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NCT03970837
This study \[contRAst 2 (201791: NCT03970837)\] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARD(s) or bDMARD(s). The study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with csDMARD(s). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165 may be included in the long-term extension study \[contRAst X (209564: NCT04333147)\]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.
NCT05295875
This study will evaluate the efficacy and safety of ALT-801 once-weekly versus placebo as an adjunct to a reduced-calorie diet and increased physical activity in patients with obesity/overweight.
NCT05169840
The investigators propose to genotype males and females at age 40 years and older, who are asymptomatic and without known heart disease (N=2000). DNA from a blood sample will be genotyped for millions of genetic risk variants for CAD by Baylor College of Medicine Human Genome Sequencing Center Clinical Laboratory (HGSC-CL) in a CLIA-approved laboratory. The overall objective after 2 years is to determine if genetic screening for risk of CAD in asymptomatic men and women has the discriminatory power to detect those at highest risk who would potentially benefit most from appropriate primary prevention. It will also determine whether the GRS is appropriate for different ethnic and race groups such as Hispanics, African Americans and Whites, and to what extent those individuals knowing that they are at higher risk, are more likely to seek further advice on management of the risks (either through changes in lifestyle or therapy).
NCT04940390
Study STS101-007 is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of single doses of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.
NCT05044234
Psoriasis is a chronic disease characterized by marked inflammation and thickening of the skin that results in thick, scaly skin plaques. This study assessed how safe and effective cedirogant (ABBV-157) was compared to placebo in adult participants with moderate to severe psoriasis. Efficacy and safety-related measurements assessed disease activity in participants with plaque psoriasis. Cedirogant (ABBV-157) is an investigational drug being developed for the treatment of chronic plaque psoriasis. Participants were put into 1 of 4 groups, called treatment arms and each group received a different treatment. There was a 1 in 4 chance that participants were assigned to placebo. Participants received oral daily doses of cedirogant or placebo capsules for 16 weeks. There may have been a higher burden for participants in this study compared to usual standard of care. Participants attended regular visits per routine clinical practice. The effect of the treatment was checked by medical assessments, checking for side effects, and questionnaires.
NCT00506493
This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass graft (CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate Surgical Ablation System can safely and effectively treat persistent AF patients.
NCT03900650
Although correct, consistent condom use can greatly reduce sexually transmitted infections and unplanned pregnancies, resistance of condom use is common among young adults. Young men's alcohol intoxication and sexual aggression history are predictive of greater condom use resistance and other sexual risk behaviors (e.g., unprotected sex). Moreover, emotional factors may play a role in these associations, suggesting a promising avenue for continued research. This project builds upon our prior research through investigation of the emotional mechanisms involved in young men's alcohol-related sexual risk behavior. This research addresses a critical knowledge gap and advances the field through the use of multiple methods designed to evaluate distal and proximal emotional factors implicated in alcohol-related sexual risk. Male drinkers aged 21-30 who use condoms inconsistently (N = 420) will first complete a screening procedure followed by a baseline survey that will assess relevant constructs, including emotional traits, emotion dysregulation tendencies, and alcohol expectancies. They will then complete a 30-day daily diary assessment of their daily emotional states, daily coping motives pertaining to drinking and sex, and daily drinking and sexual risk behaviors to evaluate daily relationships among these factors. The same participants will complete an in-lab experiment assessing in-the-moment effects of alcohol intoxication and provocation on emotional states and sexual risk intentions. Statistical analyses will be used to examine the daily influence of emotional states and coping motives on alcohol consumption and sexual risk behaviors and the experimental effects of alcohol intoxication and provocation on emotional states and other mediators, as well as sexual risk intentions. Moderating effects of emotion dysregulation tendencies will also be examined, and the linkages between event-level and experimental relationships will be investigated. This research is both significant and innovative in that it will address the public health concern of men's sexual risk behaviors, including condom use resistance; will evaluate the role of emotional processes in men's alcohol-related sexual risk; and will use multiple methods to gather complementary types of data that will elucidate the mechanisms underlying alcohol-related sexual risk behaviors and provide an empirical evidence base from which to develop and inform prevention and intervention programs.
NCT03276195
This study is aimed to carry out a systematic study to examine the effects of genetic variants (genetic modifiers) other than TSC genes on phenotypic variability in familial TSC patients (affected parent, child and unaffected siblings) and sporadic TSC.
