Randomized clinical trial

Outdoor gait-training has been successful in improving pain and reducing contact time during outdoor running for runners with exercise-related lower leg pain (ERLLP). However, it is unclear if these adaptations translate to gold standard treadmill running and clinical strength assessments. The study purpose was to assess the influence of a 4-week outdoor gait-training intervention with home exercises (FBHE) on treadmill running biomechanics and lower extremity strength compared to home exercises alone (HE) among runners with ERLLP...

BACKGROUND: PNPLA3 is a promising target for the treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease. ARO-PNPLA3 is a drug that efficiently lowers PNPLA3 expression in hepatocytes at the mRNA level, resulting in a significant reduction in liver fat in Phase I clinical trials. However, the long-term effects and potential side effects of ARO-PNPLA3 are not well understood. METHODS: We conducted a two-sample, two-step Mendelian randomization (MR) analysis to investigate the association between PNPLA3 inhibition and 10 cardiovascular diseases (CVDs), as well as the role of lipid traits as mediators...

BACKGROUND: In the global strategy to eliminate leprosy, there remains a need for early case detection to successfully interrupt transmissions. Poor knowledge about leprosy and leprosy-related stigma are key drivers of delayed diagnosis and treatment. Sensitization campaigns to inform and increase awareness among the general population are an integral part of many national neglected tropical disease programs. Despite their importance, the effectiveness of such campaigns has not been rigorously studied in the West African context...

OBJECTIVE: To estimate the difference in confidence to become active despite low back pain in people who were exposed to one of two video interventions delivered on social media, compared to no intervention. DESIGN: A proof of concept three group randomised controlled trial, in a 1:1:1 ratio. METHODS: Participants aged 18 years and over, with and without low back pain, were recruited via the social media channel Facebook, to view either a humorous video, a neutral video or to no intervention. The videos were delivered online, explained evidence-based management for low back pain, and were designed to "go viral"...

PURPOSE: The multicenter, open-label, randomized phase 2 NCI-9944 study (NCT02595892) demonstrated that addition of ATR inhibitor (ATRi) berzosertib to gemcitabine increased progression-free survival (PFS) compared to gemcitabine alone (hazard ratio [HR]=0.57, one-sided log-rank P = .044, which met the one-sided significance level of 0.1 used for sample size calculation). METHODS: We report here the final overall survival (OS) analysis and biomarker correlations (ATM expression by immunohistochemistry, mutational signature 3 and a genomic biomarker of replication stress) along with post-hoc exploratory analyses to adjust for crossover from gemcitabine to gemcitabine/berzosertib...

Cucurbita moschata (Butternut squash) seeds are a rich source of nutrition containing nutrients including iron, zinc, copper, calcium, potassium, and phosphorus. The aim of this study was to determine if Cucurbita Moschata squash seed paste improves zinc and iron status, anthropometric status, and dietary intake in preschool children. A pretest-posttest control group trial using cluster randomisation was conducted over 6 months. Four preschools were randomly assigned to receive 100 g of intervention or 100 g of a placebo as the control to enhance iron and zinc status...

BACKGROUND: Insomnia has emerged as a major public health issue jeopardizing human wellbeing. Furthermore, insomnia and angina arise concomitantly and exert reciprocal effects. Multiple studies suggest that perimenopausal females are more prone to experiencing both angina and insomnia, consequently substantially compromising their quality of life.Credible evidence suggests that acupuncture exerts a beneficial impact in alleviating insomnia. Nevertheless, the exhaustive investigation into the potential of acupuncture for mitigating insomnia co-occurring with stable angina in perimenopausal females remains a realm yet to be traversed in the realm of randomized controlled trials...

BACKGROUND: Aromatase inhibitors have positive impacts on the disease-free life of patients with breast cancer. However, their side effects, especially arthralgia, may be experienced by many patients. This study sought to assess the efficacy of Progressive Relaxation Exercises on the prevalent side effects of Aromatase Inhibitors in patients with breast cancer. MATERIALS AND METHODS: This clinical trial was conducted with single-blind randomization at a physiotherapy department in a local hospital...

BACKGROUND: Subtotal esophagectomy with lymph node dissection followed by neoadjuvant chemotherapy (NAC) is the standard treatment for stage II-III esophageal cancer. Esophagectomy is still associated with high morbidity rates, and reducing these rates remains challenging. Among several complications, postoperative pneumonia (PP) is sometimes fatal, which has been reportedly caused by sarcopenia. Thus, nutritional support and rehabilitation may be promising for preventing skeletal muscle mass loss and reduce the incidence of PP...

BACKGROUND: Faced with the increase in the number of chronic diseases with the aging of the population, and with the observation of the insufficiency of therapeutic control, a new need has emerged, that of having a patient as a partner in care. METHODS: This study is a randomized controlled trial. Patients with coronary heart disease will be recruited from one clinical site and randomly assigned into two groups: the intervention group and the control group. All participants will be followed up for a total of one year (with three-time points for data collection)...

