Site for Site for CTN-0100: Optimizing Retention Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)
The main aims are:1. To test, among patients seeking treatment for opioid use disorder(OUD), strategies to improve retention in treatment on medications foropioid use disorder (MOUD).2. To test strategies to improve outcomes among patients who haveachieved stable remission on MOUD and want to discontinue MOUD.3. To develop predictive models of successful discontinuation of MOUDamong patients who discontinue medication, based on patientcharacteristics, including duration of MOUD prior to discontinuation.The study will have a multicenter, randomized, pragmatic non-blinded design, and incorporate two phases:In the Retention Phase, patients seeking treatment for OUD will enter the study as part of intake into standard-of-care MOUD treatment. They will choose between MOUD with buprenorphine (BUP) or extended-release naltrexone (XR-NTX). Participants choosing MOUD with BUP will be randomly assigned in a 3 by 2 factorial design with 3 pharmacological conditions (standard dose sublingual BUP (SL-BUP); high dose SL-BUP; or extended-release injection BUP (XR-BUP)) crossed with 2 behavioral conditions (Medical Management and usual counseling (MM) or MM plus a technology-based behavioral component (MMR)). Participants choosing MOUD with XR-NTX will only be randomized to one of the 2 behavioral interventions (MM or MMR). Participants are eligible to receive their assigned study MOUD for 72 weeks following randomization and will be followed for an additional 24 weeks, for a total of 96 weeks post-randomization.In the Discontinuation Phase, participants will not be actively recruited; instead, stable patients seeking to discontinue MOUD will be referred to the study (either from the participating site's existing caseload or from the Retention Phase). Participants must meet study-defined stability and abstinence criteria as part of eligibility. Eligible participants who enter the study on SL-BUP will be randomly assigned in a 2 by 2 factorial design with 2 pharmacological conditions (standard taper using SL-BUP or taper with XR-BUP) crossed with 2 behavioral conditions (MM or MM plus a technology-based behavioral component (MMD)). Participants entering the Discontinuation Phase on XR-BUP or XR-NTX will only be randomized to one of the 2 behavioral interventions (MM or MMD). Participants have up to 48 weeks to complete their medication taper. Upon completion of taper (or following the end of the taper period, whichever comes first), all participants will enter a follow-up period lasting 24 weeks (and up to 72 weeks, if the overall study timeline allows). BUP participants may receive up to 6 injections of XR-NTX during the follow-up period.
Site for Studies of Patients with Implanted Intracranial Electrodes
Site for The overall goals of this research protocol are 1) to better understand the function of cortical sites that are measured with scalp electrodes (electroencephalography, or EEG) and/or implanted intracranial electrodes (electrocorticography, or ECoG) and 2) to determine the most effective and safe testing methods, including cortical stimulation and passive EEG or ECoG recordings, for defining this cortical function so that post-operative neurological impairments are avoided.
Site for Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease (SPARC IBD)
Site for IBD Plexus is a research and information exchange platform whose goal is to accelerate research and transform the care of patients with IBD. IBD Plexus will unite clinicians, patients, academic and industry researchers to answer questions that are critically important to advance the field of IBD research and to accelerate progress toward precision medicine.IBD Plexus connects and centralizes clinical, patient-reported, biosamples and derived ‘omic/ expression data across multiple patient cohorts. IBD Plexus consists of a biobank, registries to capture clinical, patient-reported, and biosample data, a centralized analytics lab to conduct omics and expression analysis, a large data management platform to house, organize, aggregate and disseminate data, and a researcher portal which provides access to prep-to-research tools and high performance cloud computing.The various components of IBD Plexus provide the infrastructure and capacities to dramatically shift the IBD research paradigm by facilitating novel, potentially groundbreaking studies into IBD’s causes and treatments.These components will include data from the CCFA’s Quality of Care Initiative, the CCFA Partner’s cohort study, the RISK cohort study, and the SPARC IBD study described in this protocol.
