cyrilzakka/clinical-trials huggingface dataset:
Achieving Better Control for Older Adults With Asthma

Asthma in older adults has been overlooked, understudied, and inadequately treated. While asthma programs targeting the unique needs of children, teenagers, women, minorities, and other populations have been successfully developed, there are currently none for older adults. This is particularly distressing as the asthma hospitalization rates, mortality rates, quality of life, and control are significantly worse in the elderly as compared to other age groups. It is clear that novel approaches are needed to improve the care in this population.

The investigators group has been active in the research of asthma in the elderly. The investigators have analyzed national asthma data sets to look for disparities in older adults, have conducted qualitative research to determine factors associated with poor control in the elderly, and have performed a pilot study of a self-regulation intervention which was able to improve outcomes. The investigators also have over 20 years of experience in asthma self-regulation interventions and physician communication enhancement for multiple populations of asthma patients. The investigators will combine these strengths into their current protocol.

The intervention program will be based on the self-regulation theory of behavior, which will enhance the participants' ability to self-manage this chronic condition, actively involve the participant in their own health care management, and produce sustained results. In this proposal, the investigators will evaluate a self-regulation asthma intervention in a diverse population of older adults. The intervention will be personalized to the challenges and goals each individual faces, which will enhance its applicability in different populations. This intervention will incorporate standard asthma education, complementary techniques for which older adults have expressed a strong interest, and enhanced communication with each participant's physician. Asthma specific outcomes will be assessed at 1, 6, and 12 months. The primary goal of this intervention is to decrease health care utilization (emergency department, urgent care, hospital, and unscheduled visits) for older adults with asthma. The investigators will also assess the ability to improve quality of life, asthma symptoms, asthma control, lung function parameters, self-efficacy, and cost effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* above the age of 55
* persistent asthma,
* have a primary care physician (PCP) who is willing to receive email communication during the study.

Exclusion Criteria:

* any other significant cardiopulmonary disease (including chronic obstructive pulmonary disease)
* a greater than 20 pack-year smoking history
* lack of telephone access
* decreased cognitive capacity such that participation in the program would not be possible
International Retrospective Study of Pipeline Embolization Device

The primary objective of this retrospective study is to determine the incidence of important safety outcomes in patients who have undergone Pipeline Embolization Device placement for intracranial aneurysms (IAs). This study does not effect patient care, simply it is designed to observe and capture information from numerous hospitals.

Data collection will be initiated starting March 2012 and continue until approximately April 2017.


Eligibility Criteria:
Inclusion Criteria:

* A patient who was treated with the Pipeline Embolization Device for treatment of a brain aneurysm
Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis

The hepatitis A virus (HAV) is a significant global public health concern. The hepatitis A virus is transmitted primarily by the faecal-oral route, leading to acute hepatitis. Symptoms include low-grade fever, anorexia, jaundice, and typically resolve without complications.

However, HAV infection in patients with chronic liver disease, especially those over 50 years old, may result in more severe outcomes, including fulminant hepatitis, with a higher mortality rate compared to the general population

HAV vaccination is a cornerstone of prevention, especially in high-risk groups. Currently, there is a recommendation to vaccinate patients with chronic liver disease against HAV infection. However, these patients often have compromised immune responses, leading to lower vaccine efficacy compared to the general population.

The goal of this randomized controlled trial is to compare the efficacy and safety of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen with an intensive 3-dose (0, 1, 6 months) schedule in patients with advanced fibrosis and cirrhosis.

The main questions it aims to answer are:

* Compared the seroconversion rate of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis.
* Compared the antibody levels against the hepatitis A virus (Anti-HAV IgG) of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Confirmed advance fibrosis (F3) or cirrhotic (F4) status (radiologic finding or liver stiffness measurement or pathological report)
* Negative anti-HAV IgM, IgG at baseline

Exclusion Criteria:

