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NCT ID: NCT05760898 Not yet recruiting - Hypertension Clinical Trials

Reducing Hypertension Disparities in Rheumatoid Arthritis

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

Rheumatoid arthritis (RA) is a autoimmune disease associated with an increased risk of developing coronary artery disease (CAD) and premature death, particularly in Black patients. Traditional CAD risk factors like hypertension (HTN) are both very common and poorly controlled among Black RA patients. Disparities in RA disease activity further increase the risk of CAD in this population. Black patients face significant barriers when seeking RA care, and the investigators suspect similar challenges affect HTN care in this population. The goals of this project are to identify and address barriers to HTN care in patients with RA to reduce disparities in HTN and CAD outcomes for Black RA patients. Interviews with Black RA patients, rheumatology providers, and primary care providers in the Duke University Health System will be conducted to describe barriers to HTN care in Black RA patients. Interviews will focus on access to care, patient-provider communication, coordination of care, and the challenges of managing HTN in patients with RA. These interviews will help us to develop an intervention that will focus on improving uncontrolled HTN in Black RA patients. The investigators plan to do this by empowering Black RA patients to actively participate in their HTN care, improving patient-provider communication, and improving coordination between primary care and rheumatology providers. If successful, our intervention has the potential to reduce rates of CAD and associated death for Black RA patients.

NCT ID: NCT05770375 Not yet recruiting - Schizophrenia Clinical Trials

Tolerability of MDMA in Schizophrenia

TMS
Start date: August 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Impaired social motivation, or "asociality," is a negative symptom of schizophrenia (SCZ) and a cause of significant functional impairment in the illness. Whereas many symptoms of schizophrenia can be treated with antipsychotic medications, deficits in social motivation persist, leading to significant social disability in patients. There is currently no effective treatment for this symptom of the illness. One promising and unexplored avenue to enhance social motivation in schizophrenia is ± 3,4-methylenedioxymethamphetamine (MDMA). MDMA is a psychostimulant that shares some pharmacological properties with amphetamines, but in addition, has pronounced pro-social effects, increasing the motivation to engage socially. In healthy volunteers, it produces feelings of empathy and closeness with others and increases attention to positive social cues, perhaps partly through its effects on the social bonding hormone, oxytocin. MDMA has shown promise in other psychiatric conditions such as PTSD. Thus, MDMA could offer a unique therapeutic benefit in patients with SCZ who suffer from impaired social motivation. The investigators plan to take the first step in testing MDMA as a treatment for these social deficits by testing the tolerability of the drug in patients with SCZ. This will be an open-label, ascending-dose, within-subject trial in which participants will receive 40mg, 80mg, or 120mg of MDMA. The doses will be administered in ascending order, but doses will be stopped if subjects experience moderate or greater psychotic symptoms at 24 hours. This trial will assess the tolerability of the drug in this population and guide in the selection of a maximum well-tolerated dose for future studies. The primary tolerability measure will be clinician-rated psychotic symptoms (disorganized speech, delusions, hallucinations) collected at 24 hours after MDMA administration. The results of this project will lay the foundation for further investigations of MDMA and other psychoactive compounds as a treatment for debilitating and difficult-to-treat social deficits in schizophrenia. Future studies will examine interactions between the effects of psychoactive compounds and nonpharmacologic psychosocial interventions targeting social symptoms.

NCT ID: NCT05796037 Not yet recruiting - Multiple Sclerosis Clinical Trials

An Observational Study of Patients Living With Chronic Neurological Diseases

Start date: August 1, 2024
Phase:
Study type: Observational

TARGET-NEURO is an observational research study to conduct a comprehensive review of outcomes for patients living with chronic neurological diseases: Alzheimer's disease and related dementia (ADRD), mild cognitive impairment (MCI), Parkinson's disease (PD), and multiple sclerosis (MS).

NCT ID: NCT05807997 Not yet recruiting - Clinical trials for Refusal of ICU Admission

Patients Who Were Not Admitted to the Intensive Care Unit: Characteristics and Clinical Outcomes. Retrospective Study

Start date: August 1, 2024
Phase:
Study type: Observational

There is extensive medical literature supporting the contribution of intensive care physicians to improvement of clinical outcomes in patients treated in an intensive care unit (1-3). There are many reasons for this contribution, including adherence to evidence-based medical protocols, as well as collaboration between different medical specialties in patient care (4-7). Over the years, several criteria have been formulated for the admission of patients to intensive care (8) according to their medical condition, but there are other factors that influence the decision whether to admit patients to intensive care, not necessarily medical ones, such as the availability of beds in the unit and the availability of medical and nursing staff. There are several studies that examined the characteristics and clinical outcomes of patients who were not admitted to the intensive care unit, for medical or paramedical reasons (9). We would like to retrospectively examine all patients in the last 5 years who were presented for admission to general intensive care from various departments in our institution but were not admitted, to characterize the reasons why they were not admitted, the clinical characteristics of the patients and their clinical outcomes. Objectives: Main objective: To characterize the clinical outcomes of the patients who were presented for admission to general intensive care but were not admitted in the last 5 years. Secondary objectives: To characterize the reasons why the patients were not admitted - medical and paramedical, and to examine the clinical characteristics of these patients (age, sex, background diseases and current disease.). Design and methods: Study design: This is a retrospective study based on data collection. Methods and materials: Collecting information from computer systems regarding the patients who were presented by the various departments at the Meir Hospital in Kfar Saba for admission to the general intensive care unit and were not admitted, starting from the beginning of January 2018 until the beginning of January 2023. These are about 1000 patients. After the end of data collection in the study, the data will be typed anonymously into a dedicated Excel file. The patients will be identified according to the patient number in the study and the case number, without specifying identifying details. Inclusion criteria: All patients aged 18--99 who were presented to the general intensive care unit from January 2018 to the end of December 2023 and were not admitted. Data collection: The research will be conducted in the format of observational data collection from the patient files and from computerized systems (Camelion system and iMDsoft software). The data collected in the study will be exposed to the research team only as long as the actual data collection is carried out. After the end of data collection in the study, the data will be typed anonymously into a dedicated Excel file. The patients will be identified according to the patient number in the study and the case number, without specifying identifying details. The data to be collected: age, sex, underlying diseases, regular medications, duration of hospitalization, need for ventilation, number of days of ventilation, mortality within 28 days, APACHE-2 score, SOFA score, lactate level, need for pressors, need for dialysis or other RRT, The reasons for not being admitted to the intensive care unit. Size of the research group: about 1000 patients - this is the estimated number of patients in the time period detailed above. The method of processing the results: all the demographic and in-hospital indicators will be tested statistically by a certified statistician depending on the type of data.

