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This database contains 664 studies, archived under the term: "Randomised Controlled Trial"

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Virgin olive oil supplementation and long-term cognition: the PREDIMED-NAVARRA randomized, trial

Objective: To assess the effect on cognition of a controlled intervention testing Mediterranean diets (MedDiet).; Design: Randomized trial after 6.5 years of nutritional intervention.; Setting: Eight primary care centers affiliated to the University of Navarra.; Participants: A random subsample of 285 participants (95 randomly allocated to each of 3 groups) of the PREDIMED-NAVARRA trial. All […]

Mediterranean diet improves cognition: The PREDIMED-NAVARRA randomised trial

Objective: Previous observational studies reported beneficial effects of the Mediterranean diet (MedDiet) on cognitive function, but results were inconsistent. We assessed the effect on cognition of a nutritional intervention using MedDiets in comparison with a low-fat control diet. Methods: We assessed 522 participants at high vascular risk (44.6% men, age 74.6 ± 5.7 years at […]

A trial of dementia caregiver telephone support

The purpose of this study was to determine if telephone support groups for dementia caregivers have an effect on bother with patient behaviours, burden, depression, and general well-being. The randomized controlled trial compared telephone support groups (15 groups of 5 or 6 caregivers) with control groups (print materials). Groups met 14 times over 1 year. […]

Effectiveness of a psychoeducational intervention group program in the reduction of the burden experienced by caregivers of patients with dementia: the EDUCA-II randomized trial

We conducted a multicenter, prospective, evaluator-blinded, 2-arm parallel randomized trial to compare the effectiveness of a group psychoeducational intervention (PIP) with that of standard care in dementia caregivers. The primary outcome was the burden experience evaluated by the Zarit Burden Interview. Secondary outcomes were psychological distress evaluated with the scaled General Health Questionnaire-28 items, and […]

Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women’s Health Initiative randomized trials

Importance: Menopausal hormone therapy continues in clinical use but questions remain regarding its risks and benefits for chronic disease prevention.; Objective: To report a comprehensive, integrated overview of findings from the 2 Women’s Health Initiative (WHI) hormone therapy trials with extended postintervention follow-up.; Design, Setting, and Participants: A total of 27,347 postmenopausal women aged 50 […]

Animal-assisted therapy and agitation and depression in nursing home residents with dementia: a matched case-control trial

Objectives: To investigate the efficacy of animal-assisted therapy (AAT) on symptoms of agitation/aggression and depression in nursing home residents with dementia in a randomized controlled trial. Previous studies have indicated that AAT has beneficial effects on neuropsychiatric symptoms in various psychiatric disorders but few studies have investigated the efficacy of AAT in patients suffering from […]

Animal-assisted therapy and agitation and depression in nursing home residents with dementia: A matched case–control trial

Objectives: To investigate the efficacy of animal-assisted therapy (AAT) on symptoms of agitation/aggression and depression in nursing home residents with dementia in a randomized controlled trial. Previous studies have indicated that AAT has beneficial effects on neuropsychiatric symptoms in various psychiatric disorders but few studies have investigated the efficacy of AAT in patients suffering from […]

Efficacy and safety of the dopaminergic stabilizer Pridopidine (ACR16) in patients with Huntington’s disease

Objectives: To evaluate the efficacy and safety of the dopaminergic stabilizer pridopidine (ACR16) in patients with Huntington’s disease (HD).; Methods: In a randomized, double-blind, placebo-controlled, 4-week trial, patients with HD received pridopidine (50 mg/d, n = 28) or placebo (n = 30). The primary outcome measure was the change from baseline in weighted cognitive score, […]

Maintenance of health and relief for caregivers of elderly with dementia by using “initial case management”: experiences from the Lighthouse Project on Dementia, Ulm, ULTDEM-study

Background: When facing the well-known demographic development with an increasing number of people suffering from dementia, there is a need of programmes to support nursing relatives and care at home. Many support services have been established in the past few years but they are rarely used by the relatives and the patients. The purpose of […]

The effect of exercise on behavioural and psychological symptoms of dementia: The EVIDEM-E randomised controlled clinical trial

Objective: The objective of this study is to evaluate the effectiveness of a simple dyadic (person with dementia and their main carer) exercise regimen as a therapy for the behavioural and psychological symptoms of dementia. Method: A two arm, pragmatic, randomised, controlled, single‐blind, parallel‐group trial of a dyadic exercise regimen (individually tailored walking regimen designed […]

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