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Discover 17,836 clinical trials near Boston, Massachusetts. Find research studies in your area.
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NCT07104565
This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.
NCT06561425
This study is evaluating whether an experimental treatment called GLPG5101 helps to treat non-Hodgkin lymphoma (NHL) and if it is safe to use. This study will be carried out in 2 phases: * The first phase is to see which doses of GLPG5101 work best with the least number of side effects. * In the second phase, participants will receive the selected dose(s) based on the results in the first phase.
NCT03960099
Newborns in the neonatal intensive care unit (NICU) are at high risk for wrong-patient errors. Effective 2019, The Joint Commission requires that health systems adopt distinct methods of newborn identification as part of its National Patient Safety Goals. Displaying patient photographs in the electronic health record (EHR) is a promising strategy to improve identification of children and adults, but is unlikely to be effective for identifying newborns. This study assesses the use of Pictographs as a "photo equivalent" for improving identification of newborns in the NICU. This multi-site, two-arm, parallel group, cluster randomized controlled trial will test the effectiveness of Pictographs for preventing wrong-patient order errors in the NICU. Pictographs consist of three elements: 1) pictorial symbols of easy-to-remember objects (e.g., rainbow, lion); 2) the infant's given name (when available); and 3) a color-coded border indicating the infant's sex. The study will be conducted at three academic medical centers that utilize Epic EHR. All parents or guardians will be asked to select a unique Pictograph for each infant admitted to the NICU to be displayed on the isolette and in the EHR for the duration of the infant's hospital stay. All clinicians with the authority to place electronic orders in the study NICUs will be randomly assigned to either the intervention arm (Pictographs displayed in the EHR) or the control arm (no Pictographs displayed in the EHR). The main hypothesis is that clinicians assigned to view Pictographs in the EHR will have a significantly lower rate of wrong-patient order errors in the NICU versus clinicians assigned to no Pictographs. The primary outcome is wrong-patient order sessions, defined as a series of orders placed for a single patient by a single clinician that contains at least one wrong-patient order. The Wrong-Patient Retract-and-Reorder (RAR) measure, a validated, reliable, and automated method for identifying wrong-patient orders, will be used as the primary outcome measure. The Wrong-Patient RAR measure identifies one or more orders placed for a patient that are retracted within 10 minutes, and then reordered by the same clinician for a different patient within the next 10 minutes. In the validation study conducted at a large academic medical center, real-time telephone interviews with clinicians confirmed that 76.2% of RAR events were correctly identified by the measure as wrong-patient orders.
NCT04452591
This is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene patients with NMIBC who have failed prior BCG therapy. Up to approximately 115 CIS bladder cancer patients with or without HG Ta or HG T1 papillary disease will be enrolled under the original protocol through Amendment 4, which will comprise Cohort C. Cohort C is closed to enrollment. Under Amendment 5-1, Cohort P was added to enroll up to 70 patients with HG Ta/T1 papillary bladder cancer. Under Amendment 6, the target number of patients enrolled in Cohort P was increased to 75. Cohort P is open to enrollment Cohort C and Cohort P will be analyzed and reported separately. Patients will have had to fail prior BCG therapy which is defined as having persistent or recurrent disease within 12 months (Cohort C) or 6 months (Cohort P) following the completion of adequate BCG therapy for HGUC
NCT07469189
We are planning a series of studies in individuals with ulcerative colitis, primary sclerosing cholangitis and pouchitis to determine if hydroxocobalamin is an effective therapy to treat these conditions. For these indications we are submitting INDs to the FDA as well as protocols to the IRB. Hydroxocobalamin, referred to as vitamin B12a has been approved by the FDA for treatment of cyanide toxicity in up to 5 grams intravenously over 15 minutes twice in a brief period. This has been tested and used in intravenous doses as high as 15 grams in a day. We will be utilizing its pharmacokinetic and safety profile to treat several subsets of patients. We are testing this initially in a healthy population to assess tolerability.
NCT07075536
Among people who do not want to get pregnant, some do not use any birth control. This is also called contraceptive nonuse. Common reasons for contraceptive nonuse include concerns about birth control safety or side effects. People with health conditions, such as diabetes or high blood pressure, also report worries about how different birth control methods might affect their health condition or medicines. The goal of this clinical trial is to learn if a web tool called My Health, My Choice helps people with health conditions understand their birth control options and choose birth control that is right for them. The study will also look at the medical safety of birth control methods that participants decide to use. The main questions it aims to answer are: • Does the My Health My Choice tool lower the number of participants who do not use any birth control method? (contraceptive nonuse) In other words, does the My Health My Choice tool increase the number of participants who use any birth control method? (contraceptive use) Participants who use the My Health, My Choice tool before a clinic visit with their clinician (Intervention Group) will be compared to participants who only go to a clinic visit with their clinician (Usual Care Group). For this study, a "clinician" is any licensed health care provider who counsels about birth control, prescribes birth control, and/or inserts birth control devices. All participants will: * Complete 4-5 online surveys that take 5-10 minutes each, over a 3 month time period * Be asked to go to a scheduled clinic visit with their health care provider * A small group of participants (about 30) will be invited to a 1 hour exit interview Participants in the intervention arm will be asked to: • Use the My Health My Choice tool before their clinic visit
NCT06556563
This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).
