Randomized Control Study

BACKGROUND: Distress is highly prevalent among patients with cancer, but supportive care needs often go unmet. Digital therapeutics hold the potential to overcome barriers in cancer care and improve health outcomes. OBJECTIVE: This study conducted a randomized controlled trial to investigate the efficacy of Mika, an app-based digital therapeutic designed to reduce distress across the cancer trajectory. METHODS: This nationwide waitlist randomized controlled trial in Germany enrolled patients with cancer across all tumor entities diagnosed within the last 5 years...

BACKGROUND AND OBJECTIVES: Vidofludimus calcium suppressed MRI disease activity compared with placebo in patients with relapsing-remitting multiple sclerosis (RRMS) in the first cohort of the phase 2 EMPhASIS study. Because 30 mg and 45 mg showed comparable activity on multiple end points, the study enrolled an additional low-dose cohort to further investigate a dose-response relationship. METHODS: In a randomized, placebo-controlled, phase 2 trial, patients with RRMS, aged 18-55 years, and with ≥2 relapses in the last 2 years or ≥1 relapse in the last year, and ≥1 gadolinium-enhancing brain lesion in the last 6 months...

OBJECTIVE: There is limited evidence for the effectiveness of mental health promotion interventions in low- and middle-income settings, especially for longer-term benefits. This study evaluates the 5-month follow-up outcomes of a movement-based mental health promotion intervention (TeamUp) for refugee children in Northern Uganda (West Nile) and further investigates what explains longer-term benefits. METHODS: This quasi-experimental study was conducted in four primary schools, randomly allocated to an experimental or a control condition...

BACKGROUND: Nonopioid management of postsurgical pain remains a major unmet need. Few studies have evaluated TRPV1 agonists for analgesia after surgery. We studied intraoperative vocacapsaicin, a novel prodrug of the TRPV1 agonist capsaicin, in a validated model of postsurgical pain. METHODS: This was a triple-blinded, randomized, placebo-controlled, dose-ranging trial in patients undergoing bunionectomy. We randomized patients 1:1:1:1 to surgical site administration of 14 mL of placebo or one of three vocacapsaicin concentrations: 0...

Corrêa Neto, VG, Silva, DdN, Palma, A, de Oliveira, F, Vingren, JL, Marchetti, PH, da Silva Novaes, J, and Monteiro, ER. Comparison between traditional and alternated resistance exercises on blood pressure, acute neuromuscular responses, and rating of perceived exertion in recreationally resistance-trained men. J Strength Cond Res 38(5): e211-e218, 2024-The purpose of this study was to compare the acute effects of traditional and alternated resistance exercises on acute neuromuscular responses (maximum repetition performance, fatigue index, and volume load), rating of perceived exertion (RPE), and blood pressure (BP) in resistance-trained men...

BACKGROUND: Diabetic peripheral neuropathy (DPN) is a chronic complication of diabetes mellitus, which is the most common neuropathy worldwide. Owing to the inadequacies of existing treatment methods, managing DPN remains a significant challenge. Studies suggest that electroacupuncture (EA) could potentially serve as a beneficial alternative treatment for this condition. Nevertheless, there is still inadequate proof of its therapeutic effectiveness and safety. As a result, the goal of this protocol is to methodically compile the data pertaining to the effectiveness and security of EA in the management of DPN...

Gait impairments negatively affect the quality of life of people with Parkinson's disease (PwPD). Aerobic exercise (AE) is an alternative to alleviate these impairments and its combination with transcranial direct current stimulation (tDCS) has demonstrated synergistic effects. However, the effect of multitarget tDCS application (i.e., motor, and prefrontal cortices simultaneously) combined with physical exercise on gait impairments is still little known. Thus, the proposed randomized clinical trial will verify the acute effects of AE combined with tDCS applied on motor and prefrontal cortices separately and simultaneously on gait (spatial-temporal and cortical activity parameters) in PwPD...

INTRODUCTION: The rise of new technologies in the field of health is yielding promising results. In certain chronic conditions such as type 2 diabetes mellitus, which ranks among the top five causes of global mortality, it could be useful in supporting patient management. MATERIALS AND METHODS: A systematic review will be conducted on scientific publications from the last 5 years (January 2019 to October 2023) to describe the effect of mobile app usage on glycated hemoglobin for the management of adult patients with type 2 diabetes mellitus who participated in randomized controlled clinical trials...

BACKGROUND: Parents of preterm infants in the Neonatal Intensive Care Unit (NICU) environment may experience psychological distress, decreased perceived self-efficacy, and/or difficulties in establishing an adaptive parent-infant relationship. Early developmental care interventions to support the parental role and infant development are essential and their impact can be assessed by an improvement of parental self-efficacy perception. The aims were to assess the effects of an early intervention provided in the NICU (the Joint Observation) on maternal perceived self-efficacy compared to controls (primary outcome) and to compare maternal mental health measures (perceived stress, anxiety, and depression), perception of the parent-infant relationship, and maternal responsiveness (secondary outcomes)...

