About 1,077,623 results

Facilitating Smoking Cessation With Reduced Nicotine Cigarettes

Oct 14th, 2022 - The current project will (1) develop a theory-based, user-friendly, and efficient set of targeted cessation materials to facilitate extinction during pre-quit VLNC smoking, (2) establish the feasibility of recruitment and measurement strategies to be used in the RCT, (3) determine whether immediate vs. gradual pre-quit nicotine tapering in combination with the targeted behavioral intervention h...

Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma

Oct 14th, 2022 - PRIMARY OBJECTIVE: I. To determine the rate of one year progression-free survival (PFS) when hydroxychloroquine sulfate (hydroxychloroquine) or placebo is added to dabrafenib mesylate (dabrafenib) and trametinib dimethyl sulfoxide (trametinib) in advanced BRAFV600E/K melanoma. SECONDARY OBJECTIVES: I. To compare the PFS of both arms. II. To evaluate the best overall response rate by treatment a...

Anxiety Intervention for Preschool Children With ASD

Oct 14th, 2022 - Anxiety is highly prevalent in individuals with ASD with lifelong impact. In this population, anxiety often emerges when children are very young, yet there are no evidence-based treatments for this age group. Cognitive-behavioral treatment (CBT) successfully reduces anxiety levels in young, typically developing children and older children with ASD. This study pilots the DINO Strategies for Anxi...

A Phase II Study of Bevacizumab and Erlotinib in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) or Sporadic Papillary Renal Cell Cancer

Oct 14th, 2022 - Background Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) is a familial cancer syndrome characterized by a propensity for developing renal cancer, and uterine and cutaneous leiomyomas. The kidney cancer associated with HLRCC is clinically aggressive and is characterized by unique histopathologic features that are sometimes described as type 2 papillary RCC. Germline mutations in the fu...

Long-term Clinical Correlates of Traumatic Brain Injury

Oct 14th, 2022 - Objective The primary objective is to contribute to the understanding of non-penetrating traumatic brain injury (TBI) through the description of the relationships between neuroimaging, hematological, and extensive functional/cognitive phenotyping measures. We will generate natural history data for cohort-based comparisons and to serve as the basis for future hypothesis-driven protocols. In addi...

A Follow-up of the Early Pregnancy Study Cohort.

Oct 14th, 2022 - We propose a follow-up study of women who participated in the North Carolina Early Pregnancy Study (EPS) in 1982-1986. Women enrolled in the study after discontinuing birth control and were followed for the occurrence of a pregnancy. Participants completed daily diaries and collected first morning urine specimens which allowed the identification of menstrual cycles. Thus each woman s time to pr...

VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older

Oct 14th, 2022 - Protocol Design: This is a specimen, imaging and data collection protocol designed with the purpose of understanding the immune responses to vaccines and infections in adult subjects through collection of tissue specimens and medical history data, and radiographic imaging. The information gained will enhance the knowledge of immune correlates of protection and will help in laboratory work relat...

COVID-19 Persistence in Stool

Oct 14th, 2022 - Approaching participants will mainly be performed in two ways: the Norfolk and Norwich University Hospital (NNUH) online booking system for SARS-CoV-2 testing will have a link to the Quadram Institute Bioscience (QIB) study webpage, which will include the Participant Information Sheet (PIS). When the NHS testing service informs individuals of their test results by text message, the QIB study pa...

Layer-specific Contribution to Consolidation of Skill Learning in the Primary Motor Cortex

Oct 14th, 2022 - Study Description: Training on a novel motor skill often involves periods of active practice interspersed with periods of rest. During early motor skill learning, performance improvements develop primarily during short offline rest periods that occur between practice blocks. These performance gains during rest have been referred to as 'micro-offline consolidation'. Primary motor cortex (M1) is ...

