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Discover 23,284 clinical trials near Maryland. Find research studies in your area.
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Showing 8941-8960 of 23,284 trials
NCT02488720
The LEARN study a multicenter, observational study will that will evaluate the rate of cognitive change in approximately 500 clinically normal older individuals who "screen-fail" for the A4 trial on the basis of their screening PET imaging not demonstrating evidence of elevated amyloid accumulation (Aβ negative) but meet all other A4 study eligibility criteria. This study will leverage the A4 infrastructure and maximize the data acquired in screening a large number of well-characterized older adults for the A4 trial. The LEARN observational cohort will provide a critical comparison group for the A4 placebo arm, and future trials in preclinical AD. Although accumulating longitudinal data suggest that older individuals with elevated Aβ burden are at increased risk of cognitive decline, it is important to demonstrate a differential rate of clinical decline between Aβe ("Aβ elevated") and Aβne ("Aβ not elevated") individuals on a standardized set of clinical outcomes. Over 2000 well-characterized, highly motivated older volunteers will "screen fail" for the A4 trial. The LEARN study will follow 500 of these individuals, matched as closely as possible to the two treatment arms, in this observation cohort. The LEARN study may selectively recruit from a specific range of SUVr that fall below the threshold for "elevated amyloid" in order to support analyses of the relationship of baseline SUVr to subsequent cognitive change and amyloid accumulation. The observational cohort will be followed for 384 weeks with identical clinical/cognitive testing performed every 24 weeks, running parallel to the A4 treatment study and open label extension.
NCT02599324
The purpose of this study is to evaluate the safety, tolerability, and efficacy of single agent ibrutinib or the combination treatments of ibrutinib with everolimus, paclitaxel, docetaxel, pembrolizumab or cetuximab in selected advance gastrointestinal and genitourinary tumors.
NCT04914507
Anterior vertebral body tethering (AVBT) is a novel, minimally invasive, growth modulation technique that was recently approved by the FDA under a Humanitarian Device Exemption (HDE). The goal of AVBT is to control curve progression by applying compression on the convex side of the spine deformity. While there has been great initial enthusiasm about the technique as an alternate treatment option to spinal fusion for skeletally immature children with scoliosis, there is a need to better understand the long-term outcomes. The purpose of this study is to report the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically: 1. The effect on three-dimensional spine growth as compared to normal controls 2. Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity 3. Complications associated with both the procedure and the device
NCT03229356
Smoking is the number one cause of preventable death in the United States. Given the magnitude of the problem, interventions aimed at promoting smoking cessation have the potential to make large changes in improving health outcomes. Resources to aid with smoking cessation such as telephone-based counseling are generally underutilized. The electronic medical record (EMR) in use at Johns Hopkins has limited decision support to promote referral to the Maryland Quit Line, a free smoking cessation counseling resource. The investigators propose a cluster randomized trial (Implementation-RCT hybrid design) with a waitlist control at the 22 Johns Hopkins Community Physicians (JHCP) sites, which offer primary care. The intervention will include a multi-modality intervention to promote provider use of smoking cessation resources which include an Epic-based Best Practice Advisory (BPA) that allows providers to electronically refer to the Maryland State Quit Line, educational materials, and provider visits with Quit Line representatives to review use of smoking cessation practices. Sites will be randomized to one of three arms with increasing support: 1) six-month waitlist control; 2) BPA with optional educational modules; 3) BPA with online educational modules, a quick-reference educational document, and additional visit with Quit Line representatives. The investigators hypothesize that by implementing a new Epic BPA that allows providers to easily refer to the Maryland Quit Line electronically, investigators will increase use of this resource. The investigators also hypothesize that adding additional educational materials and having Quit Line representatives perform educational outreach visits will further increase use of the Quit Line and will increase prescription of medications to assist with smoking cessation. Ultimately The investigators hope to improve patient care by increasing providers' use the Maryland Quit Line and pharmacotherapy. The investigators hope that the use of these resources will decrease smoking rates and thereby improve patient health and outcomes while improving JHCP quality metrics.
NCT04030143
The purpose of this trial is to determine the safety and tolerability of multiple-dose administrations of aripiprazole, to establish the similarity of aripiprazole concentrations on the last day of the dosing interval following the final administration of aripiprazole into the gluteal muscle site, and to establish the similarity of aripiprazole exposure over the dosing interval following the administration of aripiprazole into the gluteal muscle site in adult participants with schizophrenia or bipolar I disorder.
NCT02753127
This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).
