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A peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability (Active, Connected, Engaged [ACE]): study protocol for a randomised controlled trial
A peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability (Active, Connected, Engaged [ACE]): study protocol for a randomised controlled trial
The Active Connected Engaged [ACE] study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial...
Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia
Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia
This manuscript is a master statistical analysis plan for each of three-cluster randomized controlled trials to evaluate t...
The effects of Olmesartan/amlodipine administered in the Morning or At Night on nocturnal blood pressure reduction in Chinese patients with mild-moderate essential hypertension (OMAN Trial): study protocol for a prospective, multicenter, randomized, open-label clinical trial {1}
The effects of Olmesartan/amlodipine administered in the Morning or At Night on nocturnal blood pressure reduction in Chinese patients with mild-moderate essential hypertension (OMAN Trial): study protocol for a prospective, multicenter, randomized, open-label clinical trial {1}
Hypertension increases the risk of cardiovascular disease. Uncontrolled nocturnal blood pressure is prevalent in patients ...
The JUMPFOOD study: additional effect of hydrolyzed collagen and vitamin C to exercise treatment for patellar tendinopathy (jumper’s knee) in athletes—study protocol for a double-blind randomized controlled trial
The JUMPFOOD study: additional effect of hydrolyzed collagen and vitamin C to exercise treatment for patellar tendinopathy (jumper’s knee) in athletes—study protocol for a double-blind randomized controlled trial
Patellar tendinopathy (PT) is a common problem in jumping athletes. Management can be challenging and treatment outcome is...
Supporting physical activity for mobility in older adults with mobility limitations (SuPA Mobility): study protocol for a randomized controlled trial
Supporting physical activity for mobility in older adults with mobility limitations (SuPA Mobility): study protocol for a randomized controlled trial
Limited mobility in older adults consistently predicts both morbidity and mortality. As individuals age, the rates of mobi...
Hearing intervention for decreasing risk of developing dementia in elders with mild cognitive impairment: study protocol of a multicenter randomized controlled trial for Chinese Hearing Solution for Improvement of Cognition in Elders (CHOICE)
Hearing intervention for decreasing risk of developing dementia in elders with mild cognitive impairment: study protocol of a multicenter randomized controlled trial for Chinese Hearing Solution for Improvement of Cognition in Elders (CHOICE)
Age-related hearing loss (ARHL) signifies the bilateral, symmetrical, sensorineural hearing loss that commonly occurs in e...
Reducing Stress after Trauma (ReSeT): study protocol for a randomized, controlled trial of an online psychoeducational program and video therapy sessions for children hospitalized after trauma
Reducing Stress after Trauma (ReSeT): study protocol for a randomized, controlled trial of an online psychoeducational program and video therapy sessions for children hospitalized after trauma
Post-traumatic stress symptoms develop in a quarter to half of injured children affecting their longer-term psychologic an...
Perceived dyspnea and experience of hospitalized patients with acute decompensated heart failure undergoing an early MObilization protocol with immersive Virtual rEality: MOVE study protocol for a parallel superiority randomized clinical trial
Perceived dyspnea and experience of hospitalized patients with acute decompensated heart failure undergoing an early MObilization protocol with immersive Virtual rEality: MOVE study protocol for a parallel superiority randomized clinical trial
Immersive virtual reality (VR) is an innovative strategy for inpatient rehabilitation programs. Using immersive VR in earl...
Efficacy of conditioned autologous serum therapy (Orthokine®) on the dorsal root ganglion in patients with chronic radiculalgia: study protocol for a prospective randomized placebo-controlled double-blind clinical trial (RADISAC trial)
Efficacy of conditioned autologous serum therapy (Orthokine®) on the dorsal root ganglion in patients with chronic radiculalgia: study protocol for a prospective randomized placebo-controlled double-blind clinical trial (RADISAC trial)
Pulsed radiofrequency (PRF) treatment on the dorsal root ganglion (DRG) has been proposed as a good option for the treatme...
Attitudes and barriers to participation in window-of-opportunity trials reported by White and Asian/Asian British ethnicity patients who have undergone treatment for endometrial cancer
Attitudes and barriers to participation in window-of-opportunity trials reported by White and Asian/Asian British ethnicity patients who have undergone treatment for endometrial cancer
Window-of-opportunity trials (WOT) are a study design that have been used to investigate drug activity in endometrial canc...
