linjc16/ctgov huggingface dataset:
Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Silicone Hydrogel Soft Contact Lenses

Study Overview
=================
Brief Summary
-----------------
The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution in patients wearing silicone hydrogel soft contact lenses.

Official Title
-----------------
Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to Two Marketed Multi-Purpose Solutions for Care of Silicone Hydrogel Soft Contact Lenses

Conditions
-----------------
Contact Lens Care

Intervention / Treatment
-----------------
* Device: OptiFree Multi-Purpose Disinfecting Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Successful daily wear of Night & Day® or Acuvue® Advance™ silicone hydrogel contact for at least two weeks. Use of AOSEPT® ClearCare™ only as the pre-study care regimen for at least two weeks (rewetting drops use is also acceptable). Successful lens wear for at least 8 hours per day. Vision correctable to 20/30. Normal eyes - no current ocular abnormalities that prevent successful contact lens wear. No corneal surgery within the past 12 months. No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions. No over-the-counter or prescription ocular medication. No enrollment in another clinical study within 30 days prior to enrollment.
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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OptiFree Multi-Purpose Disinfecting Solution|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Fluorescein Staining (Type and Area) |  |  | 
| Conjunctival Staining |  |  | 
| Lens Deposits |  |  | 
| Subject Questions/Subject Likert Questionnaire |  |  | 
| Ocular Comfort and Symptom Scales |  |  | 
| Lens Replacement Incidence and Causality |  |  | 
| Corrected Visual Acuity with Study Lenses (Snellen) |  |  | 
| Average Lens Wearing Time |  |  | 
| Average Uncomfortable Lens Wearing Time |  |  | 
| Safety: |  |  | 
| Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications |  |  | 
| Adverse Events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contact Lens Care
Using Mobile Health (mHealth) to Improve STI Treatment Adherence Among Adolescents

Study Overview
=================
Brief Summary
-----------------
We will conduct a randomized trial to compare differences in sexually transmitted infection (STI) treatment adherence between patients receiving text messages versus those receiving usual care (e.g. no text messages). We hypothesize that STI treatment adherence will be 20% higher among patients randomized to receipt of two-way text messaging services.

Official Title
-----------------
Leveraging Health Information Technology to Reduce Health Disparities in Adolescent Health Outcomes: A Patient-Centered Approach

Conditions
-----------------
Sexually Transmitted Diseases

Intervention / Treatment
-----------------
* Behavioral: mHealth Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescent patients seen in the Emergency Department who test positive for gonorrhea, chlamydia, or pelvic inflammatory disease and are prescribed outpatient antibiotic treatment. Exclusion Criteria: Patients will be excluded if they are unable to understand English, are critically ill, have cognitive impairment or if they do not have access to a cellular telephone with text messaging capabilities.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 21 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 |
| --- | --- |
| Other: mHealth<br>Adolescents enrolled in this arm will receive treatment-related text messages. | Behavioral: mHealth Intervention<br>* Adolescents will receive text messages to facilitate treatment adherence<br>|
| No Intervention: Usual care<br>Adolescents in this arm will receive usual care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STI treatment adherence | Proportion of study participants who complete their medication as prescribed by self-report | 1-21 days after prescription filling | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STI treatment receipt | Proportion of study participants who receive STI treatment; measured by prescription filling and/or receiving treatment at a healthcare facility | 1-21 days after STI diagnosis |
Influence of Improved Formula on Fatty Acids and Mineral Metabolism in Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether different content of β-palmitate will cause significant differences on Fatty Acids and Mineral Metabolism in Infants

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: β-Palmitate Content
* Other: Placebo
* Other: β-Palmitate Content Naturely in Human Milk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy full term infants Exclusion Criteria: experienced congenital or chromosomal disorders neonatal morbidities, or metabolic illness

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Improved Infant Formula Group<br>Containing β-Palmitate Content | Other: β-Palmitate Content<br> <br> |
| Placebo Comparator: General Infant Formula Group<br>Excluding β-Palmitate Content | Other: Placebo<br> <br> |
| Active Comparator: Human Milk Group<br>Containing β-Palmitate Content Naturely in Human Milk | Other: β-Palmitate Content Naturely in Human Milk<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Content of fatty acids |  | 3 years | 
| Content of calcium and magnesium |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric measurements | Index of anthropometric measurements contains weight,height and head circumference. | 3 years | 
| Stool characteristics assessed via stool frequency |  | 3 years | 
| Stool characteristics assessed via stool consistency |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Term Infants
Evaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine whether duloxetine can help subjects with stress urinary incontinence and to see whether the effects of duloxetine can be maintained.