NCT04498910
The reason for this study is to see if the study drug LY3451838 is safe and effective in participants who have migraine that have not responded to other preventive treatments.
NCT04797715
This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.
NCT00849290
This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)
NCT04007367
This is a study with an Open-Label (OL) phase followed by a randomized, Double-Blind (DB), placebo-controlled phase to assess efficacy and safety of SAGE-217 on relapse prevention in adults with major depressive disorder (MDD).
NCT03672175
This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult participants with major depressive disorder (MDD).
NCT05269134
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
NCT02978781
This study is a three-part, multicenter, Phase 2a study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of SAGE-217 in adult participants with essential tremor.
NCT02181738
The purpose of this study is to evaluate the efficacy and safety of Nivolumab in previously treated (cohorts, A, B \& C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma participants.
NCT02551679
The primary objective of this study is to determine the efficacy and safety of intramuscular injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical limb ischemia who are receiving standard of care therapy and have no endovascular or surgical revascularization options.
NCT05395858
People with hemophilia A do not have enough of a protein found naturally in the blood called "clotting factor 8", also known as FVIII. This protein helps the blood to clump together to prevent and stop bleeding. People with lower levels of FVIII or FVIII that does not work properly may bleed for a long time from minor wounds, bleed into their joints, or have internal bleeding. The study treatment, Jivi (also called damoctocog alfa pegol), is already available as a treatment for people aged 12 years and older with hemophilia A, to help prevent bleeding, also known as "prophylactic" treatment. It works by replacing the missing FVIII, or the FVIII that does not work properly. It can also be used to stop bleeding that has already occurred and prior to surgery to prevent bleeding. The main goal of this study is to learn how damoctocog alfa pegol is used in the "real world" as a treatment in the United States (US) and how well it works and what other treatments patients use while receiving damoctocog alfa pegol treatment. It will also determine how satisfied people are with the treatment. There will be no required visits with a study doctor in this study. The study will include about 20 male or female patients in the US aged 12 years and over who have hemophilia A. All the patients in this study will have switched from their previous FVIII replacement treatment to damoctocog alfa pegol. While the patients are receiving damoctocog alfa pegol, they will complete a survey to say how they feel about the treatment. Their doctors will also record information about their treatment with damoctocog alfa pegol and how well it is working. This study will collect information from the patients' medical records and surveys. They will use this information to find out more about treatment with damoctocog alfa pegol under "real world" conditions. They will look at: * how often the patients receive damoctocog alfa pegol and how much they use * what other treatments the patients received before receiving damoctocog alfa pegol, how they used it and how much they used * how well damoctocog alfa pegol works at preventing bleeding, and how it compares to previous products used.
NCT05152953
BACKGROUND: Long-acting injectable antiretroviral therapy (LAI-ART) is poised to revolutionize HIV treatment and prevention. Community pharmacies could serve as another place for people with HIV to get their ART injections. However, pharmacist and healthcare practitioner attitudes towards pharmacist administration of LAI-ART are understudied. Financial and human resources, pharmacist training, or changes in workflow have not been outlined. Little is known about whether patients will accept ART injections given in pharmacies. OBJECTIVE: The purpose of this project is to address the above knowledge gaps. The information generated can assist in the development of tools that can help scale community pharmacy-based delivery of LAI-ART. METHODS: Using a mixed-methods approach to better understand the pre-implementation environment, the study will employ electronic surveys and will administer semi-structured interviews via telephone for three key stakeholder groups: HIV clinic staff members, community pharmacists, and persons with HIV. Surveys will assess the appropriateness, acceptability, and feasibility of LAI-ART administration in community pharmacies. A semi-structured interview guide has been developed using constructs from the Consolidated Framework for Implementation Research (CFIR). Comparisons between and across stakeholder groups will be performed, looking for common themes as well as discrepancies.
NCT04933331
The purpose of this observational study is to assess the effectiveness of Curodont Repair Fluoride Plus (CRFP) compared to other tooth-specific treatments (silver diamine fluoride (SDF), sealants, or other FDA-approved treatments) in preventing progression to cavitation in patients with at least one early non-cavitated dental caries lesion. The study will also evaluate the effectiveness of CRFP in comparison to no tooth-specific treatment control groups, including whole mouth treatments such as: 2.26% fluoride varnish, 1.23% fluoride foam, and 5000 ppm fluoride prescription toothpaste; and no treatment, on caries arrest and in preventing progression to cavitation in patients with at least one early non-cavitated dental lesion.