Awareness with paralysis and symptoms of post-traumatic stress disorder among mechanically ventilated emergency department survivors (ED-AWARENESS-2 Trial): study protocol for a pragmatic, multicenter, stepped wedge cluster randomized trial
Awareness with paralysis and symptoms of post-traumatic stress disorder among mechanically ventilated emergency department survivors (ED-AWARENESS-2 Trial): study protocol for a pragmatic, multicenter, stepped wedge cluster randomized trial
Awareness with paralysis (AWP) is memory recall during neuromuscular blockade (NMB) and can cause significant psychologica...
Effects of the “ICU Support” team meeting concept on patient-centered and staff-centered outcomes: study protocol for a randomized controlled multicenter study
Effects of the “ICU Support” team meeting concept on patient-centered and staff-centered outcomes: study protocol for a randomized controlled multicenter study
Providing optimal care for critically ill patients is an extremely important but also highly demanding task, both emotiona...
Personalized therapy in rheumatoid arthritis (PETRA): a protocol for a randomized controlled trial to test the effect of a psychological intervention in rheumatoid arthritis
Personalized therapy in rheumatoid arthritis (PETRA): a protocol for a randomized controlled trial to test the effect of a psychological intervention in rheumatoid arthritis
Rheumatoid arthritis (RA) is a chronic autoimmune disease that primarily affects cartilage and bone. Psy...
The IBD-FITT study — moderate-intensity exercise for patients with inflammatory bowel disease with moderate disease activity: an open-label randomized controlled trial
The IBD-FITT study — moderate-intensity exercise for patients with inflammatory bowel disease with moderate disease activity: an open-label randomized controlled trial
Inflammatory bowel disease (IBD), Crohn’s disease, and ulcerative colitis are chronic autoimmune lifelong diseases w...
Protocol for a randomized controlled trial to reduce pediatric anesthesia emergence delirium by titration of sevoflurane anesthesia using brain function monitoring
Protocol for a randomized controlled trial to reduce pediatric anesthesia emergence delirium by titration of sevoflurane anesthesia using brain function monitoring
Emergence agitation or emergence delirium is a common complication of unknown etiology in pediatric anesthesia. Pediatric ...
Predicting attrition of men with a history of violence from randomised clinical trials
Predicting attrition of men with a history of violence from randomised clinical trials
Preventing dropout (attrition) from clinical trials is vital for improving study validity. Dropout is particularly importa...
Partnering with social service staff to implement pragmatic clinical trials: an interim analysis of implementation strategies
Partnering with social service staff to implement pragmatic clinical trials: an interim analysis of implementation strategies
With recent growth in the conduct of pragmatic clinical trials, the reliance on frontline staff to contribute to trial-rel...
Anodal transcranial direct current stimulation associated with aerobic exercise on the functional and physical capacity of patients with heart failure with reduced ejection fraction: ELETRIC study protocol
Anodal transcranial direct current stimulation associated with aerobic exercise on the functional and physical capacity of patients with heart failure with reduced ejection fraction: ELETRIC study protocol
The hallmark symptom of heart failure (HF) is severe exercise intolerance. Fortunately, accumulated evidence suggests that...
Comparing acute normovolumic hemodilution with autologous platelet-rich plasma for blood preservation during aortic surgery : study protocol for a randomized controlled clinical trial
Comparing acute normovolumic hemodilution with autologous platelet-rich plasma for blood preservation during aortic surgery : study protocol for a randomized controlled clinical trial
Both acute normovolumic hemodilution (ANH) and autologous platelet-rich plasma (aPRP) have been demonstrated blood-protect...
Protocol update and baseline characteristics for the TRIal to slow the Progression of Diabetes (TRIPOD) randomized controlled trial
Protocol update and baseline characteristics for the TRIal to slow the Progression of Diabetes (TRIPOD) randomized controlled trial
Type 2 diabetes (T2D), a major risk factor for cardiovascular disease and other adverse health conditions, is on the rise ...