Official Title
-----------------
The Safety and Effectiveness of Duloxetine Compared With Placebo and Its Long-Term Safety and Efficacy in the Treatment of Predominant Stress Urinary Incontinence

Conditions
-----------------
Urinary Incontinence, Stress

Intervention / Treatment
-----------------
* Drug: Duloxetine Hydrochloride
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female diagnosed with stress urinary incontinence Exclusion Criteria: Currently taking a monoamine oxidase inhibitor

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Duloxetine Hydrochloride|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of Duloxetine compared with placebo in women with predominant stress urinary incontinence as measured by a reduction in incontinent episode frequency. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the maintenance of effect on IEF in long-term use |  |  | 
| Kings Health Questionnaire |  |  | 
| Patient Global Impression of Improvement Questionnaire |  |  | 
| Safety effects |  |  |
Non-Invasive Blood Test Cross-Validation Study

Study Overview
=================
Brief Summary
-----------------
The study considers a cross-validation approach to determine the effectiveness of a non-invasive comprehensive metabolic panel (NICMP), relative to the venipuncture method. The NICMP machine learned powered device utilizes a light sensor to capture readings from either palm. The study (n=90) proves an agreement and strong correlation with respect to the NICMP and venipuncture blood draw.

Official Title
-----------------
Remote Sensing Comprehensive Metabolic Panel

Conditions
-----------------
Reproducibility of Results, Safety Issues

Intervention / Treatment
-----------------
* Device: Non-Invasive Comprehensive Metabolic Panel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undiagnosed population Exclusion Criteria: Diagnosed population, pregnant women, mental heath/disabled, prisoners, fetus or deceased

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NICMP Spectral Reading<br>Non-invasive spectral data is collected from this arm to function as the intervention of interest. | Device: Non-Invasive Comprehensive Metabolic Panel<br>* The device utilizes spectroscopy and machine learning to detect metabolic analyte concentrations.<br>|
| Active Comparator: Venipuncture CMP<br>A standard CMP blood draw is performed to function as the gold standard reference value. Specifically, the outcome of the experimental arm is cross-validated against the active comparator arm to determine the NICMP accuracy, relative to the venipuncture method. | Device: Non-Invasive Comprehensive Metabolic Panel<br>* The device utilizes spectroscopy and machine learning to detect metabolic analyte concentrations.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of Non-Invasive Comprehensive Metabolic Panel | Determine the effectiveness, in terms of accuracy, of the NICMP against the venipuncture CMP (i.e. reference value). | 2-minutes |
A Survey Study to See if Patients Diagnosed With Parkinson's Disease Have Higher Incidence of Melanoma

Study Overview
=================
Brief Summary
-----------------
Patients with Parkinson's disease will be seen by a dermatologist who will biopsy any suspicious skin lesions.

Official Title
-----------------
A Survey to Assess the Incidence and Characteristics of Melanoma in Parkinson's Disease Patients

Conditions
-----------------
Parkinson's Disease, Malignant Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis Parkinson's disease Patient able and willing to give informed consent Patient must not be taking any investigational drug at the time of enrollment Exclusion Criteria: unconfirmed, undocumented Parkinson's disease unable to give consent taking any investigational product
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational procedure<br>Patients will be examined and any suspicious skin abnormalities will be biopsied | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Rosuvastatin Affecting Aortic Valve Endothelium

Study Overview
=================
Brief Summary
-----------------
Recent studies support the hypothesis that aortic stenosis (AS) develops due to atherosclerosis affecting the aortic valve endothelium. The study's aim was to assess Rosuvastatin on the hemodynamic progression and inflammatory markers of AS by treating low-density lipoprotein (LDL) in patients with AS according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATPIII) guidelines for one year.

Detailed Description
-----------------
Background: Recent retrospective studies support the hypothesis that statins slow the progression of aortic stenosis. The aim of this study was to assess the effect of Rosuvastatin on hemodynamic progression of aortic stenosis by treating patients with aortic stenosis and elevated LDL-cholesterol for 18 months. Methods: We performed an open-label, prospective study evaluating 121 consecutive patients with asymptomatic moderate to severe aortic stenosis (AVA≥ 1.0 cm2), (mean age 73.7±8.9 years; 57 men and 64 women), treated with and without Rosuvastatin according to the NCEP-ATPIII guidelines. Echocardiographic, serum lipid, and inflammatory markers were measured at baseline and every 6 months for 18 months.

