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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.
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.
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.
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.
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.
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.
NCT04529096
This study is being done to test the safety and efficacy of the study drug LY3016859 for the treatment of chronic low back pain. This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.
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.
NCT02004275
This randomized phase I/II trial studies the side effects and best dose of pomalidomide and ixazomib when given together with dexamethasone and to see how well pomalidomide and dexamethasone with or without ixazomib works in treating patients with multiple myeloma that has come back. Biological therapies, such as pomalidomide and dexamethasone, may stimulate the immune system in different ways and stop cancer cells from growing. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pomalidomide and dexamethasone are more effective with or without ixazomib in treating multiple myeloma.
NCT04937829
This study is open to adults between 18 and 65 years of age who have depression (major depressive disorder). People with a current depressive episode lasting between 2 months and one and a half years can join the study. This study is for people for whom existing treatments for depression do not work sufficiently. The purpose of this study is to test how well a medicine called BI 1569912 is tolerated and whether it may help people with depression. It is planned to test 4 different dosages of BI 1569912 in this study. Each participant gets either one BI 1569912 dosage or placebo. It is decided randomly, which means by chance, who gets which treatment. Participants take BI 1569912 or placebo as tablets once during the study. Placebo tablets look like BI 1569912 tablets but do not contain any medicine. Participants also continue taking their usual medicine for depression throughout the study. Participants are in the study for about 5 weeks. During this time, they visit the study site 4 times, with a stay at the study site for 9 days. The doctors check the health of the participants and note any health problems that could have been caused by BI 1569912. The participants fill in questionnaires about their depression symptoms.
NCT00355238
The purpose of this clinical research study is to learn if BMS-582664 can shrink or slow the growth of advanced liver cancer. The safety of this treatment will also be studied.
NCT04121221
A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing Forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks
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.
NCT00274508
To investigate whether tiotropium (Spiriva) improves exercise endurance in patients with COPD