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Discover 15,496 clinical trials near North Carolina. Find research studies in your area.
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NCT03989232
This study compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with type 2 diabetes (T2D). People taking part in the study will take the medicine together with their current diabetes medicine (sulphonylurea and/or metformin). Participants will get a dose of either 1.0 mg or 2.0 mg semaglutide once a week - which dose is decided by chance. Participants will inject semaglutide under the skin once a week. The study will last for about 49 weeks. Participants will have 9 clinic visits and 2 phone calls with the study doctor. At the visits participants will have blood taken and eye tests done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Female participants who can get pregnant will be checked 11 times for pregnancy via urine tests.
NCT03090191
The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated. Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.
NCT03175367
The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD) with persistent hypercholesterolemia despite receiving maximally-tolerated LMT. Persistent hypercholesterolemia is defined as LDL-C ≥70 mg/dL (1.81 mmol/L) for those patients with clinical ASCVD and LDL-C ≥100 mg/dL (2.59 mmol/L) for those patients without clinical ASCVD.
NCT01963208
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs).
NCT02442765
Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) was to be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association (AA) workgroups.
NCT05419297
To study the response of objective and quasi-objective 'True' functional outcomes, analgesia and safety in chronic non-radicular back pain to buprenorphine buccal film (BBF) using a small 'n' phase IV design. To assess associations between traditional pain relevant subjective outcomes and objective or quasi-objective functional outcomes; In a small 'n' construct, to assess more powerful, 'new' statistical methods (e.g. hierarchical linear models, joint trajectory analysis) compared to traditional methods, in the context of increased power, more objective outcomes and cost savings. First a 2-week washout of any opioid medication (if necessary; if not necessary subject can proceed directly to); baseline week (Single Blind Placebo Lead In (SBPLI), using the placebo film resembling the 150mcg dose; then randomization to a \~ 2 week up titration either to effective Buprenorphine Buccal Film (BBF) dose 2 day average pain better than or equal to 3/10 NRS), highest tolerated dose BBF and/or maximum dose BBF of 900 mcg BID, or identical placebo material up to these parameters. This up titration is at the discretion and timing of the blinded and experienced PI. Subject will be allowed two doses of hydrocodone/acetaminophen 5/325 daily during the washout period. A single experienced practitioner will manage the titration as to safety, detail and timing; and determine when the subject enters the 8 week stable dose trial; this practitioner will remain blinded throughout unless there is an urgent, safety reason for unblinding
NCT02603133
Resilience means a healthcare provider's ability to cope, recover, and learn from stressful events, as well as their access to resources that promote health and well-being. Neonatal intensive care unit (NICU) health professionals' need to have particularly good resilience, because their work is extremely stressful and their patients, fragile preterm infants, require their undivided attention. The investigators propose a feasible and engaging intervention to enhance resilience among NICU health professionals promoting their ability to provide safe care.
NCT02323113
The purpose of the Phase 1b dose finding phase is to determine the safety, tolerability, and maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-659 in participants with relapsed or refractory AML. The purpose of the Phase 2 expansion phase is to evaluate preliminary efficacy of TAK-659 in relapsed or refractory AML as measured by overall response rate (ORR).
NCT01003262
Syncope, defined as a transient loss of consciousness, accounts for over 700,000 annual U.S. emergency department visits and may herald a life-threatening condition in older adults (age≥60 years). Existing risk prediction instruments cannot reliably identify who among such older patients can safely be discharged home from an emergency department. As a result, the majority of older patients without a clear cause for syncope are hospitalized for diagnostic evaluation. However, current admission practices are characterized by low diagnostic yield, do not clearly improve outcomes, and account for over $2.4 billion in annual hospital costs. Most admitted patients are discharged within 48 hours, and approximately 50% of patients do not have an identified cause of syncope after their hospitalization. The implementation of an expedited and standardized Emergency Department Observation Syncope Protocol (EDOSP) may safely reduce hospitalization of older patients with syncope. The investigators propose a pilot randomized trial to implement and evaluate EDOSP at two emergency departments. This study has the following exploratory Specific Aims: 1. To compare admission rates and length-of-stay associated with EDOSP to standard care. 2. To compare serious outcomes rates associated with EDOSP to standard care. 3. To compare quality-of-life associated with EDOSP to standard care. 4. To compare the incremental costs and cost-effectiveness of EDOSP to standard care. Over a one-year period, 120 intermediate-risk older adults who present with syncope at the two study sites will be randomized to 1 of 2 arms: 1.) intervention arm: expedited and standardized EDOSP care; or 2.) control arm: routine care consisting of admission from the emergency department. If this pilot trial suggests that EDOSP can safely reduce admissions, then the investigators will plan a larger study powered to evaluate clinical, quality-of-life, and economic outcomes. A successful EDOSP intervention would have important clinical policy implications and improve the emergency department care of older adults with syncope.