Site for The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD) A Double-Blinded Phase III Randomized Trial of T-DM1 Compared with T-DM1 and Tucatinib
Site for CompassHER2 RD (A011801) is a randomized trial in patients with residual disease after a predefined course of neoadjuvant HER2-directed treatment. While CompassHER2 RD allows entry for eligible patients who did not participate in CompassHER2 pCR, there is high interest in maximizing participation from CompassHER2 pCR in whom substantial data regarding preoperative clinical and biologic characteristics will already have been obtained. We estimate that 30-50% of patients who will participate in CompassHER2 RD will also have participated in CompassHER2 pCR; the other 50-70% of patients will be recruited separately. Patients treated with de-escalated therapy on CompassHER2 pCR will be required to receive further standard of care chemotherapy (e.g. AC X 4 or Carboplatin-H(P) x 4, TH(P)) prior to randomization on CompassHER2 RD. Therefore, CompassHER2 pCR participants must have completed at least 6 cycles of chemotherapy (including treatment administered pre and postoperatively) to be eligible for CompassHER2 RD. Enrollees who did not participate in CompassHER2 pCR must have already completed a standard HER2-directed neoadjuvant regimen (e.g. TCH(P) x 6, or AC-TH(P)), so will receive no additional systemic therapy prior to randomization. In CompassHER2 RD, eligible participants with HER2-positive residual disease will be randomized 1:1 to complete a total of 14 cycles of T-DM1 and placebo vs. T-DM1 and tucatinib, with concurrent standard endocrine therapy, if applicable. Adjuvant radiotherapy +/- endocrine therapy, as applicable, can be administered in conjunction with T-DM1 and tucatinib/placebo. Selected patients who have already begun or completed adjuvant radiotherapy, and/or who have recently commenced adjuvant T-DM1 as standard of care, may also be eligible.
Site for The HEALthy Brain and Child Development Study (HBCD)
Site for This multi-site consortium research study, entitled the HEALthy Brain and Child Development (HBCD) study, will prospectively examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally through age 10 years. The study will determine the short- and long-term impacts of a variety of potentially harmful as well as protective environmental factors. These include prenatal substance use, mental health, stress, sociodemographics, biological and genetic factors, and parent/child interaction. The overall goal of this study is to understand the neurodevelopmental trajectories of children growing up in diverse environments. A sample of ~7,500 pregnant women will be recruited from 25 sites across the U.S. and they and their liveborn children will be followed for 10 years.
Site for The Parkinson s Progression Markers Initiative (PPMI) 2.0 Clinical - Establishing a Deeply Phenotyped PD Cohort
Site for The Parkinson Progression Marker Initiative 2.0 (PPMI 2.0) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson’s disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI 2.0 is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.
Site for Type 1 Diabetes Pathway to Prevention Study (Natural History) Study
Site for The goals of the TrialNet Pathway to Prevention Study are to gain information about the pathogenesis and natural history of type 1 diabetes (T1D), and to facilitate the assessment and recruitment of individuals who might qualify for T1D prevention trials.
Site for Understanding health disparities in Pakistani Bangladeshi and Asian Indian immigrants: the role of socio-cultural context acculturation and resilience resources - Mediators of Atherosclerosis in South Asians Living in America (MASALA) Study Expansion New York Site
Site for This protocol describes a mixed methods study that leverages the infrastructure of an ongoing MASALA study in Chicago and San Francisco to enroll 600 Bangladeshi and 250 Pakistani adults aged 40-84 years as part of a greater New York City cohort. These participants will be added to the 1,550 surviving participants already in MASALA for well-powered subgroup comparisons and ongoing follow-up. Participants will complete a physical exam and survey, provide biospecimens, and be followed longitudinally (12M, 24M) to complete surveys in order to identify how socio-cultural context, discrimination, acculturation strategies and resilience resources act as risk or protective factors explaining CVH disparities in Indian, Pakistani and Bangladeshi immigrants.
Site for Validation of Early Prognostic Data for Recovery Outcome after Stroke for Future Higher Yield Trials
Site for VERIFY will validate biomarkers of upper extremity (UE) motor outcome in the acute ischemic stroke window for immediate use in clinical trials, and explore these biomarkers in acute intracerebral hemorrhage. The central hypothesis is that patients have different UE outcomes depending on corticomotor system (CMS) function, measured as motor evoked potential (MEP) status with TMS, and on CMS structure, measured as acute lesion load with MRI. VERIFY will create the first multicenter, large-scale, prospective dataset of clinical, TMS, and MRI measures in the acute stroke time window.
Site for WUH APOLLO TRIAL: Transcatheter Mitral Valve Replacement with the Medtronic Intrepid TMVR System in patients with severe symptomatic mitral regurgitation APOLLO Trial
Site for Multi-center, global, prospective, randomized, interventional, pre-market trial Subjects will be randomized on 1:1 basis to either TMVR with the Medtronic Intrepid™ TMVRSystem or to conventional mitral valve surgery.Subjects ineligible for randomization may be enrolled through a single-arm trial. Subjectsenrolled in the single-arm cohort will be assigned to TMVR with the Medtronic Intrepid™ TMVR System