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NCT02815280
This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.
NCT02207075
This is pilot study designed to quantifying the innate immune inflammatory burden in a cohort of secondary progressive multiple sclerosis subjects. Innate immunity is recognized as a major cause of tissue injury in central nervous system (CNS) disease. Our hypothesis is that the innate immune response is heightened in SPMS as compared to healthy controls (HC's) and this activity increases over time and correlates with ongoing neuronal loss and disability. The investigators will test this hypothesis by using highly specific molecular imaging techniques, specifically PET, in conjunction with high field MRI. The investigators will utilize the PET radioligand \[11C\]PK11195 which will be used as a marker of activated macrophages/microglia. The investigators will correlate \[11C\]PK11195 uptake with conventional measures of inflammation and neuronal integrity on high-resolution MRI. SPMS subjects will have two baseline \[11C\]PK-11195 PET scans (separated by 24 to 72 hours, test-retest) and subsequent scans at 6, 12 and 24 months. SPMS Subjects will have brain MRI's at baseline, 6, 12 and 24 months. Healthy Controls will have 2 baseline PET scans and one MRI.
NCT03276936
The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up to an additional 40 weeks, is safe and well tolerated.
NCT03626376
This is a prospective, randomized clinical trial looking to determine the role of prophylactic treatment with topical corticosteroids in preventing recurrences in patients with a history of infectious epithelial keratitis, stromal keratitis,endotheliitis, or iridocyclitis. Patients will be enrolled to one of two treatment arms: Control arm: oral acyclovir 400 mg BID OR valacyclovir 500 mg daily or Study arm: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops.
NCT03626012
The primary objective of this study is to evaluate the safety and tolerability of BIIB078 in adults with C9ORF72-Amyotrophic Lateral Sclerosis (ALS). The secondary objectives of this study are to evaluate the pharmacokinetic profile of BIIB078 and to evaluate the effects of BIIB078 on clinical function. As the first-in-human study, the study enrolls a small number of participants in each cohort. Every participant in a cohort is treated with the same dose or placebo. The study is designed to evaluate and confirm the safety of each dose before enrolling and exposing new participants to a higher dose in the next cohort.
NCT04039503
The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits.
NCT02358681
Ketorolac is an evidence-based, first-line acute migraine therapy that is commonly used in the pediatric population; however, it is typically administered by the intravenous (IV) or intramuscular (IM) routes, both of which require a painful and distressing needle stick to administer. The intranasal (IN) route is a painless and effective way of administering analgesics, including ketorolac: IN ketorolac has been shown to be an effective analgesic in adults for painful conditions, including acute migraine headaches. However, IN ketorolac has been understudied in children, and it is not known how effective it is compared to IV ketorolac, which is currently the most common way of administering ketorolac to children. If IN ketorolac is shown to be no less effective than IV ketorolac, IN ketorolac may be a viable and painless alternative to effectively treat acute migraine headaches in children. Therefore, our primary aim is to demonstrate that IN ketorolac is non-inferior to IV ketorolac for reducing pain in children with acute migraine headaches.
NCT02347202
A 20+ year randomized controlled trial (RCT) demonstrated the many benefits of a counseling and support intervention for spouse caregivers, the NYU Caregiver Intervention (NYUCI). The NYU Caregiver Intervention (NYUCI) is an evidence-based intervention that provides counseling and support for families involved in the care of a relative or friend with Alzheimer's Disease and Related Dementias (ADRD). Most notably, the NYUCI substantially reduced caregiver's depressive symptoms, improved their physical health, and extended the time persons with ADRD remained at home by an average of 1.5 years (Mittelman et al., AG14634, formerly MH42216; See http://www.ncbi.nlm.nih.gov/pubmed/17101889). The intervention is now being widely implemented in-person, but there are barriers that prevent many caregivers from receiving its benefits, including geographic distance; impediments to older adults leaving their homes; and travel considerations for counselors which make it impossible to provide the NYUCI in person. The goal of this study is to evaluate the efficacy of an online videoconferencing version of the NYUCI. This innovative application has massive implications for social service delivery to older adults, because it will make it possible to deliver an in-person intervention, via the internet, which is already evidenced based to older adult caregivers who cannot currently be served. It will create the online reservation and management technology linking counselors with families as well as the evidence of effectiveness of providing such services via secure video teleconferencing vehicles. The proposed Telehealth Technology for Distance Counseling (TTDC) and related online educational training modules will connect skilled providers to the families of persons with dementia without regard to geographic location. Implications for rural healthcare delivery are particularly persuasive. To the investigators knowledge, this will be the first large-scale TTDC to