Objective: To report on the issues encountered in the recruitment of healthy naturally menopausal women in the community to a randomized placebo-controlled trial of dehydroepiandrosterone (DHEA) therapy for treatment of loss of sexual desire.
Methods: Recruitment of women was achieved by advertising and media publicity. We have reported on the method by which women initially contacted us and the reasons for nonparticipation.
Results: Nine hundred and eighteen women contacted us about participating in the study; 706 of these were telephoned screened, and 93 of these (10%) women were randomized to therapy. The main determinants for nonparticipation included ineligibility on phone screening (58%), withdrawal of interest either before or after screening (55%), and preexisting pathology after attending for screening (8%).
Conclusions: Despite ongoing interest by women to participate in research for therapies to treat low libido, concerns about the use of any hormonal treatment and the time poverty experienced by many women at midlife present new barriers to recruitment and need to be considered in assessing the feasibility of studies in this field.
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http://dx.doi.org/10.1089/jwh.2007.0732 | DOI Listing |
Nat Med
January 2025
Leiden University Center for Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands.
Malaria vaccines consisting of metabolically active Plasmodium falciparum (Pf) sporozoites can offer improved protection compared with currently deployed subunit vaccines. In a previous study, we demonstrated the superior protective efficacy of a three-dose regimen of late-arresting genetically attenuated parasites administered by mosquito bite (GA2-MB) compared with early-arresting counterparts (GA1-MB) against a homologous controlled human malaria infection. Encouraged by these results, we explored the potency of a single GA2-MB immunization in a placebo-controlled randomized trial.
View Article and Find Full Text PDFRMD Open
January 2025
Department of Rheumatology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Objective: The objective of this study is to evaluate the efficacy and safety of jaktinib hydrochloride tablets (jaktinib), a Janus kinase inhibitor, in patients with active radiographic axial spondyloarthritis (r-axSpA).
Methods: Adults with active r-axSpA who met modified New York criteria and had an inadequate response to non-steroidal anti-inflammatory drugs were randomised 1:1:1 to receive jaktinib 75 mg two times per day, 100 mg two times per day, or placebo. The primary and key secondary endpoints were Assessment of SpondyloArthritis international Society 20 (ASAS 20) and ASAS 40 responses, respectively, at week 16.
Alzheimers Dement
December 2024
The George Institute for Global Health, Newtown, NSW, Australia.
Background: Intracerebral hemorrhage (ICH) is the most severe and disabling stroke, accounting for up to 50% of the cases in low-to-middle-income countries. High rates of cognitive decline and dementia follow acute ICH, due to the common underlying vasculopathy of cerebral small vessel disease (CSVD). The international clinical trial, TRIDENT (Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial), aims to determine the effectiveness of the fixed low-dose Triple Pill combination of blood pressure-lowering agents (telmisartan 20 mg, indapamide 1.
View Article and Find Full Text PDFAlzheimers Dement
December 2024
Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA.
Background: Patients with dementia due to Alzheimer's disease may experience multiple different agitation symptoms - including excessive motor activity, verbal aggression, and physical aggression - at varying frequencies. The efficacy of brexpiprazole 2 or 3 mg/day on 29 individual agitation behaviors (Cohen-Mansfield Agitation Inventory [CMAI] items) was previously evaluated. Building upon that work, this post hoc analysis aimed to determine the efficacy of brexpiprazole on the same individual agitation behaviors, but specifically focusing on those patients who were frequently experiencing the behaviors at baseline.
View Article and Find Full Text PDFAlzheimers Dement
December 2024
Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA.
Background: Agitation associated with dementia due to Alzheimer's disease encompasses a wide range of behaviors, including excessive motor activity, verbal aggression, and physical aggression. In a survey of unpaid caregivers living with an individual with Alzheimer's disease, the "most bothersome" agitation behaviors (which may influence the decision to transfer the patient to long-term care) were: cursing or verbal aggression, spitting, repetitive sentences or questions, hitting, constant unwarranted requests for attention or help, trying to get to a different place, inappropriate dress or disrobing, pacing/aimless wandering, grabbing onto people, and throwing things. This post hoc analysis aimed to determine the efficacy of brexpiprazole on agitation in patients frequently exhibiting these bothersome behaviors.
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