Treatment Trials

87 Clinical Trials for Various Conditions

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COMPLETED
Diagnostic Efficiency of Touch Imprints Versus Smears
Description

Cytopathologists work along with radiologist in the diagnosis of lesions. Rapid on site interpretation (ROSE) of fine needle aspiration (FNA) smears of radiologically suspicious lesions is a common clinical practice. In the last years, the investigators have seen trend towards needle core biopsies of radiologically suspicious lesions. The investigators want to analyze the challenges of rapid on site interpretation of touch imprints (TI) of needle core biopsies (NCB) versus fine needle aspiration smears.

COMPLETED
Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions
Description

The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.

ACTIVE_NOT_RECRUITING
Adolescent Subcutaneous (SQ) Injection Video Validation
Description

This is a study to determine if a video that utilizes a peer to teach self administration of subcutaneous depot medroxyprogesterone is both effective and well accepted by adolescent patients who are already receiving ongoing treatment with depot medroxyprogesterone by a medical provider via an inter muscular injection. Self administration can be done at home and therefore offers an alternative to traveling to a medical office.

COMPLETED
Protecting Our Future Generation: Promotion of Protective Sexual Health Practices Among Native American Youth and Young Adults Through an Assets-based Self-care Intervention
Description

The aim of this research protocol is to test the efficacy of a self-care intervention through a randomized controlled trial (RCT), for increasing protective sexual health behaviors among youth in the participating Native American community. The investigators will randomize 450 youth and young adults ages 14-26 to the self-care intervention or a control program. Efficacy data will be collected up to 6 months post-intervention. The primary outcome will be uptake of sexually transmitted infection (STI) screening. Secondary outcomes will include: a) sexual risk and protective behaviors; and b) psychosocial assets and resources. The investigators hypothesize the self-care intervention will increase protective behaviors by: i) helping youth gain knowledge of their own sexual health risks, assets and resources; ii) motivating protection of those assets and resources; and iii) encouraging good health practices and making responsible choices.

SUSPENDED
Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease
Description

This study aims to investigate how knowledge of gluten immunogenic peptide (GIP) levels in stool and urine affects subsequent adherence to a gluten-free diet. Half of the participants will receive results in real-time using a home device and the other half will store samples to be tested at the end of the 30 week study. Participants will also have a diet review with a dietitian at the beginning of the end of their study and be asked questions about their symptoms, gluten-free diet adherence and quality of life.

COMPLETED
Perceptual Expertise Training for Triage of Moles
Description

The aim of this study is to assess a novel educational mobile and online application which will use images of pigmented skin lesions with question prompts to train future medical providers to more accurately detect malignant lesions. The hypothesis of this study is that this new educational tool will result in higher melanoma detection rates among future providers.

COMPLETED
Trial of an Adapted STD Screening and Risk Reduction Intervention
Description

The goal of this research study is to evaluate the impact of a paraprofessional-delivered, culturally adapted, evidence-based intervention (EBI) on sexually transmitted disease (STD), substance use and poor mental/emotional health among American Indians (AI) through a Randomized Controlled Trial (RCT). These intertwining risks have produced marked disparities and have unique cultural and social determinants in Native communities. If aims are achieved, scientific knowledge and community-based practice will be advanced in areas vital to AI communities, and to STD and drug prevention science. Prior to this study, the investigators applied findings from research protocol (IRB#00005929) and adapted a brief intervention to reduce risk and increase protective behaviors for STDs, HIV/AIDS, substance use and poor mental/emotional health, and to promote STD screening. The specific aim of the current study is to compare the efficacy of the adapted brief intervention vs. a comparison condition on participants' condom use, STD screening and treatment-seeking behaviors, substance use and emotional/mental health outcomes at 3 and 6 months post-intervention.