NCT ID: NCT05812131 Not yet recruiting - PTSD Clinical Trials

COPEWeb Training for Providers

COPEWeb
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

PTSD and substance use disorders (SUD) are two of the most common and debilitating mental health conditions afflicting military Veterans. PTSD and SUD frequently co-occur and are associated with poorer treatment outcomes. The investigators' team developed a trauma-focused intervention, Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE), which is identified by the VA as a gold standard of behavioral healthcare. However, a critical barrier to ensuring that Veterans with co-occurring PTSD/SUD receive evidence-based treatment is a lack of provider training. This project directly addresses this critical gap by developing a new web-based training program for providers (COPEWeb).

NCT ID: NCT05816317 Not yet recruiting - Suicidal Ideation Clinical Trials

Randomized Controlled Trial of a Single-session Mechanism-focused Intervention for Suicidal Thoughts and Behaviors

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

Across multiple models of suicide risk, hopelessness and perceptions of social relatedness (i.e., lack of social connection/thwarted belongingness, perceived burdensomeness) have emerged as candidate mechanisms that maintain STBs. Although these mechanisms have garnered strong empirical support in predicting STBs, there has been virtually no integration with interventions aimed for individuals at acute risk for suicide. Thus, the overarching goal of the present proposal is to evaluate a mechanism-focused intervention that explicitly targets two core mechanisms implicated in the maintenance of STBs: hopelessness and negative perceptions of social relatedness. Given that the period immediately following hospital discharge presents the highest risk for suicide attempts and up to 70% of patients admitted for a suicide attempt do not attend their first outpatient appointment, the intervention will be evaluated on an inpatient unit. Additionally, most of the extant interventions for STBs are administered across multiple sessions (i.e., 4 sessions and up to one year); however treatments of this length are unlikely to be feasible in acute care settings. Fortunately, very brief suicide prevention interventions, are effective in reducing future suicide attempts and increasing the likelihood of attending follow-up treatments. Additionally, single-session interventions (not suicide specific) have been shown to reduce hopelessness immediately and at a one-month follow-up. The present study is an RCT comparing a novel Single Session Mechanism Focused Intervention (SSMFI) for STBs to treatment-as-usual (TAU) on a psychiatric inpatient unit for patients admitted for suicidal ideation or attempt. The engagement of the putative processes (hopelessness and negative perceptions of social relatedness) that maintain STBs will be assessed, along with the feasibility and acceptability of SSMFI for STBs on an inpatient psychiatric unit.

NCT ID: NCT05818254 Not yet recruiting - Contraception Clinical Trials

The HOP-STEP Intervention: Improving Maternal Health in Women With Lupus sIRB

HOP-STEPsIRB
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

While the HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) program has been demonstrated to be effective in improving provider confidence, increasing contraception documentation, and facilitating equitable pregnancy planning care in a single sub-specialty clinic here at Duke, the delivery of HOP-STEP may need to be changed to increase its fit with the local context at the University of Chicago Medical Center (UCMC) and subsequent locations. Thus, the investigators will now fit the intervention into a high-minority, high-poverty academic rheumatology center, and later pilot it through a randomized trial to identify and overcome existing barriers to equitable pregnancy prevention and planning at another institution (The University of Chicago Medical Center). The objective of this study is to prepare for a multi-center trial of the HOP-STEP intervention by fitting and then piloting its implementation and measuring its potential impact on maternal outcomes.

NCT ID: NCT05832307 Not yet recruiting - Influenza Clinical Trials

The INFLUENTIAL Trial- Evaluation of National Inpatient Influenza Vaccination Program

Influential
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

This study plans to learn more about whether a stakeholder-informed, standardized inpatient vaccination program will increase influenza vaccination rates of hospitalized children across US pediatric health systems. The first part of the study is to form a multidisciplinary team of stakeholders, including parents, providers, nurses, pharmacists, informaticists, data analysts and communication experts across three sites in synthesizing a best practice implementation guide for an inpatient influenza vaccination program, which will then be piloted at these three sites.

NCT ID: NCT05842824 Not yet recruiting - Autoimmune Diseases Clinical Trials

An Observational Study of Patients With Autoimmune Disease

Start date: August 1, 2024
Phase:
Study type: Observational

TARGET-AUTOIMMUNE is an observational research study to conduct a comprehensive review of outcomes for patients with autoimmune and related diseases. .

NCT ID: NCT05860543 Not yet recruiting - Clinical trials for Muscle Invasive Bladder Cancer

Clinical Performance Evaluation of the C2i Test

Start date: August 1, 2024
Phase:
Study type: Observational

The overall objective of this study is to demonstrate the safety and effectiveness by means of investigation of the ability of C2i-Test to predict 2-year recurrence-free survival post-RC in stage II-IIIA MIBC patients.