Official Title
-----------------
Rosuvastatin Affecting Aortic Valve Endothelium - RAAVE

Conditions
-----------------
Atherosclerosis, Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptomatic AS Normal ejection fraction Elevated LDL >130 mg/dl Exclusion Criteria: Echocardiographic evidence of rheumatic mitral valve disease, Previous statin therapy, Congenital heart disease (bicuspid aortic valve), Subaortic obstruction, Creatinine ≥ 2,0 mg/dl (to avoid the potential confounder of an elevated serum [CaP04]), Evidence of liver disease, Greater than mild aortic regurgitation and previous aortic valve surgery

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosuvastatin|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
-----------------
Aortic Stenosis, Statins, Hypercholesterolemia
Description of the Uterine Cavity in Patients With Recurrent Miscarriages

Study Overview
=================
Brief Summary
-----------------
To be diagnosed with recurrent miscarriages, a couple might have a child, however experiences three or more miscarriages, primarily this happens during the first trimester. These miscarriages often needs medical evacuation or a D & C. Surgery or retained tissue increases the risk of complications as infection and/or adhesions, known as asherman syndrome, which may result in subfertility. Recently chronic infection in the endometrium has been proposed to contribute to the condition, as protocols including treatment with antibiotics have led to birth at term for some of these women. Using the very minimal invasive office hysteroscopy, the investigators aim to describe the uterine cavity in patients diagnosed with recurrent miscarriages regarding both abnormalities in the endometrium and chromic infection.

Detailed Description
-----------------
The Unit for Recurrent Pregnancy-loss at Rigshospitalet treats about 300 of couples with recurrent miscarriages a year. Together with the current examination program, the investigators plan to describe the uterine cavity according to abnormalities as septa, adhesions and further the condition for the endometrium regarding infection and hormone receptors. This description will include descriptive office hysteroscopy with biopsies for histologic - and immunohistochemically examinations.

Official Title
-----------------
Description of the Uterine Cavity in Patients With Recurrent Miscarriages

Conditions
-----------------
Recurrent Miscarriages, Habitual Abortions

Intervention / Treatment
-----------------
* Other: Office hysteroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Correctly diagnosed with recurrent miscarriages Exclusion Criteria: Known course of the condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Office hysteroscopy|Diagnostic hysteroscopy with biopsy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the Uterine Cavity in Patients With Recurrent Miscarriages | Observational study describing the uterine cavity in a selected patient group regarding abnormalities | 1 year | 
| Description of the Uterine Cavity in Patients With Recurrent Miscarriages | Observational study describing the uterine cavity in a selected patient group regarding chronic infection | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
miscarriage, uterine abnormalities, Chronic infection
Infection and Adverse Pregnancy Outcome

Study Overview
=================
Brief Summary
-----------------
Miscarriage (spontaneous abortion, stillbirth, and preterm birth) is the most common adverse out-come of pregnancy and a significant proportion is caused by infection. The investigators aim to study vaginal specimens from 1200 pregnant women recruited before 14 weeks of gestation with follow-up at mid-term (week 19) as well as 300 women aborting spontaneously. Adverse pregnancy outcome will be correlated to the presence of bacterial vaginosis (BV) subclasses, to vaginal fluid inflammation markers, and to the presence of novel Chlamydia-like bacteria, in particular Waddlia chondrophila. Species specific quantitative PCR assays for BV-related bacteria as well as next-generation-sequencing will be applied on selected specimens with the aim to identify markers allowing for a personalised treatment approach.

Official Title
-----------------
Infection and Adverse Pregnancy Outcome

Conditions
-----------------
Preterm Birth

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy Exclusion Criteria: None
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spontaneous abortion<br>Women attending for suspected spontaneous abortion | Other: No intervention<br> <br> |
| Normal pregnant women<br>Normal pregnant women attending for nuchal translucency scan | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm birth <37 weeks of gestation |  | 37 weeks of gestation |
Right Ventricular Hypertrophy and Pulmonary Hypertension: A Correlation Analysis

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that a quantitative index can be derived from Tc-99m myocardial perfusion scans that accurately identifies the presence of left ventricular hypertrophy and pulmonary hypertension. Echocardiography provides the reference standard.

Official Title
-----------------
Right Ventricular Hypertrophy and Pulmonary Hypertension: A Correlation Analysis Between Tc-99m Tetrofosmin SPECT Adn Echocardiography

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Other: Diagnostic imaging procedures.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have an interpretable Tc-99m myocardial perfusion scan and an interpretable echocardiogram. Exclusion Criteria: Technically inadequate noninvasive test.
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 |
| --- | --- |
| Group 1<br>Patients having both Tc-99m perfusion scan and echocardiogram. | Other: Diagnostic imaging procedures.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of quantitation of Tc-99m perfusion scans for identification of pulmonary hypertension. |  | 2 years |