RECRUITING
Craniofacial Dimensions as Determinants of the Fitted Performance of Common Face Masks (FACEFIT 2.0)
Description

This study examines the role of craniofacial dimensions and self-evaluation thereof in the protection afforded by masks commonly worn by the public as protection against aerosol contaminants. The effectiveness of instructions for self-evaluation of craniofacial dimensions will be tested against standard digital and manual craniometric methods. Approximately 500 (18-70 year old) subjects. After consenting to participate in the study, subjects will use a short self-assessment questionnaire to measure their craniofacial dimensions, and have their face measured using standard anthropological techniques and a 3D camera. They will then enter a chamber containing an atmosphere of aerosolized salt particles where the fitted filtering efficiency of 2 types of face masks will be measured briefly. Participation time is approximately 60 minutes.

Conditions
ENROLLING_BY_INVITATION
Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) Asian/Asian American Women Supplement
Description

Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. This study is a supplement to increase representation of Asian and Asian American women in a pragmatic clinical trial that evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (HPV) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.

ACTIVE_NOT_RECRUITING
Evaluation of Self-Mediated Alternatives for Risk Testing Education and Return of Results
Description

This randomized non-inferiority study will evaluate self-directed scalable electronic health platform (eHealth) methods for communicating Alzheimer's gene and biomarker results compared to videoconference telehealth disclosure with healthcare providers, as well as characterize the impacts of learning this information on the participant.

RECRUITING
HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots
Description

The goal of this observational study is to establish an operational framework for home self-collections of blood samples to be used for antiviral drug concentration measurements. Participants will continue on their prescribed antiviral(s) for HIV treatment or prevention and followed for up to approximately 1 year. The investigators will compare drug concentrations of antivirals and relevant metabolites/anabolites in clinic-collected and self-collected blood samples.

COMPLETED
Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use
Description

This study is designed to assess whether consumers select and use norgestrel 0.075 mg, a progestin only pill for contraception, in a manner consistent with the OTC package directions in an Over-the-Counter (OTC)-like setting.

Conditions
ENROLLING_BY_INVITATION
Prospective Evaluation of Self-Testing to Increase Screening
Description

Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women. This study evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (HPV) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.

COMPLETED
Evaluation of Self-help Books for Depression
Description

The goal of this study is to compare the efficacy of acceptance and commitment therapy (ACT) and cognitive behavioral therapy (CBT) for depression in a bibliotherapy format and assess hypothesized mechanisms of change in depression symptomatology, quality of life, and functioning. This study will test the following hypotheses: 1. CBT and ACT will both result in decreased depression, distress, and self-stigma associated with depression. Life satisfaction and values progress will increase in both conditions. 2. CBT will result in greater use of reappraisal than ACT. 3. ACT will results in greater use of defusion and decreased psychological inflexibility than CBT. 4. Changes in experiential avoidance and defusion will predict changes in depression in the ACT condition. 5. Changes in reappraisal will predict changes in depression in the CBT condition. 6. Participants who are given their choice of treatment will show better adherence and satisfaction in the intervention.

Conditions
COMPLETED
My Life: Evaluation of Self-determination Enhancement for Adolescents in Foster Care
Description

The purpose of the study is to implement a full-scale efficacy trial of the My Life program. Conducted in partnership with the Oregon DHS Foster Care Program, the impact of the intervention will be being evaluated with a randomized experimental longitudinal design. Two hundred and ten youth, ages 16.5-17.5, will be enrolled in 3 waves, and randomly assigned to either a comparison group that receives typical foster care services or to a treatment group that participates in the key elements of the model, including instruction in self-determination skills, support in leading their own coordinated inter-agency transition planning meetings, and participation in workshops with mentors. Outcomes, including youth self-determination, quality of life, employment, mental health, educational achievement and independent living, are assessed pre-intervention, at the conclusion of intervention, and at 12 months post-intervention. The proposed study will provide important information on the efficacy of the model for all youth exiting the foster care system, yielding unequivocal data on whether enhanced self-determination mediates, at least partially, various outcome areas, including mental health, educational achievement, employment, independent living, and quality of life; evaluating the effect of special education status, gender, and race as moderating influences on the impact of the intervention. Foster care experiences, such as trauma and placement instability, will be considered as covariates; direct effects of the intervention on these key foster care experiences will also be explored.

