random clinical trial

INTRODUCTION AND HYPOTHESIS: The goal of this study was to determine whether dietary fat/fiber intake was associated with fecal incontinence (FI) severity. METHODS: Planned supplemental analysis of a randomized clinical trial evaluating the impact of 12-week treatment with percutaneous tibial nerve stimulation versus sham in reducing FI severity in women. All subjects completed a food screener questionnaire at baseline. FI severity was measured using the seven-item validated St...

PURPOSE: Evidence on the potential beneficial effects of anthocyanin-rich foods and supplements on cognitive performance is mainly based on acute or long-term studies in older adults. However, short-term studies focusing on a younger population are lacking. Therefore, short-term effects of Aronia melanocarpa extract (AME) supplementation on cognitive performance were investigated in healthy young adults. Potential underlying mechanisms were also addressed. METHODS: A randomized, double-blind, placebo-controlled cross-over study was performed involving 35 apparently healthy young adults...

IMPORTANCE: Catheter ablation is associated with reduced heart failure (HF) hospitalization and death in select patients with atrial fibrillation (AF) and heart failure with reduced ejection fraction (HFrEF). However, the benefit in patients with HF with preserved ejection fraction (HFpEF) is uncertain. OBJECTIVE: To investigate whether catheter ablation for AF is associated with reduced HF-related outcomes according to HF phenotype. DATA SOURCE: A systematic search of MEDLINE, Embase, and Cochrane Central was conducted among studies published from inception to September 2023...

BACKGROUND AND PURPOSE: Falls are the leading reason for injury-related emergency department (ED) visits for older adults. The Geriatric Acute and Post-acute Fall Prevention Intervention (GAPcare), an in-ED intervention combining a medication therapy management session delivered by a pharmacist and a fall risk assessment and plan by a physical therapist, reduced ED revisits at 6 months among older adults presenting after a fall. Our objective was to evaluate the relationship between measures of function obtained in the ED and clinical outcomes...

Some studies suggested that gastrointestinal (GIT) decontamination with oil may improve the prognosis of patients who ingested aluminum phosphide (AlP). The aim of this study is to compare the efficacy and safety of gastric lavage with oil-based solutions to any method of gastric decontamination not using oils in patients presenting with acute AlP poisoning. The literature was searched for English-published randomized controlled trials (RCTs) from inception to 16 September 2023. The searched electronic databases included MEDLINE/PubMed, Cochrane Library, Web of Science, Egyptian Knowledge Bank, Scopus, and Google Scholar...

OBJECTIVES: This study determines the effect of an integrated 12-month follow-up support programme on the oral health of patients with head and neck cancer (HNC) who received radiotherapy (RT). METHODS: Participants were randomly assigned to an intervention group (n = 47) or a control group (n = 45). The intervention group received usual care and an integrated supportive programme, which included face-to-face education and telephone coaching...

OBJECTIVE: The objective of this study was to evaluate the effects of home-based pelvic floor muscle training in women with urinary incontinence, addressing the difficulties arising from social isolation due to the coronavirus disease 2019 pandemic by utilizing a specialized mobile app. METHODS: This randomized, single-group clinical trial aimed to assess the efficacy of pelvic floor muscle training guided by a mobile app (Diario Saúde) in women with stress urinary incontinence...

BACKGROUND: Infantile colic has a multifactorial etiology. Recent studies have suggested that probiotics may be effective in its management. OBJECTIVE: This study was carried out to evaluate the effect of the Actiregularis strain (5×106 cfu\ml) included in maternal nutrition on gastrointestinal problems, growth development, and breastfeeding outcomes in infantile colic. DESIGN AND SETTING: The study was a randomized controlled trial conducted in the neonatal outpatient clinic of a training and research hospital in Turkey...

BACKGROUND: There is still a debate regarding the most appropriate pleural collector model to ensure a short hospital stay and minimum complications. OBJECTIVES: To study aimed to compare the time of air leak, time to drain removal, and length of hospital stay between a standard water-seal drainage system and a pleural collector system with a unidirectional flutter valve and rigid chamber. DESIGN AND SETTING: A randomized prospective clinical trial was conducted at a high-complexity hospital in São Paulo, Brazil...

OBJECTIVE: to assess the efficacy of a Hospital Discharge Transition Plan in the care competence and in adherence to the therapy of dyads comprised by patients with non-communicable chronic diseases and their caregivers. METHOD: a controlled and randomized clinical trial; the sample was comprised by 80 dyads of patients with chronic conditions and their caregivers, randomly allocated as follows: 40 to the control group and another 40 to the intervention group...