INTRODUCTION: Intestinal infections are a significant health issue; antibiotics are essential in treating acute intestinal infections. However, evidence in the literature shows that the excessive use of antibiotics has created many threats to human health. This work aimed to study the impact of apple pectin in combination with antibiotics on treating patients with amebiasis and dysentery. METHODOLOGY: Patients suffering from acute intestinal diseases (amebiasis and dysentery) were treated with traditional antibiotic therapy and a new formula containing antibiotics with low and high methoxylated apple pectin in a randomized block design...

BACKGROUND: Chronic heart failure (CHF) poses a significant burden on both patients and their family caregivers (FCs), as it is associated with psychological distress and impaired quality of life (QOL). Acceptance and Commitment Therapy (ACT) supports QOL by focusing on value living and facilitates acceptance of psychological difficulties by cultivating psychological flexibility. A protocol is presented that evaluates the effectiveness of a dyad ACT-based intervention delivered via smartphone on QOL and other related health outcomes compared with CHF education only...

OBJECTIVES: Constipation is the infrequent or difficult emission of hard, dry faeces and is a common digestive condition in cats. Psyllium is a low-fermentable fibre, with soluble and insoluble components and water-holding properties. It forms a mucilaginous gel with water and is used for the symptomatic treatment of constipation in various species. This study evaluated the effect of dietary psyllium on faecal characteristics in cats. METHODS: Healthy neutered adult cats (six female and three male, aged 3...

IMPORTANCE: It is unclear whether arthroscopic resection of degenerative knee tissues among patients with osteoarthritis (OA) of the knee delays or hastens total knee arthroplasty (TKA); opposite findings have been reported. OBJECTIVE: To compare the long-term incidence of TKA in patients with OA of the knee after nonoperative management with or without additional arthroscopic surgery. DESIGN, SETTING, AND PARTICIPANTS: In this ad hoc secondary analysis of a single-center, assessor-blinded randomized clinical trial performed from January 1, 1999, to August 31, 2007, 178 patients were followed up through March 31, 2019...

IMPORTANCE: Perioperative anxiety is prevalent among patients undergoing surgical treatment of cancer and often influences their prognosis. Transcranial direct current stimulation (tDCS) has shown potential in the treatment of various anxiety-related disorders, but data on the impact of tDCS on perioperative anxiety are limited. OBJECTIVE: To evaluate the effect of tDCS in reducing perioperative anxiety among patients undergoing laparoscopic colorectal cancer (CRC) resection...

OBJECTIVE: To evaluate the effectiveness of Cogmed Working Memory Training (Cogmed) in improving working memory (WM) and decision making (DM) in childhood traumatic brain injury (TBI), and any associated increases in functional outcomes such as academic achievement in mathematics, behavior, social skills, and quality of life. METHOD: A randomized controlled trial of the Cogmed (RM version) intervention for children with TBI. A total of 69 children post-TBI were screened for WM impairments, of which 31 eligible participants ( M age : 10...

Behavioral economic theory has been extensively applied to understand alcohol use disorder (AUD). Applications of behavioral economic theory conceptualize AUD as a pattern of harmful alcohol use over extended periods of time in which choices between drinking or engaging in alcohol-free activities favor drinking. Recovery, in contrast, entails a sustained shift toward a pattern of selecting rewarding alcohol-free activities. The present study examined whether alcohol-free activity engagement and the relative-reinforcement value (RRV) of engaging in those activities predicted AUD treatment outcomes via secondary analysis of data from Project MATCH, a multisite randomized clinical trial examining behavioral treatments for AUD ( N = 1,279, 75...

The current study was designed to describe usual clinical care for youth with primary anxiety problems in community mental health centers. The observer-rated Therapy Process Observational Coding System for Child Psychotherapy - Revised Strategies scale (TPOCS-RS), designed to assess therapeutic techniques from five theory-based domains, was used to code sessions (N = 403) from the usual clinical care group of two randomized effectiveness trials: (a) Youth Anxiety Study (YAS) with 21 youth (M age = 10...

To investigate the in vivo and in situ effect of different types of lasers in prevention of enamel demineralization in high caries risk cases (around orthodontic brackets, around restoration and in caries susceptible pits and fissures). PubMed was searched using the following keyword sequence; (Laser therapy OR laser irradiation OR laser application) AND (enamel caries prevention OR enamel demineralization OR enamel remineralization OR early enamel caries OR early-enamel caries OR enamel resistance OR enamel decalcification OR white spot lesions WSLs OR incipient lesion OR enamel decay OR enamel Dissolution OR enamel microhardness) AND (clinical trial OR Randomized clinical trial OR In situ study)...

Effects of angiotensin receptor/neprilysin inhibitors (ARNI) on ventricular remodeling in patients with heart failure, especially heart failure with reduced ejection fraction (HFrEF), are better than those of angiotensin-converting enzyme inhibitors (ACEI). Acute myocardial infarction (AMI) complicated by mitral regurgitation exacerbates ventricular remodeling and increases the risk of heart failure. There is limited evidence on the effects of early administration of ARNI in patients with AMI complicated by mitral regurgitation...