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NCT04560621
The Managed Problem Solving (MAPS) behavioral intervention is an EBP for behavior change in people living with HIV (PLWH). The investigators propose that MAPS can be delivered by trained Community Health Workers (CHWs). The use of CHWs to deliver MAPS is justified by their ability to develop trusting relationships with their clients and the need for task shifting in busy clinics. In order to also address retention in care, the investigators will adapt MAPS to also focus on problem solving activities tailored toward retention in care (now termed MAPS+). CHWs will be located in clinics to implement MAPS+ to improve viral suppression and care retention in PLWH. Data-to-care allows for identification of people who are lost to care and link these patients back to care. Currently, medication adherence and retention in HIV care are not targeted in data-to-care so the investigators will build on this approach to facilitate the identification of PLWH who are out of care and not virally suppressed to offer them MAPS+. The set of implementation strategies include task-shifting the delivery of MAPS+ to CHWs, providing the CHWs training and ongoing support, and increasing communication between the CHWs and medical care team via standardized protocols. The investigators will conduct a hybrid type II effectiveness-implementation trial with a stepped-wedge cluster randomized design in 12 clinics to test MAPS+ compared to usual care using a set of implementation strategies that will best support implementation. Each clinic will be randomized to one of three implementation start times. Baseline (usual care) data will be collected from each clinic for 6 months, followed by MAPS+ and the package of implementation strategies for 12 months, in three cohorts of 4 clinics each. Aim 1 will test the effectiveness of MAPS+ on clinical effectiveness outcomes, including viral suppression (primary) and retention (secondary). Aim 2 will examine the effect of the package of implementation strategies on reach. Implementation cost will also be measured. Aim 3 will apply a qualitative approach to understand processes, mechanisms, and sustainment of the implementation approach. The results will guide future efforts to implement behavioral EBPs across the HIV care continuum, consistent with the "treat" pillar of EHE, and move the science of implementation services, consistent with NIH strategic priorities.
NCT04267055
DISSECT-N is a post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections in real world practice.
NCT04488250
Today, nearly 37 million people are living with HIV (PLHIV) worldwide and 30 to 40% of them will have neurologic complications leading to disability. Our long-term working hypothesis is that an effective solution for increasing rehabilitation access in Botswana and improving functional outcomes of PLHIV having experienced a stroke with or without HIV uses an affordable robot and mobile health technologies to create a cost-effective intervention strategy. For this project, we test the feasibility of affordable robot therapy.
NCT04641962
The purpose of this study was to evaluate the dose response of Bocidelpar on functional improvement relative to placebo, safety, and tolerability in participants with Primary Mitochondrial Myopathy.
NCT04737265
Investigators will evaluate the safety and feasibility of a biomarker-guided cardioprotection strategy using NTproBNP, as compared to usual care, in breast cancer and lymphoma patients treated with anthracyclines.
NCT05714605
The goal of this stepped wedge pragmatic trial is to compare referral patterns and post discharge outcomes in Medicaid insured individuals discharge following a hospitalization\]. The aims are to 1) evaluate the implementation of the THRIVE clinical pathway, including feasibility, appropriateness, and acceptability and 2) examine referral patterns, 30- day readmission and Emergency Department (ED) utilization patterns for participants who receive THRIVE support services. During hospitalization participants will receive a referral to home care services and will be seen by a home care nurse within 48 hours following discharge. A discharging physician or Advanced Practice Provider will maintain clinical oversight for 30 days or until the patient sees primary care provider or specialist. A Care Coordination Team conducts weekly case conferences to ensure social and health needs are being addressed for 30 days post-discharge. Researchers will compare Medicaid insured patients discharged during the study, to those receiving usual care to determine if there are differences in post-acute utilization outcomes.
NCT03567642
The purpose of this study is to test the safety of combining Osimertinib with either Cisplatin or Carboplatin (at different dose levels) and Etoposide, to find out what effects, if any, this combination of drugs has on people with EGFR mutant lung cancer.
NCT05424029
The purpose of this study is to find out if fluid rinsed from peoples' airways (bronchial washing samples) during routine surgery to remove (resect) their non-small cell lung cancer (NSCLC) tumors contains enough vesicles to do testing that may help the researchers learn more about their NSCLC.
NCT03085056
The purpose of this study is to test the safety and tolerability of this treatment combination of paclitaxel and trametinib. Additionally, this study aims to to find out what effects the combination of paclitaxel and trametinib has on the shrinkage and growth of anaplastic thyroid cancer.
NCT02605486
The purpose of this study is to test the safety and effectiveness of the investigational drug, palbociclib with bicalutamide for the treatment of triple negative, androgen receptor positive breast cancer.
NCT05757570
The goal of this clinical study is to evaluate povetacicept in adults with autoimmune cytopenias of immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month study treatment extension period.
NCT03912532
This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3 Fibrosis.
NCT05131477
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 5-arm study to assess the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis. The estimated duration is 28 days for screening and then up to approximately day 477 (last dose no later than day 337+140 days safety follow-up) for all patients unless enrolled into the Long-Term Extension (LTE) protocol (NCT05492578) at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.
NCT06544564
This study is designed to assess the clinical effectiveness of Membrane Wrap, a human amniotic membrane for the management of difficult to heal partial- or full-thickness venous leg ulcers (VLUs)
NCT05574296
The purpose of this project is to test the feasibility and safety of inhaled hydrogen gas (H2) administration as a rescue therapy during cardiac arrest requiring extracorporeal cardiopulmonary resuscitation (ECPR, i.e. mechanical circulatory support). Under exemption from informed consent, patients undergoing refractory cardiac arrest in the cardiac ICU at a participating center will be randomized to standard therapy with or without the administration of 2% hydrogen in gases administered via the ventilator and ECMO membrane for 72 hours.
NCT05153330
A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with AML, ALL (with KMT2A/ MLL1r, NPM1 mutations), DLBCL, MM, and CLL/SLL.
NCT04554212
This research study is designed to allow health care professionals and researchers to answer many questions about whether a new type of physical therapy called blood flow restriction training (called BFRT) will improve recovery for those with patellar instability.
NCT03778502
Unusual site venous thromboembolism (VTE) refers to thrombosis occurring in venous districts outside the veins of the lower extremities and the pulmonary arteries, and includes splanchnic vein thrombosis (SVT), cerebral vein thrombosis (CVT), retinal vein thrombosis, ovarian vein thrombosis, and renal vein thrombosis. The use of the novel direct oral anticoagulants (DOAC), thrombin or factor Xa-inhibitors (such as dabigatran, apixaban, edoxaban, rivaroxaban), in patients with unusual VTE in clinical practice is increasing. Through an international multicentre prospective registry, the investigators aim to evaluate the rationale for the use of the DOAC for the treatment of unusual site VTE and to assess the safety and effectiveness of this approach in real life clinical practice.
NCT04573660
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.
NCT06314971
Tumor recurrence significantly affects survival rates following the local resection of submucosal colorectal cancers (T1 CRC). Despite this, there are currently no reliable biomarkers established to predict recurrence in T1 CRC. This study seeks to improve the prediction of recurrence-free survival in individuals who have survived T1 CRC.
