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Clinical Trials: Other
IRB No. 15-118-1 (Dr. Bruce Strober, PI): A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis (VOYAGE 1)
Study description not available
IRB No. 16-055-2 (Dr. David Steffens, PI): Department of Psychiatry: Adult Repository
The purpose of the repository is to prospectively collect biological samples along with clinical data to facilitate future research studies and pilot analysis related to medical and behavioral health research.
IRB No. 16-086-1 (Dr. Kai Chen, PI): Endothelial Dysfunction in Coronary Artery Disease and Diastolic Heart Failure
Congestive Heart failure, including systolic and diastolic heart failure, is a major public health hazard and its prevalence continues to rise. While the mortality of systolic heart failure has significantly reduced over the past decade thanks to the advances in pharmacological therapy, there has not been a single therapy that has shown to be survival benefit on diastolic heart failure. A significant gap in knowledge on diastolic heart failure has to be bridged before we may design a therapeutic strategy to target this disease. Recent elegant studies have revealed evidence of systemic and myocardial inflammation in endomyocardial tissues. A new paradigm of the pathophysiology of diastolic heart failure has been proposed - systemic proinflammatory state, coronary endothelial inflammation, impairment in endothelial-cardiomyocyte nitric oxide signaling, inflammatory cell infiltration and proinflammatory cytokines, collectively lead to diastolic dysfunction. Therefore, our central hypothesis is endothelial dysfunction contributes to diastolic function and clinical exacerbation of heart failure.
IRB No. 16-111-1 (Dr. Efthimia Ioannidou, PI): Novel Paradigm to Improve Inflammatory Burden in ERSD
The study proposes to examine, for the first time in dialysis patients, the short and long-term effect of systemic and repeated oral health interventions on inflammation and clinical oral parameters. The ultimate goal of this proposal is to improve access to oral care and quality of life by implementing continuous and repeated in-center oral health programs in dialysis populations.
IRB No. 16-098-1 (Dr. Jayesh Kamath, PI): A 12-Month Randomized, Open-Label Study of Caregiver Psycho-education and Skills Training in Patients Recently Diagnosed with Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder and Receiving Paliperidone Palmitate or Oral Antipsychotic Treatment. Family Intervention in Recent onset Schizophrenia Treatment (FIRST)
Family education and training has been shown to have a positive impact on both the individual with psychosis and their caregivers when it is embedded within a treatment program. Providing support to caregivers to help make them be more active and effective participants in the patient's recovery can be a cost-effective approach that contributes to better patient outcomes. This study will enroll patients recently diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder that are prescribed either paliperidone palmitate or oral antipsychotic treatment, and their designated caregivers. Outcomes in patients with caregivers receiving a study-provided psycho-education and skills training program will be compared to patients with caregivers receiving usual caregiver support (caregiver support that is customarily provided by the study site, if any). OBJECTIVE AND HYPOTHESES Primary Objective: To evaluate the overall effect of caregivers receiving a study-provided caregiver psycho-education and skills training program on the number of treatment failures (psychiatric hospitalization, psychiatric ER visit, crisis center visit, mobile crisis unit intervention, arrest/incarceration, and suicide or suicide attempt) in patients under their care during a 12 month period. Primary Hypothesis: When caregivers receive a study-provided psycho-education and skills training, patients with schizophrenia, schizoaffective disorder, and schizophreniform disorder under their care will have fewer treatment failures compared with patients whose caregivers receive usual caregiver support. Secondary Hypotheses: Over a 12 month period study-provided caregiver psycho-education and skills training will be superior to usual caregiver support in reducing caregiver burden and distress. Patients diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder receiving oral antipsychotic treatment and who have caregivers receiving a study-provided caregiver psycho-education and skills training program will have fewer treatment failures compared with patients receiving oral antipsychotic treatment that have caregivers receiving usual caregiver support. Patients diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder receiving paliperidone palmitate treatment and who have caregivers receiving study-provided caregiver psycho-education and skills training program will have fewer treatment failures compared with patients receiving paliperidone palmitate that have caregivers receiving usual caregiver support.
IRB No. 16-164J-3 (Dr. George Kuchel, PI): Combination Adjuvants to Activate Human Dendritic Cell Subsets and B Cells
Vaccination is the most effective method for preventing infectious diseases. Many current vaccines are "inactivated" or "subunit" vaccines composed of purified or recombinant pathogen components to which an adjuvant is often added to increase the magnitude of antibody responses. However, subunit vaccines formulated with current FDA-approved adjuvants do not sufficiently boost immunity in some populations, particularly immunocompromised and elderly subjects. Numerous adjuvants have been discovered in recent years and show enhanced immunogenicity as single agents; however, little is known about the activity of their combination, their safety, their efficacy and their mechanisms of action. Responses to vaccination and adjuvants involve dendritic cells (DCs), which capture and present vaccine antigens thereby facilitating the differentiation of follicular helper T cells (Tfh) and B cells and subsequent humoral immunity Therefore, we will examine the molecular mechanisms and functional outputs of human DC subsets exposed to combination adjuvants ex vivo and in vivo (humanized mouse models). The focus on human DCs is essential given the substantial differences in innate immune receptor distribution and function between the mouse and the human. Healthy human subjects will be recruited to provide blood, waste skin or blood and waste skin from planned plastic surgical procedures along with skin specimens acquired from the UConn Health Research Biorepository to provide the human dendritic cells required for this research. Our goal is to select a combination adjuvant using functional assays, followed by in-depth investigation of molecular pathways accounting for enhanced immunogenicity. Our Specific Aims are built towards this goal. Specific Aims Aim 1: We will screen adjuvant combinations by assessing the capacity of adjuvant-activated human DC subsets to skew the differentiation of naive CD4+T cells into Tfh cells that secrete IL-21 and induce B cells to produce IgG and IgA antibodies. Aim 2: Promising combinations will be further studied in DCs using validated, sensitive and high-throughput transcriptomic epigenomic, proteomic and metabolomic methods, and by functional knockdown in vitro, to determine the underlying molecular pathways of adjuvant efficacy. Aim 3: We will then validate the identified molecular pathways through functional knockdown studies in vivo using humanized mice carrying a functionally reconstituted human immune system, which will also enable the examination of possible side effects This research program will leverage cutting-edge epigenetic (ATAC-seq), transcriptional, gene editing (CRISPR/Cas9) and metabolomic technologies; innovative humanized mouse models; a powerful computational and bioinformatics infrastructure at The Jackson Laboratory. Our deliverable is a combination adjuvant for enhanced humoral immunity and molecular pathways that are essential for its efficacy.
IRB No. 16-234-1 (Dr. Bruce Liang, PI): UConn Health Cardiology Center Research Screening Protocol
This protocol will be used to gain permission from cardiology patients for Cardiology research staff to access health medical records in order to determine eligibility for research studies and clinical trials. The protocol does not involve actual scientific research.