* Positive anti-HAV IgG at baseline
* Autoimmune hepatitis
* Current hepatocellular carcinoma
* Active other malignancies
* Presence of antibodies against Human Immunodeficiency Virus
* Received immunosuppressive drugs
* Pregnancy or lactation
* Decompensated cirrhosis with MELD ≥ 15
* Chronic illness or bedridden patient who cannot travel to hospital
* Lack of consent to participate in the study
The Effect of Motivational Interviews on the Digital Game Addiction Levels of Nursing Students

The aim of this study is to reveal the effect of motivational interviewing based on change stages on digital game addiction. This study will be conducted with a total of 72 individuals assigned by a randomization site from all nursing students who study at Sivas Cumhuriyet University, Faculty of Health Sciences, voluntarily participated in the study, and were found to be digital game addicts. These individuals will be equally distributed to the intervention and control groups. Personal Information Form, Stages of Change Questionnaire and Digital Game Addiction Scale will be distributed to individuals to answer. The obtained data will be analyzed statistically.

The aim of this study is to reveal the effect of motivational interviewing based on change stages on digital game addiction. This study will be conducted with a total of 72 individuals assigned by a randomization site from all nursing students who study at Sivas Cumhuriyet University, Faculty of Health Sciences, voluntarily participated in the study, and were found to be digital game addicts. These individuals will be equally distributed to the intervention and control groups. Each group will contain 36 participants. the participants in intervention group will take motivational interventions while the individuals who have digital game addiction in control group will not take this application. Personal Information Form, Stages of Change Questionnaire and Digital Game Addiction Scale will be distributed to individuals to answer. The obtained data will be analyzed statistically.

Eligibility Criteria:
Inclusion Criteria:

Nursing students who:

* agree to participate in the study
* are over 18 years
* have game addiction
* agree to participate in the negotiations

Exclusion Criteria:

Individuals who:

* do not agree to participate in the study
Clinical Performance Comparison of Several Different Contact Lenses

The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.


Eligibility Criteria:
Inclusion Criteria:

Subjects must:

* be existing soft contact lens wearers of the study control lenses
* require a distance visual correction in both eyes
* have a contact lens spherical distance requirement between -1.00 diopters (D) and -8.00D in both eyes
* have astigmatism less than or equal to 1.00D in both eyes
* be able to wear lenses available for this study
* be corrected to a visual acuity of 6/9 (20/30) or better in each eye
* have normal eyes with no evidence of abnormality or disease

Exclusion Criteria:

Subject are excluded for the following reasons:

* monovision corrected
* worn lenses extended wear in the last 3 months.
* require concurrent ocular medication
* grade 3 or 4 abnormalities
* grade 3 corneal staining in more than two regions
* anterior ocular surgery
* any other ocular surgery or injury within 8 weeks prior to study enrollment
* abnormal lachrymal secretions
* pre-existing ocular irritation that would preclude contact lens fitting
* corneal irregularities
* Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in past 12 weeks
* any systemic illness which would preclude contact lens wear
* diabetes
* infectious or immunosuppressive disease
* pregnancy or lactating, or planning pregnancy at time or enrollment
* participating in a concurrent clinical study or within last 60 days
* allergy to the standardized study care solution
A Multi-omic Approach to Evaluate and Characterize the Polycystic Ovary Syndrome (PCOS) Phenotype

The purpose of this research study is to explore the relationship between the gut microbiome and hormone levels in women diagnosed with PCOS and determine whether there are differences in the gut microbiome between women with PCOS and women without PCOS.

Consented, enrolled participants will complete a health questionnaire, complete a fasted blood draw at a local laboratory, and provide a stool, saliva, and vaginal swab sample for comprehensive biomarkers, hormones, metagenomics, and metabolomics analysis.


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with PCOS or Women who are considered Healthy
* 18-40 years old
* Residing in the USA, except for exclusion states
* Have not been using hormonal therapy for at least 3 months

Exclusion Criteria:

* Women using hormonal therapy within the last 3 months
* Diagnosed with other significant health conditions or using medications that will affect hormone levels
* Residing in NY, NJ, MD, RI, ND, SD, or HI
* Pregnant or nursing
Image Narrative With College Students

The PI developed the Image Narrative Intervention (INI) based on the research using visual images in which visual images and narratives were found to support trauma survivors in narrating their experiences and in meaning making. The proposed study is the first study to test the therapeutic effect of the INI program. The investigators propose to assess, both qualitatively and quantitatively, the feasibility and preliminary effect of the INI through a pilot randomized control trial (RCT) design with a wait list control.