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)

Oct 14th, 2022 - Participants will be treated for a minimum of 120 weeks in the double-blind phase. Upon positive primary results after the double-blind phase, an optional higher dose extension treatment (OLE phase) is planned for eligible participants. The OLE will be carried out for approximately 96 weeks. Participants will be followed for safety for 48 weeks thereafter. Participants whose B-cell levels still...

Analysis of the Distribution of Regulatory B Cells in Blood of Multiple Sclerosis Patients

Oct 14th, 2022 - Multiple sclerosis (MS) is a progressive immuno-inflammatory and degenerative disease of the central nervous system (CNS) and represents the second most common cause of disability in young people. The pathophysiologic mechanisms involved are complex and effective therapeutic strategies have yet to be defined. Moreover it's today evident that treatment approaches have to be performed in a person...

A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

Oct 14th, 2022 - This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy, safety, and immunogenicity of RSVpreF or placebo (1:1 randomization) in infants born to healthy women vaccinated during pregnancy, as well as the safety and immunogenicity in the pregnant women. This will be a global study which will span multiple RSV seasons.

A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis

Oct 14th, 2022 - This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).

Safety and Efficacy Study of SAR442720 in Combination With Other Agents in Advanced Malignancies

Oct 14th, 2022 - This open label Phase 1 multicenter study is designed to evaluate the safety and maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SAR442720 in combination with pembrolizumab in participants with solid tumors in Part 1. In Part 2, in the expansion cohort (Cohort A) we will assess the antitumor activity and safety of SAR442720 combined with pembrolizumab in participants with me...

VRC 611: Human Monoclonal Antibody (mAb) VRC-HIVMAB0102-00-AB (CAP256V2LS)Administered Via Subcutaneous and Intravenous Injection in Healthy Adults

Oct 14th, 2022 - Design: This open-label study will evaluate CAP256V2LS (VRC-HIVMAB0102-00-AB) in healthy adults. The primary hypothesis is that subcutaneous (SC) and intravenous (IV) administrations of CAP256V2LS will be safe and well-tolerated in healthy adults. A secondary hypothesis is that CAP256V2LS will be detectable in human sera with a definable half-life. Study Product: The CAP256V2LS broadly neutrali...

A Study of JNJ-64407564 in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Oct 14th, 2022 - The purpose of this study is to evaluate the safety and tolerability in Japanese participants with relapsed or refractory multiple myeloma (MM) at the recommended Phase 2 dose (RP2D) identified in NCT03399799 study.

Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Oct 14th, 2022 - Title: Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies Study Description: Wearable and sensor digital devices have the potential to be important tools in infectious diseases surveillance. In this study, digital devices will be used to evaluate responses before and after respiratory virus challenge on a separate NIH protocol. Participants already enrolled in a ch...

A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme

Oct 14th, 2022 - Berubicin is one of the first anthracyclines that crosses the blood brain barrier and overcomes drug resistance (i.e. it is not a substrate for multi-drug resistant/breast cancer resistant transporters). A Phase 1 clinical trial of berubicin in patients with primary CNS malignancies demonstrated a durable response (one subject alive 13+ years) as well as stable disease in heavily pretreated pat...

Understanding How Cigarette Direct Mail Marketing Influences Smoking Behaviors Among High and Low Socioeconomic Status Young Adult Smokers

Oct 14th, 2022 - Smoking remains a public health problem in the US, and cigarette marketing has been concluded as one of the causal factors for the epidemic. Previous studies on cigarette direct mail marketing yielded a limited data on mechanisms influencing smoking behavior. Therefore, there is a need for a study that would provide a stronger evidence on how direct mail marketing influences smoking behavior. T...

Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders

Oct 14th, 2022 - This protocol is designed as an adjunct to other National Institutes of Health (NIH) IRB approved protocols that allow for genetic testing, which may include those that are screening protocols for patients with rare primary immunodeficiency or immunodysregulation disorders. Patients deemed of sufficient research interest after review of outside medical records, clinical evaluation, and testing,...