be developed and rigorously tested with a randomized controlled trial. The investigators hypothesize that such a system, coupled with online training for providers and families on tele- counseling and distance caregiving, will have similar benefits to those achieved with in-person counseling during the original NYUCI RCT. This project includes an online reservation and management technology linking counselors with families via secure videoconferencing vehicles. The Telehealth Technology for Distance Counseling (TTDC), and online technology developed as part of this overall effort, will connect skilled providers to the families of persons with dementia without regard to geographic location. The related online clinical modules (i.e., interactive, computer-based educational materials) developed as a part of this grant effort will prepare counselors to provide the intervention, and caregivers to utilize the internet software, to be able to participate in counseling. The TTDC will include a scheduling system to link counselors to families at their mutual convenience and assure delivery in a cost-effective manner. The TTDC has the additional potential to transform ADRD care in ethnic and culturally diverse communities by connecting highly trained NYUCI counselors with specialized language and cultural skills to families who would not have access to these resources locally. In this study investigators will have 240 caregivers navigate the online educational module and the online reservation system for connecting caregivers with social workers. Half of the caregivers will then be paired with social service providers to receive counseling over the telephone, and the other half with be paired with social service providers to receive counseling via Zoom, a video conferencing program. Recruiting across the United States and Toronto, Canada.
NCT02424019
This study will assess the safety in patients treated with ILUVIEN, with primary focus on IOP.
NCT04377620
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) who require mechanical ventilation.
NCT03453125
The goal of this study is to establish that a memory retraining protocol, originally developed for English-speakers, and translated into Spanish, is effective.
NCT04674436
This study will ask ranked first person shooters in esports to participate on three separate days from their home computer to test executive function prior tp play and following two hours of play. One testing day will incorporate a 6 minute walk break, another day will incorporate a 6 minute rest break, and the third day will be continuous play. Executive tests will be administered electronically prior to game play and post game play.
NCT03636581
This study will be a randomized cross-over design over the course of 2 academic years. 40 subjects -20 overweight women and 20 over weight men will be recruited. Each subject will have body composition tested, blood lipid profile, and resting metabolic rate done in the beginning of the first academic year and at the end of the first academic year. The intervention group will receive activity trackers, diet counseling, and fitness counseling for one academic year. The second year, all outcome measures (a body scan, blood lipid profile, and resting metabolic rate) will be performed again at the start of the academic year 2, except the intervention group will now be the control group and the control group will now receive the same intervention. All final outcome measures will be performed at the end of the second year.
NCT01248247
Different people have different biomarkers (chemical "markers" in the blood that may be related to your reaction to study drugs). If researchers know about your biomarkers before you receive treatment, they may be able to prescribe a treatment that is better suited to your body's specific needs. The goal of this clinical research study is to learn if drug or drug combinations based on your biomarkers can help to control NSCLC. The safety of these drug combinations will also be studied.
NCT04534517
The clinical study is a bilateral, single-masked (partial), single-arm, clinical trial. A total of approximately 60 eligible subjects both near-sighted and far-sighted, will be targeted to complete the study. Subjects will be fit in the study lens for approximately 2-4 days then undergo lens optimization, if required. Subjects will then be given a new pair of lenses that will be worn for approximately 2 weeks.
NCT03439657
The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered subsequent to Prevenar13.
NCT02387398
This study is a pilot, multi-centered, randomized, clinical trial to evaluate the safety and efficacy of performing early Coronary Angiography (CAG) versus no early CAG in post-cardiac arrest patients without ST segment elevation. Safety will be assessed by evaluating the association of major adverse events (re-arrest, bleeding, pulmonary edema, hypotension, acute renal insufficiency, and pneumonia) with early coronary angiogram. Efficacy will be assessed by a composite endpoint of improved left ventricular regional and global function (both regional wall motion analysis and left ventricular ejection fraction) as measured by echocardiography prior to hospital discharge and favourable neurological function (Cerebral Performance Categories 1 or 2) at discharge.
NCT01956110
This trial investigates the effects of FE 999049 compared to GONAL-F.
NCT01978938
This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy and safety of eravacycline compared with levofloxacin in participants with complicated urinary tract infections (cUTI).
NCT03556358
This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.