AIM 1. To understand the unique experiences of emerging adult college students during the Covid-19 pandemic (especially around the themes of the self, relationships with others, and the future).

AIM 2. To evaluate the feasibility of the INI for emerging adult college students during the Covid-19 pandemic, both quantitatively and qualitatively.

AIM 3. To evaluate the preliminary efficacy of the INI on distress, PTG, Quality of Life and Meaning-Making.

Eligibility Criteria:
Inclusion Criteria:

* 18-29 in age
* college students at the University of Utah
* reporting moderate or higher levels of distress in DASS21

Exclusion Criteria:

-
A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

The objective of this study is to evaluate the product performance of a new silicone hydrogel soft contact lens when worn by current soft contact lens wearers on a daily wear basis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye
* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
* Subjects must be myopic and require lens correction from -0.25 D to -6.00 D in each eye.
* Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week.
* Subjects must spend at least 3 hours each workday using a computer or electronic device (ie, smartphones, tablets, eReaders).
* Subjects must habitually wear soft contact lens.
* Subject must have no active ocular disease or allergic conjunctivitis.
* Subject must not be using any topical ocular medications.
* Subjects must be bothered (occasionally or frequently) by blurriness or fluctuations in vision with their current contact lenses.
* Subjects must habitually use a lens care product for cleaning, disinfection, and storage.

Exclusion Criteria:

* Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
* Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or who are using any ocular medication.
* Subjects who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
* Subjects who are presbyopic or currently wear monovision, multifocal, or toric contact lenses.
* Subjects with an ocular astigmatism of 1.00 D or greater in either eye.
* Subjects with anisometropia (spherical equivalent) of 2.00 D or greater in either eye.
* Subjects with any Grade 2 or greater finding during the slit lamp examination.
* Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects with any scar or neovascularization within the central 4 mm of the cornea.
* Subjects who are aphakic.
* Subjects who are amblyopic.
* Subjects who have had any corneal surgery (eg, refractive surgery).
* Subjects who are allergic to any component in the study care products.
* Subjects who are bothered by blurriness or fluctuations in vision due to itchy eyes, something on or under the lens, allergies, or cigarette smoke.
Genomic Sequencing in Patients With HCM Undergoing Septal Myectomy

Investigators aim to use comparative exome and/or genome sequencing to discover causative molecular lesions for phenotypes hypothesized to be caused by somatic mutations. For this study, investigators have targeted hypertrophic cardiomyopathy.

The hypothesis is that sporadic or simplex occurrences of what are typically autosomal dominantly inherited diseases can instead be caused my mosaic mutations, specifically, mutations in the heart itself.

This hypothesis mandates that investigators sequence both affected and unaffected tissues, which in this case, investigators will construe to be peripheral blood DNA and discarded myocardium from cardiac procedures.

Eligible individuals will first undergo informed consent to be part of the study prior to their scheduled myomectomy. The study participants will also have phlebotomy for research samples.

The NIH Intramural Sequencing Center (NISC) will perform paired exome or genome sequencing and we will first screen for germline mutations in known cardiomyopathy genes that meet ACMG standards of likely pathogenic or pathogenic.

Then, if this is negative, investigators will screen for sequence variants that are present in cardiac tissue but absent in the blood DNA. Investigators will also screen blood DNA for secondary findings in genes recommended for annotation and results return by the ACMG and sequence variants deemed clinically relevant in this gene set will be validated in a CLIA-certified laboratory and the results returned to that participant.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years and older has a clinical diagnosis of hypertrophic cardiomyopathy.
* Patient scheduled for clinically-indicated myomectomy.
* Patient has a negative family history of hypertrophic cardiomyopathy
* Patient is willing to receive results of secondary variant screen

Exclusion Criteria:

* Pregnant
* Inability to give informed consent
Improving HPV Vaccination Rates Among Rural and Native American Adolescents

This study will develop and implement a multi-level intervention aimed at improving human papillomavirus (HPV) vaccination rates at an Indian rural health clinic.