NCT01673867
The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy
NCT02051608
Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE). A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.
NCT02049957
This is a phase 1b/2 study of the safety and efficacy of sapanisertib (MLN0128) in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer who progressed on treatment with everolimus in combination with exemestane or fulvestrant.
NCT05418023
This study involves sample collection to identify biomarkers relating to Autism Spectrum Disorder(ASD) in the saliva of children who are between the ages of 18 months to 6 years and 11 months. Participants will at each timepoint have a non-invasive saliva swab collected and complete a brief demographic and medical history questionnaire as well. Children in the pediatric/provider setting who will receive a referral for an ASD diagnosis because they were determined to have a suspicion of developing ASD will be enrolled in the study. Children will also be enrolled in the specialist evaluation setting where they will receive a DSM-5 diagnosis. A subset of both enrollment cohorts will also be followed up with at a third time point in which their diagnosis will be confirmed, and information about any ongoing treatment will be gathered.
NCT03739307
This is a five year multi-site, cross sectional, observational study designed to examine chronic pain and pain treatment after moderate to severe TBI.
NCT04169815
The purpose of the pivotal study is to collect blood specimens and clinical data from patients suspected of having Heart Failure (HF), which will be tested at a future date on Natriuretic Peptide assay(s) to validate diagnostic cutoffs and assess HF severity.
NCT05653583
This is a three-arm, single-blinded, randomized, sham-controlled, nonsignificant risk study to assess the feasibility of reducing Atrial Fibrillation burden with peripheral nerve stimulation. The three arms include treatment with a wrist-worn neuromodulation ("wrist device"), treatment with an ear-worn neuromodulation device ("ear device") and sham stimulation with wrist-worn device that does not actually deliver stimulation ("sham device"). ECG patches will be worn on the chest to measure AF episode onset and duration ("ECG Patch"). Additionally, a wrist-worn monitoring device will be used for the measurement of heart rate (HR), heart rate variability (HRV), and other biomarkers ("Cardiac Measurement Device (CMD)"). Finally, subjects will track AF episode onset, duration, and symptom type in an AF diary.
NCT04458298
The primary purpose of Stage-I of this study is to evaluate the safety and tolerability of OP-101 in patients with severe COVID-19 and of Stage 2 of this study is to evaluate the efficacy of OP-101 in patients with severe COVID-19. The secondary purpose of Stage 1 and Stage 2 of this study is to determine the effect of OP-101 reducing proinflammatory cytokines biomarkers in severe COVID-19 Patients. A further secondary objective of Stage 2 of this study is: To evaluate the safety and tolerability of OP-101 in patients with severe COVID-19.
NCT02256631
The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.
NCT02997423
This is a multi-institutional, consortium-based, non-interventional prospective blinded endpoints clinical study to determine whether high activity of Cytochrome C Oxidase (CcO) in tumor specimens from subjects with newly diagnosed primary GBM is associated with shortened OS (primary outcome) and PFS (secondary outcome) times.
NCT02865460
The primary objective of this clinical trial is to determine if treatment with ubiquinol, a form of coenzyme Q10, improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short Form Health Survey 36-item (SF-36), with respect to physical functioning and symptoms. Secondary outcome measures include changes from baseline levels on GWI-associated biomarkers in peripheral blood and GWI-associated symptoms of chronic pain, fatigue, insomnia, activity level, and cognitive and mental functioning.
