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NCT02718417
This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy. The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients.
NCT03592342
Participants with symptomatic Oral Lichen Planus lesions will be treated with Rivelin® patches containing either 0, 1, 5, or 20 μg clobetasol per patch. Each participant will apply up to 6 patches twice daily for 4 weeks.
NCT00385268
Trial to determine the safety, efficacy and tolerability of acamprosate for the treatment of cocaine dependence.
NCT01984073
The purpose of this study is to understand whether a vitamin called NIcotinic ACid vitamIN (NIACIN for short, also known as vitamin B3) helps the body process dietary fat more efficiently. This is important because people with dyslipidemia have a problem with how they process fat, which raise the risk of heart disease.
NCT03487094
Growth and Tolerance Trial of Iron-fortified infant formulas
NCT03609502
This study tests a memory-based account of atypical speech perception in adults with language-based learning disability (also known as developmental language impairment \[LI\]). One perspective regarding the its etiology considers impoverished speech sound representations to be central to the linguistic symptoms observed in LI. This project examines a potential abnormality in the process of building speech sound representations in LI. Previous work by the PI has found that sleep is important for learning speech sounds. Furthermore, different measures of speech perception (identification and discrimination), reveal distinct patterns of learning that are consistent with that of declarative and procedural memory consolidation. A division of labor by declarative and procedural memory systems in the building of speech representations may imply that problems with phonology may stem from selective weaknesses in declarative or procedural memory in predictive ways. The first project Aim is to identify the memory substrates of novel phonetic category formation. In Experiment 1, the investigators will obtain behavioral measures of declarative, procedural, and speech sound learning before and after post-training sleep in 40 typical adults and 20 adults with LI. Among typical adults, a double dissociation is predicted in which speech identification will be predicted by individual differences in declarative memory, and speech discrimination will be predicted by individual differences in procedural memory. Moreover, adults with LI are predicted to demonstrate consolidation deficits across memory types. The second project Aim is to identify the neural substrates of phonetic category formation. In Experiment 2, the investigators will obtain functional magnetic resonance (fMRI) recordings of 20 TD and 20 LI adults performing post-training identification and discrimination tasks on a trained speech contrast before and after sleep. In typical adults, a Time by Speech-task interaction is predicted. Speech identification will recruit episodic (hippocampal) information on Day 1 relative to classic regions for phonological processing on Day 2. Speech discrimination will result in a change in magnitude of activation from Days 1 and 2 in the left inferior frontal gyrus (IFG), reflecting an overnight decrease in effort. LI (n=20) is predicted to demonstrate reduced overnight change in neural activation relative to TD in both tasks.
NCT03559257
The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.
NCT02782117
A single-arm, multi-center, open-label pilot study to evaluate the feasibility, safety, and efficacy of the Luminopia One digital therapeutic in improving visual acuity in a pediatric amblyopia population.
NCT01611558
To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall response associated with ipilimumab treatment
NCT03416790
IMPAACT 2015 is a cross-sectional, exploratory study that will investigate the central nervous system (CNS) reservoir in perinatally HIV-infected adolescents and young adults on effective antiretroviral therapy with neurocognitive impairment. The study will assess the frequency with which HIV is detected in the cerebral spinal fluid (CSF) in this population and assess whether detectable HIV in the CSF correlates with markers of inflammation and neuronal injury. Findings from this study will advance understanding of the role of the CNS in HIV-1 persistence and its implications for future HIV-1 remission research.
NCT04465682
The Dip Home-Based Dipstick Analyzer (henceforth HBDA) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance, including providing a urine sample and scanning the urine strip after placing it on the Color-Board. The user will also complete a questionnaire to collect information regarding the use of the HBDA device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device. The use of the HBDA device will be evaluated for accuracy and identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.
NCT04466501
The ACR LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The test is for the qualitative and semi- quantitative detection of Albumin, Creatinine, and the Albumin-to- Creatinine Ratio. The device is composed of a kit and a smartphone application using an image recognition algorithm. The degree of agreement of the ACR \| LAB as compared to the comparator device will be tested. Urine samples will be tested by a separate professional user on each device.
NCT04385147
In this study, investigators aim to explore the status of advanced endoscopy in different endoscopy units all over the world.
NCT03093324
The objectives of this study are to evaluate the utility of two gastrointestinal (GI) symptom scales (Individual GI Symptom and Impact Scale {IGISIS} and Global GI Symptom and Impact Scale {GGISIS}) in assessing GI tolerability in adult subjects with RRMS after administration of ALKS 8700 or Dimethyl Fumarate (DMF) in Part A, to compare the GI tolerability of ALKS 8700 and DMF in adult subjects with RRMS using IGISIS and GGISIS in Part B, and to Evaluate the safety and tolerability of ALKS 8700 in adult subjects with RRMS in Parts A and B.
NCT02753595
The primary objective for the study is as follows: For the Phase 1b - to determine safety tolerability and recommended Phase 2 dose (RP2D) of eribulin mesylate in combination with PEGylated recombinant human hyaluronidase (PEGPH20) in participants with Human Epidermal Growth Factor Receptor (HER2)-negative metastatic breast cancer (MBC) previously treated with up to two lines of systemic anticancer therapy in the metastatic setting. For the Phase 2 - to evaluate objective response rate (ORR) of eribulin mesylate in combination with PEGPH20 in participants with HER2-negative, High-Hyaluronan (HA)-high, MBC previously treated with up to 2 lines of systemic anticancer therapy in the metastatic setting.
NCT03243292
To confirm the long-term efficacy and safety of Bronchial Thermoplasty (BT) at 10 years follow-up or beyond in subjects previously enrolled in any of the following Boston Scientific-sponsored, controlled pre-approval studies: AIR, RISA and AIR2.
NCT04060329
The purpose of this study is to identify new methods of measuring and improving collaborative goal setting between patients and clinicians in adult cystic fibrosis care.
NCT03231800
A study to evaluate the efficacy and safety of dasotraline in children 6 to 12 years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.
NCT00867516
The purpose of this study is to determine the safety and efficacy of ALD518 in three different doses in patients who have not had an adequate response to methotrexate.
NCT02292784
The primary objective of this study is to assess the safety and outcomes of infants and children who were exposed to retosiban or comparator in utero in the Phase III spontaneous preterm labor (SPTL) treatment studies, to provide assurance that treatment is not associated with significant adverse outcomes in early childhood. The enrolled infants and children will be followed at pre-specified intervals until they reach 24 months chronological age. This study does not require medical interventions or study visits to an investigational site, instead, parents or legal guardians will be prompted at certain time points to complete developmental questionnaires and other data on their children's health status via an electronic device. Data collected during the infant and child follow up study will be managed by a centralized research coordinating center (RCC). Regionally based pediatricians will serve as study principal investigators (referred to as RCC-PIs) for this study. All communications the RCC-PI has with the parent/legal guardian or the child's health care provider (HCP) will occur remotely; there will be no clinic visits.