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NCT ID: NCT04894110 Active, not recruiting - Clinical trials for Endothelial Dysfunction

Study of Safety and Tolerability of EO2002 in the Treatment of Corneal Edema

Start date: June 22, 2021
Phase: Phase 1
Study type: Interventional

Corneal edema is the most common indication for corneal transplantation, accounting for approximately 70% of penetrating keratoplasty (PK), and 100% of endothelial keratoplasty (EK) procedures annually. There is currently no disease-modifying treatment for corneal edema. Topical treatments like hypertonic saline are not effective on a long-term basis. For those with advanced disease, where edema and vision loss are not controlled by topical treatment, the only option is a corneal transplant. A potential approach to avoidance of the risks of corneal transplantation is to inject cultured human corneal endothelial cells (HCECs) into the anterior chamber of the eye. This approach may avoid surgery by re-populating the inner most aspect of the cornea with functioning endothelial cells. Emmecell has developed a treatment based on technology integrating biocompatible magnetic nanoparticles with cultured HCECs to treat corneal edema in a minimally invasive way. The primary objective of this phase 1, prospective, multi-center, open-label, dose-escalation study is to evaluate the safety and tolerability of 3 doses of EO2002 with and without endothelial brushing (EB) or Descemet Stripping (DS) in eyes with corneal edema secondary to corneal endothelial dysfunction that qualify for surgery involving full-thickness corneal transplantation or EK.

NCT ID: NCT04893447 Active, not recruiting - Depression Clinical Trials

Suicide Prevention Among Recipients of Care

SPARC
Start date: May 20, 2021
Phase: N/A
Study type: Interventional

Randomized controlled trial to determine the best brief suicide prevention intervention for adults and adolescents who screen positive for suicidal ideation or behavior in emergency departments or primary care clinics. Aim 1: Compare the effectiveness of two brief suicide prevention interventions (safety planning intervention plus structured phone-based follow-up from a suicide prevention hotline (SPI+), versus safety planning intervention plus caring contacts (CC)) to (a) reduce suicidal ideation and behavior, (b) reduce loneliness, (c) reduce return to care for suicidality, and (d) increase uptake of outpatient mental healthcare services over 12 months among adult and adolescent patients screening positive for suicide in emergency departments (EDs) and primary care clinics. Aim 2: Assess the acceptability of connection and support planning and the safety planning intervention, with or without follow-up among providers and clinical staff in EDs and primary care clinics. Aim 3: Assess the acceptability of SPI+ and SP+CC among adult and adolescent patients.

NCT ID: NCT04893265 Active, not recruiting - Clinical trials for Educational Activities

Getting Asian Americans INFORMED to Facilitate COVID-19 Testing and Vaccination

INFORMED
Start date: September 30, 2021
Phase: N/A
Study type: Interventional

This study develops and evaluates the "INdividual and Family-Oriented Responsive Messaging EDucation" (INFORMED) intervention in increasing knowledge about COVID-19 testing and decreasing decisional conflicts of getting tested for COVID-19. A 2-arm randomized controlled trial will compare INFORMED delivered by LHW educational outreach plus Short Message Service (SMS) text messaging to SMS text with LHW support.

NCT ID: NCT04892797 Active, not recruiting - Covid19 Clinical Trials

Understanding Immunology and Patient Outcomes of COVID-19 in Hospitalized Patients