NCT05074498
Part 1 of this study will be conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of multiple doses of TB006, as well as the maximum tolerated dose of TB006, and to assess the immunogenicity of TB006 (production of anti-TB006 antibody). Part 2 of this study will be conducted to determine the clinical efficacy of TB006 in participants with mild to severe Alzheimer's Disease.
NCT03149003
This is an event driven, adaptive design, a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 3 study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients with recurrent or progressive glioblastoma multiforme (GBM) following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.
NCT02352558
This is a multicenter, open label, Phase 1 dose-escalation study of BBI608 administered to patients with relapsed, refractory hematologic malignancies, including multiple myeloma, lymphoma, and others.
NCT02826161
This is an international, multi-center, prospective, randomized, open-label Phase 3 clinical trial of the cancer stemness inhibitor napabucasin administered with weekly paclitaxel versus weekly paclitaxel alone in patients with advanced non-squamous non-small cell lung cancer who have disease progression following systemic treatment with a platinum-based combination regimen in the metastatic setting, who have received treatment with an immune checkpoint inhibitor if a candidate, additional approved therapies, and for whom weekly paclitaxel is an acceptable treatment option.
NCT02231723
This is an open label, multi-center, multi-arm, dose-escalation study of BBI608 administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin.
NCT03859973
This is a study in adults with schizophrenia. The study tests whether a medicine called BI 425809 together with brain training improves mental abilities. Participants take study medication once a day for 12 weeks. At the start of the study, the participants are put into 2 groups. It is decided by chance who gets into which group. One group gets BI 425809 tablets every day. The other group gets placebo tablets every day. Placebo tablets look like the BI 425809 tablets, but contain no medicine. During the study, all participants do brain training using a computer. The doctors regularly test mental abilities of the participants. The results of the mental ability tests are compared between the groups. The doctors also check the general health of the patients.
NCT05719935
The goal of this observational study is to learn about functional and patient reported outcomes in patient undergoing total wrist replacement with the KinematX total wrist replacement study. The main questions it aims to answer are: * What is the range of motion (flexion, extension, radial, ulnar, grip and pinch strength) at 3-, 6-, and 12-months after surgery and yearly up to 10 years among patients having total wrist replacement with the KinematX implant. * What are the patient reported outcomes (PROMIS, PRWE, HSS wrist expectations) at 3-, 6-, and 12-months after surgery and yearly up to 10 years among patients having total wrist replacement with the KinematX implant. * How do range of motion and patient reported outcomes change over the 10 years after total wrist replacement surgery? Participants will be followed according to standard of care and preoperative and post-operative information for up to 10 years after surgery will be collected and entered into an electronic data base. Patients are eligible to enroll into the registry before or after they have had their wrist replacement surgery.
NCT04614038
The purpose of this study is to determine the relationship between wound alkalinity and the non-healing status of chronic ulcer wounds. It is hypothesized that wounds with an alkaline environment as indicated by DETEC pH will have a high chance of not healing over 12 weeks of wound care.
NCT05390775
The main objective of this study is to determine whether remote delivery of written exposure therapy after motor vehicle collision reduces incidence and severity of posttraumatic stress symptoms in high risk individuals. This randomized controlled trial is a pilot study to determine feasibility and potential efficacy. This data can be used to adequately power a larger randomized controlled trial.
NCT05793684
The VicTor Study is a randomized, double blind, placebo-controlled, 3-period, multiple-dose crossover study in participants with OSA.
NCT05745064
In this prospective, Phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, approximately 100 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally BID. The study will comprise two phases: 2-weeks screening/run-in and 4-weeks double-masked treatment.
NCT01775423
This is an open label, single arm, dose escalation study of BBI608 in patients with advanced malignancies.
NCT03806933
The purpose of the study is to investigate the safety and duration of effect following different doses of Botulinum Toxin A (NT 201) in the treatment of glabellar frown lines (GFL).
NCT06136702
This study includes a community-based, two-arm prospective acceptability study, whereby arm 1 consists of an educational session on sexual health and cervical cancer (screening) and a follow-up assessment after 3 months. Arm 2 consists of an educational session on sexual health and cervical cancer (screening) and self-sampling, additionally women will be asked to take a self-sample on-site, followed by a follow-up assessment after 3 months. Attitudes, uptake and users' experiences related to the use of a HPV self-sampling test will be assessed, additionally, the impact on looking for follow up care of self-sampling with standard cervical screening strategies will be assessed and finally the feasibility of an HPV self-sampling in hard-to-reach groups versus educational sessions and standard care will be compared (arm 1 and 2).