NCT06525623
The goal of this interventional study is to evaluate two strategies for how to provide intravenous (IV) fluids for treating patients with acute kidney injury (AKI) in cirrhosis. The main question it aims to answer is: what is the safety, efficacy, and feasibility of providing a recommendation to use a Volume Assessment Guidance Algorithm (VAGA) or give standard of care doses of IV albumin? Patients will be randomly assigned where their treating teams will receive a VAGA-based recommendation or a standard of care IV albumin recommendation.
NCT03091257
This research study is studying a targeted therapy as a possible treatment for multiple myeloma. The names of the study drugs involved in this study are: * Trametinib * Dabrafenib
NCT07290803
The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions. The study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.
NCT04181827
The purpose of this study is to compare the efficacy of ciltacabtagene autoleucel (cilta-cel) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).
NCT05907954
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
NCT06382155
The purpose of this study is to evaluate i) the effect of multiple doses of vosoritide and ii) the effect of the therapeutic dose of vosoritide compared to human growth hormone (hGH)(hGH; only in the United States), in children with idiopathic short stature (ISS).
NCT06990867
The goal of this study is to evaluate the safety and efficacy of JX10 versus placebo in participants with Acute Ischemic Stroke (AIS) who present for care within 4.5 to 24 hours. The main question the study aims to answer are: 1. JX10 improves functional outcomes as measured by the modified Rankin Scale score when compared with placebo following AIS. 2. Risk of symptomatic intracranial hemorrhage of JX10 in participants with AIS. During Part 1, participants will be randomized to JX 10 (1mg/kg, 3 mg/kg) or placebo. During Part 2, participants will receive JX10 (optimal dose chosen from Part 1) or placebo.
NCT05935098
This study aims to evaluate how safe and well-tolerated the treatment is, how the body processes it, how it works on the tumors, and whether it shows early signs of fighting cancer in people with certain advanced or metastatic solid tumors. Key details of the study include: * The study is expected to last about 36 months. * Participants will receive treatment until they either no longer benefit from the treatment, experience side effects that are too severe, or choose to stop participating.
NCT07069400
Prospective, longitudinal studies of people with acute infections are essential to understand risk factors, clinical manifestations, pathobiology, and management strategies. Observational studies can provide data necessary to select interventions and strategies for testing in clinical trials and to develop key design features of trials. Observational studies can be particularly important for establishing an early knowledge base after emergence of a new pathogen, as illustrated by the recent emergence of influenza A (H1N1), SARS-CoV-2, and Mpox. This observational study protocol describes collection of data and biospecimens from sites across the world for characterizing acute infections in hospitalized patients. The protocol is designed to study respiratory infections, infections outside the respiratory tract, established infectious diseases, and emerging infectious diseases. Data generated in this study will be used to efficiently characterize acute infectious diseases and plan future clinical trials.
NCT06550895
The purpose of this study is to define the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in participants with high-risk multiple myeloma (MM).
NCT03989947
This is a Phase 2, open-label multi-center long-term extension study, with approximately 70 subjects, to evaluate the safety and efficacy of BMN111 in children with Achondroplasia until subjects reach near-adult final height. Eligible subjects will have completed 1 year of BMN111 or placebo treatment in the 111-206 study and once enrolled in the 111-208 extension study will receive a daily dose of BMN111 by subcutaneous injection according to their age as determined by 111-206.
NCT07176650
This is a multicenter, randomized, double-blind, parallel-controlled, phase I clinical study to evaluate the PK characteristics, safety, efficacy, and immunogenicity of HLX13 and US-sourced YERVOY® in patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.
NCT07105007
Heart failure (HF) is a growing health and economic burden around the globe, and it remains a leading cause of morbidity and mortality among the general population. HIV is recognized as an independent risk factor for HF, due to direct and indirect effects. Furthermore, people living with HIV (PLWH) now have an increased life expectancy due to the evolution and widespread use of antiretroviral therapy (ART), leading to a rising burden of cardiovascular disease (CVD) and HF among this population. Yet, the provision of appropriate guideline-recommended cardiovascular care is lower in PLWH compared to the general population, and there are no studies testing HF prevention interventions focused on PLWH. Current guidelines for HF management highlight the importance of a healthy lifestyle in preventing and treating HF. Among PLWH, tailored, innovative, and sustainable exercise delivery models are necessary to overcome barriers and increase physical activity (PA) adherence in this population. Building on the research team's prior mixed methods work and research expertise on exercise trials for PLWH, the investigators propose the Hybrid Exercise Intervention for Cardiovascular Health of People living with HIV (HEICA-HIV). HEICA-HIV is a novel multi-component 8-week intervention that will simultaneously deliver a supervised center-based (once a week) and a tailored home-based (twice a week) exercise intervention, together with exercise and cardiovascular health education. It will also involve behavioral coaching and mobile health support. The investigators evidence suggests that, by providing weekly exercise supervision together with a home-based prescription, the investigators can overcome difficulties associated with home-based programs (e.g., less intensive exercise training, less social support, and less face-to-face monitoring), and still observe the augmented health benefits obtained from supervised programs. Additionally, by requiring less time at the training center, this hybrid model can help with time restraints and transportation issues affecting marginalized populations, potentially increasing long-term exercise adherence in those who need it most. In this initial stage, HEICA-HIV will be focused on improving time in moderate-to-vigorous physical activity (MVPA). International guidelines recommend that every adult should engage in at least 150 minutes of MVPA per week in order to achieve optimal health benefits.