The focus of this study is to develop, implement, and evaluate a human papillomavirus (HPV) vaccination program aimed at accelerating vaccine uptake among rural and Native American adolescents ages 11-17. HPV vaccination coverage with at least one dose remains disproportionately lower among rural adolescent compared to adolescents residing in urban areas and the rate of series completion is lower among Native American adolescent girls compared to non-Hispanic White adolescent girls.

Eligibility Criteria:
Inclusion Criteria:

* Clinic patients between the ages of 11-17 who are eligible for the HPV vaccine

Exclusion Criteria:

* None
Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men With Prostate Cancer That Has Spread to the Bone

This trial studies how well fluciclovine 18F PET/CT imaging works in assessing hormone-naive men with prostate cancer that has spread to the bone. Fluciclovine 18F is a radioactive drug used to measure tumor growth. PET/CT uses x-rays to take pictures inside the body. Comparing results of fluciclovine 18F PET/CT imaging may help doctors predict a patient's response to treatment and help plan the best treatment.

PRIMARY OBJECTIVES:

I. Abnormal fluciclovine F18 (\[18F\] fluciclovine) uptake on visual assessment will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed).

II. Maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean) on (18F) fluciclovine-positron emission tomography (PET)/computed tomography (CT) imaging will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed).

SECONDARY OBJECTIVES:

I. Determine if a 25% or greater reduction in average (ave) SUVmax or ave SUVmean on (18F) fluciclovine-PET/CT imaging after completion of all radiation therapy will be predictive of increased time to biochemical failure.

II. Determine the correlation between the number of lesions, their visual uptake, and semi-quantitative uptake on technetium tc-99m medronate (99mTc-MDP) bone scintigraphy and (18F) fluciclovine- PET/CT at baseline.

III. Determine the correlation between the number of lesions, their visual uptake, and semi-quantitative uptake on 99mTc-MDP bone scintigraphy and (18F) fluciclovine- PET/CT after 3 and 6 cycles of treatment.

OUTLINE: This is a companion imaging study to Institutional Review Board (IRB) #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).

Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy.

After completion of diagnostic testing, patients are followed for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment on IRB #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).
* Patients must document their willingness to be followed for up to 24 months after recruitment by signing informed consent documenting their agreement to allow access to the data obtained on IRB #102312 and information and data entered into a research database.
* All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines.

Exclusion Criteria:

* Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator?s discretion.
* Patients who require monitored anesthesia for PET scanning.
* Patients who are too claustrophobic to undergo PET scanning.
Bedside Ultrasound Identifies Congestive Heart Failure

Patients often arrive to the Emergency Department with the chief complaint of shortness of breath. The cause of the shortness of breath may be due to many things, such as pneumonia, emphysema, a heart attack, heart failure, and others. It is often very difficult for the physician to determine the cause of the shortness of breath in the first two hours in the Emergency Department. This ambiguity makes treating the patient very difficult. Although a patient could benefit from treatment upon arrival, the emergent treatment of the condition must wait until a final diagnosis is made.

Recently, emergency physicians have been using portable ultrasound at the patient's bedside to diagnose numerous conditions, including trauma, blood clots, kidney stones, etc. Recent research suggests that heart failure, one of the causes of shortness of breath, may be diagnosed within 5 minutes or less using ultrasound. Most of these studies come from the intensive care and cardiology. However, no research has yet been performed to determine if emergency physicians can effectively use ultrasound to quickly diagnose and treat heart failure within the first few minutes of a patient's arrival to the emergency department. The hypothesis of this study is to evaluate the ability of residents in emergency medicine to use ultrasound to diagnose patients in heart failure who presented with the chief complaint of shortness of breath. The final diagnosis of the patient upon discharge from the hospital will be compared to the preliminary diagnosis based on the portable ultrasound findings.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* presenting complaint of shortness of breath or dyspnea

Exclusion Criteria:

* prisoners
* pregnant women
* shortness of breath clearly secondary to another diagnosis (i.e. trauma)