Cerebral cavernous malformation (CCM) has variable clinical symptoms, including potentially fatal hemorrhagic stroke. Treatment options are very limited, presenting a large unmet need. REC-994 (also known as tempol), identified as a potential treatment through an unbiased drug discovery platform, is hypothesized to treat CCMs through a reduction in superoxide, a reactive oxygen species. We investigated the safety, tolerability, and pharmacokinetic profile of REC-994 in healthy volunteers. Single- and multiple-ascending dose (SAD and MAD, respectively) studies were conducted in adult volunteers (ages 18-55)...

OBJECTIVE: Shenkang injection (SKI) has been widely used in China for many years for the treatment of kidney disease. The objective of this systematic review was to assess the efficacy of Shenkang injection for the treatment of acute kidney injury (AKI). METHODS: A search was conducted across seven databases, encompassing data from the inception of each database through October 8th , 2023. Randomized controlled trials comparing SKI-treated AKI patients with control subjects were extracted...

BACKGROUND: Endoscopic healing is generally defined as Mayo endoscopic subscore (MES) ≤1 in ulcerative colitis (UC). However, patients with an MES of 1 are at higher relapse risk than those with an MES of 0. This study evaluated the therapeutic efficacy of proactive dose escalation of oral 5-aminosalicylic acid (5-ASA) in UC patients with an MES of 1. METHODS: An open-label, randomized controlled trial was conducted in 5 hospitals between 2018 and 2022. Ulcerative colitis patients in clinical remission under oral 5-ASA therapy and diagnosed as having an MES of 1 were enrolled...

The randomized AMBORA trial showed that medication errors are frequent in patients treated with oral antitumor therapeutics and that they can be substantially reduced by an intensified clinical pharmacological/pharmaceutical care program. While randomized controlled trials are essential to generate clinical evidence, their generalizability in real-world is not always given. The AMBORA care program was implemented in clinical routine within the AMBORA Competence and Consultation Center (AMBORA Center) at the Comprehensive Cancer Center Erlangen-EMN, allowing a thorough comparison of medication error frequencies and characteristics...

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OBJECTIVE: This study (CRD42023464989) aimed to explore the effects of pre-operation immunonutrition on safety and immune related factors in colorectal cancer patients undergoing surgery. METHODS: We systematically searched PubMed, Embase, and Wanfang databases to collect all clinical randomized controlled trials of the application of pre-operation immunonutrition for patients with colorectal cancer, published until July 2023. The primary outcomes were safety and immune related factors...

OBJECTIVE: This randomized controlled clinical trial compared the clinical efficacy of self-adhesive bulk-fill Surefil One with a traditional bulk-fill composite in class II restorations. MATERIALS AND METHODS: Sixty-four direct class II composite restorations were categorized into two groups. Group I, control group (n = 32): cavities were restored by Filtek One bulk-fill composite with Scotchbond Universal (SBU) adhesive in self-etch mode, Group II, test group (n = 32): cavities were restored by Surefil One self-adhesive bulk-fill composite...

OBJECTIVE: This review aims to evaluate the effectiveness of silver diamine fluoride application along with atraumatic restorative treatment in arresting the progression of dental caries when compared with other caries-arresting treatments in children and adults. INTRODUCTION: A combination of silver diamine fluoride with atraumatic restorative treatment is a minimally invasive and cost-effective method to treat dental caries. It offers a solution for the progression of caries and restoration of cavitated lesions in both primary and permanent teeth...

OBJECTIVE: This study aimed to compare the clinical outcomes of double kissing mini-culotte (DKMC) stenting with those of mini-culotte (MC) stenting in treating patients with true coronary bifurcation lesions (CBLs) in the clinical real world. METHODS: This retrospective observational cohort study included 180 consecutive patients with true CBLs (Medina type 1,1,1; 1,0,1; 0,1,1). All eligible patients underwent coronary angiography and percutaneous coronary intervention with two-stent techniques in our hospital; among them, 97 received DKMC treatment and 83 MC treatment...

OBJECTIVE: Researchers from underrepresented groups leave research positions at a disproportionate rate. We aim to identify factors associated with self-efficacy in career advancement and career commitment among underrepresented post-doctoral fellows and early-career faculty. METHODS: Building Up is a cluster-randomized trial with 25 academic health institutions. In September-October 2020, 219 Building Up participants completed the pre-intervention assessment, which included questions on demographics, science identity, mentoring, self-efficacy in career advancement (i...