BACKGROUND: SHEN26, an oral broad-spectrum antiviral drug, possesses potent preclinical activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and has a favorable safety profile. METHODS: We report safety, tolerability, and pharmacokinetic data from a randomized, double-blind, placebo-controlled phase I study of SHEN26. Eighty-six healthy subjects were enrolled in the three studies: a single ascending-dose study (SAD), a multiple ascending-dose study (MAD), and a food-effect study (FE)...

OBJECTIVE: Pharmacological prevention of postoperative pancreatic fistula (POPF) after pancreatectomy is open to debate. The present study compares clinically significant POPF rates in patients randomized between somatostatin versus octreotide as prophylactic treatment. PATIENTS AND METHODS: Multicentric randomized controlled open study in patient's candidate for pancreaticoduodenectomy (PD) or distal pancreatectomy (DP) comparing somatostatin continuous intravenous infusion for 7 days versus octreotid 100 μg, every 8 hours subcutaneous injection for 7 days, stratified by procedure (PD vs...

OBJECTIVE: People living with chronic kidney disease (CKD) and receiving hemodialysis (HD) have impaired respiratory muscle strength and endurance. The objective of this study was to systematically review the effects of inspiratory muscle training (IMT) on respiratory muscle strength, functional capacity, lung function, quality of life, endothelial function, and oxidative stress in people living with CKD and receiving HD. METHODS: An electronic search was conducted from inception to June 2023...

BACKGROUND: The current prediction models for the risk of infection during immunosuppressive treatment for lupus nephritis (LN) lack a prediction time window and have poor pertinence. This study aimed to develop a risk stratification to predict infection during immunosuppressive therapy in patients with LN. METHODS: This retrospective nested case-control study collected patients with LN treated with immunosuppressive therapy between 2014 and 2022 in the Nephrology ward in Huashan Hospital affiliated to Fudan University and Huashan Hospital Baoshan Branch...

BACKGROUND: Advance care planning (ACP) allows patients to define their goals and preferences. Spending more time at home and less time in the hospital, along with avoiding death in the hospital, are often considered desirable outcomes of palliative care (PC). In 2015, 36% of cancer patients died in the hospital and 13% died at home in Norway. METHOD: From 2015 to 2022, this prospective controlled non-randomized intervention trial observed 144 cancer patients with or without an organized ACP conversation in primary health care and a summarizing palliative plan (ClinicalTrials...

BACKGROUND AND OBJECTIVE: Temporal summation of pain (TSP) and conditioned pain modulation (CPM) are the two most commonly used clinical measures of central sensitization (CS). However, the effectiveness of exercise on TSP and CPM has yet to be evaluated. This review aims to investigate the effect of exercise alone on CS outcomes in individuals with chronic musculoskeletal pain. DATABASES AND DATA TREATMENT: This is a systematic review and meta-analysis. MEDLINE, EMBASE, CINAHL, PEDro and Cochrane databases were searched...

BACKGROUND: While it is well recognized that an automated insulin delivery (AID) algorithm should adapt to changes in physiology, it is less understood that the individual would also have to adapt to the AID system. The adaptive bio-behavioral control (ABC) method presented here attempts to compensate for this deficiency by including AID into an information cloud-based ecosystem. METHODS: The Web Information Tool (WIT) implements the ABC concept via: (1) A Physiological Adaptation Module (PAM) that tracks metabolic changes and adapts AID parameters accordingly, and (2) a Behavioral Adaptation Module (BAM) that provides information feedback...

IMPORTANCE: The pharmacokinetics of abatacept and the association between abatacept exposure and outcomes in patients with severe COVID-19 are unknown. OBJECTIVE: To characterize abatacept pharmacokinetics, relate drug exposure with clinical outcomes, and evaluate the need for dosage adjustments. DESIGN, SETTING, AND PARTICIPANTS: This study is a secondary analysis of data from the ACTIV-1 (Accelerating COVID-19 Therapeutic Interventions and Vaccines) Immune Modulator (IM) randomized clinical trial conducted between October 16, 2020, and December 31, 2021...

PURPOSE: New-generation anesthesia machines administer inhalation anesthetics and automatically control the fresh gas flow (FGF) rate. This study compared the administration of minimal flow anesthesia (MFA) using the automatically controlled anesthesia (ACA) module of the Mindray A9 (Shenzhen, China) anesthesia machine versus manual control by an anesthesiologist. METHODS: We randomly divided 76 patients undergoing gynecological surgery into an ACA group (Group ACA) and a manually controlled anesthesia group (Group MCA)...

We used results from an optimization randomized controlled trial which tested five behavioral intervention components to support HIV antiretroviral adherence/HIV viral suppression, grounded in the multiphase optimization strategy and using a fractional factorial design to identify intervention components with cost-effectiveness sufficiently favorable for scalability. Results were incorporated into a validated HIV computer simulation to simulate longer-term effects of combinations of components on health and costs...

BACKGROUND: Bariatric surgery (BS) is the most effective treatment for severe obesity and it has beneficial effects on glycemic control and metabolism outcomes. However, the effects of BS on nutritional outcomes are controversial. Therefore, we aimed to evaluate the changes in several nutritional outcomes after Roux-en-Y gastric bypass (RYGB). METHODS: A comprehensive search was performed using the following databases: PubMed, Embase, Web of Science, Cochrane Library, WanFang and Chinese National Knowledge Infrastructure...