COMPLETED
Evaluation of a Self-Monitoring Intervention to Reduce Safety Behavior in Social Anxiety
Description

The current study aims to explore the efficacy of a text message based Safety Behavior Fading Intervention compared to an active control intervention.

Conditions
COMPLETED
Feasibility and Evaluation of a Self-care App to Enhance Purposeful Living
Description

In this pilot study, ovarian cancer survivors will be enrolled and followed for six months to evaluate usage of an eHealth app called "Purposeful".

Conditions
UNKNOWN
Evaluation of a Self-Care Toolkit in Surgical Breast Cancer Patients
Description

This randomized controlled trial (RCT) in newly-diagnosed breast cancer patients seeks to determine the effectiveness of a self-care toolkit on specific symptoms associated with surgery as compared to a standard care group.

UNKNOWN
An Evaluation of a Self-contained Direct Digital Radiography System for Breast Specimen Imaging
Description

The objective of this study is to evaluate the image quality and operation of a self-contained direct digital radiography system for breast specimen imaging.

Conditions
COMPLETED
Clinical Evaluation of a Self-etch Adhesive Using a Selective Etch Technique
Description

Study hypothesis: Etching the enamel followed by use of a self-etching adhesive on enamel and dentin is as effective as a one-step etch and rinse approach.

Conditions
COMPLETED
Evaluation of Integrating Self Blood Pressure Monitoring Into Urban Primary Care Practices
Description

Background: Hypertension (HTN) is a major risk factor for cardiovascular disease (CVD), the leading cause of death in the United States and New York City (NYC). One in 4 NYC adults has hypertension, with higher prevalence in both Blacks and Latinos compared to Whites (Angell 2008). In NYC, only 65% of all adults with HTN and on treatment are controlled (Angell 2008). Self-blood pressure monitoring (SBPM) is associated with reduced blood pressure in patients with hypertension (Cappuccio 2004). Studies suggest that SBPM may increase control either by inducing clinicians to titrate medication more actively, (Agency for Healthcare Research and Quality 2002) by engaging patients to participate in their own health care, (Taylor 2007) or a combination of the two. However, minimal research has been done to evaluate the effectiveness of SBPM in different racial and/or ethnic groups or in low income populations or to discern effective patterns of SBPM use by patients. Best practices for integration of self monitoring into HTN into regular treatment have also yet to be established. Objectives: The goal of this study is to assess the impact of SBPM under conditions consistent with existing community health clinic resources and infrastructure in NYC's medically underserved neighborhoods using commonly available automated home BP monitors. By using a community clinic's electronic health record (EHR) and automated BP monitors with the capability to transmit readings to a research database, we can facilitate a more rigorous evaluation of a pilot SBPM intervention and assess patterns of home monitor use and clinical management and their association with outcomes. The three specific aims of this intervention are to: 1. Assess whether use of SBPM reduces elevated BP and increases HTN control to similar levels in two historically understudied minority populations, Blacks and Latinos. 2. Confirm pilot findings by assessing the impact of SBPM on BP and HTN control compared to usual care using randomized controlled trial methodology. 3. Develop standards and refine guidance for the effective use of SBPM that can be easily communicated to key stakeholders.

COMPLETED
Evaluation of Diabetes Self-Management Consultant Care
Description

The purpose of this study is to find out if Self-Management Consultant (SMC) intervention will be more effective than usual care in improving blood glucose control and diabetes-related quality of life for adults with type 2 diabetes.

