Clinical Trials
Category Added in a WPeMatico Campaign
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A randomized controlled double-blinded trial to assess the risk of gestational diabetes mellitus in non-anemic pregnant women who receive oral iron supplementation
BACKGROUND: Pregnant women in India are routinely prescribed oral iron supplements as part of the national Anemia Mukt Bharat (AMB) program for anemia control. In women with iron-deficiency anemia, the benefits of iron supplementation during pregnancy, both for the mother and child, are very clear. In non-anemic pregnant women, however, the benefits of iron supplementation…
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Effects of short foot exercises with and without blood flow restriction on Foot Posture Index, sensory organization, and center of pressure displacement in middle-aged women with flexible flatfoot: a randomized controlled trial
CONCLUSION: Six weeks of SFE, with or without BFR, significantly improved foot posture, sensory organization, and postural stability in middle-aged women with flexible flatfoot. Under the current protocol and within the limitations of this study, BFR did not confer additional statistically significant benefit. SFE is a safe and effective intervention for this population; its cost‑effectiveness…
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Wireless Home Blood Pressure Monitoring With Health Coaching for Hypertension Management at a Federally Qualified Health Center: Pilot Randomized Controlled Feasibility and Acceptability Study
CONCLUSIONS: Among analyzed participants, wireless HBPM was feasible, and survey respondents reported high acceptability in a medically underserved, predominantly Hispanic FQHC population. Feasibility among all randomized participants could not be estimated because arm-level allocation counts were not retained. The absence of a between-arm difference in BP control is not evidence of equivalence because this pilot…
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Feasibility of a Co-Designed Personalized Cognitive Reablement Program Delivered via Digital Voice Assistants for Older Adults Living With Early-Stage Dementia or Mild Cognitive Impairment: Pilot Randomized Controlled Trial
CONCLUSIONS: This co-designed VOICE-COG program, delivered via DVAs, was feasible for older adults living with early-stage dementia or MCI, resulting in most participants meeting their reablement goals and increases in the use of memory strategies. System usability issues should be addressed in future adequately powered trials.
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Quantitative Flow Ratio- vs Angiography-Guided Percutaneous Coronary Intervention: A Secondary Analysis of the FAVOR III China Trial
CONCLUSIONS AND RELEVANCE: In this prespecified secondary analysis of a randomized clinical trial of patients undergoing PCI, QFR-guided PCI was associated with a lower 3-year MACE rate among patients with MVD; however, no significant interaction was observed between treatment effect and MVD status. These findings provide longer-term randomized evidence supporting QFR-guided PCI across MVD strata…
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Statistical analysis plan for transfusion of modified whole blood versus blood components therapy in patients with severe trauma: randomized controlled trial — WEBSTER trial
CONCLUSION: This statistical analysis plan prespecifies transparent methods to assess the effect of whole blood versus blood-component therapy in trauma patients. The hierarchical framework, complementary sensitivity analyses and comprehensive interpretation are intended to provide a robust and clinically meaningful assessment of whole blood effects.
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Antidopaminergic Medications and Clinical Outcomes in Huntington Disease: Evidence From the PROOF-HD Placebo-Controlled Trial
BACKGROUND AND OBJECTIVES: Antidopaminergic medications (ADMs), including vesicular monoamine transporter-2 (VMAT2) inhibitors and antipsychotics, are widely used to manage motor and psychiatric symptoms in Huntington disease (HD). Observational evidence suggests that ADM use may be associated with accelerated worsening of clinical outcome measures used in HD trials, but this relationship has not been examined in…
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Addressing the challenges of including older people with osteoarthritis and multi-morbidity in digitally enabled trials: a mixed methods Study Within a Project (TIPTOE SWAP)
CONCLUSION: Embedding a SWAP in TIPTOE enabled a greater understanding about recruiting older people who experience intersectional barriers to inclusion. Approaches to support recruitment included providing telephone support for those less confident navigating digital consent and data collection processes and the creation of guidance for sites. The findings could support future trials to better include…
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Efficacy of progressive muscle relaxation training in post-traumatic stress disorder after the Kahramanmaras earthquake: a randomized controlled trial
CONCLUSION: PMRT was associated with greater improvements in PTSD symptoms, psychological well-being, sleep quality, fatigue, and quality of life compared to an education-only control group. Telerehabilitation may offer a practical advantage when face-to-face care is limited, although this remains speculative.
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Feasibility of a multidimensional interdisciplinary rehabilitation program for people with dementia and their informal primary caregivers — a randomized pilot trial with a caregiver focus
CONCLUSIONS: The program, combining rehabilitation for the person with dementia with caregiver support, seems feasible regarding caregivers’ participation in the intervention and study evaluation, and thus further evaluation in an adequately powered randomized controlled trial seems relevant. A future definitive trial should evaluate continuous support over a longer period adapted to the caregiver and refine…