Correction: Efficacy and safety assessment of different dosage of benznidazol for the treatment of Chagas disease in chronic phase in adults (MULTIBENZ study): study protocol for a multicenter randomized Phase II non-inferiority clinical trial
Correction: Efficacy and safety assessment of different dosage of benznidazol for the treatment of Chagas disease in chronic phase in adults (MULTIBENZ study): study protocol for a multicenter randomized Phase II non-inferiority clinical trial
Infectious Diseases Department, Vall d’Hebron University Hospital, PROSICS Barcelona, Universitat Autònoma de Barcelona, P...
Statistical analysis plan for the LAKANA trial: a cluster-randomized, placebo-controlled, double-blinded, parallel group, three-arm clinical trial testing the effects of mass drug administration of azithromycin on mortality and other outcomes among 1–11-month-old infants in Mali
Statistical analysis plan for the LAKANA trial: a cluster-randomized, placebo-controlled, double-blinded, parallel group, three-arm clinical trial testing the effects of mass drug administration of azithromycin on mortality and other outcomes among 1–11-month-old infants in Mali
The Large-scale Assessment of the Key health-promoting Activities of two New mass drug administration regimens with Azithr...
Multisensory stimulation bundles on sleep and neurobehavioral development in the first year after birth in very preterm infants: a randomized crossover controlled study protocol
Multisensory stimulation bundles on sleep and neurobehavioral development in the first year after birth in very preterm infants: a randomized crossover controlled study protocol
Disrupted sleep is believed to contribute to short- and long-term neurodevelopmental problems in very preterm infants (VPI...
Effect of inulin supplementation on clinical symptoms, inflammatory and oxidative stress markers in women with migraine: study protocol for a randomized clinical trial
Effect of inulin supplementation on clinical symptoms, inflammatory and oxidative stress markers in women with migraine: study protocol for a randomized clinical trial
Migraine is a complex, chronic, and debilitating multifactorial disorder characterized by recurrent episodes of headache a...
End-on versus parallel radiofrequency lesioning for neurotomy of the cervical medial branch nerves: a study protocol of a prospective, randomized, double-blind clinical trial: the “EndPaRL” study
End-on versus parallel radiofrequency lesioning for neurotomy of the cervical medial branch nerves: a study protocol of a prospective, randomized, double-blind clinical trial: the “EndPaRL” study
Cervical facet joint disease is a common source of neck pain and its prevalence increases with aging. Conservative multimo...
Beneficial effects of the combination of BCc1 and Hep-S nanochelating-based medicines on IL-6 in hospitalized moderate COVID-19 adult patients: a randomized, double-blind, placebo-controlled clinical trial
Beneficial effects of the combination of BCc1 and Hep-S nanochelating-based medicines on IL-6 in hospitalized moderate COVID-19 adult patients: a randomized, double-blind, placebo-controlled clinical trial
In the severe forms of COVID-19 and many other infectious diseases, the patients develop a cytokine storm syndrome (CSS) w...
Comparison of S-ketamine and midazolam for intravenous preoperative sedative and anxiolytic effects in preschool children: study protocol for a randomized controlled clinical trial
Comparison of S-ketamine and midazolam for intravenous preoperative sedative and anxiolytic effects in preschool children: study protocol for a randomized controlled clinical trial
Preoperative anxiety management is gaining particular attention in paediatric anaesthesia. Pharmacological and non-pharmac...
SMARTERscreen protocol: a three-arm cluster randomised controlled trial of patient SMS messaging in general practice to increase participation in the Australian National Bowel Cancer Screening Program
SMARTERscreen protocol: a three-arm cluster randomised controlled trial of patient SMS messaging in general practice to increase participation in the Australian National Bowel Cancer Screening Program
Australia persistently has one of the highest rates of colorectal cancer (CRC) in the world. Australia’s National Bo...
i-MoMCARE: Innovative Mobile Technology for Maternal and Child Health Care in Cambodia—study protocol of a cluster randomized controlled trial
i-MoMCARE: Innovative Mobile Technology for Maternal and Child Health Care in Cambodia—study protocol of a cluster randomized controlled trial
The Government of Cambodia established the village health support groups (VHSGs) in 2003 to facilitate primary healthcare ...
Correction: COMPASS: deCOMPressing stomA and two-Stage elective resection vs. emergency reSection in patients with left-sided obstructive colon cancer
Correction: COMPASS: deCOMPressing stomA and two-Stage elective resection vs. emergency reSection in patients with left-sided obstructive colon cancer
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, whi...
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