RECRUITING
Evaluation of Tasso+ Blood Self-Collection for Clinical Diagnostic Assessment of Various Biomarkers
Description

This study aims to assess the effectiveness and reliability of the Tasso+ capillary blood self-collection device in the clinical diagnostic assessment of various biomarkers. The study will collect blood specimens using both the Tasso+ self-collection device and traditional venipuncture. The biomarker analysis results from both specimen types will be compared for correlation.

RECRUITING
Evaluation of My Future Self, an New Teen Pregnancy Prevention Group Intervention for Youth in Non-traditional Settings
Description

Children's Hospital Los Angeles and ETR will implement and test the effectiveness of a pregnancy prevention intervention, My Future Self, targeting youth ages 16-19 in Los Angeles and San Diego Counties who, for a variety of reasons, are receiving education or training in non-traditional settings. These youth typically experience a combination of needs related to unstable or no housing, extreme poverty, involvement with child welfare or juvenile justice, historical trauma, and/or learning differences. My Future Self is a 5 week program consisting of 5 group sessions. Our study will enroll up to 704 highly mobile youth from various sites in Los Angeles and San Diego. Youth will be randomized to receive the My Future Self intervention in conjunction with their regular services or just their regular services. All youth enrolled will complete baseline, 6 month and 12 month surveys.

Conditions
COMPLETED
Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
Description

The purpose of this study is to evaluate the performance of the Bio-Self COVID-19 Antigen Home Test. The study will evaluate the accuracy (sensitivity and specificity) in a simulated home use environment when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay.

Conditions
COMPLETED
Evaluation of e-Practice Self-Regulation (e-PS-R)
Description

The purpose of the study is to determine the impact of the offer to participate in the e-Practice Self-Regulation (e-PS-R) (treatment) relative to the control condition on increasing knowledge of sexual health and the impact of trauma on sexual decision-making and preventing teen pregnancy and high-risk behaviors 12 months after enrollment.

COMPLETED
Evaluation of Rapid HIV Self-testing Among MSM (eSTAMP)
Description

This study seeks to determine the public health impact of providing rapid HIV test kits to men who have sex with men (MSM) so they may test themselves at their convenience. The study will determine if men who receive the rapid HIV test kits report HIV testing at least three times per year. This study will be conducted in four consecutive parts. The first three parts are formative in nature to guide the development and implementation of Part 4 of the study. The research study will use two different types of rapid HIV tests. The OraQuick® In-Home HIV Test for oral fluid (FDA approved for home use) and Sure Check® HIV 1/2 Assay, currently FDA-approved for professional use and distributed in the U.S. as Clearview® Complete HIV-1/2 Rapid Test. An Investigational Device Exemption will be obtained from the FDA to allow the contractor to supply the Sure Check® HIV 1/2 Assay to study participants since it is not approved for home use.

Conditions
TERMINATED
Method Comparison/User Evaluation of the i-SENS Self-Monitoring Blood Glucose / β-Ketone System
Description

The goal of this clinical trial is to assess the accuracy and usability of the blood glucose meter in untrained participants, both with or without diabetes, as well as those with pre-diabetes.

Conditions
RECRUITING
Evaluation of Repeated, In-Clinic, Self-Imaging by DME Patients Using the Notal Vision Home OCT
Description

Evaluation of Repeated, In-Clinic, Self-Imaging by DME Patients Using the Notal Vision Home OCT The purpose of this study is to collect data on the NVHO device at up to three sites.

COMPLETED
Evaluation of a Digital Diabetes Self-Management Education and Support Program
Description

The goal of this study is to examine the efficacy of an integrated solution, defined as a combination of the Abbott FreeStyle Libre 14-day CGM sensor and the Omada care team's receipt of real-time, continuous glucose data from the sensor and incorporation of this data into their care delivery within the context of the Omada for Diabetes program for adults with Type 2 Diabetes (T2D). This randomized control trial will test the impact of the integrated solution on HbA1c, CGM-derived metrics and other relevant diabetes management outcomes over six months compared to the current standard of care.

Conditions