Start date: February 3, 2021
Phase:
Study type: Observational

The adaptive immune response, consisting of antiviral T and B cells, is critical for providing protection against viruses such as SARS-CoV-2, both during an active infection and later following a subsequent exposure. They can both also potentially contribute to pathogenesis if they are overstimulated. Despite these advances in knowledge, there are still significant gaps in understanding of what constitutes a protective or immunopathologic immune response and its durability. Significant knowledge gaps also remain pertaining to the early recognition of COVID patients with increased risk of clinical deterioration who require continued hospitalization and the use of more intensive treatments designed to improve outcomes. Data from non-COVID patients with MI show that platelet surface expression of FcγRIIa, the low-affinity receptor for the Fc fragment of immunoglobulin (Ig) G, identifies patients at high and low risk of subsequent cardiovascular events. Platelet expression of FcγRIIa is increased by interferon γ20 that is significantly elevated in severe COVID-19 infections. The high prevalence of arterial thrombosis among COVID-19 patients and the central role of thrombosis in respiratory failure support the hypothesis that elevated platelet expression of FcγRIIa will identify COVID patients at increased risk of thrombotic complications and clinical deterioration. In addition to the potential role of platelet activation in thrombosis associated with COIVD-19, the endothelium may also play a significant role. The investigators hypothesize that elevated EMPs in plasma will identify patients at high risk of thrombosis and clinical deterioration. To begin to address the knowledge gaps above and obtain preliminary data for future large grant submission, the investigators propose a small, prospective, single-center cohort study that will enroll patients hospitalized for COVID-19 infection and exhibiting a range of disease severity. Biosamples will be obtained and used to study T and B cells, antibody repertoire, and durability of protective immunity, and also to quantify platelet expression of FcγRIIa and circulating EMPs, as described in the protocol.

NCT ID: NCT04890574 Active, not recruiting - Burns Clinical Trials

CellMist™ Autologous Cells to Treat Deep Second-Degree Burns

CELLMIST1
Start date: May 26, 2021
Phase: Phase 1
Study type: Interventional

The overall purpose of this study is to evaluate the safety of the CellMist™ System in the treatment of deep second degree burns (II°B) in a prospective, multicenter, feasibility pilot study.

NCT ID: NCT04890314 Active, not recruiting - Prostate Cancer Clinical Trials

Prostate Cancer - Comparative Outcomes of New Conceptual Paradigms for Treatment

PC-CONCEPT
Start date: May 15, 2021
Phase:
Study type: Observational

This study will use a population-based cohort design to study men with newly diagnosed low- and intermediate-risk prostate cancer at high-volume centers in Southern California (SCa) and New York State (NYS). Complications of contemporary treatments for prostate cancer and quality of life outcomes, such as general health, urinary, sexual, and bowel function, cancer anxiety, and treatment regret will be compared and tracked over the course of this study.

NCT ID: NCT04890054 Active, not recruiting - Clinical trials for Colorectal Carcinoma

Screening More Patients for Colorectal Cancer Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings, SMARTER CRC

SMARTER CRC
Start date: May 14, 2021
Phase: N/A
Study type: Interventional

This study collects information to provide a model for how to rapidly adapt and scale-up multilevel interventions through clinic-health plan partnerships to reduce the burden of colorectal cancer (CRC) on the United states population. This study may improve colorectal cancer screening rates, follow-up colonoscopy, and referral to care in rural Medicaid patients.

NCT ID: NCT04889079 Active, not recruiting - Contraception Clinical Trials

Assessing Adolescent Use of Nexplanon Over Time

Start date: June 6, 2021
Phase:
Study type: Observational

The purpose of this study is to compare Nexplanon decision-making, uptake, satisfaction and contraceptive outcomes (continuation, switching, discontinuation) over a 12-month period among adolescents ages 15-18 to adolescents ages 19-24, living in Utah. Data from this study will provide valuable information for clinical and public health offerings, counseling and support for Nexplanon use across stages of adolescence.

NCT ID: NCT04888845 Active, not recruiting - Clinical trials for Narrative Assessment

Refinement of Suicide Risk Management Intervention

Start date: April 22, 2021
Phase: N/A
Study type: Interventional

Participants will be randomly assigned to 1 of the 4 interventions using a sequential stratified randomization procedure. We will use sex (M, F) and history of suicide attempts (never, 1, and multiple) as our randomization strata. Participants will be assessed before and after the intervention to study the potential effects of each approach on suicide-related clinical outcomes.

NCT ID: NCT04887870 Active, not recruiting - Clinical trials for Advanced or Metastatic Solid Malignancies

Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study

Start date: June 30, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

A Study of Sitravatinib Alone or in Combination with Other Anticancer Therapies in Advanced or Metastatic Malignancies