eligible veterans were randomized to either in-person treatment or remote treatment. Treatment occurred over six months and consisted of psychotropic medication and psycho-education concerning the disease, medications, and side effects. The major outcome variables included changes in Ham-D depression ratings and Beck Depression Inventory (BDI) self-reported depression ratings. Status: Completed.

Official Title
-----------------
Efficacy of Telepsychiatry in the Treatment of Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Procedure: Telepsychiatry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Depression, Hamilton 16 or above, SCID-IV depression diagnosis Exclusion Criteria:
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Procedure: Telepsychiatry<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Intraoperative Analysis of the Central Retina in ERF

Study Overview
=================
Brief Summary
-----------------
Changes in the retinal anatomy that occur in epiretinal fibrosis have not been sufficiently studied. It is possible that epiretinal fibrosis leads not only to traction dislocation of the macula, but also to ILM anatomical disorders.

Detailed Description
-----------------
Purpose: to study anatomical changes in the Central retina in epiretinal fibrosis. Surgical treatment: standard vitrectomy 25-27G; ERM amd ILM stainig by Membrane Blue Dual; epiretinal membrane removal, ILM peeling if the divulsion of ILM was detected. Expected results: improving the quality of epiretinal fibrosis surgery by obtaining a more detailed picture of the pathological process

Official Title
-----------------
Intraoperative Analysis of the Central Retina in Epiretinal Fibrosis

Conditions
-----------------
Epiretinal Membrane, Macular Pucker

Intervention / Treatment
-----------------
* Procedure: Intraoperative ERM and ILM staining with their assessment and removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BCVA < 0,6; Exclusion Criteria:. secondary ERM, glaucoma, diabetic retinopathy, high myopia, BCVA>0,6

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 82 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 |
| --- | --- |
| Other: epiretinal membrane group<br>Patient with epiretinal fibrosis confirmed by OCT with BCVA< 0,6 and complaints of metamorphopsies | Procedure: Intraoperative ERM and ILM staining with their assessment and removal<br>* ERM and ILM staining is performed after vitrectomy. After that we evaluate the condition of macular zone and make a decision to remove the ERM and the need to remove the ILM<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ILM integrity | Visual intraoperative assessment of the ILM integrity | intraoperative | 
| Length and localization of the ILM dialysis | Length (in degrees) and localization of the ILM dyalisis | intraoperative | 
| ILM displacement | ILM displacement direction during the formation of detachment and divulsion. | intraoperative | 
| Occurence of ILM dyalisis | Determination of the ratio of patients with ILM dialysis to the total number of patients with ERF | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epiretinal membrane, internal limiting membrane, epiretinal fibrosis, macular pucker, central retina
Exercise and Blood Pressure in Children: A Meta-Analysis

Study Overview
=================
Brief Summary
-----------------
To use the meta-analytic approach to examine the effects of aerobic exercise on resting systolic and diastolic blood pressure in children.

Detailed Description
-----------------
BACKGROUND: Approximately 50 million Americans suffer from hypertension, a condition associated with increased risk for stroke, heart attack, and kidney failure. While non-pharmacological intervention has resulted in dramatic reductions in resting systolic and diastolic blood pressure for those with elevated pressures, a debate continues over the efficacy of pharmacological intervention because of deleterious side effects. As a result, there has been an increased interest in aerobic exercise as a non-pharmacologic approach in treating hypertension. Recent reviews of literature have synthesized research using the 'traditional' approach (chronologically arranging and describing the studies, perhaps by sub-topic) which may result in subjective, non-replicable conclusions. Consequently, the relationships among such variables as subject characteristics, experimental design quality, training program characteristics, and how they contribute to changes in resting systolic and diastolic blood pressure is not clear. The meta-analytic approach is used in the study to synthesize research on the relationships among variables associated with aerobic exercise intervention and resting systolic and diastolic blood pressure in adults. Meta-analysis is a method of pooling the results of separate studies. It is a quantitative approach for increasing statistical power of primary end points and subgroups, resolving uncertainty when studies disagree, improving estimates of effect sizes, and answering questions not posed at the start of individual trials. DESIGN NARRATIVE: In the first two years of the study, a meta-analysis was conducted of all studies published since 1966 on aerobic exercise and blood pressure. The study was renewed in FY 2000 to conduct meta-analysis of all studies of exercise training in children and youth under age 21 years in which resting BP was measured. This will include both randomized and non-randomized clinical trials of at least eight weeks duration found in English journals and theses between 1966 and 1999. Standard meta-analysis techniques will be applied. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |